Food and Cosmetic Statutory and Regulatory Compliance Matters

OFW Law’s attorneys and advisors counsel food and cosmetic industry clients regarding compliance with a variety of statutory and regulatory requirements, guidance documents, and informal policies, including those governing:

  • Labeling and advertising claims, including triggered disclaimers
    • Nutrient content claims
    • Structure/function claims
    • Health claims and qualified health claims
    • Cosmetics claims
    • Miscellaneous descriptive claims (e.g., "organic," "natural," "fresh," "pasteurized," "GMO free," "no MSG," "gluten free")
  • Labeling representations
    • Statements of identity, including names specified by a statute, standard of identity, or established common or usual name
    • Net contents declarations
    • Nutrition information (i.e., Nutrition Facts), including format, display, and exemptions
    • Ingredients listings, including incidental additives
    • Major food allergen labeling
    • Names and places of business of manufacturers, packers or distributors (a/k/a "signature line")
    • Country of origin markings and "Made in USA" representations
    • Spices, natural and artificial flavors, colorings, and chemical preservatives
    • Percent-juice declarations
    • Warning, notice, and safe handling statements
    • Irradiation disclosures
    • Voluntary nutrition labeling at retail of raw fruit, vegetables, and fish
  • Product formulation, manufacturing, and packaging
    • GRAS (generally recognized as safe) ingredients, including GRAS self-affirmation
    • Color additives and food additives, both direct and indirect
    • Cosmetics ingredients
    • Fortification policy
    • Current good manufacturing practices (cGMPs)
    • Hazard analysis and critical control point (HACCP) systems
    • Tamper-resistant packaging
  • Mandatory and voluntary submissions
    • Nutrient content claim, health claim, and qualified health claim petitions
    • FDAMA notifications for nutrient content claims and health claims
    • "Pasteurized" notifications
    • Citizen petitions
    • Temporary marketing permit applications
    • New infant formula notifications and infant formula recall notifications
    • Establishment registrations and process filings for acidified food and low-acid food in hermetically sealed containers
    • GRAS notifications
    • Food additive and color additive petitions
    • Food contact substance notifications
    • Notices for biotechnology products and bioengineered foods
  • Bioterrorism Act
    • Food facility registration
    • Prior notice of food imports
    • Recordkeeping and records access
    • Administrative detention

Our counseling addresses strict compliance, but we also advise clients regarding enforcement risk and options for mitigating risk in areas where compliance requirements are unclear. Our primary objective is to help clients accomplish their business goals while complying with the law.

For more information about our services, contact OFW Law’s Washington D.C. offices by telephone at (202) 789-1212 or complete our online contact form. We look forward to working with you.