FDA Proposed Dietary Supplement Rules Called Too Lax

The U.S. Food and Drug Administration’s (FDA) proposed dietary supplement rules are being called too lax. The proposal is meant to strengthen the agency’s power to regulate dietary supplements, but some feel it falls short.

Supplement makers manufacturing vitamins, minerals, and botanical extracts, are angry about the propsed new rules, but others disagree, said The LA Times, pointing to a New England Journal of Medicine editorial that says the FDA proposed powers are simply not strong enough.

A $28-biilion annual market, industry broadly creates and sells formulations that utilize so-called “novel” products, including minerals, plants, and amino acids that give the impression of being “newly promising,” explained the LA Times. The products, however, have not been extensively sold and used in the United States or are touted with “mega-doses” in amounts significantly greater than what is considered typical with such supplements, said the LA Times.

In 1994—when the regulatory structure for dietary supplements was put into law—industry manufactured and marketed 4,000 individual products; today, some 55,000 products are sold to Americans who believe them to be safe, noted the LA Times. As we’ve written, 2/3rd of all Americans take some sort of dietary supplement.

Since 1994, firms selling “novel” products were required to supply federal regulators with proof of the product’s “reasonable expectation of safety,” explained the LA Times. However, according to a New England Journal of Medicine “Perspective” article published this week by Dr. Pieter Cohen, assistant professor of Medicine at Harvard University, even the current, ambiguous criterion has received lax FDA enforcement and has probably been ignored by industry.

In July, we wrote that the FDA sought clarification on safety rules in effect for dietary supplements, issuing draft guidelines mandating supplement makers notify regulators about new ingredients used. The guidelines were meant to assist with firms’ compliance with the 1994 regulation of new dietary ingredients in tablets, powders, liquids, and other supplements, and ordered makers to file a safety notification with the agency prior to marketing any dietary ingredient not on the market in 1994. Since the 1994 law’s passage, the FDA said it only received about 700 such notifications despite that over 55,000 dietary supplement products are sold and marketed today.

In some cases, said the LA Times, the FDA would accept documentation of a particular product’s “historical use” outside the U.S. Also, for “mega-doses” exceeding commonly used levels of any given supplement, manufacturers must product proof of safety from animal and test-tube studies; human trials are allowed, but not required.

Dr. Cohen feels the guidelines are insufficient. For instance, “historical use” of a product is too low to ensure safety, he said, wrote the LA Times. Also, noted Dr. Cohen, there is no mandate that supplement makers provide unfavorable safety data to the FDA as long as they provide studies showing the product is safe. As for products with no history of common use or marketed at mega doses, “not even single-dose tolerability studies in humans would be required” under the proposed rules, said Dr. Cohen who pointed out that “If the FDA succumbs to industry pressure, the public health consequences will be significant,” wrote the LA Times.

To date, the FDA has only ever banned one supplement ingredient: ephedrine alkaloids.