In the quest to be healthy, dietary supplements continue to be a popular option with some people but the U.S. Food and Drug Administration’s recent warnings to companies hawking such products should cause potential customers to proceed with caution.
The agency recently sent out warnings to several companies that it said did not adhere to government guidelines on dietary supplement claims and their purported benefits.
FDA warns 12 companies over dietary supplement claims
Three of the companies ran afoul of the law by making claims about phenibut, which is sometimes marketed as a sleep aid. According to the FDA, phenibut does not meet the statutory definition of a dietary ingredient.
The FDA also issued nine warning letters to companies marketing DMHA (Dimethylhexylamine or 2-aminoisoheptane) as an ingredient in numerous dietary supplements.
In April 2019, the FDA determined that DMHA, which is often marketed for weight loss and sports performance, is either a “new dietary ingredient” for which the agency has yet to receive the mandatory New Dietary Ingredient notification or is “an unsafe food additive.”
The violations ultimately mean that American consumers may be buying and using products that are not approved for consumption. It also means the remedial claims of the products are as of yet unproven.
On the FDA’s website, a dietary supplement is defined as “a dietary ingredient as a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances.”
But then there is this major distinction: “Unlike drugs, supplements are not intended to treat, diagnose, prevent, or cure diseases. That means supplements should not make claims, such as ‘reduces pain’ or ‘treats heart disease.’ Claims like these can only legitimately be made for drugs, not dietary supplements.”
Here are the FDA warning letters to the 12 companies
Warning Letters (DMHA):
- Line One Nutrition
- Iron Brothers Supplements
- Eflow Nutrition LLC
- Hi-Tech Pharmaceuticals, Inc.
- IQ Formulations, LLC / DBA Metabolic Nutrition Inc.
- Down To Earth Solutions, LLC
- Forbidden Labz
- Total Body Nutrition Labs, LLC
- Goldstar Performance Products