"ISSUES RELATING TO EPHEDRA-CONTAINING
Prepared Statement of the Federal Trade Commission
J. Howard Beales, III
Director, Bureau of Consumer Protection
Committee on Energy and Commerce
Subcommittee on Oversight and Investigations
Subcommittee on Commerce, Trade and Consumer Protection
United States House of Representatives
July 24, 2003
Mr. Chairman and members of the Subcommittees, I am
Howard Beales, Director of the Bureau of Consumer Protection, Federal Trade
Commission ("FTC" or "Commission").(1) The
Commission is pleased to have this opportunity to testify about our efforts to ensure the truthfulness and
accuracy of marketing for dietary supplements, including weight loss products and other supplements
containing the herbal ingredient, ephedra. I will discuss the Commission's mission and our latest
activities in this area.
The mission of the Federal Trade Commission is to prevent unfair competition and to protect
consumers from unfair or deceptive acts or practices in the marketplace. As part of this mission, the
Commission has a longstanding and active program to combat fraudulent and deceptive advertising
claims about the benefits or safety of health-related products, including dietary supplements.(2) The
dietary supplement industry encompasses a broad range of products, from vitamins and minerals to
herbals and hormones, and represents a substantial segment of the consumer healthcare market.
Industry sales for 2001 were estimated to be $17.7 billion.(3)
Some dietary supplement products offer the potential for real health benefits to consumers.
Unfortunately, unfounded or exaggerated claims in the marketplace are proliferating. As the level of
deceptive claims has expanded, however, so too have our enforcement actions. Since December
2002, the Commission has targeted deceptive claims for more than $1 billion(4) in health care products, a
majority of which were dietary supplements.
This testimony will provide an overview of our enforcement efforts and other activities to
combat deception in the supplement marketplace, including our efforts in the weight loss area. It then
will focus on our specific efforts to challenge deceptive safety and efficacy claims in the marketing of
supplements containing ephedra.
The FTC's Law Enforcement Actions Against Misleading Dietary Supplement Ads
Challenging misleading or unsubstantiated claims in the advertising of health care products, and
particularly dietary supplements, is a priority of the FTC's consumer protection agenda. The
Commission has filed more than ninety law enforcement actions over the past decade challenging false
or unsubstantiated claims about the efficacy or safety of a wide variety of supplements.(5) In this year
alone, the Commission has filed or settled fifteen cases challenging claims for various supplement
products, including three cases that specifically challenged safety and efficacy claims for ephedra.(6) The
Commission focuses its enforcement priorities on claims for products with unproven benefits or that
present significant safety concerns for consumers, and on false and unsubstantiated claims for products
purported to treat or cure serious diseases.
The Commission's enforcement actions seek to stop deceptive advertising and obtain
meaningful relief for consumers. In addition to obtaining cease and desist orders, in appropriate cases,
the Commission secures substantial monetary relief for consumer redress or disgorgement of profits.(7)
Further, when the marketing of a supplement involves misleading or unsubstantiated safety claims, the
Commission requires that strong warning statements be placed in labeling and advertising.(8)
Weight Loss Advertising Report
As the Subcommittees are aware, ephedra often has been marketed as an aid to weight loss.
Consumers spend billions of dollars on products that purport to promote weight loss.(9) In September
2002, the staff of the Federal Trade Commission released the Report on Weight-Loss Advertising:
An Analysis of Current Trends ("Weight Loss Advertising Report").(10) The Report analyzed claims
from 300 advertisements disseminated during 2001 and concluded that the use of false or misleading
claims in weight-loss advertising is widespread. Nearly 40% of the 300 ads made at least one
representation that was almost certainly false. An additional 15% of the ads made at least one
representation that was very likely to be false, or, at the very least, to lack substantiation.
