FDA Warns Supplement Companies for Disease Claims, cGMP Violations
In today’s regulatory climate, where FDA, FTC, state attorneys general, industry self-regulatory organizations, class action lawyers, and even individual U.S. Senators are leading a patchwork of crusades against dietary supplement companies, it is vital to keep up to date with the latest enforcement efforts and trends. Every two weeks, we send out an email that gives a brief synopsis of enforcement actions in the dietary supplement space (we never share our subscription list, and you can opt out at any time at the bottom of each email). Staying apprised of enforcement trends in the industry, from FDA warning letters to FTC false advertising allegations, can help you to stay above the fray and off of the regulatory radar. Learning from others’ mistakes is cheaper than learning firsthand what kinds of practices and violations lead to enforcement.
Here are the recent enforcement actions taken against purportedly non-compliant dietary supplement companies, and the claims made against them:
On July 29, FDA sent a warning letter to Prime Health Products citing a host of violations of the Food, Drug, and Cosmetic Act. Because of their claims, FDA states that the products are unapproved new drugs/misbranded drugs. The products are promoted for conditions like gallbladder problems, sleep disorders, arthritis, allergies, and kidney stones. Next, FDA writes that even if the products were not unapproved new drugs, they would be adulterated dietary supplements because they were not produced in compliance with GMPs. Further, they would be misbranded supplements because of a number of labeling violations, including not listing a U.S. address or phone number through which a responsible person can receive a serious adverse event report, not bearing nutrition labeling in the form of a supplement facts panel, and failing to declare a serving size, among other errors.
In a July 31 FDA warning letter to Ten Ren Tea Company of San Francisco, Ltd., FDA restates its position that it is “not aware of any basis to conclude that Stevia leaf is GRAS [Generally Recognized as Safe] for use in conventional foods,” which makes the ingredient an “unapproved food additive” and foods containing the ingredient “adulterated.” FDA states that the literature reports on whole-leaf Stevia or its crude extracts have raised safety concerns about the ingredient, including “control of blood sugar, and effects on the reproductive, cardiovascular and renal systems.” FDA writes that the Ten Ren tea products are adulterated because they contain Stevia leaf.
However, it should be noted that there are many Stevia ingredients that are GRAS for use in food, including thirty-five with notices filed on FDA’s GRAS Notices webpage. FDA had “no questions” regarding any of these filings. Further, other firms have self-affirmed the GRAS status of Stevia ingredients without notifying FDA.
On July 31, R Thomas Marketing received an FDA warning letter for selling unapproved new drugs/misbranded drugs. According to FDA, the products, “Black Ant,” “Herb Viagra,” “Stree Overlord,” and “Real Skill,” not only have disease claims on their labels (for example, “[Stree Overlord] can also treat those (sic) sexual impotence caused by diabetes, etc.”), but also contain sildenafil, the active pharmaceutical ingredient in Viagra™.
On August 7, FDA sent a lengthy warning letter to New Dawn Nutrition, Inc. Echoing a number of letters it mailed earlier this year, FDA warns New Dawn for selling products containing DMBA (also known as AMP Citrate). Interestingly, DMBA was not declared on the product’s label, but DMAA was. FDA states that its tests showed that the product did not contain DMAA. Next, FDA alleges that the brand’s products are adulterated because they were not produced in compliance with GMPs. Even though the brand contracted its manufacturing to another entity, as the marketer of its supplements, it (and not its manufacturer) is ultimately responsible for complying with GMPs. Finally, FDA writes that New Dawn’s products are misbranded for a variety of reasons. Most notably, FDA claims that a protein product contained as little as 11% of the amount of protein declared on the label. And FDA reports that a product’s sugar content was as much as 1,814% higher than reported on the label.
On August 5, Tayfun Karauzum was sentenced to five years in federal prison for making and selling a product called Potion 9. Potion 9 contained butanediol, “an industrial solvent that rapidly metabolizes into gammahydroxybutyric acid (GHB) – commonly referred to as a ‘club drug’ or ‘date rape drug.’ ” Karauzum’s efforts resulted in the manufacture of almost 13.5 million milliliters of Potion 9. Earlier this year, Karauzum pleaded guilty to one count of conspiracy to misbrand a product for human consumption and one count of money laundering. An FDA taskforce and the U.S. Attorney’s Office for the District of Rhode Island spearheaded the investigation, with assistance from the U.S. Postal Inspection Service and IRS Criminal Investigation.
On August 17, the U.S. District Court for the Northern District of Iowa entered a consent decree permanently enjoining Iowa Select Herbs LLC and its two co-owners from producing and distributing its unapproved, adulterated, and misbranded products, and requiring them to recall the products. The defendants are not allowed to resume manufacturing or distributing any supplements or drugs without FDA approval. Iowa Select Herbs had marketed its products with claims that they could treat cancer, malaria, herpes, heart disease, and other medical conditions. These claims made what would be “supplements” into “drugs.” Moreover, the products were not made in compliance with GMPs, making them adulterated. The consent decree stems from Iowa Select Herbs’ failure to address these same concerns that FDA raised in a warning letter in 2014.
If you have a dietary supplement company and have any questions about your responsibilities under the law, including label claims, labeling requirements, advertising review, Good Manufacturing Practices, or anything else, give us a call anytime at 516-294-0300.