FDA warns 3 area firms on ad claims

Suppliers of dietary supplements told to change labeling

Federal regulators sent warning letters to three local dietary supplement companies, claiming they made false marketing claims abut their products.

In letters dated Feb. 28, the Food and Drug Administration asked Anabolic Store, AST Sports Science and Natural Balance Inc. to change some product labels. The companies have until today to respond.

In one instance, the FDA said that muscle builder NitroPhen cannot legitimately claim to be "the first step to getting shredded."

"Based on the scientific data available to us, we do not believe that these claims are substantiated," wrote Joseph Baca, director of the office of compliance for FDA's food unit.

If the companies don't respond, the agency could seize products or file an injunction against the companies, said Susan Kruzan, an FDA spokeswoman.

"(Warning letters) are a significant regulatory action," she said.

Neither Golden-based AST Sports Science or Aurora- based Anabolic Store returned calls for comment.

Four years ago, the Federal Trade Commission sued AST for false claims about supplement androgen.

AST was forced to include a warning label that said the over-the-counter product was made with "steroid hormones that may cause breast enlargement, testicle shrinkage and infertility in males."

Castle Rock-based Natural Balance said it has discontinued Power Shape and changed the label on Turbo Charge, products the FDA questioned.

"There were some statements on the labels that the FDA deemed inappropriate," said Scott Smith, vice president of corporate development.

"We believe that it was perhaps triggered by the recent increase in concerns over ephedra-containing products," he said.

Public discussion over stimulant ephedra skyrocketed after the supplement was linked to the death of Baltimore Orioles pitcher Steve Bechler in mid- February.

But in general, the FDA is stepping up efforts to regulate the dietary supplement industry, which doesn't require formal approval before marketing.

The agency said it received 1,214 reports last year of complications suffered by people who took supplements such as ephedra - more than double the 2001 total.

Stores in question

The FDA warned these stores that they made false claims about supplements:

• Anabolic Store

Location: Aurora

Supplements:

Rage

NitroPhen

• AST Sports Science

Location: Golden

Supplements:

EPH 833

Dymetadrine Xtreme

3 Andro Xtreme

• Natural Balance Inc.

Location: Castle Rock

Supplements:

Turbo Charge

Power Shape