Under the current Administration, the FDA has taken several actions to slow down the implementation of new food and supplement labeling rules. Showing a new tack this week, officials at the U.S. Food and Drug Administration put dietary supplements in the crosshairs when Commissioner Dr. Scott Gottlieb announced the agency would crack down on brand owners who make unsubstantiated claims.
The FDA shared a dozen warning letters and five online advisory letters the agency sent to companies found to be selling nearly 60 products illegally. The FDA claims the companies are either selling untested products or supplements that are misbranded. The products in questions make claims regarding the treatment of Alzheimer’s as well several other serious medical conditions.
“Today’s actions are part of the FDA’s larger effort to address the booming growth of the dietary supplement industry through the implementation of modern regulatory initiatives that will enable the agency to preserve the balanced vision of the Dietary Supplement Health and Education Act,” Gottlieb explained in a statement. “That law sought to achieve the right balance between preserving consumers’ access to lawful supplements, promoting innovation in these products, while upholding our obligation to protect the public from unsafe and unlawful products, and holding accountable those actors who are unable or unwilling to comply with the requirements of the law.”
Gottlieb also walked through other steps needed to make dietary supplements safer for consumers, including “communicating to the public as soon as possible when there is a concern about a dietary supplement on the market, ensuring that our regulatory framework is flexible enough to adequately evaluate product safety while also promoting innovation, continuing to work closely with our industry partners, developing new enforcement strategies and continuing to engage in a public dialog to get valuable feedback from dietary supplement stakeholders.”
The tougher enforcement trails the last significant dietary supplement legislation by more than 25 years. When Congress passed DSHEA, the supplement industry generated $4 billion in revenue on sales of roughly 4,000 different products. In 2017, the market hit $43.5 billion, according to the Nutrition Business Journal with shelves filled with more than 50,000 unique products.
According to the Council for Responsible Nutrition’s 2018 Consumer Survey on Dietary Supplements, 75 percent of Americans use dietary supplements. The FDA Commissioner shared his personal experience taking dietary supplements, “I’ve personally benefited from the use of dietary supplements and, as a physician, recognize the benefits of certain supplements as a part of a comprehensive care plan. It’s clear to me that dietary supplements play an important role in our lives as we strive to stay healthy.”
Demand for supplements is stronger than ever, but consumers also demand to know exactly what goes into the supplements they take. They’re savvier than ever, and much more skeptical of the claims that supplement manufacturers make. Dietary supplement companies remain under increased pressure from both consumers and regulators to manage claims more effectively and transparently.
Formulating new dietary supplements continues to be an arduous task. Until recently, researching ingredients to substantiate claims was a manual and time-consuming process that involved reviewing catalogs, searching the internet for journal articles and monographs, and emailing or calling suppliers for samples.
Today, TraceGains’ Smart Library can simplify and centralize these tasks and help dietary supplement makers substantiate claims and ensure compliance with regulations. To learn more, please register for our upcoming webinar “Stay Ahead of the FDA’s Evolving Rules for Dietary Supplements.”