When was the first Pteranodon fossil found?

"Pteranodon" was the first pterosaur found outside of Europe. Its fossils first were found by Othniel Charles Marsh in 1870, in the Late Cretaceous Smoky Hill Chalk deposits of western Kansas. These chalk beds were deposited at the bottom of what was once the Western Interior Seaway, a large shallow sea over what now is the midsection of the North American continent. These first specimens, YPM 1160 and YPM 1161, consisted of partial wing bones, as well as a tooth from the prehistoric fish "Xiphactinus", which Marsh mistakenly believed to belong to this new pterosaur (all known pterosaurs up to that point had teeth). In 1871, Marsh named the find ""Pterodactylus oweni"", assigning it to the well-known (but much smaller) European genus "Pterodactylus". Marsh also collected more wing bones of the large pterosaur in 1871. Realizing that the name he had chosen had already been used for Harry Seeley's European pterosaur species "Pterodactylus oweni" in 1864, Marsh re-named his giant North American pterosaur Pterodactylus occidentalis, meaning "Western wing finger," in his 1872 description of the new specimen. He also named two additional species, based on size differences: Pterodactylus ingens (the largest specimen so far), and Pterodactylus velox (the smallest).

Pteranodon

Pteranodon (; from Greek πτερόν ( pteron, "wing") and ἀνόδων (anodon, "toothless") is a genus of pterosaur that included some of the largest known flying reptiles, with wingspans over 8 meters (26 feet). They lived during the late Cretaceous geological period of North America in present-day Kansas, Alabama, Nebraska, Wyoming, and South Dakota. More fossil specimens of "Pteranodon" have been found than any other pterosaur, with about 1,200 specimens known to science, many of them well preserved with nearly complete skulls and articulated skeletons. It was an important part of the animal community in the Western Interior Seaway.

"Pteranodon" were pterosaurs, not dinosaurs. By definition, all dinosaurs belong to one of the two groups within Dinosauria, i.e. Saurischia or Ornithischia. As such, this excludes pterosaurs. Nonetheless, "Pteranodon" are frequently featured in dinosaur media and are strongly associated with dinosaurs by the general public. While not dinosaurs, they form a sister clade to dinosaurs within the clade Avemetatarsalia.

"Pteranodon" species are extremely well represented in the fossil record, allowing for detailed descriptions of their anatomy and analysis of their life history. Over 1,000 specimens have been identified, though less than half are complete enough to give researchers good anatomical information. Still, this is more fossil material than is known for any other pterosaur, and it includes both male and female specimens of various age groups and possibly species.

Adult "Pteranodon" specimens from the two major species can be divided into two distinct size classes. The smaller class of specimens have small, rounded head crests and very wide pelvic canals, even wider than those of the much larger size class. The size of the pelvic canal probably allowed the laying of eggs, indicating that these smaller adults are females. The larger size class, representing male individuals, have narrow hips and very large crests, which were probably for display.

Adult male "Pteranodon" were among the largest pterosaurs, and were the largest flying animals known until the late 20th century, when the giant azhdarchid pterosaurs were discovered. The wingspan of an average adult male "Pteranodon" was. Adult females were much smaller, averaging in wingspan. The largest specimen of "Pteranodon longiceps" from the Niobrara Formation measured from wingtip to wingtip. An even larger specimen is known from the Pierre Shale Formation, with a wingspan of, though this specimen may belong to the distinct genus and species "Geosternbergia maysei". While most specimens are found crushed, enough fossils exist to put together a detailed description of the animal.

Methods used to estimate the mass of large male "Pteranodon" specimens (those with wingspans of about 7 meters) have been notoriously unreliable, producing a wide range of estimates from as low as to as high as. In a review of pterosaur size estimates published in 2010, researchers Mark Witton and Mike Habib demonstrated that the latter, largest estimates are almost certainly incorrect given the total volume of a "Pteranodon" body, and could only be correct if the animal "was principally aluminium". Witton and Habib considered the methods used by researchers who obtained smaller mass estimates equally flawed. Most have been produced by scaling modern animals such as bats and birds up to "Pteranodon" size, despite the fact that pterosaurs have vastly different body proportions and soft tissue anatomy from any living animal.

Other distinguishing characteristics that set "Pteranodon" apart from other pterosaurs include narrow neural spines on the vertebrae, plate-like bony ligaments strengthening the vertebrae above the hip, and a relatively short tail in which the last few vertebrae are fused into a long rod. The entire length of the tail was about 3.5% as long as the wingspan, or up to in the largest males.

Unlike earlier pterosaurs, such as "Rhamphorhynchus" and "Pterodactylus", "Pteranodon" had toothless beaks, similar to those of birds. "Pteranodon" beaks were made of solid, bony margins that projected from the base of the jaws. The beaks were long, slender, and ended in thin, sharp points. The upper jaw, which was longer than the lower jaw, was curved upward; while this normally has been attributed only to the upward-curving beak, one specimen (UALVP 24238) has a curvature corresponding with the beak widening towards the tip. While the tip of the beak is not known in this specimen, the level of curvature suggests it would have been extremely long. The unique form of the beak in this specimen led Alexander Kellner to assign it to a distinct genus, "Dawndraco", in 2010.

The most distinctive characteristic of "Pteranodon" is its cranial crest. These crests consisted of skull bones (frontals) projecting upward and backward from the skull. The size and shape of these crests varied due to a number of factors, including age, sex, and species. Male "Pteranodon sternbergi", the older species of the two described to date (and sometimes placed in the distinct genus "Geosternbergia"), had a more vertical crest with a broad forward projection, while their descendants, "Pteranodon longiceps", evolved a narrower, more backward-projecting crest. Females of both species were smaller and bore small, rounded crests. The crests were probably mainly display structures, though they may have had other functions as well.

The wing shape of "Pteranodon" suggests that it would have flown rather like a modern-day albatross. This is based on the fact that "Pteranodon" had a high aspect ratio (wingspan to chord length) similar to that of the albatross — 9:1 for "Pteranodon", compared to 8:1 for an albatross. Albatrosses spend long stretches of time at sea fishing, and use a flight pattern called "dynamic soaring" which exploits the vertical gradient of wind speed near the ocean surface to travel long distances without flapping, and without the aid of thermals (which do not occur over the open ocean the same way they do over land). While most of a "Pteranodon" flight would have depended on soaring, like long-winged seabirds, it probably required an occasional active, rapid burst of flapping, and studies of "Pteranodon" wing loading (the strength of the wings vs. the weight of the body) indicate that they were capable of substantial flapping flight, contrary to some earlier suggestions that they were so big they could only glide.

Like other pterosaurs, "Pteranodon" probably took off from a standing, quadrupedal position. Using their long forelimbs for leverage, they would have vaulted themselves into the air in a rapid leap. Almost all of the energy would have been generated by the forelimbs. The upstroke of the wings would have occurred when the animal cleared the ground followed by a rapid down-stroke to generate additional lift and complete the launch into the air.

Historically, the terrestrial locomotion of "Pteranodon", especially whether it was bipedal or quadrupedal, has been the subject of debate. Today, most pterosaur researchers agree that pterosaurs were quadrupedal, thanks largely to the discovery of pterosaur trackways.

The possibility of aquatic locomotion via swimming has been discussed briefly in several papers (Bennett 2001, 1994, and Bramwell & Whitfield 1974).

The diet of "Pteranodon" is known to have included fish; fossilized fish bones have been found in the stomach area of one "Pteranodon", and a fossilized fish bolus has been found between the jaws of another "Pteranodon", specimen AMNH 5098. Numerous other specimens also preserve fragments of fish scales and vertebrae near the torso, indicating that fish made up a majority of the diet of "Pteranodon" (though they may also have taken invertebrates).

Traditionally, most researchers have suggested that "Pteranodon" would have taken fish by dipping their beaks into the water while in low, soaring flight. However, this was probably based on the assumption that the animals could not take off from the water surface. It is more likely that "Pteranodon" could take off from the water, and would have dipped for fish while swimming rather than while flying. Even a small, female "Pteranodon" could have reached a depth of at least with its long bill and neck while floating on the surface, and they may have reached even greater depths by plunge-diving into the water from the air like some modern long-winged seabirds. In 1994, Bennett noted that the head, neck, and shoulders of "Pteranodon" were as heavily built as diving birds, and suggested that they could dive by folding back their wings like the modern gannet.

"Pteranodon" was notable for its skull crest, though the function of this crest has been a subject of debate. Most explanations have focused on the blade-like, backward pointed crest of male "P. longiceps", however, and ignored the wide range of variation across age and sex. The fact that the crests vary so much rules out most practical functions other than for use in mating displays. Therefore, display was probably the main function of the crest, and any other functions were secondary.

Scientific interpretations of the crest's function began in 1910, when George Francis Eaton proposed two possibilities: an aerodynamic counterbalance and a muscle attachment point. He suggested that the crest might have anchored large, long jaw muscles, but admitted that this function alone could not explain the large size of some crests. Bennett (1992) agreed with Eaton's own assessment that the crest was too large and variable to have been a muscle attachment site. Eaton had suggested that a secondary function of the crest might have been as a counterbalance against the long beak, reducing the need for heavy neck muscles to control the orientation of the head. Wind tunnel tests showed that the crest did function as an effective counterbalance to a degree, but Bennett noted that, again, the hypothesis focuses only on the long crests of male "P. longiceps", not on the larger crests of "P. sternbergi" and very small crests that existed among the females. Bennett found that the crests of females had no counterbalancing effect, and that the crests of male "P. sternbergi" would, by themselves, have a negative effect on the balance of the head. In fact, side to side movement of the crests would have required more, not less, neck musculature to control balance.

