“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 & CEO, 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 mismarketed as dietary supplements. Among the many challenges the responsible 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. Coinciding with FDA’s position that products containing SARMs do not meet the definition of a dietary supplement, CRN’s guidelines recommend that responsible 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,” surmised Mr. 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.”
An integral component of the association’s self-regulatory initiatives, CRN’s voluntary guidelines and best practices raise the bar for responsible industry and provide a roadmap for companies to follow, ensuring all products abide by high-quality and reliable standards consumers can trust and rely on. In addition to the two guidelines listed above, CRN has previously released best practice guidelines for iodine in supplements for pregnancy, melatonin, probiotics, protein in dietary supplements and functional food, enzyme dietary supplement products, and safety considerations for dosage recommendations and labeling.