Washington, D.C.—U.S. Sen. Mike Lee (R-UT) and Rep. Mark Pocan (D-WI) have written a letter calling on U.S. government officials to oppose a move by the World Health Organization (WHO) that could add kratom to the 1971 UN Convention on psychotropic substances, according to the American Kratom Association. As Lee...
Silver Spring, MD—A dietary supplement manufacturer and its owners have been ordered to stop selling products until they come into compliance with the FD&C Act, according to an announcement from FDA. The U.S. Department of Justice filed the complaint on behalf of FDA, and the U.S. District Court for the...
Washington, D.C.—President Biden has nominated Robert M. Califf, M.D., for Commissioner of the FDA. FDA hasn’t had a permanent chief since President Biden took office, reports the New York Times, and acting FDA Commissioner Dr. Janet Woodcock is nearing the end of the term that acting officials are allowed to...
Silver Spring, MD—The American Herbal Products Association (AHPA) announced that it has joined the Natural Products Association (NPA) and the Council for Responsible Nutrition (CRN) in calling on the Food and Drug Administration (FDA) to clarify that N-acetyl cysteine (NAC) is a lawful dietary ingredient. As WholeFoods previously reported, despite decades...
Washington, D.C.—The Consumer Healthcare Products Association (CHPA) held its 2021 Regulatory, Scientific, and Quality (RSQ) Conference virtually last week., with a dietary supplement track featuring panels on emerging trends and issues for the category. CHPA shared in a press release that the event featured record participation from the U.S. Food...
Silver Spring, MD—FDA has released a consumer update listing five things the agency wants consumers to know about Delta-8 THC (tetrahydrocannabinol), a psychoactive substance found in both marijuana and hemp. The five things on FDA's list include: Delta-8 THC products have not been evaluated or approved by FDA for safe...
Washington, D.C.—The FDA and FTC have posted warning letters to 10 companies for illegally selling dietary supplements claiming to cure, treat, mitigate, or prevent diabetes. "More than 34 million Americans— just over 1 in 10 people— are living with diabetes. Dietary supplements that make fraudulent claims to treat diabetes are...
Washington, D.C.—The Natural Products Association (NPA) has filed a Citizen’s Petition with the Food and Drug Administration, requesting that N-acetyl-L-cysteine (NAC) not be excluded from the definition of a dietary supplement. As WholeFoods previously reported, despite decades on the marker as a dietary supplement, in July 2020, FDA issued multiple...
Guelph, ON—Nutrasource Pharmaceutical and Nutraceutical Services announced that GRAS Associates, a fully owned subsidiary of Nutrasource, has successfully submitted a GRAS Notice to the FDA on behalf of Nascent Health Sciences' sweetener extract. “GRAS Associates is pleased to have assisted Nascent Health Sciences in realizing their goals of GRAS status...
Washington, D.C.—FDA has rejected two new dietary ingredient (NDI) notifications for full-spectrum hemp extract containing cannabidiol (CBD), one from Charlotte’s Web and one from Irwin Naturals. The Charlotte’s Web product contained 19.5mg CBD/day and the Irwin Naturals product contained approximately 65mg CBD/day. FDA’s reasoning: CBD is an approved drug, and...
