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Questions and Answers: FDA alerts companies to stop the illegal sale of products claiming to treat Alzheimer’s disease

The FDA has issued warning letters and online advisory letters to a number of domestic and foreign companies illegally selling unapproved new drug and misbranded drug products that claim to prevent, treat, mitigate or cure Alzheimer’s disease. The agency has asked the companies—which are marketing most of the products as dietary supplements—to provide written responses to address the violations covered in the warning letters and online advisory letters. Companies that fail to respond and make adequate corrections could be subject to further actions. 

Q1. Why is the FDA taking these actions?
Q2. What types of unapproved products are illegally sold to treat Alzheimer’s disease?
Q3. What are the products cited in the FDA's recent letters?
Q4. How are these products marketed?
Q5. Where are these products marketed and sold?
Q6. Why should consumers be concerned about these products?
Q7. Do these products make unproven claims only related to Alzheimer's disease?
Q8. What should consumers do to protect themselves from these products?
Q9. What should I do if I experience an adverse event from one of these products?
Q10. Have there been any actions taken against companies that claim to prevent, diagnose, treat, mitigate or cure Alzheimer's disease?
Q11. How can I get more information about health fraud scams? 

 

Q1. Why is the FDA taking this action?

A. This initiative is part of the FDA’s ongoing efforts to remove from the market certain unapproved products that purport to prevent, treat, mitigate or cure Alzheimer’s disease. This is a particular concern given the increasing popularity of online sellers and social media sites today.

Q2. What types of unapproved products are illegally sold to treat Alzheimer’s disease?

A. The products come in many forms, including pills, tablets, and oils. These products make claims related to preventing, treating, and “fighting” Alzheimer’s disease. Some products also claim to aid with diseases of the brain and reduce the risk for neurodegenerative diseases.

Q3. What are the products cited in the FDA's recent letters?

A. Please see the warning letters and online advisory letters.

Q4. How are these products marketed?

A. Companies illegally marketing unapproved new drugs and/or misbranded drugs purporting to treat Alzheimer’s disease—which products are often marketed as “dietary supplements”—use unproven and often exaggerated claims to promote these products. They may claim that some of the products are natural cures, but such products have not been proven to be safe and effective for the claimed uses. Such claims often take the form of unconfirmed testimonials on websites or social media to promote the products.

Q5. Where are these products marketed and sold?

A. These products are often marketed and sold on the Internet, including online marketplaces and various social media sites, such as Facebook, Twitter and Instagram. They may be sold in retail stores or non-traditional marketplaces.

Q6. Why should consumers be concerned about these products?

A. Alzheimer’s disease requires diagnosis and treatment under the supervision of a licensed health care provider. Such products may pose a danger to a consumer who takes them either because of the products themselves or because a patient uses the products in place of medications that have been proven safe and effective. The FDA has received numerous consumer complaints about the safety and availability of illegally marketed Alzheimer’s products.

Q7. Do these products make unproven claims only related to Alzheimer’s disease?

A. No. Many of the unapproved new drugs and misbranded drugs we identified make illegal claims related to several serious conditions, including dementia, Parkinson’s disease, attention deficit disorder (ADD), attention-deficit/hyperactivity disorder (ADHD), cancer, diabetes, obesity, insulin resistance, heart disease, autoimmune diseases, transient ischemic attack, male infertility, and depression. The products have not be proven safe and effective for any of these uses.

Q8. What should consumers do to protect themselves from these products?

A. The FDA continues to monitor the marketing and sale of such unapproved treatments to minimize the number of potentially dangerous products on the market. However, we encourage all consumers to exercise caution before using products that have not been approved by the FDA for their intended uses in the diagnosis, cure, mitigation, treatment, or prevention of disease. Consumers should always talk with their licensed health care provider before starting new treatments or adding products to existing Alzheimer’s disease treatments. The FDA has additional resources available on medication health fraud to help consumers make informed choices.

Consumers using any of the products mentioned in the FDA warning and advisory letters are urged to talk with their licensed health care providers. Consumers who suspect they have experienced adverse events as a result of taking any of these products or other suspicious Alzheimer’s disease products should contact their licensed health care provider immediately.

Q9. What should I do if I experience an adverse event from one of these products?

A. The FDA encourages consumers to first talk their health care provider and to report any serious adverse event associated with the use of an FDA-regulated drug, biologic, medical device, dietary supplement or cosmetic. Complete and submit the FDA’s MedWatch Online Voluntary Reporting Form.

Q10. Have there been any actions taken against companies that claim to prevent, diagnose, treat, mitigate or cure Alzheimer’s disease?

A. As part of the FDA’s ongoing effort to protect consumers, the FDA has issued more than 40 warning letters in the past 5 years to companies marketing unapproved products for the cure, mitigation, treatment, or prevention of Alzheimer’s disease on websites, social media, and in stores.

While such FDA actions can help stop the sale of specific products through specific retail locations, numerous unapproved new drug products continue to be sold directly to consumers due in part to the ease with which companies can move their marketing operations to new websites. The FDA continues to monitor and take action against companies promoting and selling unproven treatments in an effort to minimize the potential dangers to consumers and to educate consumers about the risks.

Q11. How can I get more information about health fraud scams?

A. To learn more about identifying and avoiding health fraud scams, visit www.fda.gov/healthfraud