FDA announced today a new tool designed to quickly alert consumers of ingredients unlawfully marketed as supplements.
Dubbed the Dietary Supplement Ingredient Advisory List, the tool is intended to provide rapid notification to consumers of unlawful ingredients in order to better protect them from potentially dangerous ingredients. Included in the list are ingredients FDA deems not permissible for use in dietary supplements based on its “initial assessment” of an ingredient.
The tool is part of the agency’s efforts announced earlier this year to modernize its regulatory framework over supplements to meet the demands of an industry that has grown significantly over the last 25 years.
“As the dietary supplement marketplace has grown, the introduction of new ingredients often raises complex questions involving science, policy and the law,” said Frank Yiannas, FDA’s deputy commissioner for food policy and response, in a statement announcing the tool. “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.”
Yiannas also pointed to “bad actors” who “seemingly ignore the legal requirements for dietary supplements” as an issue threatening the safety of consumers.
“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,” he said. “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.”
FDA cited potential reasons for adding an ingredient to the list, including lack of pre-market notification based on regulatory requirements; exclusion from use in a dietary supplement; and/or not fitting FDA’s definition of a dietary ingredient.
Ingredients currently on the list include andarine, higenamine, hordenine and 1,4- dimethylamylamine (DMAA).
However, the list is not exhaustive and will “always be a work in progress,” Yiannas said in the statement. “Additionally, we expect the list will evolve as new ingredients are identified and others are removed,” he added.
The tool is intended to supplement FDA’s current enforcement practices, which, per Yiannas, will remain effective.
For example, the webpage features links to other ingredients that have raised concern with FDA. These include 1,3 DMAA, DMHA, phenibut, Acacia rigidula, BMPEA, DMBA, methylsynephrine, picamilon, tianeptine, vinpocetine and highly concentrated caffeine.
Stakeholders react to ingredient list
In a statement responding to FDA’s implementation of the advisory list, the Council for Responsible Nutrition (CRN) welcomed FDA’s efforts to keep consumers informed.
“Protecting consumers from ingredients that appear to be unlawfully marketed in dietary supplements is a critical component of FDA’s regulatory oversight, and so we are pleased that a new platform to alert consumers more rapidly than in the past has been established,” said Andrew Shao, Ph.D., interim senior vice president, scientific & regulatory affairs, CRN. “In addition to rapidly alerting the public, the new tool will allow FDA to exert greater regulatory enforcement in the face of limited resources.”
Critics of the tool expressed concern over whether the list will tangibly contribute to a safer marketplace for consumers.
“It's laudable that the FDA will be operating with a bit more transparency as they share with the public and industry the ingredients they are concerned about before they make a final determination,” said Pieter Cohen, M.D., associate professor of medicine at Harvard Medical School, in an emailed statement about the advisory list. “Unfortunately, I suspect that the FDA's new list of questionable ingredients will have little, if any, effect on what is actually on the market and therefore not create a safer environment for consumers.”
Cohen cited vinpocetine as an example. Vinpocetine is not on the advisory list, but is included on the advisory list webpage. FDA tentatively concluded in 2016 that vinpocetine did not qualify as a dietary ingredient and is excluded from the definition of a dietary supplement. But the agency requested commments on its tentative conclusion, which the dietary supplement industry heavily criticized.
“The FDA has not only made it clear that it has questions, the agency has actually determined vinpocetine is not a legitimate dietary ingredient and made this information publicly available back in September of 2016,” said the physician, whose research has identified several potentially dangerous ingredients marketed in dietary supplements. “The outcome? Almost three years later, vinpocetine is sold in dozens of brands of supplements, including from mainstream retailers. If vinpocetine is not removed from store shelves after clear communication from the FDA, then in all likelihood, all these other concerning ingredients listed in the new database, including higenamine and 1,4-DMAA, will remain available, as well.”
Daniel Fabricant, Ph.D., president and CEO of the Natural Products Association (NPA), noted in a phone interview that the list lacks context that could be important for consumers.
He explained, “I always hate when people go, ‘We’re going to inform the consumer, but we’re not going to give them all of the information or what the agency bases the cases on,’” he said, adding, “It’s a little bit disingenuous. Either we’re going to give the consumer every piece of information as to why this [belongs] on this list or we’re not going to have a list. It’s gotta be one of the two, right?”
FDA warning letters
Also announced in Yiannas’ statement was notification of FDA action taken against 11 marketers of products containing either DMHA or phenibut. FDA issued warning letters to eight companies marketing products containing DHMA, which is considered a new ingredient and requires a new dietary ingredient (NDI) notification, and to three companies marketing products containing phenibut, which does not meet the definition of a dietary ingredient per FDA regulations.
FDA requested the companies respond to the agency within 15 working days. As is customary, FDA cautioned the firms that it may take further enforcement action without further notice if they do not immediately stop distributing the products.
“A reaffirmed commitment to traditional advisory and enforcement actions, such as warning letters, in combination with the newly launched rapid-response tool, the Dietary Supplement Ingredient Advisory List, are integral parts of the FDA’s overall effort to strengthen the agency’s regulation and oversight of dietary supplements,” the agency noted in a constituent update, announcing the warning letters. “We continue to look for ways to modernize our approach to protecting consumers from misbranded, unsafe, or otherwise unlawful dietary supplements.”
Editor’s note: This article was revised and updated on April 17 to provide clarification between ingredients on the advisory list and other ingredients for which FDA has raised concern.