Gaitan Law Group represents manufacturers, importers, processors and distributors of cosmetic products, to insure compliance with FDA and FTC requirements as well as other applicable law. We advise clients on issues pertaining to:
- Cosmetic product labeling
- Cosmetic ingredients
- Cosmetic product claims
- Descriptive cosmetic claims (e.g., “organic,” “natural”)
- Cosmetic advertising, promotional literature and websites
With the passing of the Dietary Supplement Health and Education Act (DSHEA) in October 1994, the FDA created a new regulatory framework for the safety and labeling of dietary supplements. Our attorneys counsel clients regarding compliance with the statutory and regulatory requirements, affecting the manufacturers, importers, processors and distributors of dietary supplements, including:
- Dietary supplement product labeling
- Supplement facts panels
- Dietary ingredients
- Structure/function claims
- Third-party literature
- Major food allergen labeling
- Bioterrorism Act preparedness
- Food advertising, promotional literature and websites
- Food facility registration, and acting as U.S. agent for foreign facilities
Over-the-Counter (“OTC”) Drugs
Gaitan Law Group provides legal counsel regarding every aspect of the regulatory process related to bringing an OTC drug product to market, including:
- OTC drug product labeling
- OTD drug ingredients
- Drug facts panels
- Health claims
- Drug facility registration
- Drug product listing
- Florida wholesale drug distribution requirements
- OTC drug advertising, promotional literature and websites
Gaitan Law Group provides legal counsel to growers, manufacturers, importers, processors and distributors of food products, to ensure compliance with the regulations of the FDA,USDA, EPA, and FTC, among others. We counsel clients on issues relating to conventional, functional and medical food products, including:
- Food product labeling
- Nutrition facts panels
- Food ingredients
- Food allergen labeling
- Nutrient content claims
- Qualified health claims
- Descriptive food claims (e.g., “organic,” “natural.” “pasteurized” “fresh” “healthy”)
- Juice labeling
- Bioterrorism Act preparedness
- Food advertising, promotional literature and websites
- Food facility registration, and acting as U.S. agent for foreign facilities
With over 35 years combined experience in the health care sector, we have the industry background and legal knowledge necessary to resolve the complex and highly regulated issues that face medical providers and suppliers. The law firm of Gaitan Law Group helps clients in all different sectors of the health care industry, including:
- Medicare and Medicaid Providers and Suppliers
- Physicians, dentists, therapists, health care clinics, home health agencies, rehabilitation facilities (ORF or CORF), Community Mental Health Centers and Partial Hospitalization Programs (PHP), pharmacies, nursing homes, assisted living facilities (ALF), independent diagnostic testing facilities (IDTF), medical device companies
- Medical Device Manufacturers and Distributors