A comparison of these ads with a sample from 1992 revealed a much higher frequency of
questionable claims and marketing techniques in 2001 compared to a decade ago. For example, ads in
the 2001 sample were much more likely to promise substantial, rapid and permanent weight loss, often
without any diet or exercise. Furthermore, two-thirds of the products promoted in 2001 were dietary
supplements, representing a major shift from 1992 when meal replacement products were the most
Of the 300 advertisements sampled for the Weight Loss Advertising Report, twenty-three, or
about 8%, identified ephedra, ephedrine or Ma Huang as an ingredient. Of these, eleven made safety
claims, and seven included a specific health warning about ephedra's potential adverse effects. Given
that 60% of the sampled ads that made safety claims did not identify ingredients at all, these numbers
almost certainly understate the prevalence of ephedra product advertising.
Public Workshop on Weight Loss Products
In light of the Weight Loss Advertising Report's findings, the Commission held a public
workshop in November 2002 to explore the impact of deceptive weight loss product ads on the public
health and identify new approaches to fighting the proliferation of misleading claims.(12) Government
officials, scientists, public health groups, marketers of weight loss products, advertising professionals,
and representatives of the media participated in the day-long event. A report on the results of the
workshop will be released later this year.
In addition, our staff has been meeting with members of the media, and other interested parties
to encourage them to weed out facially false weight loss advertising before it runs.(13) We are exploring
what assistance the Commission can provide to the media in this effort.
Coordination with the Food and Drug Administration
Under a longstanding liaison agreement,(14) the
FTC has primary responsibility for the advertising of foods, cosmetics, devices,
and over-the-counter drugs while the Food and Drug Administration
("FDA") has primary responsibility for the labeling of those products and advertising
of prescription drugs. Our dietary supplement activities follow the same model.
We coordinate our enforcement
efforts closely with the FDA. Our enforcement actions targeting false or unsubstantiated
supplement safety claims play an important supporting role to the FDA's more
comprehensive efforts to ensure the
safety of supplement products.(15)
Since December 2002, the FTC and FDA have intensified the level of their cooperation. The
Commission staff actively participated in the work of the FDA's Consumer Health Information for
Better Nutrition Initiative to better provide reliable information to consumers about important
developments in nutrition and health, and to step up enforcement actions against deceptive claims for
dietary supplements and other health products. On July 10, 2003, the FTC and the FDA announced
the results of the first six months of coordinated enforcement efforts, including joint actions against
widely advertised supplements claiming cures for serious diseases.(16)
Recent Developments Involving the Marketing of Ephedra Products
The FTC has challenged marketers of dietary supplements containing ephedra when they make
claims that the products cause substantial weight loss or are safe or have no side effects. The recently
released Department of Health and Human Services report, Ephedra and Ephedrine
for Weight Loss and Athletic Performance Enhancement: Clinical Efficacy and Side
Effects ("Rand Report"),
concluded that the existing scientific evidence on the efficacy for weight loss of ephedra-containing
dietary supplements supports only "modest" weight loss of about ½ pound per week
for up to four to
six months.(17) Furthermore, in contrast to assurances
in ads that ephedra is safe or without side effects, the Rand Report concluded
that "the use of ephedrine and/or the use of ephedra or ephedrine plus
caffeine is associated with two to three times the risk of nausea, vomiting,
psychiatric symptoms such as anxiety and change in mood, autonomic hyperactivity,
and palpitations."(18) Moreover, the Rand Report
noted that adverse event reports for the supplement contain a sufficient number of cases of death,
myocardial infarction, cerebrovascular accident, seizure, or serious psychiatric illness in young adults to
warrant a case-control study to determine whether ephedra consumption may be causally related to
these serious adverse events.(19)
Since 1997, the FTC has brought seven enforcement actions challenging efficacy and safety/no
side effects claims for supplements containing ephedra.(20)
These cases have challenged claims for
ephedra products marketed for weight loss, body-building and energy supplements, and as alternatives
to street drugs such as Ecstasy. In these cases, we have challenged allegedly deceptive efficacy and
safety claims as false or unsubstantiated. Our orders have required a strong disclosure warning about
safety risks in future advertising and labeling.(21)
For example, the Commission filed two additional settlements with companies that made
allegedly deceptive safety and weight loss claims for ephedra supplements. In one case, the
Commission's complaint challenged, as false or unsubstantiated, dramatic claims of substantial and safe
weight loss for users of a product called Berry Trim Plus.(22) Ads
for this product made claims such as "Teacher Loses 70 lbs. In Only 8 Weeks Easily!" and "100% safe!" In
the second case, the FTC challenged as false or unsubstantiated claims for an
ephedra product called Meta Biological.(23) Ads
this product claimed that "you lose pounds and inches SAFELY. . . without counting
depriving yourself of tasty, delicious foods."
