Rooting out the bad actors: FDA launches new dietary supplements protection platform

17 Apr 2019 --- In a move to significantly “modernize” dietary supplement regulations and root out “bad actors” that distribute and sell dangerous products, the US Food and Drug Administration’s (FDA) overhaul of supplement regulation has taken a major stride forward. As a reference tool for consumers and manufacturers, the new Dietary Supplement Ingredient Advisory List contains warnings about unlawful ingredients in dietary supplements.

The trade association for the dietary supplement and functional food industry, the Council for Responsible Nutrition (CRN), has applauded the launch, hoping it demonstrates how regulators “are coming for you if you attempt to skirt the law.”

“Protecting consumers from ingredients that appear to be unlawfully marketed in dietary supplements is a critical component of FDA’s regulatory oversight. We are pleased that a new platform to alert consumers more rapidly than in the past has been established,” says Andrew Shao, Interim Senior Vice President, Scientific & Regulatory Affairs, CRN. “We recommend that consumers bookmark and regularly visit the Ingredient Advisory List.”

Shao explains how CRN stands strong with the FDA in its fight against companies who are deliberately violating the law. The association encourages the mainstream dietary supplement industry to do the same. 

“By embracing FDA’s new tool, the industry demonstrates support for the Agency’s efforts to preserve the balance between access and safety for the 170 million Americans taking dietary supplements each year,” he adds.

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, according to the FDA. 

“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,” says an FDA statement. 

The Dietary Supplement Ingredient Advisory List will be on the FDA website and consumers can steer clear of buying and using dietary supplements containing ingredients on the list. It will also help industry to avoid making or selling dietary supplements that contain ingredients listed there. 

Ingredients will be added to the list following an initial FDA assessment indicating that 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, the inclusion of an ingredient on this list is not necessarily an indication of safety concerns, notes the FDA.

The FDA says it will “communicate separately and clearly” any time it identifies 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,” continues the FDA statement.

“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.”

The list is expected to evolve as new ingredients are identified and others are removed.

In addition, the FDA stresses it will continue to take action against “bad actors” who seemingly ignore the legal requirements for dietary supplements. The Agency also reveals it 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 FDA has also issued warnings to three companies for marketing dietary supplements containing phenibut, a central nervous system depressant with anxiolytic and stimulant effects which is used in the treatment of anxiety, insomnia. 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 FDA says that it takes these violations very seriously and is ready to take enforcement action if the companies do not immediately cease distribution of the products.

By Gaynor Selby