In a Constituent Update dated March 6, 2023, the Agency noted that the directory is intended to be a “one stop shop of ingredient information that was previously found on different FDA webpages”.
Indeed, it appears to be the old ingredient advisory list with a few other ingredients added, including NAC and biotin.
The new directory focuses on 27 ingredients, including 5-Alpha-Hydroxy-Laxogenin; Acacia rigidula; Biotin; BMPEA; Cannabidiol; Cesium chloride; Comfrey; DMAA; DMBA; DMHA; Ephedrine alkaloids; Higenamine; Higenamine HCl; Hordenine; Hordenine HCl; Kava; Kratom; Methylsynephrine; N-acetyl-L-cysteine; Octopamine; Phenibut; Picamilon; Pure and Highly Concentrated Caffeine; Pyridoxamine; Red yeast rice; Tianeptine; and Vinpocetine.
Daniel Fabricant, PhD, president and CEO of the Natural Products Association (NPA), said it was interesting that the Agency lists NAC next to DMAA, while also omitting SARMs like ostarine or other performance-enhancing ingredients such as GW501516, a drug candidate from the 1990s with potential performance-enhancing effects. Development of GW501516 was abandoned after the drug was found to rapidly cause cancer in lab animals.
Both ostarine and Gw501516 were highlighted as being common contaminants in sports nutrition products by Dr Amy Eichener, Special Advisor to the US Anti-Doping Agency, during NutraIngredients-USA’s recent Sports & Active Nutrition Summit.
According to the FDA in its update: “This directory is intended to help manufacturers, retailers, and consumers stay informed about ingredients that may be found in products marketed as dietary supplements and quickly locate information about such ingredients on the FDA’s website.”
The Agency stressed that the directory is not intended to be a comprehensive list of all ingredients used in products marketed as dietary supplements and may not include all actions the agency has taken with respect to a particular ingredient.
Commenting on the new directory, Steve Mister, President and CEO for the Council for Responsible Nutrition, said: “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, compiled 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."