Silver Spring, MD—The U.S. Food and Drug Administration (FDA) has released its new Dietary Supplement Ingredient Directory, which it says is intended to be "a one stop shop of ingredient information that was previously found on different FDA webpages." The list is not comprehensive. FDA said is only including select ingredients used in products marketed as dietary supplements, and it may not include all actions the agency has taken on included ingredient, especially if those actions do not reflect its current position.
Currently, the list includes 27 ingredients, including biotin, cannabidiol (CBD), kava, and N-acetyl-L-cysteine (NAC).
According to FDA's announcement, the directory "enables the public to look up ingredients used in products marketed as dietary supplements and quickly find what the FDA has said about that ingredient and whether the agency has taken any action with regard to the ingredient." This directory also is intended to help manufacturers and retailers stay informed about ingredients. It includes links to FDA’s actions and communications for each ingredient that is included on the list. The directory will be updated periodically to reflect new developments.
The agency invited feedback and information regarding listed ingredients, which can be submitted to the FDA's Office of Dietary Supplement Programs.
For members of the dietary supplement industry, FDA noted that the manufacturer, packer, or distributor whose name appears on the label of a dietary supplement (the “responsible firm”) is required to record and report to FDA any reports it receives of serious adverse events associated with the use of its products. The responsible firm also must keep records of any non-serious adverse event reports it receives. The reporting form on the Safety Reporting Portal can be used meet the reporting requirements in section 761 of the FD&C Act.
FDA also announced that it is retiring the FDA Dietary Supplement Ingredient Advisory List, which is described as "a rapid-response tool meant to quickly alert the public when the agency identified ingredients that did not appear to be lawfully marketed in dietary supplements."
Industry Weighs In on Dietary Ingredient Directory
"It is disappointing to see an FDA ‘dietary ingredient directory’ that lumps kava, kratom, and red yeast rice, on the one hand, with articles such as picamilon, phenibut, and DMAA,” said Michael McGuffin, President, American Herbal Products Association (AHPA), in an update from the association. “This sort of communication, without providing any new information for stakeholders, will reinforce industry misgivings about giving the agency even more authority.”
Len Monheit, CEO at Industry Transparency Center (ITC), commented, "Until recently, I was truly on the fence and seeing both sides of the mandatory product listing argument. In support, surely responsible industry should be in favor of this type of disclosure; why wouldn't we want transparency with the agency and ultimately with consumers? On the other hand, relations with the agency have been fractious and somewhat opaque. Can they really be a good faith partner? The publication last week of FDA's Dietary Supplement Ingredient Directory has pushed me solidly in the camp of distrust in the agency and against them accessing new tools that will inevitably be abused, and in a non-transparent manner. This list of FDAs perceived problem products, which includes kava and biotin by the way, is nothing more than a hit list masquerading as an innocent directory."
Council for Responsible Nutrition (CRN) President & CEO Steve Mister noted: "Any efforts taken by the FDA to provide consumers, regulators, and retailers with accurate information about the ingredients contained in supplements is a productive undertaking. The agency's newly announced Dietary Supplement Ingredient Directory, however, only provides a partial list of ingredients contained in supplements, complied from already-available sources, and does not require companies to provide listings of ingredients. We continue to emphasize the need for a comprehensive registry of all supplement products and continue to agree with the FDA commissioner's recent position that 'supplements should be required to list with the FDA and companies should be accountable for revealing what is in the supplement being sold.' Until then, we encourage supplement companies to voluntarily register their products and ingredients with our registry."