On Tuesday, April 25th, the FDA released warning letters that were recently issued to 14 US-based companies. These warning letters were issued with regards to the illegal sale of products that claim to “prevent, diagnose, treat, or cure” cancer. The products that are being referenced in these warning letters have not been approved by the FDA, but are being marketed and sold most commonly through websites and social media platforms.
In FDA’s press release, it states that “it is a violation of the Federal Food, Drug and Cosmetic Act to market and sell products that claim to prevent, diagnose, treat, mitigate or cure diseases without first demonstrating to the FDA that they are safe and effective for their labeled uses.”
The companies receiving warning letters concerning the sale of these unapproved products include the following:
- AIE Pharmaceuticals, Inc.
- Amazing Sour Sop, Inc.
- BioStar Technology International, LLC
- Caudill Seed & Warehouse Inc.
- Everything Herbs
- Hawk Dok Natural Salve, LLC
- Healing Within Products & Services, Inc.
- LifeVantage Corporation
- Nature’s Treasure, Inc.
- Oxygen Health Systems, LLC
- Sunstone, Inc.
- The Vibrant Health Store, LLC dba Dr. Christopher’s Herbs
- The Vitamin C Foundation
The products in question include a variety of product types, such as pills, topical creams, ointments, oils, drops, syrups, teas, and diagnostics.
“The FDA has requested responses from the 14 companies stating how the violations will be corrected.” Any company that fails to correct the violations in a timely manner could face legal action, such as product seizure, injunction, and/or criminal prosecution.
FDA takes this issue very seriously; and in an effort to protect consumers from this type of fraud, the Agency states that it “has issued more than 90 warning letters in the past 10 years to companies marketing hundreds of fraudulent products making cancer claims on websites, social media and in stores.” The Agency notes that although many companies have stopped selling these products and making these illegal claims, there are still a number of unsafe and unapproved products being sold directly to consumers. The FDA informs consumers that it will continue to monitor this issue and will take action against companies that are found to be promoting and selling unapproved products.
For additional information, view FDA’s press release.