House Legislation Prohibiting Certain “Designer” Steroids Easily Muscles its Way Through the Senate and Awaits President Obama’s Signature

December 16, 2014

By Karla L. Palmer

The Senate passed a bill last Thursday, December 11, 2014, that will prohibit the use of certain designer anabolic steroids.  H.R. 4771, titled the Designer Anabolic Steroid Control Act (“DASCA”), adds 25 specific over-the-counter designer substances to the category of "anabolic steroids" classified as Schedule III under the Controlled Substances Act.  Senator Orrin Hatch (R-Utah), a co-sponsor of the legislation, stated that the law is intended to prevent steroid products from being marketed as nutritional supplements or being distributed using false labeling.   "Designer steroids are produced by reverse engineering existing illegal steroids and then slightly modifying their chemical composition, so the resulting product is not on the [DEA’s] list of controlled substances," Senator Hatch explained.

In the United States, both possession and distribution of anabolic steroids can be an illegal felony offense; unless the drug substance is prescribed by a physician for a legitimate medical purpose (and enhancing athletic performance or building muscles typically does not achieve that requirement).

The DASCA also provides that a drug or hormonal substance (other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone) that is not listed as a scheduled drug, but which is derived from, or has a chemical structure substantially similar to, an anabolic steroid that is listed, shall be considered to be a listed anabolic steroid if the drug or hormonal substance:

  1. has been created or manufactured with the intent of producing a substance that either promotes muscle growth or otherwise causes a pharmacological effect similar to that of testosterone; or
  2. has been, or is intended to be, promoted in any manner suggesting that consuming it will promote any pharmacological effect similar to that of testosterone.

So, any substance “like” one of the newly listed steroids that is manufactured or promoted for muscle growth or an effect similar to testosterone will be regulated. 

Importantly, the Attorney General will be authorized to issue an order adding a substance to the definition of "anabolic steroid" upon finding that: (1) the substance satisfies the criteria for being considered an anabolic steroid, and (2) such addition will assist in preventing abuse or misuse of the substance.  This authority permits temporary scheduling for a period of 24 months (to occur not less than 30 days after publication of the temporary scheduling notice). This is a far less cumbersome and complicated process than engaging in legislative scheduling or the eight-factor scheduling analysis under 21 U.S.C. § 812.  The Act also provides that the temporary scheduling order is not subject to judicial review.   The new law will give DEA significantly more power to quickly act to schedule substances that are similar to their illegal counterparts.  

However, DASCA specifically prohibits a substance from being considered to be a drug or hormonal substance covered by the Act if it is:

  1. an herb or other botanical, a concentrate, metabolite, or extract of, or a constituent isolated directly from, an herb or other botanical, or a combination of two or more such substances; or
  2. a dietary ingredient for purposes of the FDCA and is not anabolic or androgenic.

However, any person claiming the benefit of the herbal/dietary supplement exception bears what is likely a difficult burden of providing the appropriate evidence supporting the exception. 

The law will also increase penalties for importing, exporting, manufacturing, distributing, or dispensing anabolic steroids unless the product is clearly identified as an anabolic steroid or is approved by FDA. Violators may be fined up to $500,000 per violation.

DASCA will allow DEA to quickly crack down on criminals creating new anabolic substances that closely resemble red-flagged counterparts listed, but altered minimally with the intent of evading enforcement.  “When criminal outliers are not stopped, not only does it put consumers at risk, but it unjustly blackens the reputation of responsible dietary supplement companies that manufacture and market legitimate, high-quality and beneficial supplements for sports nutrition and performance,” Mister said. “The passage of DASCA brings a welcome protection against that.”