FDA Issues Final Ruling on Ephedra

ecat

Regulation Bans Sales of Supplements Effective April 12; "Traditional Asian Medicine" Exempted
The Food and Drug Administration has issued a final ruling prohibiting the sale of dietary supplements containing ephedrine alkaloids because, in its estimation, such supplements present an "unreasonable risk of illness or injury" to the general public. The complete 263-page rule was published in the Federal Register Feb. 11, and becomes effective April 12, 60 days from the date of publication.
"This FDA rule reflects what the scientific evidence shows - that ephedra poses an unreasonable risk to those who use it," remarked Health and Human Services Secretary Tommy Thompson. "The regulations prohibit the sale of dietary supplements containing ephedra, and we intend to take swift action against anyone who puts consumers at risk by continuing to sell such products after the prohibition takes effect."
In traditional Chinese medicine, ephedra - also known as ma huang - has been used for thousands of years, primarily to relieve colds and treat conditions such as asthma and edema. When taken in the proper dosage, combined with other herbs, and used under the care of a licensed acupuncturist or doctor of Oriental medicine, ephedra is considered quite safe. In the United States, however, the herb has been marketed as a major component of weight-loss pills and formulas, and in the past decade, it became a favorite among people trying to shed extra weight or enhance athletic performance. By the year 2000, ephedra became one of the most popular herbs in the country, generating approximately $1 billion in annual sales.
As ephedra increased in popularity, several private agencies, particularly sports organizations, began restricting or banning its use. In 1997, the National Collegiate Athletic Association banned the use of all ephedra-containing products. (Ephedrine had previously been banned by the International Olympic Committee and the United States Olympic Committee.) Between 1999 and 2003, additional bans on ephedra were instituted by the National Football League, National Basketball Association and Major League Soccer. In 2002, the U.S. military banned the sale of ephedra from all post exchanges after a report attributed the deaths of approximately 30 servicemen to ephedra-containing supplements.
Following the death of Baltimore Orioles pitcher Steve Bechler in February 2003, state legislatures began drafting laws to ban or curb the sales of ephedra. On May 25, 2003, Illinois became the first state in the U.S. to ban the sale of ephedra supplements. New York and California quickly followed suit; however, the laws in those states included exemptions that allowed for ephedra to be dispensed by licensed acupuncturists and doctors of Oriental medicine.
The first serious federal action toward ephedra took place in June, 1997, when the FDA issued a proposal requiring that dietary supplements containing ephedrine alkaloids include a warning that they are hazardous and should not be used for more than seven days. It also proposed to restrict the amount of ephedrine alkaloids in supplements. In February 2003, the agency announced a series of measures that included taking action against firms that made unsubstantiated claims about products containing ephedra and enhanced athletic performance. The following month, it published a notice in the Federal Register seeking public comment on the regulation of ephedra supplements. After collecting and analyzing those comments, in December 2003, Sec. Thompson announced that the agency had decided to move forward on banning the sale of all dietary supplements containing ephedra, making it the first supplement ever to be banned by the federal government.
Ruling Offers Exemption for "Traditional Asian Medicine"
In issuing its ruling, the FDA concluded that supplements containing ephedrine alkaloids "present an unreasonable risk of illness or injury under the conditions of use recommended or suggested" on the labeling of such products. This conclusion was based, the FDA said, due to studies on the pharmacology of ephedrine alkaloids, scientific literature on their effects, and several adverse events purported to have occurred following consumption of ephedra or ephedrine-containing supplements.
According to Section III B of the final rule, the ban applies only to "dietary supplements containing ephedrine alkaloids, including, but not limited to, those from the botanical species ephedra sinica Stapf, ephedra equisetina Bunge, ephedra intermedia var. tibetica Stapf, ehpedra distachya L., sida cordifolia L. and pinellia terneta (Thunb.) Makino or their extracts." However, "conventional food products" that contain ephedrine alkaloids are exempted, as are "OTC (over-the-counter) or prescription drugs that contain ephedrine alkaloids."
Section III B also includes a caveat for the use of ephedra as it applies to "traditional Asian medicine":
Several ephedra species (including those known as ma huang) have a long history of use in traditional Asian medicine. These products are beyond the scope of this rule because they are not marked as dietary supplements. The use of ephedrine alkaloids in traditional Asian medicine is discussed in more detail in section V B 5 of this document. As we describe there, this rule does not change how these products are regulated under the act.
Section V B 5 of the ruling deals with the specific use of ephedra as a component of traditional Asian medicine. The FDA received several comments from licensed acupuncturists, herbalists and doctors of Oriental medicine regarding ephedra's safety, preparation, use and long safety record. In response, the FDA stated:
"This final rule does not affect the use of ephedra preparations in traditional Asian medicine, although we considered the comments' views and information on the use of ephedra in traditional Asian medicine in the context of their possible relevance to the risks of dietary supplements containing ephedrine alkaloids. This rule applies only to products regulated as dietary supplements"

兰心

we talked about this topic 5 month ago already. it was a bad news for us.

ecat

What confuses me was the exemption part in Section VB5:
the FDA stated:
"This final rule does not affect the use of ephedra preparations in traditional Asian medicine, ....... This rule applies only to products regulated as dietary supplements"
Any thoughts on that?
thanks

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my god ,I can't understand!

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