In 1943, Dominik von Kripp suggested that the crest may have served as a rudder, an idea embraced by several later researchers. One researcher, Ross S. Stein, even suggested that the crest may have supported a membrane of skin connecting the backward-pointing crest to the neck and back, increasing its surface area and effectiveness as a rudder. The rudder hypothesis, again, does not take into account females nor "P. sternbergi", which had an upward-pointing, not backward-pointing crest. Bennett also found that, even in its capacity as a rudder, the crest would not provide nearly so much directional force as simply maneuvering the wings. The suggestion that the crest was an air brake, and that the animals would turn their heads to the side in order to slow down, suffers from a similar problem. Additionally, the rudder and air brake hypotheses do not explain why such large variation exists in crest size even among adults.

Alexander Kellner suggested that the large crests of the pterosaur "Tapejara", as well as other species, might be used for heat exchange, allowing these pterosaurs to absorb or shed heat and regulate body temperature, which also would account for the correlation between crest size and body size. There is no evidence of extra blood vessels in the crest for this purpose, however, and the large, membranous wings filled with blood vessels would have served that purpose much more effectively.

With these hypotheses ruled out, the best-supported hypothesis for crest function seems to be as a sexual display. This is consistent with the size variation seen in fossil specimens, where females and juveniles have small crests and males large, elaborate, variable crests.

Adult "Pteranodon" specimens may be divided into two distinct size classes, small and large, with the large size class being about one and a half times larger than the small class, and the small class being twice as common as the large class. Both size classes lived alongside each other, and while researchers had previously suggested that they represent different species, Christopher Bennett showed that the differences between them are consistent with the concept that they represent females and males, and that "Pteranodon" species were sexually dimorphic. Skulls from the larger size class preserve large, upward and backward pointing crests, while the crests of the smaller size class are small and triangular. Some larger skulls also show evidence of a second crest that extended long and low, toward the tip of the beak, which is not seen in smaller specimens.

The sex of the different size classes was determined, not from the skulls, but from the pelvic bones. Contrary to what may be expected, the smaller size class had disproportionately large and wide-set pelvic bones. Bennett interpreted this as indicating a more spacious birth canal, through which eggs would pass. He concluded that the small size class with small, triangular crests represent females, and the larger, large-crested specimens represent males.

Note that the overall size and crest size also corresponds to age. Immature specimens are known from both females and males, and immature males often have small crests similar to adult females. Therefore, it seems that the large crests only developed in males when they reached their large, adult size, making the sex of immature specimens difficult to establish from partial remains.

The fact that females appear to have outnumbered males two to one suggests that, as with modern animals with size-related sexual dimorphism, such as sea lions and other pinnipeds, "Pteranodon" might have been polygynous, with a few males competing for association with groups consisting of large numbers of females. Similar to modern pinnipeds, "Pteranodon" may have competed to establish territory on rocky, offshore rookeries, with the largest, and largest-crested, males gaining the most territory and having more success mating with females. The crests of male "Pteranodon" would not have been used in competition, but rather as "visual dominance-rank symbols", with display rituals taking the place of physical competition with other males. If this hypothesis is correct, it also is likely that male "Pteranodon" played little to no part in rearing the young; such a behavior is not found in the males of modern polygynous animals who father many offspring at the same time.

Specimens assigned to "Pteranodon" have been found in both the Smoky Hill Chalk deposits of the Niobrara Formation, and the slightly younger Sharon Springs deposits of the Pierre Shale Formation. When "Pteranodon" was alive, this area was covered by a large inland sea, known as the Western Interior Seaway. Famous for fossils collected since 1870, these formations extend from as far south as Kansas in the United States to Manitoba in Canada. However, "Pteranodon" specimens (or any pterosaur specimens) have only been found in the southern half of the formation, in Kansas, Wyoming, and South Dakota. Despite the fact that numerous fossils have been found in the contemporary parts of the formation in Canada, no pterosaur specimens have ever been found there. This strongly suggests that the natural geographic range of "Pteranodon" covered only the southern part of the Niobrara, and that its habitat did not extend farther north than South Dakota.

Some very fragmentary fossils belonging to pteranodontian pterosaurs, and possibly "Pteranodon" itself, have also been found on the Gulf Coast and East Coast of the United States. For example, some bone fragments from the Mooreville Formation of Alabama and the Merchantville Formation of Delaware may have come from "Pteranodon", though they are too incomplete to make a definite identification. Some remains from Japan have also been tentatively attributed to "Pteranodon", but their distance from its known Western Interior Seaway habitat makes this identification unlikely.
"Pteranodon longiceps" would have shared the sky with the giant-crested pterosaur "Nyctosaurus". Compared to "P. longiceps", which was a very common species, "Nyctosaurus" was rare, making up only 3% of pterosaur fossils from the formation. Also less common was the early toothed bird, "Ichthyornis".

It is likely that, as in other polygynous animals (in which males compete for association with harems of females), "Pteranodon" lived primarily on offshore rookeries, where they could nest away from land-based predators and feed far from shore; most "Pteranodon" fossils are found in locations which at the time, were hundreds of kilometres from the coastline.

Below the surface, the sea was populated primarily by invertebrates such as ammonites and squid. Vertebrate life, apart from basal fish, included sea turtles, such as "Toxochelys", the plesiosaur "Styxosaurus", and the flightless diving bird "Parahesperornis". Mosasaurs were the most common marine reptiles, with genera including "Clidastes" and "Tylosaurus". At least some of these marine reptiles are known to have fed on "Pteranodon". Barnum Brown, in 1904, reported plesiosaur stomach contents containing "pterodactyl" bones, most likely from "Pteranodon".

Fossils from terrestrial dinosaurs also have been found in the Niobrara Chalk, suggesting that animals who died on shore must have been washed out to sea (one specimen of a hadrosaur appears to have been scavenged by a shark).

Meanwhile, Marsh's rival Edward Drinker Cope also had unearthed several specimens of the large North American pterosaur. Based on these specimens, Cope named two new species, Ornithochirus umbrosus and Ornithochirus harpyia, in an attempt to assign them to the large European genus "Ornithocheirus", though he misspelled the name (forgetting the 'e'). Cope's paper naming his species was published in 1872, just five days after Marsh's paper. This resulted in a dispute, fought in the published literature, over whose names had priority in what obviously were the same species. Cope conceded in 1875 that Marsh's names did have priority over his, but maintained that "Pterodactylus umbrosus" was a distinct species (but not genus) from any that Marsh had named previously. Re-evaluation by later scientists has supported Marsh's case, and found that Cope's assertion that "P. umbrosus" was a larger, distinct species were incorrect.

While the first "Pteranodon" wing bones were collected by Marsh and Cope in the early 1870s, the first "Pteranodon" skull was found on May 2, 1876, along the Smoky Hill River in Wallace County (now Logan County), Kansas, USA, by Samuel Wendell Williston, a fossil collector working for Marsh. A second, smaller skull soon was discovered as well. These skulls showed that the North American pterosaurs were different from any European species, in that they lacked teeth and had bony crests on their skulls. Marsh recognized this major difference, describing the specimens as "distinguished from all previously known genera of the order Pterosauria by the entire absence of teeth." Marsh recognized that this characteristic warranted a new genus, and he coined the name "Pteranodon" ("wing without tooth") in 1876. Marsh reclassified all the previously named North American species from "Pterodactylus" to "Pteranodon". He considered the smaller skull to belong to "Pteranodon occidentalis", based on its size. Marsh classified the larger skull, YPM 1117, in the new species "Pteranodon longiceps", which he thought to be a medium-sized species in between the small "P. occidentalis" and the large "P. ingens". Marsh also named several additional species: Pteranodon comptus and "Pteranodon nanus" were named for fragmentary skeletons of small individuals, while "Pteranodon gracilis" was based on a wing bone that he mistook for a pelvic bone. He soon realized his mistake, and re-classified that specimen again into a separate genus, which he named "Nyctosaurus". "P, nanus" was also later recognized as a "Nyctosaurus" specimen.

In 1892, Samuel Williston examined the question of "Pteranodon" classification. He noticed that, in 1871, Seeley had mention the existence of a partial set of toothless pterosaur jaws from the Cambridge Greensand of England, which he named "Ornithostoma". Because the primary characteristic Marsh had used to separate "Pteranodon" from other pterosaurs was its lack of teeth, Williston concluded that "Ornithostoma" must be considered the senior synonym of "Pteranodon". However, in 1901, Pleininger pointed out that "Ornithostoma" had never been scientifically described or even assigned a species name until Williston's work, and therefore had been a "nomen nudum" and could not beat out "Pteranodon" for naming priority. Williston accepted this conclusion and went back to calling the genus "Pteranodon". However, both Williston and Pleininger were incorrect, because unnoticed by both of them was the fact that, in 1891, Seeley himself had finally described and properly named "Ornithostoma", assigning it to the species "O. sedgwicki". In the 2010s, more research on the identity of "Ornithostoma" showed that it was probably not "Pteranodon" or even a close relative, but may in fact have been an azhdarchoid, a different type of toothless pterosaur.

