On November 17, the US Department of Justice (DOJ) announced its pursuit of civil and criminal cases against more than 100 dietary supplement companies over the past year. Other than reminding us that consumer protection law has a criminal component, what was notable about this announcement was the level of cross-agency collaboration. The sweep included coordination with the FDA, FTC, United States Postal Inspection Service, IRS, Department of Defense, and the US Anti-Doping Agency. As plainly stated in the DOJ’s press release, these federal agencies “joined forces” to enforce federal law.
The DOJ’s announcement further evidences the increased cross-agency collaboration occurring in the federal government’s regulation of consumer products. Some partnerships have been foreseeable. For example, the FDA and FTC continue to collaborate on issues related to the promotion of health-related products (e.g., coordination regarding misbranded dietary supplements/misleading advertising and unapproved new drugs, the regulation of homeopathic products (see here and here), and the sale of caffeinated alcoholic beverages (see here and here)). The FTC and Federal Communications Commission recently signed a memorandum of understanding formalizing their existing cooperation on consumer protection efforts related to telecommunication services. And various agencies partner with U.S. Customs to block the import of products that reflect enforcement priorities (see here).
Other, less obvious partnerships, have arisen as well. A great example is FDA’s January 2014 guidance document forewarning companies that FDA may consider statements made in filings with the US Securities and Exchange Commission or the US Patent and Trademark Office to determine whether a product is a dietary supplement versus a conventional food for purposes of FDA regulation. Companies often are also surprised to learn that the US Postal Inspection Service plays an active role in the government’s efforts to prevent the sale and distribution of deceptively marketed products through the mail fraud statute. Simply put, the agencies are talking to each other (and could be talking about your company).
In the wake of the government’s strengthened commitment to cross-agency collaboration, it is increasingly important for consumer product companies to ensure that they are implementing a similar cross-disciplinary strategy for the development, marketing, distribution, and sale of their consumer products. It is no longer prudent to apply a siloed approach to the regulatory review of a product’s life cycle (e.g., using separate counsel for patent filings, formulation selection, and label review without coordination). Instead, information provided to the government should be shared with a multi-disciplinary team to ensure its contents are considered at each touchpoint of a product’s life cycle with a government agency. Now’s the time to ensure you have the right legal/regulatory “Dream Team” to manage the risk for your company and ensure that your company benefits from teamwork too.