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Possible future FDA regulations
January 1999

The FDA regularly proposes new regulations for dietary supplements. Regulations proposed in 1998 sought to further restrict structure/function claims by classifying conditions such as pregnancy and aging as disease, thus subjecting such claims to regulations set forth in NLEA (which requires claims to be preapproved by the FDA). They also sought to prohibit use of supplements to treat disease - even if no such claims are made by the manufacturer on the label or in any product literature - if consumers are found to use the supplement for such purpose.

Many consumer groups and producers opposed these proposed regulations during the comment period for this proposal which ended in September of 1998. More traditional health care providers and groups favored it. The FDA issued its final rule in January 2000 -- which did not classify "normal conditions" such as pregnancy, menopause or aging as diseases.

FDA Good Manufacturing Practices (GMPs)

The Dietary Supplements Health and Education Act (DSHEA) authorizes the FDA to establish good manufacturing practices, or GMPs, for dietary supplements. In a February 1997 advance notice of proposed rulemaking, the agency said it would establish dietary supplement GMPs if, after public comment, it determined that GMPs for conventional food are not adequate to cover dietary supplements. FDA is reviewing comments on the 1997 notice.

A coalition of industry trade associations -- the Council for Responsible Nutrition (CRN), the National Nutritional Foods Association (NNFA), the American Herbal Products Association (AHPA), and the Consumer Health Products Association (CHPA) -- developed a draft version of GMPs that they submitted to the FDA in 1995. FDA is reviewing these GMPs as it considers whether to pursue mandatory industry-wide GMPs.

Because of strong ties between the FDA and large pharmaceutical companies, government standard GMPs run a high risk of imposing unnecessary yet costly mandates on manufacturers, particularly smaller ones. They would also preempt other GMP standards which may be more effective and more tailored to applicable manufacturing operations. Once forced to comply with a government-mandated GMP, it is unlikely that any manufacturer would be able to afford the time, or have any incentive, to comply with a self-regulatory GMP.

For more information about GMPs, click on one of the following topics:


 

   
 

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.