Washington, D.C., March 27, 2018—In response to an announcement, “FDA is Using Innovative Methods to Prevent Illegal Products with Hidden Drug Ingredients from Entering the United States,” published online by the Food & Drug Administration, 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 & CEO, CRN:
“We applaud FDA for increasing its efforts to prevent illegal drugs with hidden ingredients from entering the United States. The responsible industry has been adamant about the need for FDA to increase the effectiveness of its regulation of dietary supplements, and we have been fighting for more resources for the agency to achieve this. Shifting the paradigm for how the agency screens products at international mail facilities is a positive step, but increased intelligence is only valuable if it is used appropriately.
If FDA is serious about tackling the problem of tainted products containing illegal drug ingredients, the agency should use the intelligence it gathered to follow through on its allegations with enforcement. We encourage the agency to issue recalls and import alerts so that business partners and recipients of these ingredients here in the U.S. can be on alert to discontinue their affiliations with potentially nefarious sources or to implement heightened testing of incoming ingredients. We also urge the agency to make public the identities of the perpetrators and to refer them for enforcement by the Department of Justice. Bad actors deserve public scrutiny and criminal prosecution, and FDA has the authority to take these actions.
CRN also cautions against taking FDA’s findings out of context and making generalizations about the dietary supplement industry as a whole; that would be an inappropriate use of this new intelligence. The percentage of samples that tested positive for the presence of undeclared pharmaceutical ingredients, while disturbing, is not generalizable to the mainstream dietary supplement market. The agency was targeting high-risk packages at international mail facilities with additional surveillance; it specifically identified products it suspected of containing illegal ingredients, and unfortunately, in many of those packages, it found them. High-risk international mail packages are not a representative sample of the U.S. marketplace as a whole.
The mainstream dietary supplement market is comprised of safe, quality products manufactured by committed, ethical companies who follow the law—that is, the responsible industry. And the responsible industry has voiced innumerous times its suspicion of tainted products being manufactured overseas and entering the U.S. via our ports. Thus, we are pleased FDA has heard our concerns, and we are committed to support the agency’s efforts to increase consumer safety through the prevention of illegal products from entering the marketplace."
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 and LinkedIn.