Claims are a vital aspect of marketing food and dietary supplements, as they help consumers understand accurate details of the product. In the United States of America (USA), food and dietary supplement products are regulated by the United States Food and Drug Administration (US FDA).

There are three (03) types of claims, outlined by the law and/or FDA regulations, that are permitted to be used on food and dietary supplement labels such as:

  • Health Claims
  • Nutrient Content Claims
  • Structure/function Claims

Health Claims

A health claim outlines the connection between food and lowers the incidence of acquiring a disease or other health issues. This might be expressed in written form, graphic form (such as a heart), or by mentioning a third-party certification.

Requirements for Health Claims

  • Health claims must incorporate both the substance and the disease or other conditions.
  • They are restricted to statements indicating reduced disease risk.
  • A food product's nutritional content may exclude it from health claims if such nutrient levels are judged harmful.
  • Health claims are required to be reviewed and evaluated by the FDA prior to their use.
  • Claims must be accurate, comprehensive, and not manipulative.

Types of Health Claims

Two (02) categories of health claims used on food labels are as follows:

  • Authorized Health Claims
  • Qualified Health Claims

Authorized Health Claims

An FDA-approved health claim that has been evaluated and authorized is referred to as an "authorized health claim." This implies that the FDA's permission is not needed to make a genuine health claim on the required product or label.

The FDA cannot approve an Authorized Health Claim without "significant scientific consensus." This indicates that it is unlikely that the research underlying that health claim will change.

Authorized claims define a connection between a substance (a specific food component or a specific food) and an illness or other health condition and may be made on traditional foods and dietary supplements (e.g., high blood pressure). The FDA was required to create regulations allowing the use of health claims under the Nutrition Labelling and Education Act of 1990 (NLEA). The FDA must assess all health claims through a petitioning procedure.

Qualified Health Claims

Qualified Health Claims (QHCs) are supported by scientific evidence but do not meet the rigorous "significant scientific agreement" standards required for an authorized health claim. To ensure that these claims are not misleading, they must be accompanied by a disclaimer or other qualifying language to accurately communicate to consumers the level of scientific evidence supporting the claim.

Do you want to market your food products in the USA? Make sure you comprehend the practices for compliance when making claims on labels. For a cost-effective health claim review for all food and food supplement (FDS) categories in the USA, reach out to Freyr.


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