MANUFACTURER ALERT: FDA Takes Action Against New York Dietary Supplement Maker

On November 21, 2019, the U.S. Department of Justice (“DOJ”), at the request of the U.S. Food and Drug Administration (“FDA”), filed a complaint against ABH Nature’s Products, Inc., ABH Pharma, Inc.,, Inc. (together, “ABH”) and their owners in the U.S. District Court for the Eastern District of New York. According to the complaint, ABH and their owners allegedly manufactured, prepared, labeled, packed, held and distributed dietary supplements under conditions that failed to comply with current good manufacturing practices (“cGMP”).

Particularly, the complaint alleged that the FDA had observed several critical deviations from current good manufacturing practice regulations during its inspections of ABH’s manufacturing facility, including failures to (a) verify that certain dietary supplements met the product’s specifications for identity, purity, strength, and composition; (b) implement a production system that ensured the quality of the supplements; to include necessary information in its production records; and (c) properly review and investigate a consumer complaint. The complaint further alleged that defendants violated the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) by distributing unapproved and misbranded “new drugs” into interstate commerce. For example, as alleged in the complaint, the company made claims on product labeling that such products could be used to treat such medical conditions as cancer, heart disease, HIV and AIDS, even though the FDA had not approved those products for such uses, nor were there any published adequate and well-controlled investigations showing that such products are generally regarded as safe and effective. 

The case was resolved on December 23, 2019 by the Federal District Court entering a permanent injunction against the defendants via consent decree. The injunction requires ABH and their owners to destroy, within 15 days, dietary supplements that are in their possession, custody, or control. The injunction also orders ABH and their owners to implement several consumer safety measures before resuming the manufacturing or distribution of dietary supplements. Those measures include hiring an independent expert to inspect ABH’s facility and certify that the facility has corrected all deficiencies and implemented cGMPs. It also mandates that the defendants engage a labeling expert to review their product labeling and certify that claims on their products comply with the law.

The manufacture, sale and marketing of dietary supplements is governed by a patchwork of state and federal laws including the Federal Trade Commission Act (“FTCA”), the FDA’s Dietary Supplement Health and Education Act of 1994 (“DSHEA”) and the FD&C Act. In order to avoid legal challenges by government agencies and competitors alike it is imperative to understand the dietary supplement legal landscape and comply with the legal requirements, including the FDA’s comprehensive cGMP requirements. Frier Levitt attorneys have in-depth industry knowledge and provide representation and advice to manufacturers related to formulation, labeling, promotion and marketing of dietary supplement products. Contact Frier Levitt today if you have a legal question concerning dietary and food supplement law.