Issue: 61 Page: 64-55,63
FDA Announces Ban on Ephedra Supplements: Federal Move Follows Bans by California, Illinois and New York
by Mark Blumenthal
HerbalGram. 2004; 61:64-55,63 American Botanical Council
FDA Announces Ban on Ephedra Supplements: Federal Move Follows Bans by California, Illinois and New York
WEB EXCLUSIVE: To read an expanded version of this article, click here .
by Mark Blumenthal
On December 30 the Food and Drug Administration (FDA) announced
its intentions to ban the sale of dietary supplements containing the popular but
controversial herb ephedra, also known by its Chinese name ma huang (Ephedra
sinica Stapf, Ephedraceae).1
At the press conference, Secretary of Health and Human Services
(HHS) Tommy Thompson and FDA Commissioner Mark B. McClellan, MD, PhD, presented the
government’s case against herb when sold as dietary supplements. FDA’s
forthcoming regulations to ban ephedra were said as being in the final administrative
stages and would be published in the Federal Register some time in January,
and would go into effect 60 days after its publication, possibly in mid-March.
After that date, it will be illegal to manufacture or sell dietary supplements
that contain ephedrine and related ephedra alkaloids, including ephedra weight-loss
FDA also issued a Consumer Alert in which it urged consumers
"to stop buying and using [ephedra] products immediately."2
Secretary Thompson stated that the reason for the timing of the announcement came
from the agency’s wanting to discourage consumers from using supplements
containing the herb as millions of people traditionally begin new diet regimens
at the end of the Winter Holidays. "The time to stop taking these products
is now," HHS Thompson said. "They are simply too risky to be used."
Secretary Thompson and Commissioner McClellan urged retailers,
manufacturers and marketers to immediately cease sales of all ephedra products
prior to the publication of the rule in January. "By issuing these letters
today, we’re sending a strong and unambiguous signal about the safety of
dietary supplement products containing ephedrine alkaloids," said McClellan.
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."1 Curiously, but perhaps predictably,
the next day the Associated Press carried a story describing how many consumers
who successfully use ephedra-based supplements were stocking up in anticipation
of the ban.3
Secretary Thompson said, "First, I am pleased that we
were able to take the strong action against ephedra. For too long dietary products
containing ephedrine alkaloids have been heavily promoted and widely used. They
are simply too risky to be used, whether by people who want to lose weight or
by elite athletes seeking to enhance their performance, or by youngsters who want
to be like these athletes."4
New Legal Framework
Thompson continued, "Second, the regulation that FDA will
be publishing will set a new significant legal precedent. For the first time,
we will be articulating the legal standard for protecting the public health under
the standards of the dietary supplement law which Congress passed approximately
10 years ago [DSHEA]. This is a workable and I think coherent standard that will
enable Americans to have access to dietary supplements while enabling FDA to be
able to protect consumers from adulterated products."4
As intimated by Thompson, HHS and FDA announced the creation
of a forthcoming new "framework" for determining if a dietary supplement
"presents a significant or unreasonable risk of illness or injury under conditions
of use suggested in the labeling or under ordinary conditions of use." The
new framework will be published in the upcoming Federal Register notice
with the proposed rule.
The impact of the proposed ban on ephedra on other herbs and
supplements was unclear. Despite the good safety record of most popular herbs
in the U.S. market, the language used in announcing the ephedra ban implicated
some of FDA’s long-held irritation with the "burden of proof" provision
of the Dietary Supplement Health and Education Act of 1994 (DSHEA). Thompson said
that the FDA could not have acted any sooner because DSHEA does not require manufacturers
to prove a product safe prior to bringing it to the market. To remove an unsafe
supplement from the market, FDA must prove a clear danger to public health. Thompson
called this "a tremendous burden of proof’." "We have to prove
scientifically that they’re unsafe. That’s a completely different burden
of proof that FDA has [than it had prior to DSHEA]. Now, Congress should take
a look at whether or not they want that to continue." In response to a reporter’s
question, he said that he was not working with members of Congress to change
DSHEA, calling it the prerogative of Congress, not HHS or FDA.4
[Editor’s Note: The question surrounding FDA’s
authority to protect the public against unsafe dietary supplements has been at
the core of the debate on ephedra. To clarify this issue, a leading Washington,
D.C. regulatory attorney, Stephen McNamara, formerly an attorney for the FDA,
has written that, according to federal law, FDA does have adequate authority.5]
The issue of FDA’s authority was the subject of editorials
in The New York Times and USA Today which both decried the fact
that it the ban took too long and suggested that increased safety regulation was
In an action related to the announcement, FDA sent letters
to 62 firms that market dietary supplements containing ephedrine alkaloids "to
give you advance notice of the publication of this rule to facilitate your earliest
compliance," and to inform these firms that "FDA intends to begin enforcing
the rule as soon as it becomes effective" (i.e., 60 days from the date it
is issued).1 The contents of the letter and the list of companies to
whom the letters were are also posted on the FDA’s website (see below).
