Fwd: HHS RELEASE--EPHEDRA

[Guest guest]

Hi All,

 

I am forwarding this release to you. I haven't checked the websites given, but

they might yield more details.

 

By the way, anyone can to the Health and Human Services email list.

 

 

 

" Henneghan, Martha (HHS/OS) " <MARTHA.HENNEGHAN wrote:

Tue, 30 Dec 2003 11:39:50 -0500

" Henneghan, Martha (HHS/OS) "

HHS RELEASE--EPHEDRA

HHSPRESS

 

December 30, 2003

For Release: Immediately

Contact: FDA Press Office

(301) 827-6242

 

 

Headline: FDA ANNOUNCES PLANS TO PROHIBIT SALES OF DIETARY SUPPLEMENTS

CONTAINING EPHEDRA

Consumers Advised to Stop Using Ephedra Products Immediately

 

HHS Secretary Tommy G. Thompson today announced that the Food and Drug

Administration (FDA) has issued a consumer alert on the safety of dietary

supplements containing ephedra and has notified manufacturers of its intent

to publish a final rule on dietary supplements containing ephedrine

alkaloids. The rule will state that dietary supplements containing ephedrine

alkaloids present an unreasonable risk of illness or injury. The rule would

have the effect of banning the sale of dietary supplements containing

ephedrine alkaloids when it becomes effective, 60 days following

publication.

 

" FDA will publish a final rule as soon as possible that will formalize its

conclusions that dietary supplements containing ephedrine alkaloids present

unreasonable risks to those who take them for any reason, " Secretary

Thompson said. " Today's action puts companies on notice of our intentions,

and it tells consumers that the time to stop using ephedra products is now. "

 

 

" We are taking action today to notify Americans about the unreasonable risk

of ephedra as currently marketed in dietary supplements, " said FDA

Commissioner Mark B. McClellan, M.D., Ph.D. " Our action is based on

diligent and thorough work by the agency as required by the challenging

legal standard in the dietary supplement law. We worked hard to obtain and

review all the available evidence about the risks and benefits of ephedra,

including its pharmacology, studies of ephedra's safety and effectiveness,

adverse event reports, and reviews by independent experts. "

 

" By issuing these letters today, we're sending a strong and unambiguous

signal about the safety of dietary supplement products containing ephedrine

alkaloids. Consumers should stop buying and using ephedra products right

away, and FDA will make sure consumers are protected by removing these

products from the market as soon as the rule becomes effective. "

 

According to the Federal Food, Drug, and Cosmetic Act, a dietary supplement

product is adulterated if it or a dietary ingredient within it presents a

significant or unreasonable risk of illness or injury under conditions of

use suggested in the labeling or under ordinary conditions of use. Under

the Dietary Supplement Health and Education Act of 1994, the FDA bears the

burden of proof to show that a dietary supplement presents a significant or

unreasonable risk to prevent it from being marketed; in contrast, for drugs

that have similar pharmacologic properties to ephedra, manufacturers bear

the burden of proof of showing that the drug is safe and effective before it

can be marketed.

 

Ephedra, also called Ma huang, is a naturally occurring substance derived

from botanicals. Its principal active ingredient is ephedrine, which when

chemically synthesized is regulated as a drug. In recent years ephedra

products have been extensively promoted for use to aid weight loss, enhance

sports performance, and increase energy.

 

FDA's concerns about dietary supplements containing ephedra arise in part

from ephedra's mechanism of action in the body. Ephedra is an

adrenaline-like stimulant that can have potentially dangerous effects on the

heart. FDA's evaluation also reflects the available studies of the health

effects of ephedra. This includes many studies reviewed by the RAND

Corporation, which found little evidence for effectiveness other than for

short-term weight loss, as well as evidence suggesting safety risks. Other

recent studies have also confirmed that ephedra use raises blood pressure

and otherwise stresses the circulatory system, effects that have been

conclusively linked to significant and substantial adverse health effects

like heart problems and strokes.

 

FDA's notification reflects the agency's recent comprehensive evaluation of

the science as well as a public comment period intended to cap years of

debate about the risks and safety of ephedra in dietary supplements. In

1997, FDA first proposed a rule on dietary supplements containing ephedra

including requiring a warning statement on these products. FDA modified

this proposed rule in 2000, and last February the agency announced a series

of comprehensive actions designed to protect Americans from the potentially

serious risks of dietary supplements containing ephedra. To solicit

comments on new evidence about ephedra as well as on a proposed warning

statement, last February's actions included publishing a Federal Register

notice outlining FDA's concerns and reopening the comment period.

 

Following publication of this notice, FDA received and reviewed tens of

thousands of comments. The agency has also reviewed a comprehensive RAND

Corporation report on the data on ephedra and a series of adverse event

reports that it was unable to obtain more quickly because under the Dietary

Supplement Health and Education Act such adverse event reports are not

required to be submitted to FDA.

 

" We are going to issue a rule that clarifies and applies a legal standard

that that has never been used before. Using the challenging standard

provided under the law, we have done all we can to make sure our regulatory

action will succeed, " said Dr. McClellan.

 

FDA has sent 62 letters to firms marketing dietary supplements containing

ephedra and ephedrine alkaloids alerting them of this future rule.

 

While working on the forthcoming rule, FDA has been actively protecting the

public health through a series of high-profile enforcement actions aimed at

addressing the public health danger. Dietary supplement enforcement actions

include inspections that resulted in voluntary compliance, voluntary

recalls, warning letters, seizures and injunctions, criminal enforcement and

joint enforcement actions with the Federal Trade Commission and the

Department of Justice. In conjunction with FDA's actions to date, classes of

ephedra products have already been removed from the market (for example,

many products marketed for enhancing sports performance), the demand for

ephedra products has declined significantly, and many companies have already

ceased marketing. (More detail on these actions can be found at

http://www.fda.gov/ola/2003/dietarysupplements1028.html).

 

Additional materials relating to today's announcement are available online

at www.fda.gov.

 

Additional materials:

FDA letter:

http://www.fda.gov/oc/initiatives/ephedra/december2003/warningltr.html

List of companies receiving letter:

http://www.fda.gov/oc/initiatives/ephedra/december2003/letterslist.html.

2/03 press release: http://www.fda.gov/bbs/topics/NEWS/2003/NEW00875.html

Consumer Advisory:

http://www.fda.gov/oc/initiatives/ephedra/december2003/advisory.html

 

 

 

 

 

 

 

 

 

 

 

 

 

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Note: All HHS press releases, fact sheets and other press materials are

available at http://www.hhs.gov/news.

 

 

 

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