FDA Announces Enforcement Discretion for Food-Contact Substance Compliance with FSVP
The U.S. Food and Drug Administration (FDA) announced January 4, 2018, that it intends to exercise enforcement discretion with respect to requiring importers of food-contact substances to comply with the Foreign Supplier Verification Program (FSVP) regulations. The FSVP was promulgated by FDA to implement the FDA Food Safety Modernization Act (FSMA). (For further background on the FSVP, see the PackagingLaw.com article, FSMA Final Foreign Verification Rule Includes Food-Contact Materials.)
The goal of the FSVP rule was to ensure the use of processes and procedures by foreign suppliers of food additives and ingredients to provide the same level of public health protection as required by domestic suppliers.
The FSVP requires importers of covered products, which include food-contact substances, such as finished packaging material, or components of such materials, to undertake the following tasks:
- Analyze the hazards of the imports;
- Evaluate the performance of potential foreign suppliers and the risks posed by imported products; and
- Determine and conduct appropriate activities to verify that foreign suppliers' products are not adulterated or misbranded.
Now that FDA has decided that such tasks are not necessary
in light of the characteristics of such substances and the Agency's existing premarket review and oversight programs, importers of such products will NOT be required to meet these regulatory mandates. Such products, however, still must comply with the adulteration requirements of the Food, Drug, and Cosmetic Act, which means, among other things, that they must not be deleterious or harmful to human health and they must comply with FDA premarket clearance requirements, or be exempt from such requirements.
More information on FDA's enforcement discretion policy for food-contact substances can be found here.