The Food & Drug Administration (“FDA”) regulates cancer drugs and devices, both for use by humans and pets. Such drugs and devices must obtain FDA approval or clearance before they can be marketed or sold to consumers, so that the FDA can ensure each product is safe and effective for its intended use. The FDA is concerned about the marketing and selling of products that have not been approved, particularly because such products may contain dangerous ingredients or may cause harm by negatively impacting beneficial treatments. Often such products are advertised as “natural” or are labeled as a dietary supplement, which may be a tip-off to consumers that the products have not been approved by the FDA.
The FDA has identified the following advertising phrases as “red flags” that may signify a fraudulent product:
- Treats all forms of cancer
- Miraculously kills cancer cells and tumors
- Shrinks malignant tumors
- Selectively kills cancer cells
- More effective than chemotherapy
- Attacks cancer cells, leaving healthy cells intact
- Cures cancer
Additionally, the FDA has stated that the following catch phrases should tip-off consumers to a potentially bogus health-related product:
- One product does it all
- Personal testimonials
- Quick fixes
- “All natural”
- “Miracle cure”
- Conspiracy theories
In April, the FDA sent 14 warning letters to companies that it determined were making fraudulent claims on their websites related to purported cancer treatments. Fraudulent claims are those that deceptively promote a product as effective against a specific condition—in this instance, cancer—that has not been scientifically proven to be safe and effective for its claimed purposed. According to the FDA, if the companies to which it sent letters do not comply with its warnings, the FDA may take further legal action in order to ensure that such products do not reach consumers.
The FDA requests that consumers avoid use of potentially unsafe or unproven products and to discuss any cancer treatments with their healthcare providers (or, in the case of pets, with their veterinarian and veterinary oncologist). As always, companies that market or sell products requiring FDA approval should ensure that such products are fairly advertised, are properly labeled, are effective and safe for their intended use, and are indeed approved as required.