Reviewed labels and promotional labeling for compliance with the FDCA and its implementing regulations.
Assisted clients with various FDA enforcement initiatives, including Current Good Manufacturing Practices (CGMP) inspection product recalls, responses to Warning Letters, border detentions, seizure actions, consent decrees, and injunctions.
Reviewed advertising claims in print and electronic media (e.g., Internet and infomercials) regarding compliance with the Federal Trade Commission Act (FTCA). Represented clients before FTC state agencies and the National Advertising Division of the Better Business Bureau on false or misleading claims allegations.
Advised clients on parameters for making health claims for various traditional or functional foods.
Advised dietary supplement makers regarding proper dietary supplement claims and avoidance of drug claims identified in FDA regulations.
Advised dietary supplement makers regarding new dietary ingredient filing requirements.
Assisted clients in creating expert panels for evaluations as to the GRASE status of the product.
Assisted clients in the preparation of food additive applications.
Represented clients whose food products were contaminated with various microorganisms, such as E. Coli or Salmonella, and a client whose grain products were sprayed with unapproved pesticides.
Advised prebiotic ingredient maker on clinical testing issues and regarding formula requirements.
Expert witness regarding food labeling requirements for blended juices in private law suit.
Advised various energy drink marketers on ingredient label content and Internet issues for compliance with the FDCA and the FTCA.
Advised beer clients on various ingredient safety and adulteration issues, use of genetically modified yeasts in the manufacturing process; Bureau of Alcohol, Tobacco, Firearms, and Explosives (BATF) label warning requirements; and EPA issues regarding the use of chlorofluorocarbon (CFC) as a refrigerant.
Advised foreign beer maker regarding contaminated agricultural ingredient and its regulatory impact.
Advised several clients on medical food regulatory criteria and FDA enforcement.