Williston was also the first scientist to critically evaluate all of the pteranodont species classified by Cope and Marsh. He agreed with most of Marsh's classification, with a few exceptions. First, he did not believe that "P. ingens" and "P. umbrosus" could be considered synonyms, which even Cope had come to believe. He considered both "P. velox" and "P. longiceps" to be dubious; the first was based on non-diagnostic fragments, and the second, though known from a complete skull, probably belonged to one of the other, previously-named species. In 1903, Williston revisited the question of "Pteranodon" classification, and revised his earlier conclusion that there were seven species down to just three. He considered both "P. comptus" and "P. nanus" to be specimens of "Nyctosaurus", and divided the others into small ("P. velox"), medium ("P. occidentalis"), and large species ("P. ingens"), based primarily on the shape of their upper arm bones. He thought "P. longiceps", the only one known from a skull, could be a synonym of either "P. velox" or "P. occidentalis", based on its size.

In 1910, Eaton became the first scientist to publish a more detailed description of the entire "Pteranodon" skeleton, as it was known at the time. He used his findings to revise the classification of the genus once again based on a better understanding of the differences in pteranodont anatomy. Eaton conducted experiments using clay models of bones to help determine the effects of crushing and flattening on the shapes of the arm bones Williston had used in his own classification. Eaton found that most of the differences in bone shapes could be easily explained by the pressures of fossilization, and concluded that no "Pteranodon" skeletons had any significant differences from each other besides their size. Therefore, Eaton was left to decide his classification scheme based on differences in the skulls alone, which he assigned to species just as Marsh did, by their size. In the end, Eaton recognized only three valid species: "P. occidentalis", "P. ingens", and "P. longiceps".

The discovery of specimens with upright crests, classified by Harksen in 1966 as the new species "Pteranodon sternbergi", complicated the situation even further, prompting another revision of the genus by Miller in 1972. Because it was impossible to determine crest shape for all of the species based on headless skeletons, Miller concluded that all "Pteranodon" species except the two based on skulls ("P. longiceps" and "P. sternbergi") must be considered "nomena dubia" and abandoned. The skull Eaton thought belonged to "P. ingens" was placed in the new species Pteranodon marshi, and the skull Eaton assigned to "P. occidentalis" was re-named Pteranodon eatoni. Miller also recognized another species based on a skull with a crest similar to that of "P. sternbergi"; Miller named this Pteranodon walkeri. To help bring order to this tangle of names, Miller created three categories or "subgenera" for them. "P. marshi" and "P. longiceps" were placed in the subgenus "Longicepia", though this was later changed to simply "Pteranodon" due to the rules of priority. "P. sternbergi" and "P. walkeri", the upright-crested species, were given the subgenus "Sternbergia", which was later changed to "Geosternbergia" because "Sternbergia" was already in use ("preoccupied"). Finally, Miller named the subgenus "Occidentalia" for "P. eatoni", the skull formerly associated with "P. occidentalis". Miller further expanded the concept of "Pteranodon" to include "Nyctosaurus" as a fourth subgenus. Miller considered these to be an evolutionary progression, with the primitive "Nyctosaurus", at the time thought to be crestless, giving rise to "Occidentalia" (with a small crest), which in turn gave rise to "Pteranodon" with its long backwards crest, finally leading to "Geosternbergia" with its large, upright crest. However, Miller made several mistakes in his study concerning which specimens Marsh had assigned to which species, and most scientists disregarded his work on the subject in their later research, though Wellnhofer (1978) followed Miller's species list. and Schoch (1984) somewhat oddly published another revision that essentially returned to Marsh's original classification scheme, most notably sinking "P. longiceps" as a synonym of "P. ingens".

During the early 1990s, S. Christopher Bennett also published several major papers reviewing the anatomy, taxonomy and life history of "Pteranodon".

Fragmentary fossils assigned to "Pteranodon" have also been discovered in Skåne, Sweden.

"Pteranodon" fossils are known primarily from the Niobrara Formation of the central United States. Broadly defined, "Pteranodon" existed for more than four million years, during the late Coniacian to early Campanian stages of the Cretaceous period. The genus is present in most layers of the Niobrara Formation except for the upper two; in 2003, Kenneth Carpenter surveyed the distribution and dating of fossils in this formation, demonstrating that "Pteranodon sternbergi" existed there from 88 to 85 million years ago, while "P. longiceps" existed between 86 and 84.5 million years ago. A possible third species, which Kellner named "Geosternbergia maysei" in 2010, is known from the Sharon Springs member of the Pierre Shale Formation in Kansas, Wyoming, and South Dakota, dating to between 81.5 and 80.5 million years ago.

In the early 1990s, Bennett noted that the two major morphs of pteranodont present in the Niobrara Formation were precisely separated in time with little, if any, overlap. Due to this, and to their gross overall similarity, he suggested that they probably represent "chronospecies" within a single evolutionary lineage lasting about 4 million years. In other words, only one species of "Pteranodon" would have been present at any one time, and "P. sternbergi" (or "Geosternbergia") in all likelihood was the direct ancestor species of "P. longiceps".

Many researchers consider there to be at least two species of "Pteranodon". However, aside from the differences between males and females described above, the post-cranial skeletons of "Pteranodon" show little to no variation between species or specimens, and the bodies and wings of all pteranodonts were essentially identical.

Two species of "Pteranodon" are traditionally recognized as valid: "Pteranodon longiceps", the type species, and "Pteranodon sternbergi". The species differ only in the shape of the crest in adult males (described above), and possibly in the angle of certain skull bones. Because well-preserved "Pteranodon" skull fossils are extremely rare, researchers use stratigraphy (i.e. which rock layer of the geologic formation a fossil is found in) to determine species identity in most cases.

"Pteranodon sternbergi" is the only known species of "Pteranodon" with an upright crest. The lower jaw of "P. sternbergi" was long. It was collected by George F. Sternberg in 1952 and described by John Christian Harksen in 1966, from the lower portion of the Niobrara Formation. It was older than "P. longiceps" and is considered by Bennett to be the direct ancestor of the later species.

Because fossils identifiable as "P. sternbergi" are found exclusively in the lower layers of the Niobrara Formation, and "P. longiceps" fossils exclusively in the upper layers, a fossil lacking the skull can be identified based on its position in the geologic column (though for many early fossil finds, precise data about its location was not recorded, rendering many fossils unidentifiable).

Below is a cladogram showing the phylogenetic placement of this genus within Pteranodontia from Andres and Myers (2013).

Due to the subtle variations between specimens of pteranodontid from the Niobrara Formation, most researchers have assigned all of them to the single genus "Pteranodon", in at least two species ("P. longiceps" and "P. sternbergi") distinguished mainly by the shape of the crest. However, the classification of these two forms has varied from researcher to researcher. In 1972, Halsey Wilkinson Miller published a paper arguing that the various forms of "Pteranodon" were different enough to be placed in distinct subgenera. He named these "Pteranodon (Occidentalia) occidentalis" (for the now-disused species "P. occidentalis") and "Pteranodon (Sternbergia) sternbergi". However, the name "Sternbergia" was preoccupied, and in 1978 Miller re-named the species "Pteranodon (Geosternbergia) sternbergi", and named a third subgenus/species combination for "P. longiceps", as "Pteranodon (Longicepia) longiceps". Most prominent pterosaur researchers of the late 20th century however, including S. Christopher Bennett and Peter Wellnhofer, did not adopt these subgeneric names, and continued to place all pteranodont species into the single genus "Pteranodon".

In 2010, pterosaur researcher Alexander Kellner revisited H.W. Miller's classification. Kellner followed Miller's opinion that the differences between the "Pteranodon" species were great enough to place them into different genera. He placed "P. sternbergi" into the genus named by Miller, "Geosternbergia", along with the Pierre Shale skull specimen which Bennett had previously considered to be a large male "P. longiceps". Kellner argued that this specimen's crest, though incompletely preserved, was most similar to "Geosternbergia". Because the specimen was millions of years younger than any known "Geosternbergia", he assigned it to the new species "Geosternbergia maysei". Numerous other pteranodont specimens are known from the same formation and time period, and Kellner suggested they may belong to the same species as "G. maysei", but because they lack skulls, he could not confidently identify them.

A number of additional species of "Pteranodon" have been named since the 1870s, although most now are considered to be junior synonyms of two or three valid species. The best-supported is the type species, "P. longiceps", based on the well-preserved specimen including the first-known skull found by S. W. Williston. This individual had a wingspan of. Other valid species include the possibly larger "P. sternbergi", with a wingspan originally estimated at. "P. occidentalis", "P. velox", "P. umbrosus", "P. harpyia", and "P. comptus" are considered to be "nomina dubia" by Bennett (1994) and others who question their validity. All probably are synonymous with the more well-known species.

Because the key distinguishing characteristic Marsh noted for "Pteranodon" was its lack of teeth, any toothless pterosaur jaw fragment, wherever it was found in the world, tended to be attributed to "Pteranodon" during the late nineteenth and early twentieth centuries. This resulted in a plethora of species and a great deal of confusion. The name became a wastebasket taxon, rather like the dinosaur "Megalosaurus", to label any pterosaur remains that could not be distinguished other than by the absence of teeth. Species (often dubious ones now known to be based on sexual variation or juvenile characters) have been reclassified a number of times, and several subgenera have in the 1970s been erected by Halsey Wilkinson Miller to hold them in various combinations, further confusing the taxonomy (subgenera include "Longicepia", "Occidentalia", and "Geosternbergia"). Notable authors who have discussed the various aspects of "Pteranodon" include Bennett, Padian, Unwin, Kellner, and Wellnhofer. Two species, "P. orogensis" and "P. orientalis", are not pteranodontids and have been renamed "Bennettazhia oregonensis" and "Bogolubovia orientalis" respectively.

