This is what I know of it so far... but so far it isnt a law... yet. But with the DEA, they can install it very, very quickly.
IMPORTANT NEWS ALERT:
Classification of Three Substances as Schedule III Anabolic Steroids
Under the Controlled Substances Act
On April 25th, the Department of Justice (DOJ) and the Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) to classify three substances as Schedule III anabolic steroids under the Controlled Substances Act (CSA). The substances in question, boldione (1,4 androstadienedione), desoxymethyltestosterone (also known as Madol or DMT), and 19-nor-4,9(10)- androstadienedione (also known as Estra-4,9-dien-3,17-dione), are currently available on the dietary supplement market. If this proposal takes effect, they will be classified as anabolic steroids under Federal law. This Alert seeks to inform industry about this significant development.
How does the rulemaking process work?
The rulemaking process generally consists of a proposed rule stage and a final rule stage. For most categories of rulemaking, the federal department or agency provides notice of a proposed regulation and any person or organization may review this document and submit comments on it in writing. The period during which public comments are accepted varies, but is usually 30, 60, or 90 days. As part of the rulemaking process, the department or agency is required to consider the public comments received on the proposed regulation. When the department or agency publishes the text of the final regulation in the Federal Register, it generally incorporates a response to the significant issues raised by those who submitted comments and discusses any changes made to the regulation as a result. The DOJ is currently accepting written and electronic comments on this proposal until June 24, 2008.
Is this an unprecedented approach to steroidal dietary supplements?
Yes. This proposed rule marks the first time the DEA has sought to administratively schedule an anabolic steroid following the passage of and in accordance with the Anabolic Steroid Control Act of 2004. The 2004 Act, which was signed into law on October 22, 2004 [Public Law No: 108-358; 118 Stat. 1661 (2004)] and took effect on January 20th, 2005, amended the original 1990 law by adding many new steroid compounds to the previous list of substances that were legally defined as anabolic steroids and classified as Schedule III controlled substances. Some of these new substances had previously been widely marketed as dietary supplements, such as androstenedione, norandrostenedione, norandrostenediol, 1-testosterone, and 4-hydroxytestosterone. Others, such as bolasterone, calusterone, furazabol, and stenbolone, were actually very old pharmaceutical steroids that were missed in the original federal law (note, however, that some states, among them California, did include some of these compounds in their own steroid laws.) The 2004 law also changed the general requisite elements of how an anabolic steroid is defined by removing the “promotes muscle growth” criterion that had preceded the list of compounds in the original 1990 law.
Any previous attempts to restrict these kinds of steroidal substances have either been regulatory action by the Food and Drug Administration (i.e., the ban on androstenedione) or legislative initiatives by Congress (e.g., the 2004 law itself as well as recent unsuccessful efforts to criminalize DHEA). The proposed rule is especially important because it explicitly sets forth DEA’s criteria for administratively scheduling a steroidal compound. The proposed rule sets forth information about what tests and assays will be used to determine whether a substance is chemically and pharmacologically related to testosterone.
What does the proposed rule mean for these three substances?
If the proposed rule is adopted, then following the comment period DEA will publish a final rule in the Federal Register. Upon the effective date of the final rule, these substances would be criminalized, meaning that any manufacturer, distributor or retailer who sells a product containing one of these substances would be committing a federal felony punishable by imprisonment. Any consumer possessing a product containing one of these substances for personal use would be committing a federal misdemeanor. Presumably, some state laws would be eventually amended to comport with the federal rule.
What does this mean for the rest of the sports nutrition industry?
The proposed rule contains detailed information about the three substances and their availability to consumers, proving that DEA is actively policing this market. While these particular three substances seem to have been overlooked in the 2004 legislation, the proposed rule shows that DEA is serious about catching up. It took three years for these to be addressed, but there’s no guarantee that DEA is not or will not be moving more quickly to administratively schedule additional substances now that they have established the protocol for scheduling.
What does this mean for the prudent dietary supplement company?
Everyone in the industry needs to be aware of and fully compliant with the Food, Drug and Cosmetic Act (FDCA) and other federal and state laws and regulations that govern the marketing and distribution of dietary supplements. If your company markets steroidal products, in addition to making sure your ingredients are compliant with the Dietary Supplement Health and Education Act (DSHEA), you should be aware of whether your products meet the general definition of an anabolic steroid under the Anabolic Steroid Control Act of 2004, and whether there is the potential for your product or ingredient to meet the criteria for administrative scheduling.
Michael J. DiMaggio, Esq.
Collins, McDonald & Gann, P.C.