Recently, the U.S. District Court for the Eastern District of New York (at the request of the U.S. Food and Drug Administration (“FDA”)) enjoined three companies and their owner from distributing and manufacturing adulterated and misbranded dietary supplements in violation of the Food Drug and Cosmetic Act (“FDCA”). An earlier complaint related to the violative activities alleged that the owner and the companies manufactured dietary supplements without establishing product specifications for finished batches and without testing the finished batches. The allegations also indicate that the companies did not test ingredients to confirm their identity before incorporating them into supplements. The companies’ facilities were inspected by the FDA four times in the past seven years, and violations of FDCA were identified during each inspection. The companies and their owner were also subject to FDA warning letters in 2016, 2017 and 2019.
The Dietary Supplement Health and Education Act (“DSHEA”) of 1994, which amended the FDCA, defines the term “dietary supplement” in part as a product intended for ingestion that contains a “dietary ingredient” intended to supplement the diet. “Dietary ingredients” include vitamins, minerals, herbs and other botanicals, amino acids, and “dietary substances,” which include enzymes, probiotics, concentrates, metabolites, constituents, and extracts. Under the FDCA, dietary supplements are regulated as foods, not as drugs. Accordingly, they are not as rigorously regulated as drugs, which require premarket approval. However, manufacturers of supplements must ensure that they are safe, labels are truthful and not misleading, and no unapproved drug claims are made related to the supplements.
In the immediate instance, the complaint outlined reoccurring violations from 2016 through 2023, including consistent failure to verify that finished batches of dietary supplements met product specifications. These include specifications for identity, purity, strength, composition and limits on contamination that may adulterate, or lead to adulteration, of finished batches. Furthermore, based on the claims made on the supplements’ labels and companies’ websites, the products were considered unapproved and misbranded drugs pursuant to the FDA’s rules regarding marketing and claims associated with products. The companies additionally failed to include adequate directions for safe use of multiple products.
As part of the action, the Acting Associate Commissioner of the FDA’s Office of Regulatory Affairs emphasized that the FDA is committed to taking action against adulterated dietary supplements. In light of recent enforcement and FDA’s statement in connection with this matter, manufacturers and distributors of dietary supplements are cautioned to ensure that they are adhering to their obligations under FDCA, which may be less onerous than drug manufacturing compliance, but nevertheless must be adhered to. Moreover, third parties using contract manufacturers or otherwise white labeling dietary supplements must be aware of their subcontractors’ compliance with FDCA and what liability this can create for them. Contact Frier Levitt for assistance understanding compliance requirements, reviewing contractual obligations, or evaluating and mitigating risk in connection with the manufacturing or distribution of dietary supplements.
