CRN Applauds FDA for Taking Action Against Companies Selling Illegal Ingredient

Washington, D.C., April 4, 2016In response to Warning Letters issued today by the Food & Drug Administration (FDA) to distributors of products that list methylsynephrine as a dietary ingredient on their product labels, the Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, issued the following statement:

Statement by Steve Mister, president and CEO, CRN: 

“We applaud FDA for taking action against companies breaking the law and potentially putting consumers at risk. Selling products that list methylsynephrine as a dietary ingredient is illegal because the ingredient, also known as oxilofrine, has not been subjected to the New Dietary Ingredient (NDI) notification process, a requirement under the law. Responsible marketers and manufacturers of supplements who compose the mainstream dietary supplement industry are in lockstep with FDA when it comes to enforcing the law and protecting the safety of their consumers, and we strongly urge the companies that received these warning letters—and any others that may be selling this illegal ingredient—to heed the agency’s warning immediately. For any companies that do not take these warnings seriously, we expect FDA to move quickly and aggressively to the next steps available to it under the law to get these products off the market. We urge consumers to follow FDA’s advice and not to use products containing methylsynephrine, oxilofrine, or p-hydroxyephedrine.”

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 Follow us on Twitter @crn_supplements and @wannabewell and on Facebook.