Next Upcoming Seminar: Implementing SQF 8.0 Systems – May 17-18, 2017

Specializing in FDA Regulatory Matters

Dietary Supplement Labeling and Claims

With the amendment in 1990 of the Nutrition Labeling and Education Act, the requirement for dietary supplements to have nutrition facts labels created a new era of transparency and safety for the industry. It was further enhanced by the Dietary Supplement Health and Education Act of 1994 (the DSHEA), which further defined dietary supplements and added specific labeling requirements for them as well as optional labeling statements and by subsequent amendments requiring the addition of such things like extracts, iron and trans fats on labels.

The various requirements for information coupled with the typically smaller size of a dietary supplement label and packaging can make for, at times, a complicated puzzle of fitting the pieces together in a compliant manner. A lack of compliance can cause your product to be considered mis-branded and subject to regulatory action and penalties.

EAS Consulting Group can design or review your company’s label and package inserts to ensure compliance with FDA regulations for:

  • health claims
  • structure function claims
  • Preparation of 30-day notification for submission to FDA
  • nutrient content claims
  • formatting
  • Clinical study design to substantiate product label claims
  • Scientific literature review in the preparation of petitions for FDA approvals of conventional and qualified health claims for dietary supplement ingredients
  • allergen labeling