In these two cases, we alleged that there is not sufficient evidence to show that these products
work as advertised or are safe for everybody. In both cases, the defendants agreed to an order that
bans them from making certain false weight loss claims, requires substantiation for other weight loss
claims, prohibits safety claims for ephedra without reliable scientific evidence, and requires the
defendants to include a strong warning about safety risks in future advertising and labeling.(24) Both
orders also require the defendants to pay consumer redress.
In addition, last month, the U.S. Department of Justice, on the Commission's behalf, sued
Michael Levey, Gary Ballen, and their companies.(25) The
complaint alleges that these defendants deceptively claim that their ephedra
products, "Zymax" and "MillinexES," cause fast, substantial weight
loss without dieting or exercise or side effects.(26) The Commission has asked the court to enjoin the
defendants from making similar deceptive claims in the future and order the defendants to pay consumer
redress. In addition, because the challenged claims violate an earlier Commission order, we have
asked the court to award civil penalties. The case remains in litigation.
Deceptive advertising and unsubstantiated claims about the health benefits or safety of dietary
supplements put consumers' health at risk. The Commission will continue to take law enforcement
action against marketers who make safety and efficacy claims for any product without reliable scientific
evidence to back up the claims.
The Commission thanks the Subcommittees for focusing attention on this important consumer
health issue and for giving the Federal Trade Commission an opportunity to discuss its role. The
Commission looks forward to working with the Subcommittees on our initiatives involving the marketing
of dietary supplements, and, in particular, products containing ephedra.
1. The written statement presents the views of the Federal Trade Commission. Oral testimony and
responses to questions reflect my views and do not necessarily reflect the views of the Commission or
2. Our authority
in this area derives from Section 5 of the Federal Trade Commission Act,
prohibits "unfair or deceptive acts and practices in or affecting commerce," and Section 12, which
prohibits the false advertisement of "food, drugs, devices, services or cosmetics." 15 U.S.C. §§ 45,
3. Supplement Business Report 2002,
Nutrition Bus. J., § 2 (2002)
4. This represents the total sales for products the Commission challenged in seventeen actions since
5. See, e.g., FTC v. A. Glenn Braswell, et al., Civ. Action No. CV 03-3700 DT (PJWx) (C.D.
Cal. filed May 27, 2003)(complaint for permanent injunction and other equitable relief); FTC v.
Enforma Natural Prod., Inc., No. 00-4376JSL (Cwx) (C.D. Cal. Apr. 25, 2000) (stipulated final
judgment with $10 million in consumer redress); FTC v. Slim Down Solution, LLC, No. 03-80051-CIV-PAINE (S.D. Fla. filed Jan. 24, 2003) (complaint for permanent injunction and other equitable
relief); FTC v. KCD Inc., 123 F.T.C. 1535 (1997) (consent order). A
complete list of the
Commission's dietary supplement cases is available at <http://www.ftc.gov/bcp/conline/pubs/buspubs/dietadvertisingcases.pdf>.
