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FDA is warning consumers and health care professionals that several companies have sold products illegally claiming to prevent, diagnose, treat, or cure cancer. These claims are a direct violation of the Federal Food, Drug and Cosmetic Act because these products have not demonstrated safety and efficacy required for FDA approval. In addition to potentially causing direct harm to patients with unsafe ingredients, these products may delay patients from receiving evidence-based cancer treatments. Some companies marketed the products for humans and pets. Most of the products are sold on the internet, including social media platforms or product websites. The illegal products include many formulations such as pills, creams, drops, syrups, and teas.
FDA issued 14 warning letters and 4 online advisory letters for more than 65 products. A list of the 18 companies and their products is included in a link below (List of illegally sold cancer treatments). The companies have 15 business days to respond to the warning letter stating how they will correct the violation. FDA will pursue further legal action if needed. Do not use these or similar products because they may be ineffective and unsafe. Encourage patients to avoid purchasing products without proof of efficacy and to always consult their health care professional when considering non-prescription products. Report adverse effects to the FDA MedWatch Adverse Event Reporting Program.
Additional Information
- MedWatch Safety Alert – April 25, 2017
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm554777.htm - FDA News Release – April 25, 2017
www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm554698.htm - List of Illegally Sold Cancer Treatments – April 25, 2017
www.fda.gov/ForConsumers/ProtectYourself/HealthFraud/ucm533465.htm - Consumer Update: Products Claiming to “Cure” Cancer Are a Cruel Deception – April 25, 2017
www.fda.gov/ForConsumers/ConsumerUpdates/ucm048383.htm - Questions and Answers – April 25, 2017
www.fda.gov/ForConsumers/ProtectYourself/HealthFraud/ucm533467.htm - FDA Voice Blog – April 25, 2017
blogs.fda.gov/fdavoice/index.php/2017/04/fda-takes-action-against-fraudulent-cancer-products/