*This is the first in a two-part series on the regulatory road ahead for life sciences companies. Our next post examines developments in animal health, drugs, medical devices, and tobacco.
In 2015, the FDA unleashed a surge of new regulations on the food industry carrying key compliance deadlines in 2016. As the FDA continues to intensify its enforcement over its regulated industries, food companies should prepare now to manage their risk by developing and implementing a set of strict compliance programs to avoid enforcement action.
Setting the stage for 2016
Recapping 2015, the year was one of the most active ever in terms of food-safety regulation, which was set into motion by a 2014 consent decree forcing the FDA to speed up its implementation of the Food Safety and Modernization Act (FSMA).
Among the most notable developments were five FSMA-related Final Rules published in the last quarter of 2015:
- Final Rule for Preventive Controls for Human Food
- Final Rule for Preventive Controls for Animal Food
- Final Rule on Produce Safety
- Final Rule on Foreign Supplier Verification Programs for Importers of Foods for Humans and Animals
- Final Rule on Accredited Third-Party Certification
In addition, the FDA issued proposed Rules on changes to nutrition facts labels and released other guidance documents, including a finding that trans fats are not “Generally Recognized as Safe” for human food.
Each of these new Rules and guidance outline a more stringent set of regulations to which both human and animal food companies will need to quickly adapt. This will require the industry to develop and implement extensive compliance programs, as well as providing training for employees.
A taste of what’s ahead
What follows is a rundown of expected actions in 2016 for which the food industry should be on alert:
- The beginning of the FDA’s “FSMA Implementation Phase 2,” which focuses on designing strategies to promote food industry compliance with FSMA rules.
- A continuing FDA crackdown on dietary supplement manufacturers, distributers and retailers, with a focus on unapproved dietary ingredients.
- An increased frequency in inspections of domestic food facilities based on the risk posed by the facility. Thus, facilities with histories of compliance issues or those that handle foods that are particularly susceptible to contamination should be especially prepared.
- New FSMA guidance further explaining the implementation of preventive control rules (for humans and animals) including:
- Environmental monitoring
- Food allergen controls
- Validation of process controls
- The use of human food byproducts for use as animal food
- A small entity guide
- Hazard Analysis and Risk-Based Preventive Controls
- New guidance on current Good Manufacturing Practices (cGMPs) and how they differ from the ones they replace (currently in 21 C.F.R. § 110). Implementation is expected fairly quickly under these new cGMPs.
- The full implementation of the FDA FSMA Technical Assistance Network, a group of FDA regulators working with third-party scientists, universities and industry members to serve as a contact for the industry as FSMA enforcement begins.
- The finalization and publication of two proposed Rules: “The Sanitary Transportation of Human and Animal Foods” and “Focused Mitigation Strategies to Protect Food Against Intentional Adulteration.”
- Enforcement of the FDA’s new Rules requiring calorie disclosure on restaurant and vending machine foods by December 2016.
- Increased monitoring of domestic and imported food recalls, along with a review of the FDA’s internal processes for recalls and monitoring.
Food companies, including those that manufacture ingredients to be used in final products, must be doing more than just thinking about the impact of these regulations. Instead, they should be drafting a plan for compliance and thinking through the implementation of these plans. The time is fast approaching when the FDA will commence inspections and subsequent enforcement actions.
Our life sciences practice has developed a template for our clients to follow in staying up-to-date and in compliance with all of the food regulatory changes that will roll out this year. If you or others at your company would like to discuss the best way to manage these changes and best practices in developing compliance programs, please contact Thompson Coburn LLP partner Diane Romza-Kutz. Our life sciences practice has decades of experience working with FDA-regulated industries and interfacing with the agency.
Diane Romza-Kutz is a partner in Thompson Coburn's Health Law Practice Group.