Status of names listed below follow a survey by Bennett, 1994 unless otherwise noted.

Pteranodon

"Pteranodon" were pterosaurs, not dinosaurs. By definition, all dinosaurs belong to one of the two groups within Dinosauria, i.e. Saurischia or Ornithischia. As such, this excludes pterosaurs. Nonetheless, "Pteranodon" are frequently featured in dinosaur media and are strongly associated with dinosaurs by the general public. While not dinosaurs, they form a sister clade to dinosaurs within the clade Avemetatarsalia.

"Pteranodon" species are extremely well represented in the fossil record, allowing for detailed descriptions of their anatomy and analysis of their life history. Over 1,000 specimens have been identified, though less than half are complete enough to give researchers good anatomical information. Still, this is more fossil material than is known for any other pterosaur, and it includes both male and female specimens of various age groups and possibly species.

Other distinguishing characteristics that set "Pteranodon" apart from other pterosaurs include narrow neural spines on the vertebrae, plate-like bony ligaments strengthening the vertebrae above the hip, and a relatively short tail in which the last few vertebrae are fused into a long rod. The entire length of the tail was about 3.5% as long as the wingspan, or up to in the largest males.

Like other pterosaurs, "Pteranodon" probably took off from a standing, quadrupedal position. Using their long forelimbs for leverage, they would have vaulted themselves into the air in a rapid leap. Almost all of the energy would have been generated by the forelimbs. The upstroke of the wings would have occurred when the animal cleared the ground followed by a rapid down-stroke to generate additional lift and complete the launch into the air.

Historically, the terrestrial locomotion of "Pteranodon", especially whether it was bipedal or quadrupedal, has been the subject of debate. Today, most pterosaur researchers agree that pterosaurs were quadrupedal, thanks largely to the discovery of pterosaur trackways.

The possibility of aquatic locomotion via swimming has been discussed briefly in several papers (Bennett 2001, 1994, and Bramwell & Whitfield 1974).

The diet of "Pteranodon" is known to have included fish; fossilized fish bones have been found in the stomach area of one "Pteranodon", and a fossilized fish bolus has been found between the jaws of another "Pteranodon", specimen AMNH 5098. Numerous other specimens also preserve fragments of fish scales and vertebrae near the torso, indicating that fish made up a majority of the diet of "Pteranodon" (though they may also have taken invertebrates).

With these hypotheses ruled out, the best-supported hypothesis for crest function seems to be as a sexual display. This is consistent with the size variation seen in fossil specimens, where females and juveniles have small crests and males large, elaborate, variable crests.

The sex of the different size classes was determined, not from the skulls, but from the pelvic bones. Contrary to what may be expected, the smaller size class had disproportionately large and wide-set pelvic bones. Bennett interpreted this as indicating a more spacious birth canal, through which eggs would pass. He concluded that the small size class with small, triangular crests represent females, and the larger, large-crested specimens represent males.

Note that the overall size and crest size also corresponds to age. Immature specimens are known from both females and males, and immature males often have small crests similar to adult females. Therefore, it seems that the large crests only developed in males when they reached their large, adult size, making the sex of immature specimens difficult to establish from partial remains.

It is likely that, as in other polygynous animals (in which males compete for association with harems of females), "Pteranodon" lived primarily on offshore rookeries, where they could nest away from land-based predators and feed far from shore; most "Pteranodon" fossils are found in locations which at the time, were hundreds of kilometres from the coastline.

Fossils from terrestrial dinosaurs also have been found in the Niobrara Chalk, suggesting that animals who died on shore must have been washed out to sea (one specimen of a hadrosaur appears to have been scavenged by a shark).

During the early 1990s, S. Christopher Bennett also published several major papers reviewing the anatomy, taxonomy and life history of "Pteranodon".

Fragmentary fossils assigned to "Pteranodon" have also been discovered in Skåne, Sweden.

Many researchers consider there to be at least two species of "Pteranodon". However, aside from the differences between males and females described above, the post-cranial skeletons of "Pteranodon" show little to no variation between species or specimens, and the bodies and wings of all pteranodonts were essentially identical.

"Pteranodon sternbergi" is the only known species of "Pteranodon" with an upright crest. The lower jaw of "P. sternbergi" was long. It was collected by George F. Sternberg in 1952 and described by John Christian Harksen in 1966, from the lower portion of the Niobrara Formation. It was older than "P. longiceps" and is considered by Bennett to be the direct ancestor of the later species.

Because fossils identifiable as "P. sternbergi" are found exclusively in the lower layers of the Niobrara Formation, and "P. longiceps" fossils exclusively in the upper layers, a fossil lacking the skull can be identified based on its position in the geologic column (though for many early fossil finds, precise data about its location was not recorded, rendering many fossils unidentifiable).

Below is a cladogram showing the phylogenetic placement of this genus within Pteranodontia from Andres and Myers (2013).

Status of names listed below follow a survey by Bennett, 1994 unless otherwise noted.


When was the FDA formed?

The 1906 Act paved the way for the eventual creation of the Food and Drug Administration (FDA) and is generally considered to be that agency's founding date, though the agency existed before the law was passed and was not named FDA until later. "While the Food and Drug act remains a foundational law of the FDA mission, it's not the law that created the FDA. [Initially,] the Bureau of Chemistry (the precursor to the FDA) regulated food safety. In 1927, the Bureau was reorganized into the Food, Drug, and Insecticide Administration and the Bureau of Chemistry and Soils. The FDIA was renamed the FDA in 1930."

Pure Food and Drug Act

The was the first of a series of significant consumer protection laws which was enacted by Congress in the 20th century and led to the creation of the Food and Drug Administration. Its main purpose was to ban foreign and interstate traffic in adulterated or mislabeled food and drug products, and it directed the U.S. Bureau of Chemistry to inspect products and refer offenders to prosecutors. It required that active ingredients be placed on the label of a drug’s packaging and that drugs could not fall below purity levels established by the United States Pharmacopeia or the National Formulary. "The Jungle" by Upton Sinclair was an inspirational piece that kept the public's attention on the important issue of unsanitary meat processing plants that later led to food inspection legislation. Sinclair quipped, "I aimed at the public's heart and by accident I hit it in the stomach," as readers demanded and got the pure food law.

The Pure Food and Drug Act of 1906 was a key piece of Progressive Era legislation, signed by President Theodore Roosevelt on the same day as the Federal Meat Inspection Act. Enforcement of the Pure Food and Drug Act was assigned to the Bureau of Chemistry in the U.S. Department of Agriculture which was renamed the U.S. Food and Drug Administration (FDA) in 1930. The Meat Inspection Act was assigned to what is now known as the Food Safety and Inspection Service, which remains in the U.S. Department of Agriculture. The first federal law regulating foods and drugs, the 1906 Act's reach was limited to foods and drugs moving in interstate commerce. Although the law drew upon many precedents, provisions, and legal experiments pioneered in individual states, the federal law defined "misbranding" and "adulteration" for the first time and prescribed penalties for each. The law recognized the U.S. Pharmacopeia and the National Formulary as standards authorities for drugs, but made no similar provision for federal food standards. The law was principally a "truth in labeling" law designed to raise standards in the food and drug industries and protect the reputations and pocketbooks of honest businessmen.

Under the law, drug labels, for example, had to list any of 10 ingredients that were deemed "addictive" and/or "dangerous" on the product label if they were present, and could not list them if they were not present. Alcohol, morphine, opium, and cannabis were all included on the list of these "addictive" and/or "dangerous" drugs. The law also established a federal cadre of food and drug inspectors that one Southern opponent of the legislation criticized as "a Trojan horse with a bellyful of inspectors and other employees." Penalties under the law were modest, but an under-appreciated provision of the Act proved more powerful than monetary penalties. Goods found in violation of various areas of the law were subject to seizure and destruction at the expense of the manufacturer. That, combined with a legal requirement that all convictions be published as Notices of Judgment, proved to be important tools in the enforcement of the statute and had a deterrent effect upon would-be violators. Deficiencies in this original statute, which had become noticeable by the 1920s, led to the replacement of the 1906 statute with the Federal Food, Drug, and Cosmetic Act which was enacted in 1938 and signed by President Franklin Roosevelt. This act, along with its numerous amendments, remains the statutory basis for federal regulation of all foods, drugs, biological products, cosmetics, medical devices, tobacco, and radiation-emitting devices by the U.S. Food and Drug Administration.

