How Is Ephedra Linked To Herbal Ecstasy?
Legitimate Ephedra products are not. There are unscrupulous businesses that market products containing Ephedra to minors as illicit drugs. Responsible members of Industry have for years urged FDA to use its enforcement powers to take these illegal products off the market. In fact, Industry has submitted a Citizen Petition (see below) to FDA urging appropriate regulation of Ephedra products. One of the statements in the petition is a specific ban on claims that Ephedra “may be useful to achieve an altered state of consciousness, euphoria, or as a “legal” alternative for an illicit drug.”
October 25, 2000
Dockets Management Branch
Food and Drug Administration
Department of Health and Human Services
12420 Parklawn Drive, Room 1-23
Rockville, Maryland 20857
CITIZEN PETITION
The American Herbal Products Association, The Consumer Healthcare Products Association, The National Nutritional Foods Association and The Utah Natural Products Alliance (”trade associations”) submit this petition under 21 C.F.R. §§ 10.25 and 10.30 to request that the Commissioner of Food and Drugs withdraw the remaining portions of its June 4, 1997 proposed rule, Dietary Supplements Containing Ephedrine Alkaloids; Proposed Rule (Docket No. 95N-0304), 62 Fed. Reg. 30678, and adopt and implement in its place a standard for the labeling and marketing of dietary supplement products containing ephedrine alkaloids, as set forth below. These trade associations, which represent the vast majority of the manufacturers and distributors of ephedra products, have uniformly adopted a voluntary program that includes all of the elements provided below, and several states have considered and enacted these or similar provisions as state law. As such, the elements of the voluntary program and the several state laws represent a standard (hereafter referred to as “the standard” or “the current standard”) that is applied nationally by all the major companies marketing ephedra-containing dietary supplements.
Recent analyses of the safety of ephedra, presented at the Department of Health and Human Services public meeting on August 8-9 (HHS public meeting) and submitted to FDA as comments, confirm that ephedra products are safe when marketed and consumed according to the current standard. Further, new data presented at the HHS public meeting confirmed the significant public health benefits that ephedra products provide in the area of weight loss. The consensus of the HHS meeting, as stated in the HHS’s Office on Women’s Health Report on the meeting, was that industry and government should work together to educate consumers about ephedra products and to conduct further research into the safety and benefits of these products. This will also ensure that the standard continues to be evaluated and reevaluated.
Therefore, by withdrawing the remaining portions of the 1997 proposed rule and adopting the standard contained in this petition, FDA will assure continued access to safe and useful products and will open the door to cooperative efforts with industry and other government agencies to allow public education and to produce additional data.
A. ACTION REQUESTED
The trade associations request that the Commissioner of Food and Drugs withdraw the remaining portions of FDA’s proposed rule, Dietary Supplements Containing Ephedrine Alkaloids; Proposed Rule (Docket No. 95N-0304), 62 Fed. Reg. 30678 (June 4, 1997), and adopt the current standard for the formulation, labeling and marketing of dietary supplement products containing ephedrine alkaloids as set forth below:
Labeling
1. The label of the goods should bear an adequate cautionary statement, which shall at a minimum include the following language, or comparable language:
WARNING: Not intended for use by anyone under the age of 18. Do not use this product if you are pregnant or nursing. Consult a health care professional before using this product if you have heart disease, thyroid disease, diabetes, high blood pressure, depression or other psychiatric condition, glaucoma, difficulty in urinating, prostate enlargement, or seizure disorder, if you are using a monoamine oxidase inhibitor (MAOI) or any other prescription drug, or you are using an over-the-counter drug containing ephedrine, pseudoephedrine or phenylpropanolamine (ingredients found in certain allergy, asthma, cough/cold and weight control products).
Exceeding recommended serving will not improve results and may cause serious adverse health effects.
Discontinue use and call a health care professional immediately if you experience rapid heartbeat, dizziness, severe headache, shortness of breath, or other similar symptoms.
2. The product label shall list the amount of ephedrine alkaloids and caffeine alkaloids, if present, per serving.
Serving Limits
Products are not to contain in excess of 25mg of total ephedrine alkaloids per serving; usage instructions should limit daily consumption to 100mg of total ephedrine alkaloids.
Herbs of Commerce Conformity
Label identification must be in conformity with the standard common name listed in Herbs of Commerce.
Synthetic Ingredients
Neither finished consumer goods nor raw materials used in their manufacture are to contain any synthetically derived ephedrine alkaloids or their salts (e.g., ephedrine sulfate; pseudoephedrine hydrochloride; phenylpropanolamine hydrochloride).
