The Department of Justice (DOJ) and its federal partners are being very vocal about turning up the heat on compounders and dietary supplement manufacturers and marketers in 2016 and beyond. At a recent Food, Drug, and Law Institute (FDLI) Enforcement, Litigation and Compliance conference in Washington, D.C., Jonathan Olin, deputy assistant attorney general within the DOJ’s Civil Division, stated that DOJ in the coming year will increase its focus on compounders and dietary supplement manufacturers and marketers.
In the past few years, FDA has closely focused its attention on compounders across the nation, ever since the 2012 fungal meningitis outbreak that killed 64 people and sickened over 750 patients in 20 states resulting from violative manufacturing practices. Clearly, FDA will continue its efforts until management responsible for these facilities adhere to the recent statutory and regulatory requirements to ensure product quality and patient safety. According to its website, FDA has to date inspected over 230 compounding pharmacies and issued close to 90 Warning Letters to send a clear message to the industry that the Agency is serious about enforcing the regulations (as has been covered on this blog in previous posts here, here, and here). In addition, a spate of product recalls has followed the issuance of either FDA 483 observations or a Warning Letter to these compounders. A closer look at the Agency’s website relative to the citations listed show some firms receiving FDA 483 observations after a re-inspection from a Warning Letter; a strong indication that the industry is still grappling with meeting the regulatory requirements, which FDA clearly intends to enforce.
On another note, increasing criminal and civil actions (including Consent Decrees) have been initiated by DOJ and its federal partners against dietary supplement manufacturers and marketers. From the nationwide sweep that was conducted from November 2014 to November 2015, there have been over 100 such cases. The collaboration netted federal court cases in 18 states with participating federal partners, such as FDA, FTC, U.S. Postal Inspection Service (USPIS) and the IRS Criminal Investigation Division. Criminal and civil enforcement actions were brought against 117 individuals and entities. The DoJ actions stem from recurring failures to follow good manufacturing requirements to ensure safety and quality of product, increasing use of unapproved dietary ingredients, inclusion of undeclared drug substances in dietary supplements, unsupported medical claims, and fraud committed by management which led to adulterated and misbranded products, among other violations.
Most recently, an 11-count indictment was brought against the manufacturer of a highly popular workout and weight loss supplement with allegations that the company engaged in a conspiracy to import ingredients from China using false certificates of analysis, false labeling, withholding information on actual source and nature of the ingredients used in in its products, as well as conspiracy to commit money laundering.
The nationwide sweep also charged a number of dietary supplement manufacturers for making unsupported medical claims for the treatments of Alzheimer’s disease, herpes, arthritis, malaria, heart disease, and cancer, as well as the use of unapproved dietary ingredients. Most of these charges have resulted in Warning Letters.
FDA has also long been vigilant in pursuing dietary supplement manufacturers using unapproved dietary ingredients in their products. Warning Letters have been issued to manufacturers who use R-betamethylphenethylamine (also known as BMPEA, 2phenylpropylamine, and alphabenzylethylamine) as a dietary ingredient in the form of an extract of Acacia rigidula (leaves), Picamilon (also known as pikatropin, nicotinylgammaaminobutyric acid, nicotinylGAB), and DMBA (also known as 1,3Dimethylbutylamine, 2amino4methylpentane, AMP citrate, and 4methyl2pentanamine). These ingredients do not meet the statutory definition of a dietary ingredient. Under the FD&C Act, a dietary ingredient is a vitamin; mineral, herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances.
To make sure that manufacturers take heed, the Department of Defense (DOD) and the U.S. AntiDoping Agency (USADA) are also further collaborating in the sweep to introduce new tools with the goal of increasing the awareness to the risks by consumers, and those targeted by makers of illegal athletic performance supplements that are non-compliant and unlawful dietary supplements
2016 is guaranteed to be a record year for enforcement actions against manufacturers of these products that are not in compliance with the regulatory framework governing their manufacture and distribution. Stay tuned!