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DIETARY SUPPLEMENTS


PRODUCT EVALUATION AND REGULATORY COMPLIANCE

The science in support of a role for nutrition in the maintenance of health and in the prevention of disease continues to evolve. Worldwide, regulations are in place to ensure that health claims are scientifically substantiated; that is, that they are based on evidence from well-designed human experimental studies. MEDERA understands the regulatory hurdles to health claims and can assist you with documentation and submissions. Our function is to ensure that your business complies with the Dietary Supplement Health and Education Act (DHSEA) of 1994.

Our services in this area include:

  • FTC, FDA and DSHEA compliance
  • Product formula review to determine whether it qualifies for a health claim 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

Keeping up with the ever-changing regulatory landscape and the differing pre-market requirements is challenging. Developing a well thought-out regulatory strategy is key to identifying the most efficient route to market for any product, whether you wish to gain approval in one or one hundred jurisdictions.

A good regulatory strategy will outline the scientific and technical data requirements for each market of interest, identify any data gaps that will need to be addressed prior to submission, consider time lines for approval, and set forth the best approach to ensure timely and successful product approvals.

MEDERA can provide a Free Assessment of how these regulations apply to your particular product. Simply contact us to provide information about your specific product(s). To receive our free white paper on marketing a healthcare product in U.S., please click here.