FDA Warning Draws Solid Line Between Steroid Products And Supplements

FDA's enforcement approach toward a firm warned about marketing synthetic steroids as dietary supplements represents a more watertight legal strategy than the agency has used in similar scenarios.

The agency asserts the substances in American Cellular Labs' bodybuilding products are not dietary ingredients and are ineligible to be sold as supplements. This precludes the possibility that the company would claim its products contain grandfathered ingredients or attempt to submit safety notifications to FDA.

Further, the products create a risk of health problems for users, FDA says. A July 28 release warns consumers to avoid all bodybuilding supplements that claim the presence of steroid-like substances or promise "to enhance or diminish androgen-, estrogen-, or progestin-like effects in the body."

The agency's July 27 warning letter to Pacifica, Calif.-based ACL explains that, in addition to failing to qualify as dietary supplements, the products TREN-Xtreme , Estro Xtreme , MASS Xtreme and others are unapproved and misbranded new drugs with "potentiality for harmful effect."

The agency's communication to ACL is a "kitchen sink-type warning letter" in which FDA showcases the breadth of its powers, said Marc Scheineson, a food and drug attorney with Alston & Bird in Washington.

Scheineson said he expects the ACL case will result in the agency seizing product or a consent decree of permanent injunction filed against the company.

In March 2004, FDA warned 23 manufacturers using the steroid precursor androstenedione in products that the substance was a new dietary ingredient that had not been addressed in a pre-market notification (¹ (Also see "Andro Targeted By FDA In Coordination With Capitol Hill Action" - Pink Sheet, 15 Mar, 2004.)).

The 2004 warnings technically gave the firms legal leeway to contest the charge that andro was an NDI.

However, FDA expressed confidence at the time that no evidence existed of andro's use as a dietary ingredient before the passage of the Dietary Supplement Health and Education Act. Thus, in effect FDA's actions banned the substance from use in dietary supplements.

Retailer and marketer Bodybuilding.com received a similar NDI warning in July 2006 regarding the designer steroids in several of its products (² (Also see "Are Designer Steroids Dietary Ingredients? FDA Warning Letter Skirts Issue" - Pink Sheet, 7 Aug, 2006.)).

Pinpointing The Problem

Five serious adverse events have been reported linked to ACL products, with 10 other serious AERs associated with these general types of products since late 2007, said Michael Levy, director or FDA's Office of Compliance in the Division of New Drugs and Labeling. The AEs include reports of liver injury, kidney failure and blood clots in the lungs.

A spokesman added in an e-mail that many AERs stemming from steroid products likely go unreported by men due to their embarrassing nature, such as gynecomastia, or breast enlargement.

FDA said ACL's products are sold in gyms, at athletic competitions, online and through mail-order operations. The spokesman said these and similar products "appear to be widely marketed and popular."

The availability of such steroid products through mainstream retail outlets is not clear, however. GNC, for instance, said it does not carry ACL's products, and other chains did not comment on whether they offer the firm's products.

A spokeswoman added GNC "does not sell products that make claims on their labels relating to containing steroids or steroid-like substances."

Levy said FDA is evaluating products from companies in addition to ACL and "is currently considering all of its enforcement options in terms of following up with those firms."

Accepted supplements for increasing muscle mass -- including whey protein, creatine, L-carnitine and amino acids -- comprised a $2.66 billion U.S. marketplace in 2008, according to market research firm Euromonitor International.

Euromonitor projects the segment will reach $2.9 billion in 2013.

Ramifications For Legitimate Supplements?

Sheldon Bradshaw, a partner in the Washington office of Hunton & Williams and a former FDA chief counsel, noted FDA's refusal to consider ACL's synthetic steroids to be dietary ingredients could awaken a dormant controversy: whether synthetic versions of dietary ingredients can be deemed dietary ingredients themselves.

"That's a big issue and ultimately has ramifications for I think quite a few existing dietary supplements on the market that are based on synthetic versions of a naturally occurring vitamin or mineral," he said.

While DSHEA has no provision excluding synthetic substances as dietary ingredients, a 2004 citizen petition pointed out FDA once took the position that DSHEA requirements apply to synthetics only if they -- not just their natural equivalents -- are commonly found in the diet (³ (Also see "FDA Miscasts “Dietary Substance” In Statements On DSHEA – Petition" - Pink Sheet, 12 Apr, 2004.)).

Bradshaw acknowledged the synthetics issue is "more of a pure legal question" and said FDA's position may have shifted given the advances in recombinant -- artificially created DNA -- technology in recent years and the prevalence of synthetic additives in foods.

Natural Products Association interim Executive Director and CEO Daniel Fabricant said FDA would have to take "a bit of creative license" to dispute the use of synthetic dietary ingredients.

"I don't think FDA can argue from a safety standpoint that a nature-identical compound, a synthetic compound, is any way, shape or form different from a naturally sourced" one, he said.

Although much of the supplement industry likely shuns firms marketing steroids and their analogs as "supplements," the ACL case could still affect the category, according to NSF International executive Ed Wyszumiala.

"It's really easy to say that we don't have a problem because it's not technically a supplement," but the associated safety concerns "can really damage consumer confidence for the whole industry," he said.

Additionally, steroids may find their way into mainstream retailers by being obscured in product labeling as part of a "proprietary blend," said Wyszumiala, general manager of the nonprofit health organization's dietary supplement programs.

"You see some very carefully crafted products" in the bodybuilding space, he added, explaining that some chemical formulations metabolize into banned substances after being consumed.

Fabricant said NPA is focusing on helping legitimate supplement makers adopt FDA's good manufacturing practices and does not consider the ACL case a supplement issue at all.

Regardless, the supplement industry has been on the defensive of late as some in the sports world have tried to pin the blame for positive drug tests on tainted supplements.

The Council for Responsible Nutrition refuted recent comments by Travis Tygart, CEO of the U.S. Anti-Doping Agency, who assailed the supplement industry for selling steroid- and stimulant-containing products (⁴ (Also see "CRN Stands Up Against U.S. Sports Official's Criticism Of Supplement Quality" - Pink Sheet, 20 Jul, 2009.)).

The industry has also contended with attempts to group the legitimate supplement ingredient dehydroepiandrosterone -- DHEA -- in with anabolic steroids marketed to children.

David Seckman, then head of NPA, said at the Natural MarketPlace trade show and convention in Las Vegas July 9 that legislation to ban sales of DHEA to minors -- perennially introduced by Sen. Charles Grassley, R-Iowa -- is misguided because DHEA abuse by children is not a widespread problem.

"The real issue we have here" is unsubstantiated claims by online retailers about DHEA products, which paint the ingredient as having steroid-like muscle-building effects, Seckman said (⁵ (Also see "“Disturbing” DHEA Ads, Hill Interest Prompt CRN’s Marketing Guidelines" - Pink Sheet, 11 Aug, 2008.)).

-- Dan Schiff ([email protected])