On December 8 and 9, 2014, the Food and Drug Law Institute (FDLI) held its annual Enforcement, Litigation & Compliance Conference in Washington, D.C. Speakers from the U.S. Food and Drug Administration (FDA), Department of Justice (DOJ), and other federal agencies, as well as representatives from industry and the private bar, discussed recent activity and predictions for federal regulation of food, drugs, medical devices, cosmetics, dietary supplements, and tobacco in 2015.
- Several speakers talked about FDA’s restructuring efforts and how that will change the way the agency functions.
- Several FDA representatives explained that this is being driven in part to maximize resources and to re-align the various Centers with the Office of Regulatory Affairs (ORA), to build expertise, create sector-specific groups, and better coordinate inspection and enforcement efforts. It was predicted that generalist FDA inspectors will be a thing of the past and that there will be commodity-specific inspectors who have real time access to scientists during inspections. It was noted that this new approach may pose some challenges for FDA, which has traditionally functioned in silos.
- Panelists expressed hope that the changes will lead to more uniformity in FDA’s inspections and enforcement and will, for example, result in less strategic port-shopping by importers.
- The implementation of the Food Safety Modernization Act (FSMA), signed into law in 2011, continues to be an important area of focus. Several recently proposed supplemental FSMA rules are expected to be finalized in 2015, consistent with the judicial consent decree mandating deadlines for FSMA rulemaking. One panelist observed that a challenge for FDA in formulating rules is addressing the ambiguity in FSMA’s terms and to develop policies that are adequate for a heterogeneous food industry.
- Crowell & Moring partner John Fuson spoke about private enforcement actions relating to FDA-regulated products, focusing on the spate of litigation over “natural” food claims in courts across the country and looking at where the private plaintiffs’ bar is setting a new, heightened standard of care for regulated industry.
- Technical advances have enabled more precise targeting of FDA enforcement. The Center for Food Safety and Applied Nutrition (CFSAN) cited the availability of tools like genome sequencing that can now be used to detect foodborne illnesses in a more timely and cost-effective manner.
- There were discussions throughout the conference about the overlap of jurisdiction between the FDA and other federal agencies, such as DOJ, the Federal Trade Commission (FTC), and the Consumer Product Safety Commission (CPSC).
- In certain instances, the CPSC and FDA regulate different aspects of the same product. In most cases, the agencies work together to achieve regulatory goals, with one taking the lead, depending on the issue. A recent example involving laser pointers was discussed, with FDA and CPSC coordinating to identify and investigate the problem and then involving Customs and Border Protection (CBP) to stop the products at the border.
- The FTC and FDA are both interested in enforcement of unsubstantiated marketing claims made about drugs, devices, and dietary supplements, among other products. Mobile applications involving health claims and the social media presence of FDA-regulated firms were both discussed as recent areas of joint interest by the FTC and FDA.
- A representative from DOJ’s Consumer Protection Branch commented that it has been opening lines of communication about FDA enforcement matters in which it may become involved at earlier stages in the process.
- Import controls are as important as ever given continuing growth in international manufacturing of FDA-regulated goods. At the border, CBP and FDA work closely to implement the appropriate risk-based controls to identify and stop dangerous products. Speakers from FDA, CBP, and the State Department described efforts to implement safeguards early in the supply chain, often working with entities abroad and coordinating with foreign governments to identify unsafe and violative products early.
For additional information about the conference for FDA, please contact John Fuson or Natalia Medley.