Washington, D.C., September 12, 2018— In response to a statement published September 11 by FDA Commissioner Scott Gottlieb M.D., on new warning letters FDA is issuing to companies marketing kratom with unproven medical claims, the Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, issued the following statement:
Statement by Duffy MacKay, senior vice president, scientific & regulatory affairs, CRN:
“CRN commends the FDA’s continued actions against companies that violate federal law by making unsubstantiated disease treatment claims for products such as kratom and appreciates the agency’s commitment to public health. CRN, along with responsible supplement manufacturers, recognizes the heightened concerns regarding the significant negative health impacts associated with opioid addiction and abuse. Federal law does not allow dietary supplements to claim to treat or cure any diseases, including opioid addiction, and CRN is unaware of published scientific research that supports the use of any dietary supplement to treat opioid use disorder or to mitigate opioid withdrawal symptoms.
CRN applauds FDA’s issuance of warning letters to vendors who market kratom products with scientifically unsubstantiated claims including to ‘relieve opium withdrawals.’ Consumer safety and access to safe products and ingredients are critically important to CRN. We recommend that consumers seeking treatment of an opioid use disorder or addiction talk to a qualified healthcare professional or a public health authority.”
Note to Editor: The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing 150+ dietary supplement and functional food manufacturers, ingredient suppliers, and companies providing services to those manufacturers and suppliers. In addition to complying with a host of federal and state regulations governing dietary supplements and food in the areas of manufacturing, marketing, quality control and safety, our manufacturer and supplier members also agree to adhere to additional voluntary guidelines as well as to CRN’s Code of Ethics. Visit www.crnusa.org. Follow us on Twitter @CRN_Supplements, Facebook, and LinkedIn.