Product Labeling and Claims

As a consultant to the dietary supplement industry, NutriCompliance assists manufacturers and marketers in meeting federal government regulations and industry standards. Under the Dietary Supplement Health and Education Act, claims regarding the effect of a supplement ingredient upon the structure and function of the body are permitted provided the claims are supported by competent scientific evidence.

Companies must also have the necessary evidence to support product claims and withstand FDA scrutiny. Our team of experts stays current on ingredient research. We also conduct extensive searches of scientific literature when a client requests assistance in developing structure and function claims. We evaluate the quality of the research and its applicability.

To include structure function claims on the labels and in promotional materials, companies must notify the FDA of the claims no later than 30 days after first marketing the supplement with the claims. NutriCompliance consultants assist companies in meeting FDA rules.

Our services include writing, editing and review of labeling and advertising claims on nutritional supplements such as:

  • Descriptive claims that use words such as organic and natural
  • Health claims and qualified health claims
  • Nutrient content claims
  • Statements of nutritional support
  • Structure and function claims
  • Third-party literature

In addition, NutriCompliance advises manufacturers and marketers on how to meet federal regulations relating to:

  • Artificial and natural flavors, colorings, and chemical preservatives
  • Country of origin markings and representations on labels, plus requirements for when product is identified as being made in the United States
  • Identifying ingredients in ways that conform to statutes covering requirements such as use of common or usual name
  • Information on daily and nutritional values, with emphasis on display and format
  • Labeling of ingredients for the purpose of identifying allergens
  • Listings of ingredients, including additives that are not active
  • Names and places of business of distributors, manufacturers and packers
  • Warning, notice, and safe handling statements