FDA Statement from Deputy Commissioner for Food Policy and Response Frank Yiannas on new steps to protect consumers from unlawful ingredients in dietary supplements

FDA Statement

• For Immediate Release: April 16, 2019

Taking a dietary supplement – like vitamins, minerals, or herbs – has become a daily routine for many Americans. The $40 billion a year supplement industry reaches 170 million Americans, offering between 50,000 and 80,000 different products that claim to help maintain or improve health. For many, dietary supplements are a key part of their efforts to make healthy choices. To be able to make those choices with respect to dietary supplements, consumers need to have access to safe, well-manufactured, and appropriately labeled products.

While many dietary supplements meet the FDA’s standards, there are some companies who knowingly distribute and sell dangerous or otherwise illegal products that put consumers at risk. As the agency entrusted with the oversight of dietary supplements, we will not stand by and allow these companies to compromise the health of the very people who are seeking out supplements to aid in their well-being.

Earlier this year, we announced new efforts to strengthen the regulation of dietary supplements by modernizing our regulatory framework to meet the demands of this growing industry. Today, as part of those efforts, we are announcing an important new step and a new action to better protect consumers from potentially unlawful dietary supplements.

The FDA is launching a new tool to quickly alert the public when we become 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 for reasons including 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. The FDA will continue to communicate separately and clearly any time we identify safety concerns about dietary ingredients or dietary supplements.

As the dietary supplement marketplace has grown, the introduction of new ingredients often raises complex questions involving science, policy, and the law. In the time it takes the FDA to make a final determination, consumers and industry might mistakenly conclude that a lack of action by the FDA indicates that these ingredients are lawful. This List is intended to get information to both consumers and industry more quickly. It also provides an opportunity for stakeholders to share information with us that they think might be relevant to our determination.

While we will aim to communicate about these suspect ingredients as quickly as possible, it is important to note that the List is not exhaustive; it will always be a work in progress. Additionally, we expect the List will evolve 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.

The Dietary Supplement Ingredient Advisory List adds to our ability to inform and educate people in determining which ingredients might not be lawfully included in dietary supplements. We will continue to use our traditional enforcement tools as part of our overall strategy regarding dietary supplements.

To that end, we continue to take action against those bad actors who seemingly ignore the legal requirements for dietary supplements. Today, we are also announcing that 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.

We take these violations very seriously and stand ready to take enforcement action without further notice if the companies do not immediately cease distribution of the products. We are firmly committed to ensuring that products sold as dietary supplements meet the law’s requirements for dietary supplements, and most importantly, do not put consumers at unnecessary risk. Further, other companies marketing similar illegal products should take note—we will continue to take the necessary steps to protect the American public from ingredients that aren’t allowed in dietary supplements.

Today’s actions are part of the FDA’s overall efforts to strengthen the agency’s regulation in a manner that strikes the right 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. Just last week, we announced a public meeting to discuss responsible innovation in the dietary supplement industry. We’re excited to hear from all of our stakeholders in this arena and look forward to an in-depth conversation on May 16 to discuss ideas for facilitating responsible innovation in the dietary supplement industry while preserving the FDA’s ability to protect the public from unsafe, misbranded, or otherwise unlawful dietary supplements.

We remain committed to advancing the important work of modernizing the FDA’s oversight of the dietary supplement industry and bringing greater assurance to Americans who rely on dietary supplements on a regular basis.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.