Met-Rx, AST To Place Warnings On "Andro" Products Under FTC Settlement

Sports supplement marketers Met-Rx USA and AST Sports Science agree in individual settlements with the Federal Trade Commission to place warnings on their androstenedione ("andro") supplements as well as an additional warning on andro supplements also containing ephedra.

The andro sellers have settled FTC charges the firms were making unsubstantiated safety claims for their body-building supplements containing andro and other steroid hormones, as well as stimulants such as ephedra and caffeine, the parties announced Nov. 16. FTC voted 4-0 to authorize the proposed final orders for permanent injunction, which were filed in district courts Nov. 15 and are awaiting judges' approval.

FTC asserts the companies were advertising that their supplements would increase strength and muscle mass safely and with minimal or no side effects. The claims were primarily on the Internet. Under the settlement, Met-Rx and AST are prohibited from making unsupported safety claims for their products. AST also is enjoined from representing androgen products as not containing steroids or steroid hormones without proof.

The proposed orders require labeling and advertising include the statement: "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."

For andro products containing ephedra, the required warning is: "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 allow a shorter ephedra warning in TV or radio advertising: "Warning: This product contains ephedrine which can have dangerous effects on the central nervous system and heart and could result in serious injury. Risk of injury increases with dose."

In 1997, FDA proposed a lengthier but similar warning statement for all dietary supplements containing ephedrine alkaloids (¹ (Also see "Ephedra-containing dietary supplement across-the-board label warning suggested by FDA." - Pink Sheet, 9 Jun, 1997.)). That statement advises consumers to consult a health care provider before using such products if they are pregnant or nursing, or have heart disease, thyroid disease, diabetes, high blood pressure, depression or other psychiatric conditions, glaucoma, difficulty urinating, prostate enlargement or a seizure disorder. The warning statement was never put into effect.

Irvine, Calif.-based Met-Rx sells six androgen supplements under the name Substrate Solutions. The products range from $25-$60 for 60 capsules and are available on two Web sites and in over 400 retail outlets nationwide. One product, Andro Heat, contains ephedra and caffeine. Met-Rx's claims cited by FTC include the products are "abuse-proof" and have a "safe and mild effect (with little in the way of side effects)."

Met-Rx commented it does not object to the warning, which the firm already has implemented, because there is no reliable evidence showing a zero percent incidence rate of the conditions specified in the warning. The andro products comprise less than 1% of the company's total revenues. Met-Rx added it strongly objects to statements by FTC the product is being targeted to teenagers. The company stated it has had a warning on products "from day one" saying they should be taken only by sexually mature males.

AST, based in Golden, Colo., markets eight andro products on the Internet, through magazines, by direct mail and in stores for $39-$65 per 60-count bottle. Its 3-Andro Xtreme product contains ephedra and caffeine. The claims at issue include "completely safe and very effective," "no negative side effects," and "Andro is not a steroid and does not have steroid side effects." Commenting on the agreement, AST said it will "pave the way for more in-depth research into the safety of sports nutrition supplements and set a higher precedent for other companies to follow."

Andro has been the subject of both positive and negative publicity. Sales skyrocketed when baseball star Mark McGwire said he used it; however, McGwire later announced he had stopped using andro because he did not want to appear to endorse it (² (Also see "McGwire gives up andro" - Pink Sheet, 9 Aug, 1999.)). Iowa State University researchers concluded in JAMA in June andro supplementation "does not increase serum testosterone concentrations or enhance muscle adaptions to resistance training...and may result in adverse health consequences" (³ (Also see "Andro Does Not Boost Muscle Mass Or Serum Testosterone Levels - Study" - Pink Sheet, 7 Jun, 1999.)). The ingredient was nominated in January for toxicity testing by the National Toxicology Program (⁴ (Also see "Androstenedione Nominated For NTP Toxicology Testing" - Pink Sheet, 4 Jan, 1999.)).