Questions from reporters sought the identity of additional
herbs whose safety may be considered questionable that FDA may consider banning.
At the press conference, Commissioner McClellan did not reveal any names, but
stated, "Many dietary supplements have important values."4
On three separate occasions Secretary Thompson expressed his
desire to have the authority to receive [mandatory] reports of adverse events
from supplement manufacturers. This position is supported by a Citizen Petition
filed by AHPA last March in regard to serious adverse events.8
The FDA ban marks the first time the agency has removed a popular
dietary supplement from the market under the provisions of DSHEA. "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
FDA’s actions come after several high-profile deaths of
sports figures, most notably the untimely death of Baltimore Orioles pitcher Steve
Bechler at a Florida training camp in February 2003. Bechler’s death and
previous controversies about the safety of ephedra supplements have resulted in
many calls for the ban from Congressional members and medical groups. Numerous
professional and amateur sports associations, including the International Olympic
Committee, and various branches of the military have banned ephedra supplements.
In the past year California, Illinois and New York have banned retail sales of
dietary supplements containing the herb.
Last March, FDA proposed strict new warnings for the primary
display panel on all ephedra supplement labels.9,10 At the same time
it announced the results of the independent report from the RAND Corporation on
ephedra’s risks and benefits.11 Since then FDA has researched
all the available scientific literature and has reviewed more than 10,000 public
comments that it received in response to its proposal. FDA has apparently attempted
create a solid scientific case capable of withstanding a potential challenge in
an administrative hearing, as permitted by DSHEA.
Various official documents, press releases, questions and answers
on ephedra, the warning letter to the 62 manufacturers, the list of manufacturers,
and other communications from FDA related to the ephedra ban are available at
One of the consistent responses by leaders of the herb industry
was that this action validates that many in the industry have been saying for
years, that contrary to protestations by previous FDA officials and some members
of Congress, FDA does have adequate authority and power to remove dietary
supplements from the market that it deems unsafe. "This decision by FDA is
evidence that the agency has acknowledged its authority under the current law,"
said Michael McGuffin, President of the American Herbal Products Association.
He added, "AHPA will attentively evaluate the data on which this decision
to ban ephedrine-containing supplements was based as soon as that information
"What the ephedra ban proves is that DSHEA works,"
said David Seckman, executive director and CEO of the National Nutritional Foods
Association (NNFA) in a press release.13 "The FDA has had the
authority since the passage of DSHEA to remove products from the marketplace it
deems unsafe. For years, NNFA has urged the agency to use its powers to resolve
the debate over ephedra."
It was not clear at press time (January 12) whether any industry
group or individual companies would sue the FDA to challenge the ban. Industry
veteran Loren Israelsen, executive director of the Utah Natural Products Alliance,
a trade group representing manufacturers primarily in the Utah region, was quoted
in the New York Times calling ephedra "a political lightning rod."
The Times wrote that "Mr. Israelsen said other supplement makers feared
that if the F.D.A. did not act against ephedra, Congress would move to tighten
the agency’s jurisdiction over all dietary supplements."14
The Council for Responsible Nutrition’s John Hathcock,
PhD. was quoted by the Associated Press as saying that CRN did not oppose a ban,
that few companies are still making products with ephedra, and most of CRN members
who formerly did no longer do so. "We think the reputable players have found
so much controversy and difficulty in this marketplace that they’ve decided
to get out of it," AP quoted Hathcock. "We recognize the controversy
is a cloud over our whole industry."15
Exemption for Teas and TCM Practitioners?
