Industry Supports Strong Warning Label for Ephedra-Containing Products

Washington, D.C., Oct.11, 2002 — The Council for Responsible Nutrition (CRN), representing a substantial segment of the dietary supplement industry, today released a letter sent to Senator Durbin and other legislators addressing several issues relating to ephedra-containing dietary supplements.

CRN emphasized the industry’s full support for a comprehensive mandatory warning statement on ephedra-containing products, and noted that such warnings have already been adopted by virtually all manufacturers. These extensive warnings are recommended by all the trade associations in the industry, are required by numerous states, and contain language similar to or stronger than the wording proposed by FDA in 1997.

CRN said the industry also supports FDA action against products with added synthetic ephedrine, since this pharmaceutical ingredient is not appropriate for inclusion in supplements. Ephedra contains a mixture of naturally-occurring alkaloids, including ephedrine, but products should not contain the synthetic drug form of the ingredient. FDA has taken several enforcement actions against products that violate this rule.

Members of the dietary supplement industry have long lamented the existence of products marketed as “street drugs” masquerading as dietary supplements and have supported and encouraged regulatory action against them. FDA issued a policy statement in 2000 declaring such products to be illegal, but has taken little enforcement action in this area until very recently.

CRN pointed out that the use of ephedra-containing products to support weight loss is based on numerous clinical trials demonstrating the safety and benefit of such regimens when used appropriately in persons without diseases or risk factors that would contraindicate the use of ephedra. CRN contracted with Cantox Health Sciences International for a quantitative risk assessment for ephedra and is relying on the Cantox report as the basis for recommendations on safe dosages and conditions of use.

On the question of mandatory reporting of adverse events, CRN noted that all foods and many pharmaceutical products are currently exempt from any requirement for mandatory reporting, except for drugs approved on the basis of New Drug Applications. Most over-the-counter drugs, all dietary supplements and all conventional foods including medical foods are not required to report adverse events to FDA. While this policy may be ripe for reconsideration, the discussion should rightfully encompass all ingestible products currently exempt from mandatory reporting, according to CRN.

Alternatively, Congress and FDA could consider a narrowly targeted requirement for a post-
market surveillance system relating only to ephedra. This would be consistent with CRN policy on ephedra and also with previous FDA approaches to specific ingredients of potential concern, including aspartame and olestra.

According to CRN, three immediate actions should be undertaken in response to the concerns expressed by Senator Durbin and other legislators:

1. FDA should immediately propose a comprehensive mandatory warning statement incorporating strong language similar to that proposed by FDA in 1997, currently required by many states, and already adopted by most manufacturers of ephedra-containing products.

2. Congress and FDA should consider establishing a post-market surveillance system for ephedra-containing products, similar to the ones previously established for other ingredients presenting potential concerns, including aspartame and olestra. Reporting and evaluation of adverse events should be timely and open, and reports should be evaluated on the basis of recognized principles for assessing causality.

3. FDA should continue and accelerate enforcement activities against products containing synthetic ephedrine (a drug ingredient) and against products intended for use as “street drug” alternatives.

CRN asserted that the Dietary Supplement Health and Education Act of 1994 (DSHEA) is capable of fully protecting consumers, when it is fully implemented and enforced. CRN requested meetings with the legislators or their staff members to further explore cooperative action relating to ephedra-containing dietary supplements.

The Council for Responsible Nutrition (CRN), founded in 1973, is one of the dietary supplement industry's leading trade associations representing ingredient suppliers and manufacturers. CRN members adhere to a strong code of ethics, comply with dosage limits and manufacture dietary supplements to high quality standards under good manufacturing practices.

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