The $40 billion-a-year dietary supplement industry reaches 170 million Americans with between 50,000 and 80,000 different products that claim to help maintain or improve health. But some supplements contain unlawful ingredients that pose risks to consumers. The Food and Drug Administration (FDA) is launching a new tool to quickly alert the public when it becomes aware of suspect ingredients that appear in supplements.
“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,” Frank Yiannas, Deputy Commissioner for Food Policy and Response, said in a statement. “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 their well-being.”
The so-called Dietary Supplement Ingredient Advisory List will be housed on the FDA website. Following an initial FDA assessment, ingredients will be added to the list if they are determined to be unlawful. Inclusion of an ingredient on this list does not necessarily indicate that it is associated with safety concerns, Yiannas said. “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.”
The list is part of an effort the agency announced earlier this year designed to strengthen the regulation of dietary supplements by modernizing the regulatory framework to meet the demands of the growing dietary supplement industry.
“As the dietary supplement marketplace has grown, the introduction of new ingredients often raises complex questions involving science, policy and the law,” Yiannas said. “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.”
Ingredients currently on the list include DMHA, an unsafe food additive that the FDA found in various dietary supplements manufactured by eight companies. Recently the agency issued warning letters to those companies. “To that end, we continue to take action against those bad actors who seemingly ignore the legal requirements for dietary supplements,” Yannis said.
Yannis pointed out that the list is not exhaustive and will “always be a work in progress. … Additionally, we expect the list will evolve as new ingredients are identified and others are removed.”