It took 27 years to the 1906 statute, during which time the public was made aware of many problems with foods and drugs in the U.S. Muckraking journalists, such as Samuel Hopkins Adams, targeted the patent medicine industry with its high-alcoholic content patent medicines, soothing syrups for infants with opium derivatives, and "red clauses" in newspaper contracts providing that patent medicine ads (upon which most newspapers of the time were dependent) would be withdrawn if the paper expressed support for food and drug regulatory legislation. The Chief Chemist of the Bureau of Chemistry, Dr. Harvey Washington Wiley, captured the country's attention with his hygienic table studies, which began with a modest Congressional appropriation in 1902. The goal of the table trial was to study the human effects of common preservatives used in foods during a period of rapid changes in the food supply brought about by the need to feed cities and support an industrializing nation increasingly dependent on immigrant labor. Wiley recruited young men to eat all their meals at a common table as he added increased "doses" of preservatives including borax, benzoate, formaldehyde, sulfites, and salicylates. The table trials captured the nation's fancy and were soon dubbed "The Poison Squad" by newspapers covering the story. The men soon adopted the motto "Only the Brave dare eat the fare" and at times the publicity given to the trials became a burden. Though many results of the trial came to be in dispute, there was no doubt that formaldehyde was dangerous and it disappeared quickly as a preservative. Wiley himself felt that he had found adverse effects from large doses of each of the preservatives and the public seemed to agree with Wiley. In many cases, most particularly with ketchup and other condiments, the use of preservatives was often used to disguise insanitary production practices. Although the law itself did not proscribe the use of some of these preservatives, consumers increasingly turned away from many products with known preservatives.

The 1906 statute regulated food and drugs moving in interstate commerce and forbade the manufacture, sale, or transportation of poisonous patent medicines. The Act arose due to public education and exposés from public interest guardians such as Upton Sinclair and Samuel Hopkins Adams, social activist Florence Kelley, researcher Harvey W. Wiley, and President Theodore Roosevelt.

The law itself was largely replaced by the much more comprehensive Federal Food, Drug, and Cosmetic Act of 1938.

The Pure Food and Drug Act was initially concerned with ensuring products were labeled correctly. Later efforts were made to outlaw certain products that were not safe, followed by efforts to outlaw products which were safe but not effective. For example, there was an attempt to outlaw Coca-Cola in 1909 because of its excessive caffeine content; caffeine had replaced cocaine as the active ingredient in Coca-Cola in 1903. In the case "United States v. Forty Barrels and Twenty Kegs of Coca-Cola", the judge found that Coca-Cola had a right to use caffeine as it saw fit, although Coca-Cola eventually lost when the government appealed to the Supreme Court. It reached a settlement with the United States government to reduce the caffeine amount.

In addition to caffeine, the Pure Food and Drug Act required that drugs such as alcohol, cocaine, heroin, morphine, and cannabis, be accurately labeled with contents and dosage. Previously many drugs had been sold as patent medicines with secret ingredients or misleading labels. Cocaine, heroin, cannabis, and other such drugs continued to be legally available without prescription as long as they were labeled. It is estimated that sale of patent medicines containing opiates decreased by 33% after labeling was mandated. The Pure Food and Drug Act of 1906 is cited by drug policy reform advocates such as James P. Gray as a successful model for re-legalization of currently prohibited drugs by requiring accurate labels, monitoring of purity and dose, and consumer education.

In June 1906, President Theodore Roosevelt signed into law the Food and Drug Act, also known as the "Wiley Act" after its chief advocate. The Act prohibited, under penalty of seizure of goods, the interstate transport of food which had been "adulterated," with that term referring to the addition of fillers of reduced "quality or strength," coloring to conceal "damage or inferiority," formulation with additives "injurious to health," or the use of "filthy, decomposed, or putrid" substances. The act applied similar penalties to the interstate marketing of "adulterated" drugs, in which the "standard of strength, quality, or purity" of the active ingredient was not either stated clearly on the label or listed in the "United States Pharmacopoeia" or the "National Formulary". The act also banned "misbranding" of food and drugs. The responsibility for examining food and drugs for such "adulteration" or "misbranding" was given to Wiley's USDA Bureau of Chemistry.

History of the Food and Drug Administration

This article is about the history of the United States Food and Drug Administration.

Up until the 20th century, there were few federal laws regulating the contents and sale of domestically produced food and pharmaceuticals, with one exception being the short-lived Vaccine Act of 1813. A patchwork of state laws provided varying degrees of protection against unethical sales practices, such as misrepresenting the ingredients of food products or therapeutic substances. The history of the FDA can be traced to the latter part of the 19th century and the U.S. Department of Agriculture's Division of Chemistry (later Bureau of Chemistry). Under Harvey Washington Wiley, appointed chief chemist in 1883, the Division began conducting research into the adulteration and misbranding of food and drugs on the American market. Although they had no regulatory powers, the Division published its findings from 1887 to 1902 in a ten-part series entitled "Foods and Food Adulterants". Wiley used these findings, and alliances with diverse organizations such as state regulators, the General Federation of Women's Clubs, and national associations of physicians and pharmacists, to lobby for a new federal law to set uniform standards for food and drugs to enter into interstate commerce. Wiley's advocacy came at a time when the public had become aroused to hazards in the marketplace by muckraking journalists like Upton Sinclair, and became part of a general trend for increased federal regulations in matters pertinent to public safety during the Progressive Era. The 1902 Biologics Control Act was put in place after diphtheria antitoxin was collected from a horse named Jim who contracted tetanus, resulting in several deaths.
Much credit is given to the deaths of many people in the 1930s, including Eben Byers in 1932 from the ingestion of radithor and many women, some known as The Radium Girls, to making the FDA into the much more powerful organization we know today.

Wiley used these new regulatory powers to pursue an aggressive campaign against the manufacturers of foods with chemical additives, but the Chemistry Bureau's authority was soon checked by judicial decisions, as well as by the creation of the Board of Food and Drug Inspection and the Referee Board of Consulting Scientific Experts as separate organizations within the USDA in 1907 and 1908 respectively. A 1911 Supreme Court decision ruled that the 1906 act did not apply to false claims of therapeutic efficacy, in response to which a 1912 amendment added "false and fraudulent" claims of "curative or therapeutic effect" to the Act's definition of "misbranded." However, these powers continued to be narrowly defined by the courts, which set high standards for proof of fraudulent intent. In 1927, the Bureau of Chemistry's regulatory powers were reorganized under a new USDA body, the Food, Drug, and Insecticide organization. This name was shortened to the Food and Drug Administration (FDA) three years later.

By the 1930s, muckraking journalists, consumer protection organizations, and federal regulators began mounting a campaign for stronger regulatory authority by publicizing a list of injurious products which had been ruled permissible under the 1906 law, including radioactive beverages, the mascara Lash lure, which caused blindness, and worthless "cures" for diabetes and tuberculosis. The resulting proposed law was unable to get through the Congress of the United States for five years, but was rapidly enacted into law following the public outcry over the 1937 Elixir Sulfanilamide tragedy, in which over 100 people died after using a drug formulated with a toxic, untested solvent. The only way that the FDA could even seize the product was due to a misbranding problem: an "Elixir" was defined as a medication dissolved in ethanol, not the diethylene glycol used in the Elixir Sulfanilamide. Had it been labeled a "solution" instead, it is argued, the agency could have done nothing to track down and confiscate what medication remained in the public's hands.

President Franklin Delano Roosevelt signed the new Food, Drug, and Cosmetic Act (FD&C Act) into law on June 24, 1938. The new law significantly increased federal regulatory authority over drugs by mandating a pre-market review of the safety of all new drugs, as well as banning false therapeutic claims in drug labeling without requiring that the FDA prove fraudulent intent. The law also authorized factory inspections and expanded enforcement powers, set new regulatory standards for foods, and brought cosmetics and therapeutic devices under federal regulatory authority. This law, though extensively amended in subsequent years, remains the central foundation of FDA regulatory authority to the present day.

After passage of the 1938 Act, the FDA began to designate certain drugs as safe for use only under the supervision of a medical professional, and the category of "prescription-only" drugs was securely codified into law by the 1951 Durham-Humphrey Amendment. While pre-market testing of drug efficacy was not authorized under the 1938 FD&C Act, subsequent amendments such as the Insulin Amendment and Penicillin Amendment did mandate potency testing for formulations of specific lifesaving pharmaceuticals. The FDA began enforcing its new powers against drug manufacturers who could not substantiate the efficacy claims made for their drugs, and the United States Court of Appeals for the Ninth Circuit ruling in "Alberty Food Products Co. v. United States" (1950) found that drug manufacturers could not evade the "false therapeutic claims" provision of the 1938 act by simply omitting the intended use of a drug from the drug's label. These developments confirmed extensive powers for the FDA to enforce post-marketing recalls of ineffective drugs. Much of the FDA's regulatory attentions in this era were directed towards abuse of amphetamines and barbiturates, but the agency also reviewed some 13,000 new drug applications between 1938 and 1962. While the science of toxicology was in its infancy at the start of this era, rapid advances in experimental assays for food additive and drug safety testing were made during this period by FDA regulators and others.

In 1959, Senator Estes Kefauver began holding congressional hearings into concerns about pharmaceutical industry practices, such as the perceived high cost and uncertain efficacy of many drugs promoted by manufacturers. There was significant opposition, however, to calls for a new law expanding the FDA's authority. This climate was rapidly changed by the thalidomide tragedy, in which thousands of European babies were born deformed after their mothers took that drug - marketed for treatment of nausea - during their pregnancies. Thalidomide had not been approved for use in the U.S. due to the concerns of an FDA reviewer, Frances Oldham Kelsey, about thyroid toxicity. However, thousands of "trial samples" had been sent to American doctors during the "clinical investigation" phase of the drug's development, which at the time was entirely unregulated by the FDA. Individual members of Congress cited the thalidomide incident in lending their support to expansion of FDA authority.

