Internet Marketers of Dietary Supplement Must Place Safety Warnings On Androgen Supplement Labeling And Advertising
The Federal Trade Commission today settled charges against MET-Rx USA, Inc. and AST Nutritional Concepts involving unsupported safety claims made in the marketing of purported body-building supplements that contain androstenedione ("androgen"), and other steroid hormones, and in some cases, stimulants such as ephedra and caffeine. The two marketers of androgen supplements must disclose the potential risks of the supplements in all advertising, labeling and promotional materials that make efficacy, performance, or safety claims, as part of a settlement with the FTC. In separate complaints, the FTC alleges that the two companies advertise that their androgen supplements will increase strength and muscle mass "safely and with minimal or no negative side effects." The complaints challenge the companies' lack of substantiation for their claims about the safety or lack of side effects of the products. The claims were made primarily on Internet sites promoting the products.
Androgens are steroid hormones that are produced naturally in the body and can be synthesized from natural and artificial sources. The companies' androgen products contain various combinations of the steroid hormones androstenedione, androstenediol, norandrostenedione, and/or norandrostenediol. These substances convert in the body to testosterone, estrogen, and/or other potent hormones, and thus could pose safety risks and unwanted side effects similar to those of more potent hormones. The disclosure required by the FTC warns that these potential risks include unwanted changes in male and female sexual characteristics, and special dangers to persons at increased risk for prostate or breast cancer.
"Teenagers and athletes who are using these supplements as performance or muscle enhancers are being misled about their safety and potential negative side effects. Not any more," said Jodie Bernstein, Director of the FTC's Bureau of Consumer Protection. "Now, the labels and ads for these products will give consumers the straight story about the side effects and they'll be able to base their buying decisions on the facts. This information is especially important for teenagers, whose health may be threatened by long-term use of steroid hormones."
"Parents, coaches and athletes need to be aware of the real risks these substances pose to the lives and health of young people and athletes at all levels," said General Barry McCaffrey, Director of the Office of National Drug Control Policy. "Today's action by the FTC will help raise awareness of these risks. No victory is worth the physical harms these substances can bring. It is vital that we create a level playing field for competition where athletes no longer feel that they need to chemically engineer their bodies to compete and win. Today's action by the FTC is an important part of a larger federal effort to deal with the use of drugs in sport. We applaud the FTC for its leadership."
Robert F. Kanaby, Executive Director of the National Federation of State High School Associations, stated today that: "I support the FTC's actions to inform consumers about the risks of performance-enhancing supplements. We want student athletes to participate in athletics without the dubious aid of substances that may be harmful to their long-term well being." The Federation represents high school athletic and activity associations across the nation.
The FTC's complaints name AST Nutritional Concepts & Research, Inc. (AST), based in Colorado, and its president Paul Delia; and MET-Rx USA, Inc. and its subsidiary, MET-Rx Substrate Technology, Inc. (MET-Rx), based in Irvine, California. The complaints allege that the defendants claimed their androgen supplements, taken in recommended doses, are safe, produce no or minimal negative side effects, and do not pose health or safety risks. The FTC alleges that the defendants lacked scientific evidence to support those claims. In addition, the complaint against AST alleges that the company falsely claimed that its androgen supplements do not contain steroid hormones.
AST advertises and sells sports nutrition supplements, including eight androgen supplements, via the Internet at www.ast-ss.com, and through magazines, direct mail and retail stores. Its androgen product, 3-Andro Xtreme, also contains ephedra and caffeine. Ephedra, especially in combination with caffeine, can have dangerous effects on the heart and central nervous system. AST's androgen supplements cost between $39 and $65 per 60 capsule bottle. Its advertising has included safety claims such as "completely safe and very effective," "you'll experience no negative side effects," and "Andro is not a steroid and does not have steroid effects."
Met-Rx sells a variety of nutritional products, including six androgen supplements priced from $25 to $65 per 60 capsule bottle. Met-Rx Substrate Technology is an affiliate corporation involved in the research and development of Met-Rx products. Met-Rx markets its androgen products to consumers via the Internet at www.met-rx.com, and www.substratesolutions.com, and through over 400 retail stores nationwide. One of these products, "Andro Heat," also contains ephedra and caffeine. Met-Rx has advertised its androgen products as "abuse-proof" and as having a "safe and mild effect (with little in the way of side effects)."
The proposed settlements would prohibit the defendants from making claims about the absolute safety or side effects for any food, dietary supplement or drug, including androgen products, unless they have competent and reliable scientific evidence to substantiate those claims. In addition, the proposed AST settlement prohibits the company from representing that any androgen product does not contain steroids or steroid hormones.
The proposed orders would require the following labeling and advertising disclosure for any androgen supplement for which any efficacy, performance, or safety claim is made:
WARNING: This product contains steroid hormones that may cause breast enlargement, testicle shrinkage, and infertility in males, and increased facial and body hair, voice deepening, and clitoral enlargement in females. Higher doses may increase these risks. If you are at risk for prostate or breast cancer you should not use this product.
The proposed orders also would require the following labeling and advertising disclosure for any androgen supplement containing ephedra (also known as ephedrine):
WARNING: This product contains ephedra. Taking more than the recommended serving may result in heart attack, stroke, seizure or death. Consult a health care practitioner 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 dizziness, sleeplessness, loss of appetite, or nausea occurs.
The orders provide an abbreviated ephedra disclosure for television or radio advertising.
The Commission vote to authorize staff to file the complaints and proposed stipulated final orders for permanent injunction in the appropriate district courts was 4-0.
The AST complaint and stipulated final order were filed in the U.S. District Court for the District of Colorado, in Denver, on November 15, 1999. The Met-Rx complaint and stipulated final order were filed in the U.S. District Court, Central District of California, in Los Angeles, on November 15, 1999. The proposed settlements are subject to court approval. Final orders have the force of law when signed by the judge.
NOTE: These stipulated final orders for permanent injunction are for settlement purposes only and do not constitute an admission by the defendants of a law violation.
Copies of the complaints and proposed final orders will be available shortly from the FTC's web site at http://www.ftc.gov and from the FTC's Consumer Response Center, Room 130, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580; 877-FTC-HELP (877-382-4357); TDD for the hearing impaired 1-866-653-4261. To find out the latest news as it is announced, call the FTC NewsPhone recording at 202-326-2710.
(AST -- FTC File No. 992 3179; Civil Action No. 99-WI-2197)
(MET-Rx - FTC File No. 992 3180; Civil Action No. SAC V-99-1407)
Office of Public Affairs
Bureau of Consumer Protection
202-326-2070 or 202-326-2987