Questions and Answers: FDA alerts companies to stop the illegal sale of products claiming to treat cancer
The FDA has issued warning letters to a number of domestic companies illegally selling products that they claim can prevent, diagnose, treat, mitigate or cure cancer. The agency has asked the companies to provide written responses to address the violations covered in the warning letters. Companies that fail to respond and make adequate corrections could be subject to further actions, including seizure, injunction, and criminal prosecution.
Q1. What types of unproven products are illegally sold to treat cancer? Do they target specific cancers? What about pets?
Q2. How are these products marketed?
Q3. Where are these products marketed and sold?
Q4. What are the products cited in the FDA's recent letters?
Q5. Why should consumers be concerned about these products?
Q6. Do these products claim to cure only cancer?
Q7. What should consumers do to protect themselves from these products?
Q8. Why is the FDA taking this action?
Q9. Have there been any enforcement actions taken against companies that claim to prevent, diagnose, treat, mitigate or cure cancer?
Q10. How can I get more information about health fraud scams?
A. The products come in many forms, including pills and tablets, creams, syrups, sprays, oils, salves, teas and medical devices, among others. These products make claims related to numerous types of cancer but also target specific cancers including breast cancer, cervical cancer, and prostate cancer. These companies also sell illegal products claiming to treat a variety of cancers in pets.
A. Companies marketing illegal cancer therapies often use exaggerated and false claims to promote these products. They may claim that individuals can avoid chemotherapy or painful surgery and that their products treat all forms of cancer. They may also claim that some of the products are natural cures, but such products have not been proven to be safe and effective for these uses. Companies often falsely claim that consumers won’t get sick from their treatments and that they’re non-toxic. They also commonly use unproven claims in unconfirmed testimonials on websites or social media to promote their products.
A. These products are often marketed and sold on the Internet, including online marketplaces and various social media sites, such as Facebook and Instagram. They may be sold in retail stores or non-traditional marketplaces, such as flea markets or swap meets. The FDA has also discovered companies marketing products with unproven cancer claims at trade shows.
A. Please see the warning letters.
A. Cancer is a class of life-threatening diseases that requires diagnosis and treatment under the supervision of a licensed health care provider. Not only can these illegally sold products be ineffective and cause direct harm, but they can cause indirect harm to cancer patients by delaying the use of or interfering with proven, beneficial treatments.
The FDA has received numerous consumer complaints about the safety and availability of illegally marketed cancer treatments. Some have been found to present a direct health risk to consumers. For example, in January 2017, an FDA laboratory discovered the bacteria Variovorax paradoxus in a sample of PNC-27, an unapproved drug product promoted as a treatment or cure for cancer.
A. No. Many of these illegal products make claims related to many serious conditions, including arthritis, diabetes, high blood pressure, Alzheimer’s disease, HIV, AIDS, seizures, erectile dysfunction, and lupus. Many of these products also claim to be cure-alls that treat many different conditions.
A. The FDA continues to monitor the marketing and sale of these unproven 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. Consumers should always talk with their licensed health care provider before starting new treatments or adding products to existing cancer treatment plans. See medication health fraud for more information.
Consumers using any of the products mentioned in the FDA warning 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 cancer products should contact their licensed health care provider immediately.
The FDA encourages consumers and health care providers 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.
A.This initiative is part of the FDA’s ongoing efforts to remove fraudulent cancer products from the marketplace, especially with the steady popularity of online sellers and social media sites today. Over the past 10 years, the FDA has issued more than 90 warning letters to companies illegally marketing products that falsely promise to prevent, diagnose, treat, mitigate or cure cancer.
A.The FDA has initiated a number of enforcement actions against companies that illegally market products that claim to prevent, diagnose, treat, mitigate or cure cancer. In addition to warning letters, several firms have been subject to permanent injunctions and criminal prosecutions.
A. To learn more about identifying and avoiding health fraud scams, visit www.fda.gov/healthfraud.
Additional information about cancer fraud is also available from the Federal Trade Commission.