In a move that could greatly expand the use of herbs and other plant products as health remedies, a presidential commission Tuesday recommended that the substances be regulated like over-the-counter drugs, but not held up to prescription standards.
The recommendations are likely to intensify a long-brewing battle between the rapidly growing multibillion-dollar industry of dietary supplement manufacturers--which include several Southern California companies--and critics seeking protections for consumers.
While the industry Tuesday cheered the commission’s recommendations, consumer groups faulted it for failing to demand that herbal products, vitamins, minerals and amino acids be tested and proved safe before sale--as required for pharmaceutical drugs.
“People are going to have to die before the [Food and Drug Administration] can do anything to remove these products from the market,” said Leila Farzan of the Center for Science in the Public Interest, a Washington-based consumer group.
She noted that ephedra, used in traditional Chinese medicine, has been linked to hundreds of reports of adverse reactions, including strokes and deaths, but the FDA’s proposal that a warning be required on products containing the substance has yet to be implemented.
In fact, the commission recommended that federal regulators speed enforcement actions against the makers of dietary supplements that could be harmful.
The Presidential Commission on Dietary Supplement Labels made Tuesday’s recommendations in a draft report. Final recommendations are expected this fall, and the FDA will consider them as the agency develops regulations to flesh out a 1994 law.
The law is credited by the supplements industry for some of its growth and is blamed by critics for an explosion in misleading health claims by manufacturers--many of which have headquarters or factories in Southern California.
The commission also recommended Tuesday that health claims for supplements should be allowed on the basis of “significant scientific agreement"--a standard used for conventional foods.
Labels making claims of nutritional value should be supported by “scientifically valid evidence” substantiating that the statements are “truthful and not misleading.”
However, the commission said labels should not refer to specific diseases or disorders and should not use “drug-related terms such as ‘diagnose,’ ‘treat,’ ‘prevent,’ ‘cure’ or ‘mitigate.’ ”
Annette Dickinson, a scientist at the Council for Responsible Nutrition, a trade group of supplement manufacturers, called the report positive and upbeat for the industry.
Critics say the 1994 law gutted federal regulatory authority over the industry, in effect preventing the FDA from moving against a manufacturer unless people are harmed or killed by consuming supplements. Unlike pharmaceuticals, dietary supplements can be sold without testing for their safety or effectiveness; warnings on their potential ill effects; backup by hard-nosed science regarding their usefulness; and approvals on their labeling.