Marketing
No claims shall be made that the product may be useful to achieve an altered state of consciousness, euphoria, or as a “legal” alternative for an illicit drug.
B. STATEMENT OF GROUNDS
Industry has effectively implemented a voluntary program for ephedra products. This voluntary industry program began more than four years ago. Virtually all major manufacturers and distributors of ephedra products, who are members of the undersigned trade associations, have adopted the program. Further, these or similar standards have been incorporated into state law in Ohio, Washington, Hawaii and Michigan.1 The elements of the voluntary program and several state laws represent the current standard adopted by all the major firms marketing ephedra-containing products.
The standard is based on and supported by an ever-increasing amount of data relevant to the safety and benefits of ephedra products, including:
· The long history of safe use of ephedra and similar FDA-regulated products;
· Clinical data on ephedrine/caffeine combination products, and on ephedra alone and combined with caffeine, showing the safety and benefits of these products for weight loss; 2
· Consumption data showing that sales of ephedra products have increased exponentially over the last five years while the number of reports of adverse events have decreased; 3
· Comparisons of estimates of the incidence of strokes, heart attacks and seizures in the general population to the incidence of the same events in ephedra consumers, showing that there is no increased in risk from the consumption of ephedra; 4
· Comprehensive analyses of all adverse event reports submitted to FDA showing that there is no association between the reported serious adverse events and the consumption of ephedra products according to the current standard; 5 and
· Thorough reviews of the published literature, including all published case reports, showing that the published literature supports the safety of ephedra products when consumed according to the current standard. 6
The action requested would make it possible for consumers to have continued access to products that, based on existing and new data on their safety and usefulness in weight loss, are gaining acceptance by prominent experts in obesity. The potential importance of these products to help with weight loss, and therefore with one of the most serious public health threats to the American public, was made clear at the recent Health and Human Services public meeting on August 8-9, 2000. Formal FDA adoption of the current standard and withdrawal of the remaining portions of FDA’s existing proposal would permit the continued availability of ephedra while additional research is pursued to further optimize our understanding of ephedra’s safety and benefits.
C. ENVIRONMENTAL IMPACT
Neither an environmental assessment nor an environmental impact statement is required for the action requested of the agency because the requested agency action is categorically excluded pursuant to 21 C.F.R. § 25.30(h) in that it is concerned with issuance of procedural or administrative regulations and guidelines.
D. ECONOMIC IMPACT
According to 21 C.F.R. § 10.30(b), information on economic impact is to be submitted only when requested by the Commissioner following review of the petition.
E. CERTIFICATION
The trade associations certify, that to the best of their knowledge and belief, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioners, which are unfavorable to the petition.
Respectfully submitted,
Michael McGuffin
President
The American Herbal Products Association
Michael D. Maves, M.D., M.B.A
President
The Consumer Healthcare Products Association
David Seckman
Executive Director / CEO.
The National Nutritional Foods Association
Loren Israelsen
Executive Director
Utah Natural Products Alliance
Footnotes:
1)See Haw.Rev.Stat.Ann. 329-64(a)(5); Mich. Stat. Ann. 7220(1)(c)(ii); Ohio Rev. Code Ann. 3791.44 (K)(2)(a); Wash. Admin. Code 248-883-030(3).
2)Data presented at the HHS meeting and have been submitted by various parties to FDA in response to FDA’s request for comments. Exisiing data are summarized in a comprehensive literature review submitted to FDA on October 2, 2000 with the Ephedra Education Council Expert Panel comments (EEC Expert Panel Comments), and in other comments submitted to FDA. Important new clinical studies have been completed that are consistent with the current standards and with existing data showing benefits. These studies are expected to be publised in the near future.
3)See American Herbal Products Association Comments to FDA filed October 2, 2000; EEC Expert Panel Comments
4 & 5)See EEC Expert Panel Comments
6)See EEC Expert Panel Comments and other comments submitted to FDA.
Why Does Public Citizen Think that Ephedra Should be Banned?
Public Citizen is basing its proposed ban on the same unscientific information that was used by FDA to support the proposed limits on the sale of Ephedra products, a proposal that FDA has now substantially withdrawn. Public Citizen, like FDA in 1997, has ignored the considerable body of clinical data that shows that Ephedra is safe and effective when taken as directed. EEC agrees with one aspect of the Public Citizen proposal, synthetic products should not be sold as natural products.