One small bit of hope remained for sellers of teas and licensed
healthcare professionals who employ ephedra in their scope of practice for uses
that are consistent with ephedra’s use in traditional Chinese medicine (TCM)
for pulmonary complaints and related conditions. FDA’s website has a "Questions
and Answers on FDA’s Actions about Ephedra Dietary Supplements" section
that suggests that the Agency will continue to allow ephedra to be dispensed for
such conditions as appropriate within the practice of TCM by licensed acupuncturists
and doctors of Oriental medicine. The FDA stated, "Essentially all currently
marketed dietary supplements will be affected by the rule. The rule does not pertain
to traditional Chinese herbal remedies. It generally doesn’t apply to products
like herbal teas that are regulated as conventional foods."16
Such exemptions await clarification in the final rules.
Criticized by some for dragging its feet, the FDA is now clearly
taking a leadership role. "We are laying the strongest possible foundation
to not only take the product off the market, but to keep it off," Commissioner
McClellan said at the press conference in December.4
For details about the ban in the three states, please refer
to the extended version of this article at <www.HerbalGram.org>.
1 . FDA. FDA Announces Plans to Prohibit Sales of Dietary
Supplements Containing Ephedra (press release) Washington, DC: Food and Drug Administration,
Dec. 30, 2003.
2. FDA. Consumer Alert: FDA Plans Regulation Prohibiting
Sale of Ephedra-Containing Dietary Supplements and Advises Consumers to Stop Using
These Products. Washington, DC: Food and Drug Administration, Dec. 30, 2003. http://www.fda.gov/oc/initiatives/ephedra/december2003/advisory.html.
3. Peter J. Ephedra Products Sell Fast Ahead of Ban. Associated
Press, Dec 31, 2003.
4. A text of Health and Human Services Secretary Tommy
Thompson and FDA Commissioner Mark McClellan on Dec. 30, 2003, as transcribed
5. McNamara SH. FDA has adequate power and authority to
protect the public from unsafe dietary supplements. HerbalGram 1996;38:25-7.
6. New York Times. The ephedra ban is not enough (editorial).
New York Times Jan. 5, 2004.
7. USA Today. Law lets risky stimulant take ephedra’s
place (editorial). USA Today Jan 6, 2004.
8. AHPA. Citizens petition by the American Herbal Products
Association for regulations requiring adverse experience reporting for dietary
supplements. Silver Spring, MD: American Herbal Products Assn., Mar. 20, 2003.
9. U.S. Food and Drug Administration. Dietary supplements
containing ephedrine alkaloids; Reopening of the comment period Docket No. 95N-0304].
Federal Register Mar. 5, 2003;68(43):100417-20.
10. Blumenthal M. FDA proposes strong warnings for ephedra,
releases independent RAND report on ephedra safety and efficacy. HerbalGram.
11. Shekelle P, Hardy ML, Morton S, Maglione M, Mojica WA,
Suttorp MJ et al. Ephedra and Ephedrine for Weight Loss and Athletic Performance
Enhancement: Clinical Efficacy and Side Effects. Evidence Report/Technology Assessment
No. 76 (Prepared by Southern California Evidence-based Practice Center, RAND,
under Contract No 290-97-0001, Task Order No. 9). AHRQ Publication No. 03-E022.
Rockville, MD: Agency for Healthcare Research and Quality; February 2003
12. AHPA. FDA moves to ban ephedra: final rule due in January.
Silver Spring, MD: American Herbal Products Assn., Dec. 30, 2003.
13. NNFA. FDA to ban ephedra. Costa Mesa, CA: National Nutritional
Foods Assn., December 30, 2003.
14: Stolberg SG. U.S. to prohibit supplement tied to health
risks. New York Times, Dec. 31, 2003.
15: Solomon J. U.S. bans ephedra, drug linked to deaths.
Associated Press, Dec. 30, 2003.
16. FDA. Questions and answers on FDA’s actions about
ephedra dietary supplements. Washington, DC: Food and Drug Administration, Dec.
30, 2003. <www.fda.gov/oc/initiatives/ephedra/december2003/qa. html>.