On August 8, 2014, the U.S. Food and Drug Administration (“FDA”) obtained a court order from the United States District Court for the Middle District of Georgia against a dietary supplement manufacturer. The Order prohibits the manufacturer from selling dietary supplements until they comply with FDA good manufacturing regulations and other applicable, federal requirements. In addition to purported manufacturing deficiencies, the Company, BioAnue, sold dietary supplements that were marketed as treatments for common diseases, causing the FDA to deem these products to be unapproved new drugs. The FDA’s announcement can be found here.
BioAnue received a warning letter from the FDA on February 9, 2012, alerting the Company to what the FDA argued were numerous violations of FDA regulations. The Warning Letter can be found here. According to the FDA’s recent action, BioAnue not only failed to respond directly to the warning letter, the Company also failed to correct the violations highlighted in the Warning Letter. After having received the Warning Letter, the FDA conducted a follow-up inspection in August 2012, which, according to the FDA, revealed that BioAnue was still in violation of the FDA’s current good manufacturing practice requirements for dietary supplements and other regulatory requirements. More information about good manufacturing practices and the applicability of these practices to the dietary supplement industry can be accessed here.
In addition to FDA’s Good Manufacturing Practices, the FDA initially targeted BioAnue with a Warning Letter because they sold products that were marketed for use in the cure, mitigation, treatment, or prevention of disease. Marketing a dietary supplement for these uses causes dietary supplement products to be deem “drugs”, as defined in section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act found at 21 U.S.C. § 321(g)(1)(B). However, dietary supplements can be sold without being classified as “drugs” as long as they are not marketed with disease claims and instead are marketed with at most, structure-function claims or other permitted health claims. More information about structure-function claims may be accessed on the FDA’s website. However, it must be noted that sometimes the difference between a structure-function claim and a disease claim is not a bright line and even slight changes in wording can cause an otherwise permissible claim to be deemed a disease claim by the FDA.
We always stress the importance of responding to FDA warning letters with timely and adequate remedial measures, including resolving the issues cited in the letters, as well as promptly communicating with the FDA. You can read more about FDA warning letters and the importance of responding appropriately thereto here. FDA warning letters may be a serious threat to business, as seen in this case, where lack of response ultimately may be seen as prompting increased enforcement. Accordingly, it is possible that responding to a FDA warning letter can be the difference between maintaining business operations and being prevented from selling or marketing FDA-regulated products, as with the issuance of a permanent injunction. For more information about cases involving warning letters, please read some of our previous blog posts here.
If you have any questions about FDA labeling rules, warning letters, or compliance with FDA regulations pertaining to dietary supplements, please contact us at email@example.com.