FDA Regulation of Food Contact and Packaging Material Services

Our client counsel includes the following:

• Regulatory Requirements -
• Determine possible pathways to market outside the FCN process
• E.g., where proposed use does not meet definition of FCS or is exempted
• E.g., where product is Generally Recognized As Safe (GRAS) or is exempted
• Center for Food Safety and Applied Nutrition (CFSAN) Submissions (Where FCN Submission Is Necessary) -
• Arrange and participate in pre-submission conferences intended to refine and limit data requirements
• Review draft notifications for sufficiency, and assist with CFSAN responses
• FDA-U.S. Environmental Protection Agency (EPA) Jurisdictional Questions -
• Advise clients on matters implicating FIFRA, which falls under EPA jurisdiction (e.g., antimicrobial substances in products)
• Federal Food, Drug, and Cosmetic Act (FFDCA) Enforcement -
• Engage in dispute resolution (e.g., stemming from factory inspections) with compliance officers
• Prepare responses to Warning Letters
• Implement corrective action plans