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FDA safety monitoring
January 1999

The FDA monitors adverse events (negative side effects) for dietary supplements as part of the Special Nutritionals Adverse Event Monitoring System (SN/AEMS) program. It contains a few thousand reports -- which is a very small number compared with adverse event reports for pharmaceuticals.

Even though this database is small, it is much larger than what it should be. It is believed to contain many reports unrelated to the effect of any dietary supplement. The reports within are completely unscreened. This results in inaccuracies -- such as multiple reports of the same incident. Such an unregulated system is highly vulnerable to fraud and error.

Nonetheless, the FDA regularly cites AERs in this system as a reason why dietary supplements present a significant safety problem. FDA spends considerable resources on public affairs to inform the consuming public of safety concerns. This often takes the form of press releases that warn about the dangers of dietary supplements. Such allegations are often accompanied by claims that the FDA's hands are tied by DSHEA which prevents them from adequately protecting the public.

However, DSHEA authorizes the FDA to pull dangerous products from the shelf, so they in fact have authority to act on any product that presents a serious threat. They have exercised this authority on only a handful of occasions. The burden of proof is on the FDA to find a product unsafe before it can be pulled from the market. This is appropriate given the extraordinary safety record of dietary supplements.

It appears that FDA efforts are aimed primarily at expanding their control by convincing the public that more regulation is needed. They lobby for a more sweeping role where they preappove dietary supplements before they may be sold and thus act as gatekeeper. This would give the FDA the power to prevent products from entering the market until the agency gets around to determining that the product is safe and, in its opinion, effective and worthy of being sold.

If the FDA had such power, we can expect dietary supplements to follow the course that pharmaceuticals have taken under FDA control or that dietary supplements have taken in Germany where they are regulated more stringently. Products would be banned from the market and not returned unless and until approval is granted (which can take years). In addition, dramatic price inflation would ensue making dietary supplements unaffordable to people who would otherwise have the means to purchase them.

Rather than lobby to expand their regulatory power, the FDA would better serve consumers by acting in accordance with the proven safety record of dietary supplements and striving for less rather than more regulation.

See also our section on industry initiatives for tracking AERs.



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.