Health Claim Substantiation Assessment & Product Development

Health Claim Substantiation Assessment and Product Development is a core service that is offered by dicentra. We not only employ qualified professionals who are educated and experienced in the Human Health Sciences, but have also developed our own comprehensive and regularly updated database, currently populated by thousands of full-text research papers. This puts us in a unique position when it comes to serving our clients in the area of product development and health claim evaluation for dietary supplements.

The Food Drug and Cosmetic Act (FDCA), as amended by the Dietary Supplement Health and Education Act of 1994 (DSHEA) require that all claims related to dietary supplement labeling (including labels, website and other marketing or promotional materials at the point of sale) have scientific substantiation and that the claims are truthful and not misleading. This means that a dietary supplement distributor or manufacturer must have, at the time the claim is made, competent and reliable scientific evidence to substantiate all claims in its possession.

Our services in Health Claim Substantiation Assessment and Product Development include:

  • New product formulations
  • Substantiation of health claims
  • Substantiation for structure/function claims
  • Development of safety and toxicological profiles
  • Development of Product Monographs for consumers and professionals
  • Scientific and medical writing

Failure to have the required substantiation in your possession could result actions brought by the FDA, the FTC, or class action plaintiffs to name just a few, seeking damages in the amount of not only gross sales, but also punitive damages and criminal penalties.