Dietary Supplements – FDA Regulatory Compliance Consultants

Our services for dietary supplement regulatory affairs include

dicentra provides FDA regulatory consulting for U.S. companies involved in the selling or manufacturing of dietary supplements. We work to ensure that your business complies with the 1994 amendments to the Dietary Supplement Health and Education Act (DHSEA) and that you are well informed about the latest changes to FDA regulatory affairs.

Our services for dietary supplement regulatory affairs include:

  • FTC, FDA and DSHEA compliance
  • Product formula review and classification
  • Guidance on all aspects of labeling, marketing and advertising
  • Development of the Supplement Facts box
  • Structure/Function claim development and substantiation
  • Guidance on New Dietary Ingredients (NDI) and Old Dietary Ingredients (ODI)
  • Filing of FDA notifications
  • Consulting on GRAS classification and development
  • Quality assurance and product testing review
  • Guidance on Adverse Event Reporting (AERs)
  • Ongoing liaison with government agencies and client representation

Your Dietary Supplement Consultant of Choice

We are active and heavily involved members of the American Botanical Council (ABC), American Herbal Products Association (AHPA), Consultants Association for the Natural Products Industry (CANI), Council for Responsible Nutrition (CRN), Direct Sellers Association (DSA), and the Natural Products Association (NPA). We are the forefront of the dietary supplement industry and have become regarded as a leading FDA regulatory consultant.