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Corporate

Food, Beverage, and Dietary Supplements

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Whether it is human and animal foods, functional foods, beverages, nutraceuticals, or dietary supplements, we have the extensive experience you need for dealing with the FDA, the United States Department of Agriculture (USDA), FTC, and other relevant agencies. Our attorneys can assist you with:

  • Reviewing health claims, nutrient content claims, structure-function claims, and dietary guidance statements
  • Reviewing nutrition and organic labeling
  • Monitoring compliance with USDA and CBP country of origin labeling requirements
  • Representing you in FTC proceedings (e.g., advertising claims under the Lanham Act, as well as in proceedings before the National Advertising Division of the Council of Better Business Bureaus)
  • Handling food and beverages safety compliance issues, including product recalls, cGMPs, FDA inspection procedures and warning letters, and conducting safety assessments of food and beverage additives and ingredients
  • Monitoring compliance with the FDA’s Hazard Analysis and Critical Control Points programs
  • Monitoring compliance with the 1994 Dietary Supplement Health and Education Act (DSHEA), including advising you on general labeling and advertising issues, nutrition labeling, and evaluation of permissible claims (e.g., health claims, nutrient content claims, and structure-function claims)
  • Monitoring compliance with cGMP guidelines
  • Preparing and submitting notifications of new dietary ingredients

We can advise you on pathway issues related to the approval and marketing of direct and indirect food and beverage additives, as well as dietary ingredients for dietary supplements in the United States and a number of major international markets, including the EU, Latin American, and the Asian/Pacific regions. With your end goal as a guideline, our attorneys and scientific staff will collaborate on projects concept to commercialization. In addition, we provide strategic advice on the content and business implications of such relevant initiatives as the EU’s REACH control policy. Other services that may be of interest to your business include:

  • Counseling on approval pathways for food and beverage additives
  • Obtaining FDA approval for the use of new food and beverage additives 
  • Preparing and submitting food and beverage additive petitions and notifications establishing that an additive is Generally Recognized as Safe (GRAS)
  • Analyzing GRAS status for food and beverage additives
  • Counseling on the regulatory compliance of substances used in food and beverage packaging and processing equipment
  • Preparing and submitting food and beverage contact notifications
  • Analyzing GRAS status for food and beverage packaging materials and components of packaging materials
  • Evaluating proposed ingredients for compliance with DSHEA
  • Determining whether a proposed dietary ingredient is subject to DSHEA’s new dietary ingredient notification requirements
  • Preparing pre-market notifications for new dietary ingredients
  • Counseling on dual pathway strategies for dietary ingredient/supplement approval in combination with food and beverage additive or drug approval
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