I Am Currently Taking A Prescription Drug To Cure A Stomach Ulcer. Can I Continue To Take Ephedra?
The label adopted by responsible members of Industry states that you should consult with a health care professional before taking an Ephedra product if you are on prescription medication.
Will Taking More Than The Recommended Serving Size of Ephedra Increase My Ability To Lose Weight?
No. The label adopted by responsible members of Industry, which Industry has urged FDA to adopt and has also become law in several states, specifically states that “exceeding recommended serving will not improve results and may cause serious adverse health effects.” One should always read the label and follow directions.
My Doctor Told Me That I Need To Lose 100 Pounds. Is Ephedra An Option For Me?
While Ephedra could be an option, it will depend on a number of factors, including your overall health, your medical history and what other drugs or other products you are taking. You should consult with your health care professional.
If Ephedra Is Natural Then Why Do I Hear That It Is Unsafe?
Ephedra is safe when taken as directed. Like anything, whether it is natural or not (peanuts are natural but for some people, unsafe to eat), some people should not use Ephedra. To use it properly, one must read and follow the directions.
My Son Is Trying Out For A High School Sports Team And Wants To Take Ephedra To Better Prepare Him. Is This Okay?
No. The label adopted by responsible members of Industry, which Industry has urged FDA to adopt and has also become law in several states, specifically states that Ephedra should not be used by anyone under the age of 18.
Is Ephedra The Same Substance That Was Banned From Cold Medicines Like Sudafed Because It Causes Strokes In Women?
No. The product that was banned in certain cold medications was phenylpropanolamine. Ephedra does not contain phenylpropanolamine.
How Safe Is Ephedra-Ephedrine?
There has been some bad press regarding the safety of ephedrine & ephedra products. For example, on April 18, 2000, Dateline aired a story that questioned the safety of dietary supplements that contain ephedrine alkaloids from the herb Ephedra, also known as ma huang. The Ephedra Education Council (the EEC), composed primarily of companies that are members of the Ephedra Committee of the American Herbal Products Association (AHPA), and AHPA itself, worked closely with Dateline to assure that they had the information necessary to air a balanced news story on Ephedra products. Nonetheless, Dateline producers overlooked virtually all of the positive information provided to them on Ephedra products. Dateline’s inaccurate story implied that Ephedra products were harming unsuspecting consumers.
The truth is that millions of American consumers safely use Ephedra products for energy and weight loss. One clinician who has extensively researched the efficacy of Ephedra products on hundreds of dietary supplement consumers looking for safe alternatives to prescription drugs has recently confirmed that these products are among the most safe and useful aids to weight loss available.
Dateline’s own story best illustrates how the producers purposefully left out significant information that did not support their program’s message:
- The story – Dateline began and ended its story with the shocking death from cardiac arrest of a young New Jersey police academy trainee, John Lesemann. Dateline claimed that “two different medical labs linked” ephedrine from an Ephedra product to the young man’s death.
The FACTS – Dateline did not report that it had provided AHPA with a complete copy of the information concerning Mr. Lesemann’s death and that Dateline had asked AHPA to review and comment on this information. Representatives of the Ephedra Committee of AHPA and the EEC provided the complete file to a professor and national expert in cardiac pathology at the Johns Hopkins University, Dr. Grover Hutchins. A letter was provided to Dateline from Dr. Hutchins stating that, in his opinion as an expert in cardiac pathology, Mr. Lesemann’s death was not caused by an Ephedra product, but “to a reasonable degree of medical certainty, based on the available information, that Mr. Lesemann’s death is ascribable to an arrhythmia arising from myocarditis in the setting of physical exertion.”
The Dateline story contained nothing about Dr. Hutchins’ review or opinion.
- The story – Dateline reported that the “U.S. Food and Drug Administration says since 1994, it has received reports of 60 deaths linked to ephedrine supplements and close to 1,200 reports of people becoming sick – including dizziness, psychosis and strokes.”
The FACTS – Dateline did not report that FDA widely publicized the reports of deaths and illness, and attempted to use them as the basis for regulations, without ever reviewing the reports to determine if the reports had any connection to the consumption of Ephedra products. Nor did Dateline report that the investigative arm of Congress, the General Accounting Office (GAO), conducted an audit of FDA’s mishandling of the reports on Ephedra products. The GAO found that FDA had inexplicably attempted to use reports of adverse events about Ephedra products in an entirely new and unscientific manner that violated FDA’s own established policies. The GAO confirmed that:
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- FDA had failed to review the reports before publicizing them;
- that the reports were mostly incomplete and irrelevant; and
- that there was no scientific basis for FDA’s proposed ban on the use of Ephedra products for weight loss.
