Extension Connection: New dietary supplement rules go in effect

Published 12:00 am Wednesday, July 11, 2007

Many of the nation&8217;s nutrition and health experts have stressed that current federal policy governing dietary supplements leaves much to be desired.

One of them is Dr. Robert Keith, an Alabama Cooperative Extension System nutrition and health specialist and Auburn University professor.

Keith says dietary supplements have never been governed with the same rigorous standards associated with food and drugs. That&8217;s hopefully about to change thanks to a new rule announced by the U.S. Food and Drug Administration.

The new rule, which seeks to establish current good manufacturing practices, is designed to ensure product quality throughout the manufacturing, packaging, labeling and storing of dietary supplements.

Manufacturers also will be required to evaluate the identity, purity and composition of supplements. Any product tainted with contaminants or lacking the dietary ingredient it represents

would be considered adulterated or misbranded. The rule is designed to ensure supplements do not contain wrong ingredients, too much or too little of an ingredient or contamination by substances such as natural toxins, bacteria or heavy metals. If a product is tainted, the FDA could consider it adulterated or misbranded. The rule is intended to prevent improper packaging and labeling.

Case in point: while the Dietary Supplement, Health and Education Act of 1994 prohibits manufacturers from claiming their products &8220;treat, cure or prevent,&8221; they are allowed to make more vague claims.

Many of these problems associated with supplements can be linked to the 1994 legislation, Keith says. Instead of placing the burden of proof on manufacturers, the responsibility lies with the government. As a result, the government essentially cannot do anything until someone is hurt or killed.

Regulating the dietary supplement industry has been a lot like trying to stamp out a forest fire, Keith says. As soon as one supplement is removed, fly-by-night manufacturers often succeed in turning out some other dubious product.

Keith says that is why the phrase &8220;buyer beware&8221; applies so well. Even with new rules, Keith says the FDA will face an uphill climb in keeping the industry in line.