The Food and Drug Administration (FDA) has jurisdiction over many issues important to the more than 5 million Americans living with Alzheimer's and their 16 million caregivers. One area of particular importance is alerting the public about potential misuse or improper marketing of drugs and dietary supplements. Prescription drugs undergo rigorous scientific research, as required by the FDA. However the same is not required by law for the marketing of dietary supplements. So while some manufacturers make claims about their products, alleging connections to brain health or memory, these claims are untested.
Consequently, the FDA has issued several warnings to companies illegally selling more than 58 products, many sold as dietary supplements, that claim to prevent, treat, or cure Alzheimer's disease and other serious conditions. Among other concerns, the agency noted that the supplements — which often come in the form of tablets, capsules, or oils — have not been reviewed by the FDA, and are not proven safe and effective. Importantly, the FDA also said that patients who believe these supplements might work for them should not forgo seeking appropriate diagnoses and treatments. This isn't the first time the FDA has had to take action against such claims. In just the past five years the FDA has issued more than 40 similar warnings. The Alzheimer's Association and the Alzheimer's Impact Movement (AIM) applaud the FDA's actions to protect the health and safety of persons living with dementia awaiting a treatment.
Critically, the FDA is also responsible for fostering innovation in legitimate, potentially helpful products. To find the balance between this unique dual purpose, the agency is seeking public comment on Responsible Innovation in Dietary Supplements. This period of input allows the public to present ideas, evidence, risks, and benefits related to dietary supplements.
The Alzheimer's Association and AIM have provided a written statement expressing our concerns about dietary supplements. In the statement we noted that we share the FDA's concern that the effectiveness and safety of such supplements are unknown. We also expressed our concern that some of these products are marketed as “natural,” leading consumers to believe that they aren't harmful. In fact, their purity is also unknown. Finally, dietary supplements could interact with prescribed medications. No one should take a supplement without first consulting a physician. The Alzheimer's Association and AIM strongly encourage manufacturers to conduct definitive clinical trials to establish the safety and effectiveness of their products prior to marketing.
The Association and AIM will continue to work with government agencies including the FDA to ensure that all products being marketed to people living with dementia are properly tested and approved by the FDA. We support the FDA as it works to balance scientific integrity, the need for new products, and effective communication with the public. As researchers continue to search for treatments and a cure, the Alzheimer's Association and AIM applaud and support the FDA's work to protect all consumers, including those with Alzheimer's and related dementias.