6. FTC v. Health Laboratories of North America, Civ. No. 03 1457 (D.D.C. July 1, 2003)
(stipulated final order involving safety and weight loss claims for a supplement containing ephedra);
FTC v. USA Pharmacal Sales, Inc., Civ. No. 8:03-CV-1366-T-23EAJ (M.D. Fla. July 1, 2003)
(stipulated final order involving safety and weight loss claims for a supplement containing ephedra); U.S.
v. Michael S. Levey, Civ. No. CV-02-4670 GAF (AJWx) (C.D. Cal. June 30, 2002) (complaint
challenging no side effects and weight loss claims for a supplement containing ephedra).
7. See, e.g., FTC v. Enforma Natural Prods., Inc., 04376JSL (CWx) (C.D.Cal. Apr. 25, 2000)
(stipulated final order including $10 million in consumer redress); FTC v. Slim America, Inc., 97-6072-CIV-Ferguson (S.D. Fla. June 30, 1999) (final judgment for permanent injunction and damages,
including $8.3 million in consumer redress).
8. See, e.g., FTC v. Health Laboratories of North America, Civ. No. 03 1457 (D.D.C. July 1,
Enterprises, Inc., The U.S. Weight Loss & Diet Control Market 6
(2002). Marketdata estimated that the total U.S. weight-loss market for 2001
was $37.1 billion and
growing at a rate of 6 to 7 % a year.
10. Copies of
the Weight Loss Advertising Report can be found at <http://www3.ftc.gov/bcp/reports/weightloss.pdf>.
11. Weight Loss Advertising Report at 21.
12. Advertising of Weight Loss Products, 67 Fed. Reg. 59,289 (2002).
13. See, e.g., Remarks
of FTC Chairman Timothy J. Muris to the Cable Television Advertising Bureau
(Feb. 11, 2003), Do the Right Thing (Apologies to Spike Lee), <http://www.ftc.gov/speeches/muris/030211rightthing.htm>;
Remarks By Commissioner Sheila F. Anthony Before The Food and Drug Law Institute
45th Annual Educational Conference (Apr. 16,
2002), Combating Deception in Dietary Supplement Advertising, <http://www.ftc.gov/speeches/anthony/dssp2.htm>; Remarks of Commissioner Orson Swindle to the
Aggressive Advertising and the Law Conference (Apr. 28, 2003), Combating Deceptive
Advertising - The Role of Advertisers, the Media, and the FTC ,
14. See Working
Agreement Between FTC and FDA, 3 Trade Reg. Rep. (CCH) ¶ 9,859.01
15. The Dietary Supplement Health and Education Act of 1994, Pub. L. No. 103-417, 108 Stat.
4325 (1994), requires a manufacturer of a dietary supplement to have substantiation for any
structure/function claims it makes so that the claim is truthful and not misleading. DSHEA also
authorizes the FDA to proceed against a supplement that presents a significant or unreasonable risk of
illness or injury.
16. See FTC. v. Kevin Trudeau, et al., Civ. Action No. 03 C 904 (N.D. Ill. filed June 9, 2003)
(complaint for permanent injunction and other equitable relief); FTC v. Seasilver USA, Inc., et al.,
Civ. Action No. CV-S-03-0676-RLH-LRL (D. Nev. filed June 12, 2003) (complaint for injunctive
and other equitable relief).
17. Agency for
Healthcare Research and Quality, U.S. Dep't of Health and Human Serv., Ephedra
and Ephedrine for Weight Loss and Athletic Performance Enhancement:
Clinical Efficacy and Side Effects ("Rand Report") 219 (2003).
