Dietary Supplement Company Slammed By FDA For Failure To Comply With CGMP
Brower Enterprises was recently hit with a warning letter from the U.S. Food and Drug Administration (FDA) that excoriates them for violating Current Good Manufacturing Practices (CGMPs). The violation of CGMPs caused a number of Brower’s products to be adulterated within the meaning of the Federal Food, Drug and Cosmetic Act (the Act). Examples of violations of CGMPs included keeping written procedures for quality control operations, holding and distributing operations, returned dietary supplements, and product complaints. Additionally, Brower failed to comply with CGMPs because it did not hold reserve samples of each packaged lot and labeled supplement that it distributed. CGMPs applicable to dietary supplements can be found at 21 CFR 111. Dietary supplement manufacturers must be aware of and comply with these regulations. Developing appropriate policies and procedures and keeping them current is vital to avoiding FDA enforcement actions and civil liability.
Furthermore, the FDA slammed Brower for marketing some of its products as intended for the use in the cure, mitigation, treatment or prevention of disease, which established the products as drugs when they were not approved for such purpose. Companies in the dietary supplement industry must determine whether their promotional statements extend into the cure, mitigation, treatment or prevention of disease so that if they are not drugs, they are not considered to be drugs under the provisions of the Act. Dietary supplement companies should enlist experts with the appropriate experience and knowledge to determine whether advertising of non-drug products runs afoul of the Act.