On October 21, 2013, the U.S. Food and Drug Administration (“FDA”) announced that it is seeking a permanent injunction against James G. Cole, a dietary supplement manufacturer based in Oregon, along with the company’s president, James G. Cole, and general manager, Julie D. Graves. The complaint was filed on the FDA’s behalf by the U.S Department of Justice. If granted, the permanent injunction would prohibit James G. Cole from marketing and distributing its products until it complies with Current Good Manufacturing Practice (“cGMP”) requirements for dietary supplements and removes all unapproved drug claims from its product labels and websites. You can read the announcement here.
The FDA is targeting James G. Cole for unlawfully marketing its dietary supplements as unapproved drugs in violation of the Federal Food, Drug, and Cosmetic Act (“FDCA”). More specifically, the FDA is alleging that the company makes “drug claims” on its website and product labeling by promoting its dietary supplements as treatments for serious medical conditions such as cancer, heart disease, and arthritis. Under the FDCA, any product sold as a dietary supplement and promoted as a treatment, diagnosis, cure, or prevention of a disease or condition loses its status as a dietary supplement and is considered a new drug. Unlike drugs, the labeling of dietary supplements are only allowed to contain health claims, structure/function claims, and nutrient content claims, as permitted by FDA regulations.
Additionally, the FDA alleges that at the James G. Cole facility, the agency found serious violations of the cGMP requirements for dietary supplements, which are published in Title 21 of the Code of Federal Regulations, Part 111. These requirements mandate that any person who manufactures, packages, labels, or holds a dietary supplement establish and follow current good manufacturing practice to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled in compliance with the master manufacturing record. FDA argues that in violation of these regulations, James G. Cole did not establish an “identity specification” for each component in its dietary supplements and did not conduct at least one appropriate test to verify the identity of a dietary ingredient.
In sum, failure to comply with the laws and regulations pertaining to dietary supplement labeling and manufacturing operations can have serious consequences, including the halting of distribution altogether. Accordingly, it is important to establish compliance with the laws and regulations enforced by the FDA in order to avoid costly delays and stoppages. If you have any questions about compliance with dietary supplement regulations or other laws enforced by the FDA, please contact us at: firstname.lastname@example.org.