102.  FTC v. AST Nutritional Concepts & Research, Inc., et al, Civ. No. 99-WI-2197 (D. Colo. filed Nov. 15, 1999)

103.  FTC v. MET-RX USA, Inc., et al. Civil Action No. SAC V-99-1407 (C.D. Cal. filed Nov. 15, 1999)

Defendants: AST Nutritional Concepts & Research, Inc. and Paul Delia; Met-RX USA, Inc. and Met-RX Substrate Technology, Inc.

Type:  Unsubstantiated Body Building Claims

On their Web sites and through direct sales, magazines and retail stores, defendants allegedly advertised that their health supplements would increase strength and muscle mass "safely and with minimal or no negative side effects." The companies' androgen products contained 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 allegedly could pose safety risks and unwanted side effects similar to those of more potent hormones.

!The FTC challenged the companies' lack of substantiation for the safety or lack of side effects of their products. Without admitting liability, the defendants entered into stipulated final orders which would prohibit them from making unsubstantiated efficacy, performance or safety claims about their products. The proposed orders also 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.

Finally, 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.