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Apr 24 2018
Hatch, Whitehouse Introduce Legislation to Empower DEA’s Regulation of SARMs
Washington, DC— US Senators Orrin Hatch (R-UT) and Sheldon Whitehouse (D-RI) introduced the SARMs Control Act of 2018. Selective androgen receptor modulators, or SARMs, are synthetic drugs designed to mimic the effects of testosterone. This bipartisan bill builds on the success of the Designer Anabolic Steroids Control Act of 2014 by extending the Drug Enforcement Administration’s authority to regulate anabolic steroids to include SARMs.
SARMs are associated with serious safety concerns, including the potential to increase the risk of heart attack or stroke and life-threatening reactions like liver damage. They are not approved by the Food and Drug Administration (FDA) for human use, they are illegally marketed and sold as dietary supplements, and they are banned in all professional and college sports.
“SARMs are synthetic drugs that have negative effects similar to those of anabolic steroids,” Hatch said. “Even though SARMS are not approved by the FDA for human use and pose the same safety risks as anabolic steroids, they have proliferated under a regime in which they are not subject to the same controls. The SARMs Control Act closes this loophole to ensure that the DEA has the authority it needs to prevent abuse and diversion of these dangerous substances.”
“American consumers deserve to know if they’re buying seriously dangerous drugs slipped into everyday dietary supplements,” said Whitehouse. “This bipartisan legislation will build on successful anti-designer steroids legislation we’ve already passed to help protect American consumers.”
Statements of Support:
The legislation has received letters of support from the US Anti-Doping Agency and Federal Law Enforcement Officers Association, as well as leaders of the dietary supplement industry.
Michael McGuffin, President, Herbal Products Association; Scott Melville, President & CEO, Consumer Healthcare Products Association; Steve Mister, President & CEO, Council for Responsible Nutrition; Loren Israelsen, President, United Natural Products Alliance; Travis Tygart, President & CEO, US Anti-Doping Agency:“Each of our organizations has consistently supported efforts to enact and enforce laws to protect consumers, eliminate bad actors marketing illegal substances masquerading as legal products, and prosecute criminals who manufacture and sell them. Your bill will help move toward this goal. The SARMs Control Act is a bold step, adding teeth to prevention and enforcement efforts in the battle against illegal substances being marketed as legitimate products. The dietary supplement industry and USADA stands ready to work with you and all of Congress to deliver a strong bill to the President.”
Dominick L. Strokes, Vice President for Legislative Affairs, Federal Law Enforcement Officers Association:“FLEOA endorses this legislation giving additional authority to the Drug Enforcement Administration to enforce the illegal sales of SARMs. It is our belief this legislation will help save the lives of individuals who are unaware of the serious side effects of these supplements. We look forward to standing with you on this important bipartisan legislation.”
Background:
The FDA recently issued warning letters to three companies for distributing products that contain SARMs, noting that the products are unapproved drugs that have not been reviewed by the FDA for safety and effectiveness. The United States Anti-Doping Agency and the Department of Defense Operation Supplement Safety program warn about the risks of SARMs. Despite these enforcement actions and education efforts, SARMs are increasingly being purchased through the Internet by athletes, recreational bodybuilders, and members of the armed forces.
The SARMs Control Act of 2018 builds on the success of the Designer Anabolic Steroids Control Act of 2014 (Pub. L. No. 113-260) by extending the Drug Enforcement Administration’s authority to regulate anabolic steroids to include SARMs. Specifically, the SARMs Control Act of 2018 would:
Amend the Controlled Substances Act (CSA) to add SARMs to the list of Schedule III controlled substances, ensuring that SARMs are regulated in the same manner as anabolic steroids;
Add a definition of the term “SARM,” including a list of specified substances and a process for the Attorney General to add substances to the definition of SARM;
Prohibit importing, exporting, manufacturing, distributing, dispensing, or possessing with intent to manufacture, distribute, or dispense any SARM, or any product containing a SARM, unless it is properly labeled;
Add certain offenses related to SARMs to the definition of “felony drug offense” and the civil penalty provisions of the CSA; and
Require that the FDA provide to the DEA information related to dietary supplements that the FDA determines may contain a SARM, as it already does for supplements that may contain anabolic steroids.
