IND Warning Has US Supplement Firm ISO Answers
Vietnamese Refugee Founded RAAS In 1980, 5 Years After Beginning US Health/Wellness Career
Executive Summary
RAAS Nutritionals tells FDA “it proceeded without an IND because it believed that if it was legally able to sell its nutritional supplements ... it should be able to test and observe the effects of those supplements without an IND.”
You may also be interested in...
Microbiome Therapy Firm’s COVID-19 Medical Food Research Landed On US FDA’s Drug Study Menu
Medical food is “for the specific dietary management of a disease or condition for which distinctive nutritional requirements … are established by medical evaluation,” but no distinctive nutritional requirements are established for COVID-19, FDA says. Kaleido says in SEC filing that it “intends to continue with its plans to submit an IND for KB109 in support of future clinical research.”
CDB Supplements Next On FDA's Investigational New Drug Warning List
The agency published warnings to four firms marketing supplements containing CDB ingredients with claims to treat or cure cancer made in statements including testimonials on their websites for products varying from oils, capsules, tinctures and lotions to snacks including gummies and lollipops.
Jurors' Answers In FTC's Prevagen Complaint Might Burst A Memory Bubble For Health Claims
“No” answers in New York federal court on whether all but two of Prevagen claims were “materially misleading” could put a fork in the road of a long dispute between FTC and supplement product manufacturers and marketers.