18. Id. at 9.
19. Rand Report
at 223. In addition, at the request of the FDA, researchers conducted an
independent review of 140 reports of adverse events related to the use of
containing ephedra alkaloids that were submitted to the FDA between June 1, 1997,
and March 31, 1999. The results of the review were published in the New England
Journal of Medicine in December
2000. The authors found that "thirty-one percent of cases were considered to be definitely or probably
related to the use of supplements containing ephedra alkaloids, and thirty-one percent were deemed to
be possibly related." The authors also found that, "(o)f the sudden catastrophic cerebrovascular and
cardiovascular events, 11 occurred in previously healthy persons." Christine A. Haller & Neal
Benowitz, Adverse Cardiovascular and Central Nervous System Events Associated with Dietary
Supplements Containing Ephedra Alkaloids, 343 New Eng. J. Med. 1833-38 (2000). Other recent
studies raise further concerns about the safety of ephedra. See Stephen Bent, et al., The Relative
Safety of Ephedra Compared with Other Herbal Products, 138 Annals of Internal Med. 468-71 (2003) (Although ephedra products make up less than 1% of all dietary supplement sales, they
account for 64% of adverse events associated with dietary supplements); L.B. Morgenstern, et al., Use
of Ephedra-Containing Products and Risk for Hemorrhagic Stroke, 60 Neurology 132-35
(2003) (The rate of hemorrhagic strokes among ephedra users was statistically significantly higher than
among non-users for people taking doses above thirty-two milligrams a day).
20. In addition to the three cases listed supra note 6, at 3, and discussed in detail below, these
actions include Robert C. and Lisa M. Spencer, dba Aaron Co., FTC Docket No. C-4019 (July 30,
2001) (consent order involving safety claims for an energy product containing ephedra); FTC v. AST
Nutritional Concepts and Research, Inc., Civ. No. 99-WY-2197 (D. Col. May 4, 2000) (stipulated
final order involving safety claims for body-building supplements containing both androstenedione and
ephedra); FTC v. Mex-RX US, Inc., Civ. No. SACV99-1407-DOC(ANX) (C.D. Cal. Nov. 24,
1999) (stipulated final order involving safety claims for body-building supplements containing both
androstenedione and ephedra); Global World Media Corp., 124 F.T.C. 426 (1997) (consent order
involving street drug alternatives containing ephedra).
21. In addition,
the Commission's order against Global World Media for its marketing of ephedra
as a street drug alternative includes a prohibition against marketing in
media targeted at young audiences.
Specifically, the consent order prohibits disseminating any ads for "Herbal Ecstacy" and
similar products containing ephedra in any media where more than 50% of the audience
is under 21 years of
age. See Global World Media, 124 F.T.C. at 446.
22. FTC v. Health Laboratories of North America, Civ. No. 03 1457 (D.D.C. July 1, 2003).
23. FTC v. USA Pharmacal Sales, Inc., Civ. No. 8:03-CV-1366-T-23EAJ (M.D. Fla. July 1,
24.For example, the Commission orders
in Health Labs of North America and USA Pharmacal
Sales require the following warning in print advertising:
WARNING: This product contains ephedra or ephedrine alkaloids,
which can have dangerous effects on the central nervous system and
heart and can result in serious injury. Risk of injury can increase with
dose, and may even include heart attack, stroke, seizure, or death.
Consult a health care provider prior to use if you have high blood
pressure, heart or thyroid disease, diabetes, difficulty urinating, prostate
enlargement, or glaucoma, or are using any prescription drug. Do not
use if you are taking a MAO inhibitor or any allergy, asthma, or cold
medication containing ephedrine, pseudoephedrine, or
phenylpropanolamine. Discontinue use if you experience rapid heart
beat, chest pain, severe headache, shortness of breath, dizziness,
sleeplessness, or nausea. This product is not recommended for use if
you are or could be pregnant unless a qualified health care provider tells
you to use it. The product may not be safe for your developing baby.
We are carefully reviewing the Rand Report and monitoring the ongoing FDA proposed
rulemaking on ephedra to see if their findings would warrant any modification in the safety warnings
required by future Commission orders.
25. U.S. v. Michael S. Levey, Civ. No. CV-02-4670 GAF (AJWx) (C.D. Cal. June 30, 2002).
26. The Commission
also charged the defendants with making similar deceptive weight loss claims
for a non-ephedra supplement called "Serotril."