Legal & Regulatory Briefs

AST Nutritional Concepts & Research Inc. of Golden, CO, and Met-Rx USA Inc. of Irvine, CA, have agreed to settle a lawsuit filed by FTC concerning androgen supplements. In the proposed settlement, the two companies will agree to disclose potential risks of the supplements in advertising, labeling and promotional materials that make performance or safety claims with proposed warning language stating that androgen products “contain 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.” Androgen supplements containing ephedra will also carry warnings against possible heart attack, stroke, seizure or death if extra amounts are taken.

The Quigley Corp. (QGLY) said it received an unappealable Order of Court for the destruction of Cold-Rid, manufactured by

J-Labs Inc. of Tampa, FL. Quigley had complained to the court that Cold-Rid packaging mimicked the packaging of Quigley’s Cold-Eeze product.

Pharmanex Inc., a subsidiary of Nu Skin Enterprises Inc. (NUS), won a motion for civil contempt in its lawsuit against HPF LLC. In April the U.S. Federal District Court in San Francisco granted a preliminary injunction preventing HPF from continued use of clinical studies, literature and news stories based on Pharmanex’s Cholestin to market its product Cholestene.

Rep. Dan Burton, R-IN, has introduced in Congress a bill to amend the IRS tax code of 1986 to create a new tax deduction for purchased dietary supplements that would put them on a par for tax purposes with other medical expenses. The legislation is drafted so that the inclusion of dietary supplements as a medical exemption would not redesignate supplements as drugs and thus cause them to be regulated as such.