Assuming designer steroids are dietary ingredients, they also appear to be new dietary ingredients, FDA writes in a warning letter to the online retailer Bodybuilding.com.

The director of the agency's Seattle district signed the July 7 letter citing the firm for failure to comply with FDA's 75-day pre-market notification requirement for NDIs. Products listed by the agency include SciFit's Estro Suppress ,KiloSports' Attack and ErgoPharm's 6-OXO.

The warning letter presents an interesting but not a novel use of the NDI provisions, according to American Herbal Products Association President Michael McGuffin. Instead of focusing on whether or not designer steroids are NDIs, FDA is focusing on the lack of a notification, he said.

In 2004, FDA used the NDI provision to take a stronger stance against the anabolic steroid androstenedione. The agency sent a number of warning letters to manufacturers of the then-legal steroid directing them to halt distribution of products containing the ingredient (¹ Also see "Andro Targeted By FDA In Coordination With Capitol Hill Action" - Pink Sheet, 15 March, 2004., p.3).

Later that year, the President signed legislation placing andro on the Drug Enforcement Agency's list of controlled substances (² Also see "MLB Controversy Spotlights Line Between Steroids, Supplements" - Pink Sheet, 13 December, 2004., p. 9).

Bodybuilding.com also has caught the attention of California's Center for Environmental Health, which filed and won a Prop 65 case against andro marketers in 2001 (³ Also see "Andro Not Within "Anabolic Steroid" Definition, Prop 65 Defendants Say" - Pink Sheet, 27 August, 2001., p. 9). In late 2005, Bodybuilding.com was one of 19 dietary supplements manufacturers and retailers that received 60-day notices of Prop 65 violations from CEH (⁴ Also see "Prop 65 Steroid Suit Planned Against Supplements Named In Post" - Pink Sheet, 5 December, 2005., p. 9).

The suit against Bodybuilding.com and fellow online retailer 1fast400 was filed on behalf of CEH by San Francisco-based Lexington Law Group on July 25, according to Attorney Howie Hirsch.

Many of the firms that received 60-day notices from CEH were cited in an October Washington Post article that drew Congressional attention. However, charges against these companies were not filed because the firms employed fewer than 10 people, Hirsch said. Prop 65 allows exemptions for such companies, he explained.

Bodybuilding.com was cited for several violations in addition to failure to provide FDA with an NDI notification in the agency's warning letter.

For instance, the firm was cited for selling the "unsafe food additive" stevia. Statements such as "a no calorie sweetner" and "take 1-4 drops in tea or water as desired" for NOW Stevia represent the product as a conventional food, FDA says; currently, stevia and its extracts are not approved food additives.

Other violations in the letter include unsubstantiated structure/function claims for weight-loss products such as Xycience's XCFB and Universal's Chitosan Plus .

Statements such as Xycience's, "contains white kidney shown to reduce starch absorption 65-85 percent," as well as Universals', "when taken before or during a meal, it will bind to some of the fats before they are absorbed in the blood stream," appear to lack scientific proof, FDA writes.

Other unsubstantiated structure/function claims involve male-enhancement products such as Goliath Labs' Ejaculoid andHigher Power's Sexual Surge . The claim that Sexual Surge is "specifically formulated to support increased libido and performance" is cited in the letter.

FDA also said Bodybuilding.com conducted labeling violations for several meal replacement bars, sweetners and seasonings: "The website includes statements consistent with dietary supplement labeling but the products are excluded from the definition of a dietary supplement...because they are represented as conventional foods."

"If you intend to further market these products as meal replacements or conventional foods, they may not be represented in any manner as a dietary supplement," the agency says.

Finally, Bodybuilding.com is cited for selling unapproved new oral and topical drugs including Twinlab's Mega CoQ10 , NutraSport's Cutting Gel and GioFlex Joint and Soreness Relief .

Statements on Bodybuilding.com's website include, "In a placebo-controlled study, Coenzyme Q-10 supplementation was shown to help people with congestive heart failure."

- Rebekah Moan

Are Designer Steroids Dietary Ingredients? FDA Warning Letter Skirts Issue

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