The 1962 Kefauver-Harris Amendment to the FD&C act represented a "revolution" in FDA regulatory authority. The most important change was the requirement that all new drug applications demonstrate "substantial evidence" of the drug's efficacy for a marketed indication, in addition to the existing requirement for pre-marketing demonstration of safety. This marked the start of the FDA approval process in its modern form. Drugs approved between 1938 and 1962 were also subject to FDA review of their efficacy, and to potential withdrawal from the market. Other important provisions of the 1962 amendments included the requirement that drug companies use the "established" or "generic" name of a drug along with the trade name, the restriction of drug advertising to FDA-approved indications, and expansion of FDA powers to inspect drug manufacturing facilities.

These reforms had the effect of increasing the time required to bring a drug to market. In the mid-1970s, 13 of the 14 drugs the FDA saw as most important to approve were on the market in other countries before the United States.

One of the most important statutes in establishing the modern American pharmaceutical market was the 1984 Drug Price Competition and Patent Term Restoration Act, more commonly known as the "Hatch-Waxman Act" after its chief sponsors. This act was intended to correct two unfortunate interactions between the new regulations mandated by the 1962 amendments, and existing patent law (which is not regulated or enforced by the FDA, but rather by the United States Patent and Trademark Office). Because the additional clinical trials mandated by the 1962 amendments significantly delayed the marketing of new drugs, without extending the duration of the manufacturer's patent, "pioneer" drug manufacturers experienced a decreased period of lucrative market exclusivity. On the other hand, the new regulations could be interpreted to require complete safety and efficacy testing for generic copies of approved drugs, and "pioneer" manufacturers obtained court decisions which prevented generic manufacturers from even beginning the clinical trial process while a drug was still under patent. The Hatch-Waxman Act was intended as a compromise between the "pioneer" and generic drug manufacturers which would reduce the overall cost of bringing generics to market and thus, it was hoped, reduce the long-term price of the drug, while preserving the overall profitability of developing new drugs.

The act extended the patent exclusivity terms of new drugs, and importantly tied those extensions, in part, to the length of the FDA approval process for each individual drug. For generic manufacturers, the Act created a new approval mechanism, the Abbreviated New Drug Application (ANDA), in which the generic drug manufacturer need only demonstrate that their generic formulation has the same active ingredient, route of administration, dosage form, strength, and pharmacokinetic properties ("bioequivalence") as the corresponding brand-name drug. This act has been credited with essentially creating the modern generic drug industry.

Concerns about the length of the drug approval process were brought to the fore early in the AIDS epidemic. In the mid- and late 1980s, ACT-UP and other HIV activist organizations accused the FDA of unnecessarily delaying the approval of medications to fight HIV and opportunistic infections, and staged large protests, such as a confrontational October 11, 1988 action at the FDA campus which resulted in nearly 180 arrests. In August 1990, Dr. Louis Lasagna, then chairman of a presidential advisory panel on drug approval, estimated that thousands of lives were lost each year due to delays in approval and marketing of drugs for cancer and AIDS.

Partly in response to these criticisms, the FDA issued new rules to expedite approval of drugs for life-threatening diseases, and expanded pre-approval access to drugs for patients with limited treatment options. The first of these new rules was the "IND exemption" or "treatment IND" rule, which allowed expanded access to a drug undergoing phase II or III trials (or in extraordinary cases even earlier) if it potentially represented a safer or better alternative to treatments currently available for terminal or serious illness. A second new rule, the "parallel track policy", allowed a drug company to set up a mechanism for access to a new potentially lifesaving drug by patients who for various reasons would be unable to participate in ongoing clinical trials. The "parallel track" designation could be made at the time of IND submission. The accelerated approval rules were further expanded and codified in 1992.

All of the initial drugs approved for the treatment of HIV/AIDS were approved through accelerated approval mechanisms. For example, a "treatment IND" was issued for the first HIV drug, AZT, in 1985, and approval was granted just two years later in 1987. Three of the first five drugs targeting HIV were approved in the United States before they were approved in any other country.

In two instances, state governments have sought to legalize drugs which have not been approved by the FDA. Because federal law passed pursuant to Constitutional authority overrules conflicting state laws, federal authorities still claim the authority to seize, arrest, and prosecute for possession and sales of these substances, even in states where they are legal under state law.

The first wave was the legalization by 27 states of laetrile in the late 1970s. This drug was used as a treatment for cancer, but scientific studies both before and after this legislative trend found it to be ineffective. Federal law enforcement prevented interstate shipment, making the drug infeasible to manufacture and sell. Further studies based on a Mexican formulation also showed no effectiveness in treating cancer, but did find that some patients experienced symptoms of cyanide poisoning. Though the political movement died out in the 1980s, FDA enforcement actions against laetrile purveyors continued into the 2000s.

The second wave concerned medical marijuana in the 1990s and 2000s. Though Virginia passed a law with limited effect in 1979, a more widespread trend began in California in 1996. In 2009, the Obama Administration de-prioritized enforcement of federal law against patients using the drug in compliance with state law, but reversed this policy in 2011. Recreational marijuana remains illegal (but not necessarily criminal) in all states and at the federal level, as of 2009.
With acceptance of premarket notification 510(k) k033391 in January 2004, the FDA granted Dr. Ronald Sherman permission to produce and market medical maggots for use in humans or other animals as a prescription medical device.
Medical maggots represent the first living organism allowed by the Food and Drug Administration for production and marketing as a prescription medical device.

In June 2004, the FDA cleared "Hirudo medicinalis" (medicinal leeches) as the second living organism to be used as a medical devices.

Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic Act, (first passed in 1938 and extensively amended since) and are codified in Title 21, Chapter 9 of the United States Code. Other significant laws enforced by the FDA include the Public Health Service Act, parts of the Controlled Substances Act, the Federal Anti-Tampering Act, as well as many others. In many cases these responsibilities are shared with other federal agencies.

Important enabling legislation for the FDA includes:

Faced with the opioid epidemic, which had become a public health crisis by 2017, the FDA requested Endo Pharmaceuticals to remove "oxymorphone hydrochloride" from the market. It was the first time in FDA history, that the FDA had "taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse".


What is a Wendigo?

Wendigo (occasionally: Wen-Di-Go) is a fictional monster appearing in American comic books published by Marvel Comics. The Marvel character is based on the Wendigo legend of the Algonquian peoples. The monster first appeared in "The Incredible Hulk" #162 (April 1973), created by writer Steve Englehart and artist Herb Trimpe, fighting the Incredible Hulk in the Wendigo's first comic book appearance.

Wendigo (comics)

The Wendigo is not one specific person, but instead is the manifestation of a curse that can strike anyone who commits an act of cannibalism in the Canadian north woods. Originally only one person can become the Wendigo at the time, which has led to one Wendigo being cured if another person was struck with the curse. In later years it has been revealed that a pack of Wendigos lived in the Bering Strait. At one point the Wendigo curse infected the Hulk, turning him into Wendihulk, although he was later cured.

While normally depicted as a savage beast with no control, Wendigos have appeared as part of various villainous groups, showing some restraint when not fighting. The Wendigo character has also appeared in several Marvel cartoon series.

The Wendigo first appeared in "The Incredible Hulk" #162 (April 1973), and was created by Steve Englehart and Herb Trimpe. Englehart recalled, "I knew about the legend of the Wendigo, and thought, between his strength and his sad story, that he sounded like a good Hulk opponent."

Several people have been afflicted with the curse of the Wendigo, including Paul Cartier, Georges Baptiste, Francois Lartigue, Lorenzo, Mauvais and others.

The curse is regional to the woods of Northern Canada and takes place, under the right conditions, when a person in the forests of Canada feeds on human flesh. This "Curse of the Wendigo" was created by the Northern Gods (also known as "the Inua") in an effort to deter human cannibalism.

The cannibal transforms into a superhumanly strong, nearly indestructible, fur-covered monster: the Wendigo. He or she then roams the woods eating human beings. The Wendigo frequently fights the Hulk, Wolverine, and Alpha Flight. Paul Cartier transformed into the Wendigo, battles the Hulk, and escaped. He battles the Hulk again and encountered Wolverine, and then battles the Hulk and Wolverine; Paul Cartier is cured as college professor Georges Baptiste became the Wendigo.

Baptiste as the Wendigo later terrorizes a snowbound group. He battles Wolverine, Nightcrawler, and members of Alpha Flight; the Baptiste Wendigo is captured and cured by Shaman, although Baptiste is arrested by Department H.

Fur trapper Francois Lartigue later transforms into the Wendigo, battles the Hulk when Bruce Banner stumbled across a cabin belonging to him, and Sasquatch, and is taken to be cured by Shaman.

A reporter named Anna Brooks goes on the search for Bigfoot at the time when some children are missing where she stumbles upon a Wendigo. This sighting causes J. Jonah Jameson to dispatch Peter Parker to British Columbia. Though the Wendigo's actions also attract the attention of Wolverine. This led to Spider-Man and Wolverine working together to stop the Wendigo.

One Wendigo battles the Werewolf by Night in an issue of "Marvel Comics Presents". Its most frequent appearances were in the limited series "Sabretooth: Open Season" #1–4, where Sabretooth is hired to kill a Wendigo, ultimately succeeding.