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Permalink: https://www.hatch.senate.gov/public/...ation-of-sarms
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Hatch, Whitehouse Introduce Legislation to Empower DEA’s Regulation of SARMs
Washington, DC— US Senators Orrin Hatch (R-UT) and Sheldon Whitehouse (D-RI) introduced the SARMs Control Act of 2018. Selective androgen receptor modulators, or SARMs, are synthetic drugs designed to mimic the effects of testosterone. This bipartisan bill builds on the success of the Designer Anabolic Steroids Control Act of 2014 by extending the Drug Enforcement Administration’s authority to regulate anabolic steroids to include SARMs.
SARMs are associated with serious safety concerns, including the potential to increase the risk of heart attack or stroke and life-threatening reactions like liver damage. They are not approved by the Food and Drug Administration (FDA) for human use, they are illegally marketed and sold as dietary supplements, and they are banned in all professional and college sports.
“SARMs are synthetic drugs that have negative effects similar to those of anabolic steroids,” Hatch said. “Even though SARMS are not approved by the FDA for human use and pose the same safety risks as anabolic steroids, they have proliferated under a regime in which they are not subject to the same controls. The SARMs Control Act closes this loophole to ensure that the DEA has the authority it needs to prevent abuse and diversion of these dangerous substances.”
“American consumers deserve to know if they’re buying seriously dangerous drugs slipped into everyday dietary supplements,” said Whitehouse. “This bipartisan legislation will build on successful anti-designer steroids legislation we’ve already passed to help protect American consumers.”
Statements of Support:
The legislation has received letters of support from the US Anti-Doping Agency and Federal Law Enforcement Officers Association, as well as leaders of the dietary supplement industry.
Michael McGuffin, President, Herbal Products Association; Scott Melville, President & CEO, Consumer Healthcare Products Association; Steve Mister, President & CEO, Council for Responsible Nutrition; Loren Israelsen, President, United Natural Products Alliance; Travis Tygart, President & CEO, US Anti-Doping Agency:“Each of our organizations has consistently supported efforts to enact and enforce laws to protect consumers, eliminate bad actors marketing illegal substances masquerading as legal products, and prosecute criminals who manufacture and sell them. Your bill will help move toward this goal. The SARMs Control Act is a bold step, adding teeth to prevention and enforcement efforts in the battle against illegal substances being marketed as legitimate products. The dietary supplement industry and USADA stands ready to work with you and all of Congress to deliver a strong bill to the President.”
Dominick L. Strokes, Vice President for Legislative Affairs, Federal Law Enforcement Officers Association:“FLEOA endorses this legislation giving additional authority to the Drug Enforcement Administration to enforce the illegal sales of SARMs. It is our belief this legislation will help save the lives of individuals who are unaware of the serious side effects of these supplements. We look forward to standing with you on this important bipartisan legislation.”
Background:
The FDA recently issued warning letters to three companies for distributing products that contain SARMs, noting that the products are unapproved drugs that have not been reviewed by the FDA for safety and effectiveness. The United States Anti-Doping Agency and the Department of Defense Operation Supplement Safety program warn about the risks of SARMs. Despite these enforcement actions and education efforts, SARMs are increasingly being purchased through the Internet by athletes, recreational bodybuilders, and members of the armed forces.
The SARMs Control Act of 2018 builds on the success of the Designer Anabolic Steroids Control Act of 2014 (Pub. L. No. 113-260) by extending the Drug Enforcement Administration’s authority to regulate anabolic steroids to include SARMs. Specifically, the SARMs Control Act of 2018 would:
Amend the Controlled Substances Act (CSA) to add SARMs to the list of Schedule III controlled substances, ensuring that SARMs are regulated in the same manner as anabolic steroids;
Add a definition of the term “SARM,” including a list of specified substances and a process for the Attorney General to add substances to the definition of SARM;
Prohibit importing, exporting, manufacturing, distributing, dispensing, or possessing with intent to manufacture, distribute, or dispense any SARM, or any product containing a SARM, unless it is properly labeled;
Add certain offenses related to SARMs to the definition of “felony drug offense” and the civil penalty provisions of the CSA; and
Require that the FDA provide to the DEA information related to dietary supplements that the FDA determines may contain a SARM, as it already does for supplements that may contain anabolic steroids.
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Permalink: https://www.hatch.senate.gov/public/...ation-of-sarms
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