Dateline did not report that, embarrassed by the lack of scientific support for the agency’s public accusations, on March 31, 2000, FDA took the highly unusual step of withdrawing most of its proposed restrictions on Ephedra products.
Dateline chose to ignore the science and, instead, publish information that is over three years old and has already been discredited.
- The story – Dateline reported that, according to Bill Gurley, a Ph.D. scientist at the University of Arkansas, some Ephedra products do not contain the labeled amount of ingredients. According to Dr. Gurley, “if a drug company did have such a problem, the FDA would have that company recall that product.
The FACTS – Dr. Gurley is not a legal expert and he has misstated the law. Products that do not contain the amount of ingredients stated on the label are illegal under federal law, whether they are drugs or dietary supplements, and are subject to essentially the same FDA regulatory actions, including product seizures, injunctions, and even criminal prosecutions.
- The story – Dateline blamed the lack of regulation of supplements on Congress. “Because of a law passed by Congress in 1994, the FDA essentially has no authority to regulate herbal products. . . . [T]here are no federal safety standards or even a requirement [that] a company prove its product works.”
The FACTS – Dateline incorrectly blames Congress’s 1994 passage of the Dietary Supplement Health and Education Act (DSHEA) for the marketing of unsafe and poorly formulated dietary supplements. Contrary to Dateline’s report, DSHEA strengthened federal safety and labeling standards, adding requirements for premarket review of new dietary supplement ingredients and provisions to immediately remove from the market any supplement that poses an imminent hazard to health. DSHEA also provided FDA with specific authority to publish requirements for the manufacture of dietary supplements. Four years have passed and FDA has yet to publish these requirements even as a proposed regulation.
Contrary to Dateline’s report, manufacturers are required to substantiate all claims that they make in advertising for the products that they market, and the Federal Trade Commission has actively enforced its authority in this area, forcing companies that have violated this requirement to pay multi-million dollar fines.
The only explanation for the continued marketing of dietary supplement products that do not contain what the label states, or products that are not safe, is the lack of FDA enforcement, not the lack of authority. Responsible industry has repeatedly urged FDA to take action. FDA has conceded that it has done a poor job of enforcing the law, and has vowed to do better.
Again, Dateline chose not to report the facts.
- The story – Dateline reported that Texas has received over 700 reports of adverse events since 1994, “including at least eight deaths,” and that Texas authorities were concerned about the safety of Ephedra products.
The FACTS – Dateline did not report that virtually all of the 700 reports at issue related to one illegal product, Formula 1, against which Texas, but not FDA, took legal action in 1996. Since that illegal product was removed from the market, Texas has received only three reports of any problems that might be scientifically linked to the consumption of Ephedra products, despite widespread and increasing consumption.
Dateline chose not to report any of the existing scientific analyses of these reports.
- The story – Dateline used Dr. Gurley, who does not claim to be an expert in obesity, weight loss, or even in reviewing clinical efficacy studies, to review the scientific evidence supporting the use of Ephedra products for weight loss. Dr. Gurley reported that, in his view, these products were not very effective for weight loss because consumers who used Ephedra products and dieted over a six month period lost “less than eight pounds” more than people who dieted alone.
The FACTS – Even if Dr. Gurley were correct, his view that losing an extra eight pounds is not significant runs contrary to what every weight loss expert recognizes. Even the loss of five pounds in overweight individuals can have very significant positive health benefits, including lowering blood pressure, improving cholesterol, triglyceride levels, and reducing the risk for heart disease and stroke. Further, Dr. Gurley did not acknowledge the difficulty that many overweight Americans have in starting a diet without some form of aid, such as Ephedra products, that help curb the appetite and burn calories.
Dateline was given the names of recognized experts who had conducted research into the efficacy of Ephedra products for weight loss. These experts who have a positive view of the usefulness and safety of Ephedra products based on their own research were not interviewed and were not even mentioned in the Dateline story.
What is the Difference Between Ephedra and Phen-Fen?
Ephedra and Phen-fen are two completely different substances. Phen-Fen is a synthetic pharmaceutical drug. Ephedra, a naturally occurring substance, is derived from a plant known as Ma Huang. These are two very different substances and there are no similarities between the two.
