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FDA Adds Dietary Supplement Ingredient List to Its Website
The FDA is launching a new tool to alert the public when it becomes aware of ingredients that appear to be unlawfully marketed in dietary supplements. This Dietary Supplement Ingredient Advisory List will be housed on the FDA website. Consumers may wish to avoid buying and using dietary supplements containing ingredients on the list and industry may wish to avoid making or selling dietary supplements containing ingredients on the list.
Ingredients will be added to the list following an initial FDA assessment indicating the ingredient may not lawfully be in dietary supplements. This could be because the ingredient does not fit the definition of a dietary ingredient or the ingredient requires a pre-market notification that was not submitted; however, inclusion of an ingredient on this list is not necessarily an indication of safety concerns. This list is intended to get information to both consumers and industry more quickly.
It is important to note that the list is not exhaustive; it will always be a work in progress, as new ingredients are identified and others are removed. Consumers can sign up to receive the most recent updates and changes to the list, and all stakeholders can submit additional feedback that may support or refute the FDA’s preliminary assessment regarding the ingredients on the list.
FDA plans to continue to take action against companies that ignore the legal requirements for dietary supplements. The agency has warned eight companies for marketing dietary supplements containing DMHA. These products are considered adulterated because the FDA has determined that DMHA is either a “new dietary ingredient” for which the FDA has not received the required New Dietary Ingredient notification or that DMHA is an unsafe food additive. The agency also issued warnings to three companies for marketing dietary supplements containing phenibut. These products are misbranded because they label phenibut as a dietary ingredient when phenibut does not meet the statutory definition of a dietary ingredient. The products identified in the warning letters include Lean Pills, Chaos Unleashed, Triple X Pre-Workout Stimulator, Simply Skinny Pollen, Synedrex, E.S.P. Extreme, Ultimate Orange, HydroxyElite, Lipodrene Elite, Synadrene, Enrage Extreme, Pre-Workout Relentless V1, Kavinace, Sleep Walker, Red Dawn Liquid, and Limitless.
These companies have 15 business days from receipt of the warning letter to inform the FDA of specific steps they will take to bring their products into compliance with the law. This could include a company’s decision to recall, reformulate, discontinue sale or products, or other actions.
The creation of the list is part of the FDA’s overall efforts to strengthen the agency’s regulation in a manner that strikes a balance between preserving consumer access to lawful dietary supplements while also protecting Americans from the potential dangers of products that don’t meet the agency’s standards for dietary supplements.
Source: FDA.gov, April 16, 2019