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All partners of Supplement Safety Now strongly urge Congress to act quickly so that:
- All supplements sold over-the-counter, in retail stores and online, are safe and effective.
- The federal agencies regulating the nutritional supplement industry have the tools to effectively protect consumers’ health.
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| On September 29, 2009, the U.S. Senate Judiciary Subcommittee on Crime and Drugs hosted a hearing “Body Building Products and Hidden Steroids: Enforcement Barriers,” at which the U.S. Anti-Doping Agency testified. |
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Read our testimony  |
| Watch the hearing |
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| Specific Proposals |
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| Pre-Market Enhancements |
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- All dietary supplement companies should be required to register as “dietary supplement companies” so that the Food and Drug Administration (FDA) can identify them.
- Dietary supplement companies should provide the FDA with a comprehensive list of all dietary supplements they manufacture with a copy of the master formulas and product labels.
- Dietary supplement companies should provide a 75-day pre-market notice to the FDA not only for New Dietary Ingredients, but for all products containing steroids (including hormones, pro-hormones and hormone analogues) and must establish that the product is safe under its intended use.
- Dietary supplement companies should be required to maintain a substantiation file that is available on request to the FDA.
- Distributors and retailers of dietary supplements should obtain evidence of compliance from the manufacturers and licensors that all pre-market requirements have been complied with or bear responsibility for the products they sell as if they were the manufacturer.
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| Post-Market Enhancements |
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- Supplement companies should be required to report all adverse events not just “serious adverse events” requiring hospitalization, surgery or death.
- The FDA should be given the power to unilaterally prohibit sales and initiate immediate recall of any product that has not followed all pre-market requirements or when the FDA determines that there is a reasonable probability that the product poses a safety risk or contains an ingredient that will ultimately be scheduled as a controlled substance.
- The Drug Enforcement Agency (DEA) should be given emergency scheduling power for steroids and the criteria for scheduling steroids under Schedule III of the Controlled Substances Act (CSA) should be modified to better address the current reality of designer steroids.
- As was done in 2004, Congress should immediately amend Section 102 of the CSA to schedule the 20 or more designer steroids that have been identified but not yet scheduled as controlled substances.
- Dietary supplement companies should be prohibited from advertising that any product performs like a steroid, is named similarly to a steroid, affects the structure of the body or touts the fact that a product may soon be declared illegal.
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| We invite you to join our efforts and take action now. |
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