CRN issues voluntary guidelines on SARMs, caffeine-infused supplements

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CRN issues voluntary guidelines on SARMs, caffeine-infused supplements

By Antoinette Alexander - 06/28/2018
In light of growing concerns on the dangers of products containing selective androgen receptor modulators (SARMs) and caffeine-containing dietary supplements, the Council for Responsible Nutrition announced on Thursday that it has issued new voluntary guidelines.

“CRN’s membership is committed to consumer safety and understands the gravity of going above and beyond what is required by law to ensure their products are high-quality, consistent, and supported by sound science,” said Steve Mister, president and CEO of CRN. “Consumer access to bulk amounts of highly-concentrated powder or liquid caffeine and performance enhancing products containing SARMs are current subjects of sharp industry scrutiny. CRN is grateful for FDA’s recent consumer advisories on these ingredients, as well as for guidance providing clarity to companies attempting to navigate the industry’s strict regulatory framework. CRN’s voluntary guidelines align with FDA’s enforcement actions and help the dietary supplement industry stay on the right side of the law.”

The newly developed guidelines for products containing SARMs stem from increasing concerns raised by FDA, the U.S. Anti-Doping Agency, and the legitimate dietary supplement industry about the dangers of SARMs found in products mis-marketed as dietary supplements. Among the challenges the industry faces with respect to SARMs is the introduction of substances that do not appear to meet the definition of a dietary ingredient as outlined by the United States Federal Food, Drug, and Cosmetic Act; fail to provide proper notification to FDA as new dietary ingredients (NDI); and appear to lack scientific evidence supporting safety, CRN stated. Coinciding with FDA’s position that products containing SARMs do not meet the definition of a dietary supplement, CRN’s guidelines recommend that firms should not distribute or market products containing these ingredients.

CRN’s guidelines for caffeine-containing dietary supplements, originally created in 2013, recommend that companies disclose the amount of caffeine in a dietary supplement, provide label advisories about safe use of such products, and refrain from sale under certain conditions. The guidelines were updated in 2015 to institute restraints against the sale and marketing of bulk amounts of pure or highly-concentrated caffeine in powder form, and the 2018 revisions expand these restraints to also include concentrated liquid forms, as outlined by an FDA guidance released earlier this year.

“CRN trusts that the dietary supplement industry will adopt these two sets of crucial guidelines into its standard operating procedures,” said Mister. “As the marketplace continues to grow and innovate, we lend our full support to FDA’s proactive enforcement efforts to improve consumer safety and industry accountability.”