On Feb. 11, the U.S. Food and Drug Administration (FDA) posted 12 warning letters and 5 online advisory letters to foreign and domestic companies that are illegally selling more than 58 products, many that are sold as dietary supplements, which are unapproved new drugs and/or misbranded drugs that claim to prevent, treat or cure Alzheimer’s disease and a number of other serious diseases and health conditions. These products, which are often sold on websites and social media platforms, 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. These products may be ineffective, unsafe and could prevent a person from seeking an appropriate diagnosis and treatment.
“Science and evidence are the cornerstone of the FDA’s review process and are imperative to demonstrating medical benefit, especially when a product is marketed to treat serious and complex diseases like Alzheimer’s. Alzheimer’s is a challenging disease that, unfortunately, has no cure. Any products making unproven drug claims could mislead consumers to believe that such therapies exist and keep them from accessing therapies that are known to help support the symptoms of the disease, or worse as some fraudulent treatments can cause serious or even fatal injuries. Simply put, health fraud scams prey on vulnerable populations, waste money and often delay proper medical care—and we will continue to take action to protect patients and caregivers from misleading, unproven products,” said FDA Commissioner Scott Gottlieb, MD. “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 (DSHEA), enacted by Congress 25 years ago. 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. Our newest policy efforts will seize the game-changing opportunity to further strengthen the regulatory framework overseeing dietary supplements and will hone in on important steps to both promote industry innovation while upholding the safety of these products as part of our overall commitment to protecting public health.”
In a statement, FDA Commissioner Gottlieb also outlined several important new actions and policy priorities the agency will take in the coming months to improve the safety of dietary supplements and purported dietary supplements, including efforts to more rapidly communicate potential safety issues with dietary supplement products with the public, establishing a flexible regulatory framework that promotes innovation and upholds product safety and other, new steps the FDA could consider taking to better ensure product safety and integrity.
In response to Gottlieb’s statement regarding actions that FDA will take in the coming months, Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), expressed the trade association’s approval on the matter.
“CRN appreciates the commitment of FDA Commissioner Dr. Scott Gottlieb to strengthen the dietary supplement industry and to modernize FDA’s oversight of these products,” Mister noted. “He clearly shares our respect, both as a doctor and as a consumer, for the power of dietary supplements to improve the lives and health of all Americans, three-quarters of whom already take our products each year. His statement shares our vision to further develop the thriving, innovative and safe marketplace for dietary supplements that, as he so eloquently states, play an important role as ‘we strive to stay healthy,’ and have ‘become a routine part of the American lifestyle.’
“ … CRN looks forward to engaging with FDA as we learn more about the specific initiatives Dr. Gottlieb promises. When these new FDA proposals enhance the safety and informed decision making of consumers, improve the health, transparency and innovation of the industry, promote greater practitioner confidence, and do not restrict access or create unwarranted regulatory burdens for industry, FDA will have a willing and enthusiastic partner in CRN and its member companies.”
Daniel Fabricant, PhD, president and CEO of the Natural Products Association (NPA) also released a statement in response to the announcement:
“We welcome the need to look ahead but FDA cannot ignore today’s challenges in the meantime: their inaction on one of the hottest products, CBDs, is a case in point.
“We look forward to working with FDA on modernization, but what consumers need is action. We encourage the FDA to use the current tools it has at its disposal to protect consumers from companies selling illegal products masquerading as nutritional supplements.
“The U.S. has the safest nutritional supplements in the world because of collaborative efforts between our industry and federal regulators, and we are confident that collaboration will continue.”
