At the same time, recognizing that use of supplements is widespread in the U.S., the agency also announced a plan for modernizing its regulation and oversight of dietary supplements.
The U.S. Food and Drug Administration (FDA) recently sent warning letters to 17 companies that are “illegally selling” supplements that are marketed as preventing or curing Alzheimer’s disease. At the same time, recognizing that the use of supplements is widespread in the U.S., the agency also announced a plan for modernizing its regulation and oversight of dietary supplements.
Regarding the warning letters, FDA stated that many of the products were sold on websites and social media platforms, and “have not been reviewed by the FDA and are not proven safe and effective to treat the diseases and health conditions they claim to treat.”
The agency also published a warning letter aimed at consumers on what to look out for. Much of the advice in the consumer warning letter revolves around identifying claims that seem too good to be true. Statements like: “You can even reverse mental decline associated with dementia or even Alzheimer’s in just a week” and “Supplements are used to cure Alzheimer’s disease.”
The consumer letter also notes, “Another red flag is that many of the claims made by these companies about the supposedly curative powers of their products are often not limited to Alzheimer’s disease. Consumers should steer clear of products that claim to cure or treat a broad range of unrelated diseases.”
The 17 companies sent warning letters are expected to respond within 15 days.
In his letter about the new policies, FDA Commissioner Scott Gottlieb wrote, “In the 25 years since Congress passed the Dietary Supplement Health and Education Act (DSHEA), the law that transformed the FDA’s authority to regulate dietary supplements, the dietary supplement market has grown significantly. What was once a $4 billion industry comprised of about 4,000 unique products, is now an industry worth more than $40 billion, with more than 50,000—and possibly as many as 80,000 or even more—different products available to consumers.”
The new steps are designed to ensure a balance between “preserving consumers’ access to lawful supplements, while still upholding our solemn 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.”
The steps fall into communicating to the public concerns over any dietary supplement, making sure its regulatory framework has the flexibility to evaluate product safety while also promoting innovation, working closely with industry partners, developing new enforcement strategies, and working with the public to get feedback from dietary supplement stakeholders.
Gottlieb wrote, “The opportunity to strengthen the framework that governs dietary supplements couldn’t come at a more pivotal time. On the one hand, advances in science and the growth and development in the dietary supplement industry carries with it many new opportunities for consumers to improve their health. At the same time, the growth in the number of adulterated and misbranded products—including those spiked with drug ingredients not declared on their labels, misleading claims, and other risks—creates new potential dangers.”
Steps being taken include developing a rapid-response tool to alert the public about questionable supplements; develop a regulatory framework for the submission of new dietary ingredient (NDI) notifications; creation of the Botanical Safety Consortium, a public-private partnership to promote scientific advances in evaluating the safety of botanical ingredients and mixtures in dietary supplements; develop new enforcement strategies; and engage in public dialogue concerning whether more steps to modernize DSHEA are necessary.
Gottlieb concluded, “The steps outlined today highlight both where we are currently and where we look forward to moving toward. We are eager to continue our work with both our industry partners and dietary supplement consumers and will announce more upcoming ideas that we hope to roll out in the near future.”
