Dietary Supplement Industry Calls On FDA To Adopt National Standards On Ephedra

Dietary Supplement Industry Calls On FDA To Adopt National Standards On Ephedra

Four dietary supplement associations, representing the vast majority of manufacturers and distributors of dietary supplements containing Ephedra, today announced they are taking the initiative to work with the federal government following the overwhelming data and testimony in support of the safety of dietary supplements containing Ephedra. The action follows the August public meeting on Ephedra’s safety held by the Department of Health and Human Services, Office on Women’s Health (OWH).

The OWH’s written report of the meeting, issued in late September, concluded that, given the current widespread use of Ephedra supplements, industry and government should work together on consumer education, good manufacturing practices, reasonable dose and duration levels combined with clearly indicated warnings, and a research agenda. The OWH called on the “research community” to “take the next logical step by conducting a systematic review of the world’s literature on Ephedra.” In short, the OWH report does not support and is in conflict with the Food and Drug Administration’s earlier conclusion, based on anecdotal and unsubstantiated adverse event reports, that Ephedra dietary supplement products represent a public health hazard.

The OWH report brings to an end more than five years of unproductive and wasteful regulatory efforts on Ephedra, and signals a new phase of government and industry cooperation.

Industry today took the initiative to follow the recommendations of OWH and to develop a cooperative program with government. First, the American Herbal Products Association, the Consumer Healthcare Products Association, the National Nutritional Foods Association and the Utah Natural Products Alliance, four trade associations representing the vast majority of manufacturers and distributors of Ephedra products, submitted a Citizen Petition to FDA requesting that the agency adopt a national standard for Ephedra products, which has already been adopted by industry, and several states, as the federal standard. As support for the petition, the associations listed the following:

• The long history of safe use of Ephedra products, as well as ephedrine and pseudoephedrine as over-the-counter (OTC) drugs;
• Clinical data on ephedrine/caffeine combination products, and on Ephedra alone and combined with caffeine, showing the safety and benefits of these products for weight loss;
• Consumption data showing that sales of Ephedra products have increased exponentially over the last five years while the number of reports of possible adverse events has decreased;
• Comparisons of estimates of the incidence of strokes, heart attacks and seizures in the general population to the incidence of the same events in Ephedra consumers, showing that there is no increase in risk from the consumption of Ephedra;
• Comprehensive analyses of all adverse event reports submitted to FDA showing that there is no association between the reported serious adverse events and the consumption of Ephedra products according to the current national standards; and
• Thorough reviews of the published literature, including all published case reports, showing that the published literature supports the safety of Ephedra products when consumed according to the current national standard.

In addition, the four trade associations submitted by letter an offer to support new research on Ephedra currently being considered by the Office of Dietary Supplements within the National Institutes of Health. Congress and industry have worked together to assure funding for this research, and expect future research to add to the existing database on Ephedra.

Finally, all of the trade associations, joined by the Council for Responsible Nutrition, requested in a joint letter to FDA that the agency provide copies of every report of alleged serious adverse events regarding Ephedra within 20 days of FDA’s receipt of any such reports. An industry representative would be designated to receive the reports. On a related issue, the trade associations also requested FDA to respond to Freedom of Information Act (FOIA) requests for copies of any reports of serious adverse events for all dietary supplements within the 20-day period required by law, or within 48 hours after posting any such reports on the FDA Web site.

FDA has in the past taken months, and in some cases years, to respond to FOIA requests for AERs on Ephedra and other supplements. This has made it impossible for the scientific community to assess the validity of FDA’s public statements that the AERs were cause for concern.

The widespread speculation that Ephedra might somehow be linked to serious adverse events, caused in large part by FDA’s failure to provide the public with copies of past AERs, has now been dispelled through testimony by a multidisciplinary expert panel. Industry and FDA must now work together to assure that future reports are handled in a responsible manner.

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Suggested Reading:

1. What Is The National Standard For Ephedra?
2. Response to Consumer Reports Article about Sports Dietary Supplements Ephedra
3. Significant Growth In Consumption Of Ephedra Products With Few Adverse Reports