A few years later, a new Wendigo emerges, leading to a fight with Wolverine and She-Hulk. A local Canadian super-hero, Talisman, arrives and claims to have a magical cure for the Wendigo's condition. After a long battle, the Wendigo is defeated by a combined attack from his two opponents, and placed into S.H.I.E.L.D. custody. This Wendigo is apparently later taken in by the Canadian-based Department K and is given an electric collar that keeps the usually mindless beast under control and is integrated as a member of Weapon: P.R.I.M.E., a team of operatives each with a personal grudge against Cable. Their first mission is to take down Cable, but X-Force proves to be more than capable, as Cable teleports all their belongings out of the base and triggers the autodestruct device, though the device malfunctions and blows up early. Cut off from Cable, X-Force helps Kane, Bridge and Rictor escape the exploding base, while Grizzly, Wendigo (now referred as Yeti) and Tigerstryke are missing. Bridge and Kane still want to arrest X-Force and calls in S.H.I.E.L.D. reinforcement, but Rictor sides with X-Force, since his grudge is only against Cable, not his former teammates. Later the Wendigo's collar is exchanged with a neurological implant which gives more control to the man inside the beast, even allowing him to speak.

During the "Chaos War" storyline, it is revealed that a pack of Wendigo exist in the Bering Strait after Red Hulk is attacked by a Wendigo, attracted by his camp fire while cooking a meal. A Wendigo bites the Red Hulk on the shoulder and he bleeds hot radioactive blood. The Red Hulk kills one Wendigo, while the others come to claim the body and eat it. It is also revealed that the Great Beasts are forced to manipulate the curse of the Wendigo to allow the transformation of several people instantly instead of only one, in order to create an army to fight with them against the Chaos King Amatsu-Mikaboshi.

These Wendigos are later somehow able to invade Las Vegas. where they are confronted by the Grey Hulk. The Grey Hulk gets help in the fight against them from Moon Knight, Ms. Marvel, and Sentry. Knocked into some debris, later on the Green Hulk appears. However, the Wendigos infect Hulk, turning him into the "Wendihulk" who attacks the superheroes. The sorcerer Brother Voodoo appears and cures Hulk and the other Wendigos.

When the Avengers Academy students have an encounter with former Norman Osborn subject Jeremy Biggs, it is mentioned that Biggs' company has bought a Wendigo that killed Steve, another former Osborn subject with ice-based powers.

During the 2011 "Fear Itself" storyline, a Wendigo is among the Alpha Flight villains gathered by Vindicator and Department H to spread the Master of the World's "Unity" program and to take down Alpha Flight as a member of Alpha Strike.

As part of Marvel Comics' 2012 initiative, Marvel NOW!, a Wendigo appears as a member of Department H's Omega Flight. Wendigo and the rest of Omega Flight are sent by Department H to investigate one of the Origin Bomb sites left by Ex Nihilo in Regina, Canada, a mission in which Wendigo is killed.

A Wendigo is later recruited by Kade Kilgore to join the faculty of the Hellfire Club's Hellfire Academy.

A Wendigo is summoned to Las Vegas through the wishing well of Tyrannus along with Bi-Beast, Fin Fang Foom, Umar, and Arm'Cheddon to fight the Hulk. This Wendigo is capable of minimalistic human speech and teams up with Bi-Beast to use the well's powers to allow them to grow to about thirty feet tall for fight the Hulk. However, both creatures are easily defeated by Hulk and are imprisoned along with Arm'Cheddon in the Dark Dimension by Umar until Tyrannus and Fin Fang Foom raids the dimension, allowing them to escape in the chaos.

A later confrontation between two Canadian meat packing plant employees resulted in one accidentally killing the other, and the perpetrator trying to cover it up by running the body through the meat grinder. This resulted in a mass outbreak of the Wendigo Curse, which was greatly exacerbated by the curse being transmitted via bite wounds inflicted by the Wendigos, in a process akin to lycantrophy. An infection of this pheneomena beyond Canada's borders is initially prevented by the mystical limitations of the Wendigo Curse. With the uncontrollably of the outbreak, the Great Beast Tanaraq (the "father" of the Wendigo) gains enough power to overthrow his fellows and intended to spread the curse across the entire world. However, the combined efforts of the X-Men, the other Beasts, and Guardian defeat his plan, resulting in the elimination of the curse.

Spider-Woman, with the help of Captain Marvel and Porcupine, later shuts down a Canadian restaurant that had been secretly serving its customers human flesh in an attempt to instigate another outbreak of Wendigo.

When Jimmy Hudson appears on Earth-616 following the 2015 "Secret Wars" storyline, the townspeople mistake him for a Wendigo and shoot him before an actual Wendigo attack occurred. Recovering from the gunshot wound, Hudson fights the Wendigo.

Roxxon later goes on an archaeological expedition to find a Wendigo. When a Wendigo attacks a scientist named Ella Stirling, she is saved by Weapon H. It was revealed that Roxxon executive Mr. Banks had a miner named Philips Waggoner eat a Wendigo meat at the site where the Avingnon Party resided during a blizzard. The result of this turned Philips Waggoner into an Ur-Wendigo which is more powerful than any normal Wendigo and can grow larger when it ate flesh. The Ur-Wendigo caught up to Weapon H and tried to eat him whole only for Doctor Strange to appear. As the Ur-Wendigo is immune to enchantments, Weapon H borrowed Doctor Strange's Ax of Angarruumus and allowed himself to be eaten by the Ur-Wendigo in order to kill it from within.

The Wendigo possesses a variety of superhuman physical abilities as a result of transformation by an ancient mystical curse. The curse causes anyone that ingests the flesh of another human, while within the Canadian wilderness, to transform into the Wendigo.

The Wendigo possesses superhuman physical strength of an unknown limit. It is known that the Wendigo possesses sufficient strength to go toe-to-toe with the Incredible Hulk.

Aside from its vast strength, the tissues of the Wendigo's body are considerably stronger than those of a human being, providing it with superhuman durability. A Wendigo's body can resist high caliber machine gun rounds without sustaining injury. If a Wendigo is injured, it can recover from the physical trauma with tremendous speed and efficiency, giving rise to the quote "strike him down and he shall only rise again". The dense fur covering the Wendigo's body grants it immunity to the harsh conditions of the extreme cold weather common in the areas in which the Wendigo has appeared. The Wendigo can be rendered unconscious by sufficient force, such as severe physical injury and trauma, but it has even been able to regenerate from being completely disemboweled. It has even survived its heart being ripped from its chest. However, consumption of a removed heart will confer all powers and even the form of the Wendigo on whoever consumes it. It is not known what effect psionic attacks would have on or against a Wendigo.

Despite the Wendigo's great size, it can run at speeds greater than that of an Olympic level athlete. The enhanced musculature of the Wendigo generates less lactic acid than the muscles of a human being, granting it superhuman levels of stamina.

The Wendigo's fingers and toes are tipped with razor sharp, retractable claws that are capable of piercing even the Hulk's skin, a feat usually reserved for adamantium, due to a combination of the toughness of the claws and the Wendigo's massive physical strength.

Even though each Wendigo was once a human being, in most cases very little is left of the person it once was. It possesses little intelligence and can be considered non-sentient, and with the exception of brief and rare instances, is unable to remember things about its former life. It also lacks the ability to speak anything other than its own name, which it often will yell and repeat during its attacks. Sorcerers such as Mauvais and Lorenzo have been able to avoid this aspect of the curse, using magic to gain the power of the Wendigo while keeping their intelligence and the power of speech.

In "Amazing Spider-Man" #277, a creature called Wendigo appears. This Wendigo seemed to be a ghost-like being whose very presence in New York caused a blizzard to strike. Though the creature only makes its appearance at the end of the comic, the story makes it obvious that it is stalking Spider-Man the entire time he was chasing a group of kidnappers. This Wendigo seemed to be able to change size and become invisible; it was also reptilian in appearance and pale green in color.

In "Spider-Man" issues #8–12 (the "Perceptions" story arc), a Wendigo creature is blamed in the deaths of several children near Hope, British Columbia and terrorizing the town. Spider-Man's alter ego, Peter Parker, is sent to take pictures during the media frenzy that follows. Wolverine, having previous experience with Wendigo creatures and having concern for the creature's welfare, comes to the town and contacts Peter Parker directly, seeking Spider-Man's assistance. Together Spider-Man and Wolverine are able to determine the real cause of death among the children. The Wendigo in "Perceptions" has an appearance very similar to other incarnations of the Wendigo, yet seems to be a different manifestation. For example, this version of Wendigo is more vulnerable to harm than those that battled the Hulk as it suffers a significant wound from a hunter's bullet, and sustains injury when struck by a car. Additionally, it does not appear very aggressive, unless provoked, nor is it interested in consuming human flesh, feeding primarily on deer. In fact, when the Wendigo comes across the corpse of a child, the creature attempts to return the body to town instead of consuming it.

In the Earth X continuity, there appears a unique twist on the classic Wendigo. This variation of Wendigo is unlike the previous; while the Wendigo curse afflicts only one person at a time, an army of Wendigo is formed in this continuity, due to the curse afflicting Jamie Madrox after he chooses to eat one of his own duplicated bodies in response to the strict rationing of food that came with the declining animal population.

The Wendigo makes another appearance in the MC2 imprint of Marvel Comics, an alternate future featuring, among others, the children of existing Marvel superheroes. In an issue of "Wild Thing", Hulk, Doctor Strange, Wolverine, and Wolverine's daughter Wild Thing encounter a large number of Wendigos, which turn out to be a lost cub scout troop that had eaten its scoutmaster. Doctor Strange is able to remove the curse from the children and remove their memory of the events.A pack of Wendigos appear in "Iron Man and Hulk: Heroes United", watching Hulk and Abomination fight. Wendigos later battle Hulk and Iron Man in a cemetery but the Wendigos are warded off by the two Avengers.

