On May 9, 2022, FDA announced that 11 companies were illegally selling adulterated dietary supplements, and proceeded to send warning letters to the companies demanding they cease this practice.
In the week that followed, one of the manufacturing companies, Glanbia Performance Nutrition, was taken off the list, after it was determined that FDA incorrectly associated them with the products Uplift Max and Shred Her Max. The other 10 companies are Advanced Nutritional Supplements, LLC; Exclusive Nutrition Products, LLC (Black Dragon Labs); Assault Labs; IronMag Labs; Killer Labz (Performax Labs Inc.); Complete Nutrition LLC; Max Muscle; New York Nutrition Company (American Metabolix); Nutritional Sales and Customer Service LLC; and Steel Supplements, Inc.
The warning letters stated that the companies were manufacturing dietary supplements that, in some cases, contained new dietary ingredients not yet FDA approved or included unsafe food additives.
“The companies are receiving the warning letters because they are listing unapproved non-dietary supplement ingredients on their product label and using unsafe non-food product ingredients per their label as well,” says Bill Bremer, FDA compliance director for Adroit North America, a food and beverage consulting agency. Both actions constitute the sale of products as dietary supplements that are considered adulterated product by not using approved dietary supplement ingredients, adds Bremer. The use of other non-food grade (GRAS) ingredients results in an additional case of adulteration.
The dietary supplements contain what FDA believes to be ingredients that could cause potential adverse effects for consumers, with those ingredients being singled out in the letters including higenamine, 5-alpha-hydroxy-laxogenin, higenamine HCl, hordenine, hordenine HCl, and octopamine.
The warning letters (classified as 483 reports) allow 15 days for acceptance of the warning and the resolution taken to remove the product from market distribution; however, FDA noted in the letters that it has not evaluated whether the unapproved products are effective for their intended use, the proper dosage, potential interaction with FDA-approved drugs or other substances, or whether they have dangerous side effects or other safety concerns.
“The FDA will monitor based on the response, while the lack of response will result in more direct response by the FDA,” Bremer says. “This is important stuff because there is too much leeway and [there are] too many companies out there making supplements that really don’t know how to make an ethically produced and distributed product.”