WASHINGTON—Congress passed the Designer Anabolic Steroid Control Act (DASCA) of 2014, thanks in part to lobbying from the dietary supplement industry for a number of months leading up to its passage.
President Obama is expected to sign DASCA into law after a House version of the legislation was passed late Thursday on the Senate floor by unanimous consent.
The legislation empowers the Drug Enforcement Administration (DEA) to crack down on dangerous substances that resemble anabolic steroids on DEA’s current list of controlled substances and that have been marketed as dietary supplements.
Organizations representing varied interests supported the legislation, including a number of supplement trade organizations as well as the American Academy of Family Physicians, American Association of Nurse Practitioners, American Pharmacists’ Association and United States Anti-Doping Agency (USADA).
“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," said Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), in a statement. “The passage of DASCA brings a welcome protection against that."
DASCA will place 25 known designer anabolic steroids on DEA’s list of controlled substances and grants the U.S. Attorney General authority to temporarily schedule new designer anabolic steroids on the same list. The legislation also creates new penalties for distributing, importing or manufacturing anabolic steroids under false labels, lawmakers said.
DEA assisted in crafting the bill, including identifying the 25 new substances on the list. Although the performance-enhancing substances will fall under Schedule III of the Controlled Substances Act, none of them have medicinal benefits, a DEA spokesperson told Natural Products INSIDER.
A Senate bill was sponsored by Sens. Sheldon Whitehouse (D-Rhode Island) and Orrin Hatch (R-Utah). Reps. Frank Pallone (D-New Jersey) and Joe Pitts (R-Pennsylvania) introduced legislation in the House. The Senate passed H.R. 4771 on Thursday, Dec. 11.
Hatch and Whitehouse have said anabolic steroids are made by reverse engineering illegal steroids and slightly changing their chemical composition, avoiding placement on DEA's list of controlled substances.
“The world’s top athletes are subject to strict guidelines and rigorous testing to prevent the use of steroids, as they should be," Whitehouse said Friday in a statement. “At the same time, many American citizens may be unknowingly dosing themselves with these harmful substances."
DEA has authority to place steroids and other substances on its list of controlled substances, but it must go through an arduous and potentially years-long process that requires the consent of the U.S. Department of Human Health and Services (HHS) through FDA. For instance, DEA this year moved hydrocodone combination products from Schedule III to Schedule II after receiving the recommendation of HHS. But that rule was published 15 years after a physician filed a petition with DEA requesting reclassification, citing the potential for abuse of the products.
DASCA bears a resemblance to the 20-year-old Dietary Supplement Health and Education Act of 1994 (DSHEA) in that both pieces of legislation were passed near the end of a congressional session.
Congress is set to adjourn in the coming days. As the end of the current session approached, the Senate Judiciary Committee still had not considered DASCA. The United Natural Products Alliance (UNPA) worked with CRN and Hatch’s senior staff to develop a strategy to persuade the Judiciary Committee to forgo the opportunity to offer amendments and instead send the bill to the floor under a unanimous consent procedure, UNPA president Loren Israelsen noted in a statement.
That strategy paid off, with the bill passing by unanimous consent with no record of individual votes.
UNPA expressed gratitude to Sens. Hatch and Chuck Grassley (R-Iowa) for spearheading the effort, and thanked Sen. Mike Lee (R-Utah) for deferring his interest in offering amendments. Any amendments to DASCA in the Senate, UNPA noted, would have killed the bill because there was not time for the House to consider them.
“Passage of this bill was one of CRN’s top legislative priorities this year, as responsible member companies want to do all that they can to solve the problem of anabolic steroids illegally being sold as dietary supplements," Mister said.
Mike Greene, vice president of government relations with CRN, said the passage of DASCA was anything but a shoo-in. “This Congress hasn’t done very much and, of course, we had a major shift last month where the Republicans took over the Senate. There was a strong possibility that DASCA would not have been passed last night," he said in a phone interview.
But due to hard work and efforts from a number of stakeholders, including the trade associations, “we got it over the edge," Greene said.
The passage of DASCA this week coincided with the retirement of Sen. Tom Harkin (D-Iowa), who is considered a longtime champion of the supplement industry and is departing Capitol Hill after having served 40 years in Congress.
DASCA grants the Attorney General authority to temporarily schedule additional anabolic steroids that have recently emerged if he makes certain findings. DEA must notify HHS of such an order. The Attorney General also has authority to publish a list of products that he has determined contain an anabolic steroid and are not labeled in accordance with federal law.
Greene said the dietary supplement industry lobbied vigorously for Section 2 of the bill.
That section narrowly defines anabolic steroids, homing in on products that are marketed to promote muscle growth or a pharmacological effect similar to testosterone. A substance that is not on the controlled substances list is excluded from the definition of anabolic steroids if it is an herb or other botanical, the substance is a dietary ingredient under the Federal, Food, Drug and Cosmetic Act (FD&C), and it is not anabolic or androgenic. But a company that claims an exemption bears the burden of proof claiming it.
“We don’t want DEA going after legitimate dietary supplement products," Greene said.
Michael McGuffin, president of the American Herbal Products Association, said the industry had been concerned that the definition of anabolic steroids would inadvertently result in a ban on products that lawmakers didn’t intend to address. Although McGuffin isn’t aware of any botanicals that are marketed to promote muscular growth, it's possible future research could legitimately demonstrate such a botanical or herb could do so.
“Suppose there is an herb that promotes muscle growth," McGuffin said in a phone interview. “Why would we exclude that from the marketplace when that’s not the kind of problem that was the purpose for which this good law was passed?"