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Health benefit claims
January 1999

Under DSHEA and previous food labeling laws, the FDA permits three types of claims that manufacturers may use under specified conditions:

  1. nutrient-content claims
  2. health claims (that a substance has impact on a disease)
  3. nutrition support claims, which include "structure-function claims."

Nutrient-content claims

Nutrient-content claims describe the level of a nutrient in a food or dietary supplement. For example, a supplement containing at least 200 milligrams of calcium per serving could carry the claim "high in calcium." A supplement with at least 12 mg per serving of vitamin C could state on its label, "Excellent source of vitamin C."

Health claims

A health claim is a statement that a food or substance can diagnose, treat, mitigate, cure, or prevent a disease or health-related condition.

The Nutrition Labeling and Education Act (NLEA) passed in 1990 established the FDA's authority to require preapproval of these claims based on "significant scientific evidence".

A recent court ruling remanded the FDA to clarify its definition of this phrase.

Exception to pre-approval requirement for health claims

A provision in the Food and Drug Administration Modernization Act of 1997 allows companies to notify FDA of their intent to use a new health claim based on an authoritative statement of one or more federal scientific bodies. It gives FDA 120 days to respond. If the agency does not act to prohibit or modify the claim within that time, the claim can be used without the usual preapproval requirement.

Examples of diet-to-health links on which a manufacturer may base a health claim include:

  • the vitamin folic acid and a decreased risk of neural tube defect-affected pregnancy, if the supplement contains sufficient amounts of folic acid
  • calcium and a lower risk of osteoporosis, if the supplement contains sufficient amounts of calcium
  • psyllium seed husk (as part of a diet low in cholesterol and saturated fat) and coronary heart disease, if the supplement contains sufficient amounts of psyllium seed husk.

In a guidance document for industry, FDA established interim criteria for determining the adequacy of health claims submitted under the new procedure. Under these criteria, which will remain in place until FDA publishes final regulations, the authoritative statement, which is the basis for the health claim, must:

  • come from a federal scientific body (for example, the National Institutes of Health, national Centers for Disease Control and Prevention, U.S. Department of Agriculture, or National Academy of Sciences)
  • be published by the scientific body and be currently in effect
  • state a relationship between a nutrient and a disease or health-related condition
  • not be a statement made individually by an employee of a federal scientific body but rather reflect a consensus within the scientific body
  • be based on the scientific body's deliberative review of the scientific evidence.

FDA said it would consult with the scientific body when appropriate to determine whether a statement is an authoritative one.

Structure-function and other nutrition support claims

Two types of nutrition support claims are permitted by the FDA. One describes a link between a nutrient and the deficiency disease that can result if the nutrient is lacking in the diet. For example, the label of a vitamin C supplement could state that vitamin C prevents scurvy. When these types of claims are used, the FDA requires that the label must mention the prevalence of the nutrient-deficiency disease in the United States.

Products may also be labeled with nutrition support claims that refer to the supplement's effect on the human body's structure or function, including the overall effect on a person's well-being. These are known as structure-function claims. Examples of structure-function claims are:

  • Calcium builds strong bones.
  • Antioxidants maintain cell integrity.
  • Fiber maintains bowel regularity.

Manufacturers can use structure-function claims without FDA authorization. They base their claims on their review and interpretation of the scientific literature. Like all label claims, structure-function claims must be true and not misleading.

Structure-function claims can be easy to spot because, on the label, they must be accompanied with the disclaimer "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."

Manufacturers who plan to use a structure-function claim on a particular product must inform FDA of the use of the claim no later than 30 days after the product is first marketed. While the manufacturer must be able to substantiate its claim, it does not have to share the substantiation with FDA or make it publicly available.

If the submitted claims promote the products as drugs instead of supplements, FDA can advise the manufacturer to change or delete the claim.

The specific labeling regulations required by the FDA can be seen in Reading the Label.

More about standards & regulations:
       

Industry standards

Creating a quality model for dietary supplements

Different types of standards

Pros and cons of standards

Competing standards

Testing products for quality

Dosage recommendations

Good manufacturing practices (GMPs)

Self-regulatory quality standards

 

Government regulations

FDA safety monitoring

Federal Trade Commision (FTC)

State laws

Health benefit claims

RDA, DV, and other recommended intake values

Funding of research at the National Institutes of Health (NIH)

Possible future FDA regulations

Possible future Codex regulations

 

   
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(c) Copyright 1999-2003 Dietary Supplement Quality Initiative. For permission to reprint, please contact our editor.