FDA’s authority over food, dietary supplements and beverages is embodied primarily in the Federal Food, Drug, and Cosmetic Act (FDCA), Nutrition Labeling Enforcement Act (NLEA), Public Health Security and Bioterrorism Preparedness and Response Act (BTA), and the Food Safety Modernization Act (FSMA), among others. The FDA’s Center for Food Safety and Applied Nutrition (CFSAN) enforces the numerous complementary laws affecting the distribution, marketing and importation of food, dietary supplements and beverages in the U.S. market, assuring that the U.S. food supply is safe, sanitary, wholesome, and properly labeled. At Gaitan Law Group, our FDA food attorneys are well-versed in FDA food laws and their applicability to the global marketplace.
The FDA compliance attorneys at Gaitan Law Group provide a broad range of business and regulatory compliance legal services to clients engaged in manufacturing, producing, packaging, importing and marketing of food, dietary supplements and beverages.
Our FDA food attorneys are recognized for their experience and accomplishments in the many business and regulatory compliance issues affecting food, dietary supplement, and beverage firms. Through our documented experience over the years we have acquired a specialized proficiency and authority over the complex regulatory scheme that food manufacturers, producers, packers, importers and marketers face. Our leading FDA attorneys guide food, dietary supplement, and beverage firms through the requirements of the many government agencies that share jurisdiction over food, dietary supplement and beverage products, including the FDA, USDA, CBP, FTC and EPA.
Our FDA food compliance services include:
- Review of food and beverage labels for compliance with FDA’s food label format and content requirements
- Review dietary supplement labels for compliance with the Dietary Supplement Health and Education Act (DSHEA)
- Prepare and submit 30-day notifications of dietary supplements and new dietary ingredient notices
- Review of health claims, nutrient content claims, structure-function claims, and dietary guidance statements
- FDA Food facility registration submission and U.S. Agent Services
- FSMA Compliance
- Counsel on product specific requirements including Low Acid Canned Foods (LACF), Food Canning Establishment (FCE), as well as Juice and Seafood Hazard Analysis and Critical Control Points (HACCP) requirements
- USDA Organic labeling guidance and international equivalency program requirements
- USDA-APHIS Import Certificate requirements
- Advise on food and beverage safety compliance issues, including product recalls, Warning Letter responses, FDA inspections and Corrective Action Plans, Import Alert petitions, and Food Facility Registration revocations and appeals
- Counsel on FTC advertising and marketing requirements, as well as representation before the FTC and National Advertising Division of the Council of Better Business Bureaus (NAD)
- Respond to FDA Notice of Action, counsel on appropriate reconditioning options when submitting FDA Form 766 and negotiate releases of FDA detained goods
- Import and Export compliance
To speak with an established FDA attorney, e-mail Gaitan Law Group at [email protected] or call us at 786.440.8115. We offer flexible fee arrangements.