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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 supplements.
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 necessary.6,7
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 Dr. McClellan.1
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 <www.fda.gov/oc/initiatives/ephedra/december2003/>.
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 is available."12
"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 by eMediaMillWorks
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. 2003;58:68-70.
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>.