FDA Initiates Enforcement Against Dietary Supplement Manufacturer
On November 23, 2011, the U.S. Food and Drug Administration (FDA) announced the initiation of enforcement measures against a dietary supplement manufacturer, charging the company with several violations of the Federal Food, Drug and Cosmetic Act (FDCA). The FDAs complaint seeks a permanent injunction aimed at preventing ATF Fitness Products, Inc. (ATF) from continuing to sell its products. The complaint alleges that over 400 of ATFs dietary supplement products are in violation of the FDCA.
While this suit was recently instituted against ATF, the Complaint shows how the company has been on FDAs radar since 2004. According to FDA, ATF has “a long history of violating the Act.” In March 2004, FDA issued a Warning Letter to the Company in connection with its distribution of an adulterated dietary supplement. Later, in November 2004, FDA issued another Warning Letter, citing the president of ATF for the distribution of adulterated dietary supplements. Finding that ATF was not taking proper corrective actions to remedy these violations, the warnings ultimately culminated in a seizure action in 2006, detailed here. The most recent FDA action began after a FDA inspection conducted in March-April 2011 revealed several deviations from FDAs current good manufacturing practices (cGMPs). In particular, FDA found that several ingredients and products were being substituted during the manufacturing process without the changes being reflected in product labeling.
In addition to cGMP violations, FDAs inspection also revealed that ATF failed to report serious adverse events. Under 21 U.S.C. § 379aa-1, manufacturers of dietary supplements are required to notify the FDA within 15 days of learning of a serious adverse event. A serious adverse event is defined under the Act as an event that results in:
(i) death; (ii) a life-threatening experience; (iii) inpatient hospitalization; (iv) a persistent or significant disability or incapacity; or (v) a congenital anomaly or birth defect.
21 U.S.C. § 379aa-1(a)(2).
According to the FDA, ATF received a complaint that one of its customers had experienced a spike in blood pressure and mild heart attack, requiring hospitalization. Despite having received this complaint in July 2010, ATF did not report this event, resulting in what FDA claims was another violation of federal law.
Given the past violations of the FDCA and the several deficiencies discovered upon the recent inspection, FDA ultimately instituted the present action against ATF. While warning letters are not uncommon, the remedial measures that companies take in response to them are often determinative of how the FDA will proceed.
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