FDA Clarifies Labeling Claims for Dietary Supplements
FDA proposes nine ways to distinguish between structure and function claims, which are legal, and disease claims, which are not.
When the Dietary Supplement Health and Education Act was passed in 1994, it enabled manufacturers of dietary supplements to make certain types of claims on their labels about what their products could do.
Under the act, no claims to "diagnose, mitigate, treat, cure, or prevent a disease or specific class of diseases" are allowed, with the exception of classical nutrient deficiency diseases. But it does permit "structure/function claims," that is, descriptions of the product's effect on the structure or function of the body.
However, it is not always easy to distinguish disease claims from structure and function claims, as a report from the Commission on Dietary Supplement Labels pointed out. So FDA offered clarification, proposing a rule in the April 29, 1998, Federal Register (63FR:23623–23632).
First, the agency proposes to define disease as "any deviation from, impairment of, or interruption of the normal structure or function of any part, organ, or system (or combination thereof) of the body that is manifested by a characteristic set of one or more signs or symptoms." Then, FDA proposes nine ways to define a disease claim. They are:
- Anything that explicitly or implicitly claims an effect on a disease or specific class of diseases. Claims that do not refer explicitly or implicitly to an effect on a specific disease state would not be disease claims under this criterion. Examples include claims that the product "helps promote urinary tract health" or "promotes relaxation."
- Anything that explicitly or implicitly claims an effect on a recognizable sign or symptom of a disease.
- Any claim of an effect on an abnormality relating to natural states such as aging and pregnancy.
- Any expression or implication that a product can be used to diagnose, mitigate, treat, cure, or prevent a disease. This can mean the name of the product itself, citations to articles that make disease claims, using the word disease, or stating the product contains an ingredient regulated as a drug.
- Any claim that a product belongs in a class of products recognizable as disease treatments (such as antibiotics and laxatives).
- Any claim that a product has the same effect as a regulated drug or disease therapy if it identifies a specific drug, drug action, or therapy.
- Anything that explicitly or implicitly claims a role in the body's response to a disease or to a vector of disease.
- Any claim to treat, prevent, or mitigate adverse events associated with a medical therapy or procedure and manifested by characteristic signs or symptoms.
- Anything that otherwise suggests an effect on a disease or class of diseases.
"The [nutraceutical] companies were clearly confused," says Allen Montgomery, chief executive officer of the American Nutraceutical Association (ANA). "The new proposal does not appear to be a radical deviation from the recommendations of the commission. Some of our members are saying the guidance is surprisingly positive in some areas." The ANA, along with other trade groups such as the National Nutritional Foods Association and the Nonprescription Drug Manufacturers Association, were devising their formal responses at press time.
The new rule will take effect 30 days after it is published in final form. For existing products being sold by small manufacturers (under $20 million in annual sales), the rule becomes effective 18 months after publication. For other existing products, the rule takes effect one year after publication. The agency estimates that redesigning existing labels will cost manufacturers between $91,400 and $123,400.
The comment period ends August 27, 1998. Send comments to the Dockets Management Branch (HFA-305), FDA, 12420 Parklawn Dr., Rm. 1-23, Rockville, MD 20857.
For more information, contact Jeanne Latham, Center for Food Safety and Applied Nutrition (HFS-456), FDA, 200 C St. SW, Washington, DC 20204; 202/205-4697. The entire text of the proposed rule can be viewed on the Internet at http://www.access.gpo.gov.