US relaxes its guidelines on herbal supplements

doi:10.1136/bmj.320.7229.208/f

BMJ 2000;320:208 ( 22 January )

News extra

US relaxes its guidelines on herbal supplements

Scott Gottlieb New York

The US Food and Drug Administration (FDA) has relaxed guidelines for the sale of herbal supplements. Its decision has opened the way for manufacturers of vitamins, herbs, and dietary supplements to market their products for conditions such as morning sickness, hot flushes, and memory loss in ageing without first proving that they are safe or effective.

The decision marks the latest in a series of legal and regulatory victories for the dietary supplement business, which has been growing since Congress passed a law in 1994 that severely restricted the FDA's authority to regulate it.

Under the new law manufacturers of dietary supplements can make claims about how their products affect the structure or function of the body, but they may not claim to prevent, treat, cure, mitigate, or diagnose a disease without prior FDA approval.

The move angered and surprised consumer advocates. "This is a snake-oil exemption," said Dr Sidney Wolfe, director of the Public Citizen's Health Research Group in Washington, "it's a complete cave-in to the industry."

Agency officials insist that the rule, which will take effect from 7 February, is an important part of their 10 year strategy to increase consumer confidence in the safety, composition, and labelling of vitamins, herbs, and other nutritional aids.

The new law is part of the Dietary Supplement Health and Education Act, which distinguishes between products that claim to "affect the structure or function of the body" and those that claim to prevent, treat, or cure disease.

The law allows the manufacturers of supplements to sell products without the FDA's rigorous safety and efficacy review that is required of drugs, as long as they make claims related only to structure or function and not to disease.

In issuing the new guidelines, the FDA had decided it needed to delineate which claims fall into which category. The new rule was first proposed in April 1998. At the time, the agency said that natural states like ageing, pregnancy, menopause, and adolescence could be associated with abnormal conditions�such as morning sickness or the premenstrual syndrome�that are diseases. Products aimed at those conditions would have required FDA approval.

But after reviewing thousands of public comments from industry representatives, consumers, and others, the agency became convinced that such conditions were not diseases, so claims about them did not qualify as claims about disease.

Under the new rule, uncommon or serious conditions associated with these life stages will still be treated as diseases. So, for example, a company may market a dietary supplement for teenagers who have acne but not for acne so severe that the symptoms include cysts.

The distinction, which was first established by the Dietary Supplement Health and Education Act of 1994, had led to considerable confusion between federal regulators and manufacturers of dietary supplements in terms of what claims may be made.

Although industry representatives generally agreed with the need for federal approval of disease claims, some industry and consumer representatives felt that the agency over-expanded its authority over dietary supplements by adopting a relatively broad definition of disease.

The FDA disagreed, but in January 1999, a federal court ruled that the agency�s definition was unconstitutional because it failed to define the term disease in a way that would allow manufacturers of dietary supplements to disseminate reasonable information about their products.

As a result of that ruling, the FDA is publishing the new, more thorough definition of that term, including specific examples of how the definition may be applied.
Add to CiteULike CiteULike Add to Complore Complore Add to Connotea Connotea Add to Del.icio.us Del.icio.us Add to Digg Digg Add to Reddit Reddit Add to Technorati Technorati What's this?