Ten months later, when the FDA was flooded with millions of PMTAs, the agency distributed an internal memorandum containing a new “standard of proof” for certain PMTA for flavored ENDS products. See Triton FDA2-005144-005155 (July 9, 2021). This memo has not been made public, although it intends to “allow final action on as many applications as possible by September 10, 2021.” See Triton FDA2-005144. Given the “large number of applications that still need to be reviewed by September 9, 2021,” the memo stated that instead of an individual review of applications, the FDA would “conduct a fatal error review.” Triton FDA2-005145. The “fatal error” would be the absence of. The long-term studies, which the Agency had previously indicated, were neither necessary nor expected. Triton FDA2 005144 – 45. To put it bluntly, the memo guaranteed that even if an applicant followed the FDA`s public statements before the deadline and the proposed rule, the FDA would still reject a PMTA because it did not meet the non-public internal requirement for “the type of studies needed” in July 2021. The FDA says the Fatal Flaw memo has been repealed, but its approach appears to have been followed in a check-off “scientific review” form that only indicated whether a PMTA contained a randomized controlled trial or a longitudinal cohort study. Triton FDA1-000247-000260. Turner: Like the white lion, the so-called “spirit bear” (aka Kermode Bear, Ursus American Kermodei) is a unique genetic variant of the black bear and is found in only one place in the world: the temperate rainforests of British Columbia. Like the white lion, the white fur of the ghost bear is also considered the result of a double recessive allele (gene). The spirit bear has significant cultural significance to the Kitasoo people and has been protected by law, with 220,000 hectares set aside for their protection.
We are using this precedent in our campaign to reclassify White Lions. Working as a lawyer involves the practical application of abstract legal theories and knowledge to solve specific individual problems or promote interests. Turner: Yes, the Greater Timbavati region of South Africa is characterized by white sand river beds and in winter, the long grasses of this region are pale burned. In this habitat, which is their place of origin, they are very well camouflaged. Turner: Our scientific monitoring team records white lion behavior and hunting patterns each day during its peak activity periods. The lions are equipped with transmitter collars so that we can always track them and record their behaviors. Lions are never approached on foot. We follow a strict scientific protocol, and each visitor to the project must be accompanied by a member of the monitoring team. Boys are raised by their mothers and are never approached or touched. Turner: The more knowledge we get, the more likely we are to change legislation and protect lions. White lions need to be reclassified as endangered and protected animals of national importance, and we need to study how often this white gene appears in the Greater Timbavati/Kruger Park region of the UNESCO Kruger-in-Canyons Biosphere.
We will use this information to better protect all lions in this region. Turner: They were first sighted in 1938 and photographically documented in the 1970s, although African records suggest they resided in this area much longer. Due to the artificial resettlement of this region, there has been a period of near extinction. However, between 2006 and 2015, there were 15 births of white lions in the private nature reserves of Timbavati-Umbabat-Klaserie and 2 births of white lion cubs in the central Kruger National Park. Currently, fewer than 13 white lions live in the wild. Interestingly, this coincided with our introduction of Marah and her cubs into free-roaming bushveld conditions in the heart of their endemic areas. If this winding administrative course is not an “administrative switchover”, it is difficult to know what it is. On the one hand, it could reasonably be concluded from FDA denials of 55,000 PMTA that manufacturers other than these petitioners were deceived by previous FDA instructions.
And the fact that legitimate interests of trust have been built into previous FDA announcements is confirmed by an affidavit from the leaders of the petitioners responsible for filing their PMTAs. In addition, the petitioners` activities generated annual sales of $15 million to $20 million. The petitioners invested half a million dollars to complete their PMTAs and submitted 9 gigabytes of information, including hundreds of files, to the FDA for market authorization. They had every reason to submit PMTAs with great diligence and completeness, as the existence of the company depended on the regulatory approval of their products. Turner: After being “discovered” by Europeans in the 1930s, white lions were artificially removed from the wild to breed and hunt in captivity. With these distances, the killing of lions in the Kruger National Park and the trophy hunting of the proud male lions in Timbavati have exhausted the gene pool. Turner: White lions are classified as Panthera leo, which means they are not recognized as “different” by current scientific labeling and are therefore not protected by law. This means they can be hunted or traded to extinction – even if there are fewer than 13 white lions in the wild in their natural habitat. The white lion gene must be sought, understood and protected urgently. In terms of current scientific classifications and methodologies, this requires a list of the conservation status of lions in South Africa from Appendix II to Appendix I of CITES. Turner: In May 2006, after more than a decade without sightings of white lions, two white cubs – among the yellow-brown cubs – were born in the private nature reserve of Umbabat (neighboring Timbavati). In October 2006, two more white bear cubs were born at Tabby`s Crossing in the Timbavati Game Reserve.
Sadly, none of the white boys – or their yellow-brown siblings – survived. In the best case, the survival rate of lion cubs in adulthood is only 20%. However, these cubs faced additional challenges as their likely father was chased for trophies and packs in the area fell victim to infanticide. In 2014, the first white bear cubs were born again in the Kruger National Park (Nwanetsi-Singita Lebombo concession) – an area where there is no trophy hunting of the lion, so there is a lot of hope for the long-term survival of white lions. Despite continued commercial trophy hunting for lions in the Greater Timbavati region, there have now been several occurrences of white lions over a large area, demonstrating the conservation value of this rare phenotype for the biodiversity of this wilderness area. Turner: No, the White Lions who participate in our project are not kept in cages. That would contradict everything our project represents. The white lions in our reintroduction program have been reintroduced to a 2000 ha wildlife reserve in their endemic natural habitat in the wild under open roaming conditions.
The reintroduction programme is consistent with current lion conservation strategies that follow the “metapopulations” management approach already applied in other parts of southern Africa. In order to fully reintroduce white lions into the wild and ensure genetic diversity, the White Lion Trust aims to establish and manage a number of distinct subpopulations before reintegrating white lions with resident forest packs in the Greater Timbavati/Kruger Park region when the internal fences are eventually abandoned to form the Joint Protection Area (JPZ). which borders the Kruger National Park. Turner: This term “purist” is imprecise. In reality, there are very few ecosystems today that are not managed in one way or another. This applies to the associated private nature reserves (AFNRs) adjacent to Kruger National Park, which have intervened in the natural system in a variety of ways, including firebreaks, road and other infrastructure, and commercial trophy hunting of lions and other members of the so-called Big Five for several decades. Even the Kruger National Park itself, although larger than 20,000 km2, is not a completely autonomous system.