Silver Spring, MD—FDA has announced in a letter of enforcement discretion that it does not intend to object to the use of certain qualified health claims regarding the consumption of magnesium and a reduced risk of high blood pressure, providing that the claims are appropriately worded to avoid misleading consumers...
Washington, D.C.—The Council for Responsible Nutrition (CRN) has responded to FDA’s November 2021 letter regarding CRN’s citizen petition on NAC. Background: As WholeFoods has previously reported, FDA issued warning letters in July 2020 asserting that NAC has been previously approved as a drug in 1963, and therefore is not a...
Silver Spring, MD—FDA has granted a citizen petition on acacia (also known as gum acacia, or gum Arabic), and has proposed that acacia be included as part of FDA’s definition of dietary fiber. The citizen petition in question was submitted by Nexira, Alland & Robert, and Importers Service Corporation. Dietary...
As we head into 2022, the natural products industry, like others, is trying to return to some semblance of normalcy. One must ask though, is that retro-normal realistic, or have we entered totally uncharted ground? We suspect the latter, and know that the cycle between prediction and outcome has never...
We’ve long had a history in this industry of unscrupulous and sometimes downright shady operators being able to blend in on store shelves and with consumers. These companies take advantage of clever marketing and positioning opportunities, as well as a lack of needed transparency. This makes it extremely difficult to...
The World Health Organization (WHO) has decided against a critical review and subsequent scheduling of kratom, according to the WHO Expert Committee on Drug Dependence (ECDD) Summary assessments, findings, and recommendations. The ECDD looked at seven substances: Brorphine, Metonitazene, Eutylone, 4F-MDMB-BICA, Benzylone, Kratom, and Phenibut. The first two were added...
Washington, D.C.—The Natural Products Association (NPA) announced that it has filed a lawsuit against the Food and Drug Administration (FDA). At issue: the status of N-acetyl-L-cysteine (NAC). NPA is requesting that FDA "cease its unlawful retroactive application of the Food, Drug, and Cosmetic Act" against NAC. As WholeFoods has previously...
Washington, D.C.—The Council for Responsible Nutrition (CRN) has expressed disappointment with FDA’s response to its citizen petition about the status of N-acetyl-L-cysteine (NAC) as a legal dietary supplement. The petition, as WholeFoods previously reported, was filed in June 2021 following several meetings with FDA leadership. While NAC has been marketed...
Blackstone Labs LLC and two of its executives have pleaded guilty to conspiring to sell illegal anabolic steroids and other unlawful products marketed as dietary supplements, according to an announcement from the Department of Justice. “Dietary supplements are regulated to protect the health of American consumers,” said Acting Assistant Attorney...
Washington, D.C.—Several industry associations have reacted to the nomination of Robert M. Califf, M.D., for commissioner of FDA. As WholeFoods has previously reported, Dr. Califf is a Cardiologist who teaches at the Duke University School of Medicine. He served briefly as FDA Commissioner at the end of Barack Obama’s second...