In Algonquian folklore, the wendigo () or windigo is a mythical man-eating monster or evil spirit native to the northern forests of the Atlantic Coast and Great Lakes Region of the United States and Canada. The wendigo may appear as a monster with some characteristics of a human or as a spirit who has possessed a human being and made them become monstrous. It is historically associated with murder, insatiable greed, and the cultural taboos against such behaviours.

Wendigo

The legend lends its name to the controversial modern medical term Wendigo psychosis, described by psychiatrists as a culture-bound syndrome with symptoms such as an intense craving for human flesh and fear of becoming a cannibal. In some Indigenous communities, environmental destruction and insatiable greed are also seen as a manifestation of Wendigo psychosis.

Alternative spellings: "Wiindigoo" (the source of the English word, from the Ojibwe language), "Wendigo", "Weendigo", "Windego", "Wiindgoo", "Windgo", "Weendigo", "Wiindigoo", "Windago", "Windiga", "Wendego", "Windagoo", "Widjigo", "Wiijigoo", "Wijigo", "Weejigo", "Wìdjigò" (in the Algonquin language), "Wintigo", "Wentigo", "Wehndigo", "Wentiko", "Windgoe", "Wintsigo" and "wīhtikōw" (in the Cree language); the Proto-Algonquian term was "*wi·nteko·wa", which probably meant "owl" in their original language. "Windigoag" is a plural form (also spelled "Windegoag", "Wiindigooag", or "Windikouk")

The Wechuge is a similar being that appears in the legends of the Athabaskan people of the Northwest Pacific Coast. It too was cannibalistic. However, it was not so much insane as enlightened with ancestral insights.

The wendigo is part of the traditional belief system of a number of Algonquin-speaking peoples, including the Ojibwe, the Saulteaux, the Cree, the Naskapi, and the Innu people. Although descriptions can vary somewhat, common to all these cultures is the view that the wendigo is a malevolent, cannibalistic, supernatural being. They were strongly associated with winter, the north, coldness, famine, and starvation.

Basil Johnston, an Ojibwe teacher and scholar from Ontario, gives a description of a wendigo:

In Ojibwe, Eastern Cree, Westmain Swampy Cree, Naskapi, and Innu lore, wendigos are often described as giants that are many times larger than human beings, a characteristic absent from myths in other Algonquian cultures. Whenever a wendigo ate another person, it would grow in proportion to the meal it had just eaten, so it could never be full. Therefore, wendigos are portrayed as simultaneously gluttonous and extremely thin due to starvation.

The Wendigo is seen as the embodiment of gluttony, greed, and excess: never satisfied after killing and consuming one person, they are constantly searching for new victims.

In some traditions, humans overpowered by greed could turn into wendigos; the myth thus served as a method of encouraging cooperation and moderation. Humans could also turn into wendigos by being in contact with them for too long.

Among the Assiniboine, the Cree and the Ojibwe, a satirical ceremonial dance is sometimes performed during times of famine to reinforce the seriousness of the wendigo taboo. The ceremony, known as wiindigookaanzhimowin, was performed during times of famine, and involved wearing masks and dancing backwards around a drum. The last known wendigo ceremony conducted in the United States was at Lake Windigo of Star Island of Cass Lake, located within the Leech Lake Indian Reservation in northern Minnesota.

In historical accounts of Wendigo psychosis, it has been reported that humans became possessed by the Wendigo spirit, after being in a situation of needing food and having no other choice besides cannibalism.
In 1661, the Jesuit Relations reported:
One of the more famous cases of Wendigo psychosis reported involved a Plains Cree trapper from Alberta, named Swift Runner. During the winter of 1878, Swift Runner and his family were starving, and his eldest son died. Twenty-five miles away from emergency food supplies at a Hudson's Bay Company post, Swift Runner butchered and ate his wife and five remaining children. Given that he resorted to cannibalism so near to food supplies, and that he killed and consumed the remains of all those present, it was revealed that Swift Runner's was not a case of pure cannibalism as a last resort to avoid starvation, but rather of a man with Wendigo psychosis. He eventually confessed and was executed by authorities at Fort Saskatchewan.

Another well-known case involving Wendigo psychosis was that of Jack Fiddler, an Oji-Cree chief and medicine man known for his powers at defeating wendigos. In some cases, this entailed killing people with Wendigo psychosis. As a result, in 1907, Fiddler and his brother Joseph were arrested by the Canadian authorities for homicide. Jack committed suicide, but Joseph was tried and sentenced to life in prison. He ultimately was granted a pardon, but died three days later in jail before receiving the news of this pardon.

Fascination with Wendigo psychosis among Western ethnographers, psychologists, and anthropologists led to a hotly debated controversy in the 1980s over the historicity of this phenomenon. Some researchers argued that essentially, wendigo psychosis was a fabrication, the result of naïve anthropologists taking stories related to them at face value without observation. Others have pointed to a number of credible eyewitness accounts, both by Algonquians and others, as evidence that wendigo psychosis was a factual historical phenomenon.

The frequency of Wendigo psychosis cases decreased sharply in the 20th century as Boreal Algonquian people came into greater and greater contact with European ideologies and more sedentary, less rural, lifestyles.

In addition to denoting a cannibalistic monster from their traditional folklore, Native Americans also understand the wendigo conceptually. As a concept, the wendigo can apply to any person, idea, or movement infected by a corrosive drive toward self-aggrandizing greed and excessive consumption, traits that sow disharmony and destruction if left unchecked. Ojibwe scholar Brady DeSanti asserts that the wendigo "can be understood as a marker indicating... a person... imbalanced both internally and toward the larger community of human and spiritual beings around them." Out of equilibrium and estranged by their communities, individuals afflicted by the wendigo spirit unravel and destroy the environmental balance around them. Chippewa author Louise Erdrich's novel "The Round House (novel)", winner of the National Book Award, depicts a situation where an individual person becomes a wendigo. The novel describes its primary antagonist, a rapist whose violent crimes desecrates a sacred site, as a wendigo who must be killed because he threatens the reservation's safety.

In addition to characterizing individual people who exhibit destructive tendencies, the wendigo can also describe movements and events with similarly negative effects. According to professor Chris Schedler, the figure of the wendigo represents "consuming forms of exclusion and assimilation" through which groups dominate other groups." This application allows Native Americans to describe colonialism and its agents as wendigos, since the process of colonialism ejected natives from their land and threw the natural world out of balance. DeSanti points to the 1999 horror film "Ravenous" as an illustration of this argument equating "the cannibal monster" to "American colonialism and manifest destiny". This movie features a character who articulates that expansion brings displacement and destruction as side effects, explaining that "manifest destiny" and "western expansion" will bring "thousands of gold-hungry Americans... over the mountains in search of new lives... This country is seeking to be whole... Stretching out its arms... and consuming all it can. And we merely follow". For a more detailed exploration linking wendigo attributes to colonialism, see Jack D. Forbes's 1978 book "Columbus and Other Cannibals", which was an influential text in the American Indian Movement.

As a concept, wendigo can apply to other situations than just Native American-European relations. It can serve as a metaphor explaining any pattern of domination by which groups subjugate and dominate or violently destroy and displace. Joe Lockhard, English professor at Arizona State University, argues that wendigos are agents of "social cannibalism" who know "no provincial or national borders; all human cultures have been visited by shape shifting wendigos. Their visitations speak to the inseparability of human experience... National identity is irrelevant to this borderless horror". Lockhard's ideas explain that wendigos are an expression of a dark aspect of human nature: the drive toward greed, consumption, and disregard for other life in the pursuit of self-aggrandizement.

Although distinct from how it appears in the traditional lore, one of the first appearances of a character inspired by, or named after, a Wendigo in non-Indigenous literature is Algernon Blackwood's 1910 short story "The Wendigo". Blackwood's work has influenced many of the subsequent portrayals in mainstream horror fiction, such as August Derleth's "The Thing that Walked in the Wind" and "Ithaqua" (1933 and 1941), which in turn inspired the character in Stephen King's novel "Pet Sematary", where it is a personification of evil, an ugly grinning creature with yellow-grey eyes, ears replaced by ram's horns, white vapour coming from its nostrils, and a pointed, decaying yellow tongue. These works set the template for later portrayals in popular culture, at times even replacing the Native American lore.

The Wendigo appears in American comic books published by Marvel Comics. Created by writer Steve Englehart and artist Herb Trimpe, the monster is the result of a curse that afflicts those who commit acts of cannibalism in parts of Canada. The Wendigo first appeared in The Incredible Hulk #162 (April 1973) fighting the Incredible Hulk as well as Wolverine in his first comic book appearance.

Creatures based upon wendigos appear in a number of films, including "Dark Was the Night" and "Ravenous". They have also appeared in television series, including "Supernatural", "Blood Ties", "Charmed," and "Grimm".

In the TV series "Hannibal", FBI profiler Will Graham has several dreams or visions that feature a Wendigo which serves as symbolism for the cannibalistic titular character of the series. The Wendigo featured is tall and thin, emaciated, with tar-black skin and antlers protruding from the top of its head.

Characters with the name appear in a number of computer and video games, including "Until Dawn", "The Legend of Dragoon", "The Secret World", "Fallout 76", and the "Warcraft" universes, as well as role-playing games such as "Dungeons & Dragons".