Dietary Supplement Industry Statutory and Regulatory Compliance

OFW Law professionals counsel clients regarding compliance with a variety of statutory and regulatory requirements, guidance documents, and informal policies of the Food and Drug Administration (FDA), Federal Trade Commission (FTC), and numerous other federal agencies. Our expertise includes the following areas.

Product Formulation, Manufacturing and Packaging

  • Dietary ingredients, including any new dietary ingredient (NDI)
  • GRAS (generally recognized as safe) ingredients, including GRAS self-affirmation
  • Color additives and food additives, both direct and indirect
  • Current good manufacturing practices (CGMPs)
  • Hazard analysis and critical control point (HACCP) systems
  • Tamper-evident packaging

Labeling Representations

  • Statement of identity (e.g., "_____ Supplement")
  • Net contents declaration
  • Nutrition information (i.e., Supplement Facts), including format, display, and exemptions
  • Other ingredients listing, including incidental additives
  • Food allergen labeling
  • Name and place of business of manufacturer, packer or distributor (a/k/a "signature line")
  • Country of origin marking and "Made in USA" representation
  • Warning and notice statements
  • Irradiation disclosure

Labeling Claims, Including Triggered Disclaimers

  • Nutrient content claims
  • Health claims and qualified health claims
  • Statements of nutritional support (structure/function claims)
  • Third-party literature exemption
  • Miscellaneous descriptive claims (e.g., "organic," "natural," "fresh")

Mandatory and Voluntary Submissions

  • Statement of nutritional support (structure/function claim) notifications
  • New Dietary Ingredient (NDI) notifications
  • Reports of serious adverse events
  • Facility registration
  • Nutrient content claim, health claim, and qualified health claim petitions
  • FDAMA notifications for nutrient content claims and health claims
  • Prior notice of imports
  • Citizen petitions
  • GRAS notifications
  • Food additive and color additive petitions
  • Food contact substance notifications
  • Notices for products of biotechnology

We regularly advise dietary supplement industry clients regarding enforcement risk, and options for mitigating risk in areas where compliance requirements are unclear. Our strategic objective is to help clients accomplish their goals while complying with governing laws.

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.