By Mitchell Clute
On June 17, the U.S. Food and Drug Administration sent warning letters to more than two dozen Internet-based companies selling supplements with cancer claims. Approximately 125 individual products were targeted, and ingredients touted by marketers for their anti-cancer properties included bloodroot, shark cartilage, coral calcium and a variety of medicinal mushrooms, according to the FDA.
Each of the targeted companies—some based in the U.S., others overseas—received an FDA warning letter. Though the specifics of the letters varied depending on each company's products and claims, the gist of each letter was the same: Targeted products are illegally being marketed as drugs, and thus are in violation of U.S. law.
In many cases, the claims and even product names were anything but subtle. Among the claims the FDA cited were "80% more effective than the world's number one cancer drug" and "Causes cancer cells to commit suicide!" The products listed included "Malignant Lymphoma Tea Formula" and "Nasal Cancer Tea Formula".
The move was supported by supplements industry trade associations, which have worked diligently in recent years to self-regulate the industry and combat the perception that the industry is unregulated.
"Companies should know better," said Michael McGuffin, president of the American Herbal Products Association, based in Silver Spring, Md. "We're not allowed to make drug claims. [The] FDA has the authority to tell companies to stop doing it, and that's what they did. The agency should be applauded for its enforcement efforts."
The FDA has authority to take any of several follow-up actions, including levying fines and seizing products. But the agency has acknowledged that the Internet makes it easy for marketers to set up new sites, and difficult for ownership of a given site to be clearly determined.
Writing about the action in his folksy column, Andy's Take, published June 27, Commissioner of Food and Drugs Andrew von Eschenbach wrote, "Your grandparents may tell you stories of a shady salesman who came knocking at their door selling "snake oil" containing a "miracle ingredient" that would cure a family member's malady…. My take on this is that today, instead of knocking at your front door, the quacks and con artists now use the Internet—and so we still need a strong but a modern day FDA to protect you and your family from fraudulent claims and fake 'cures.'"
But others caution that, though the marketing and claims are clearly illegal, the issue of efficacy is not something the FDA's action addressed. "It's not about whether or not [a product] works," McGuffin said. "That's not the issue, and not what the FDA said."
In a related story, Health Canada issued a warning to consumers against several Chinese herbal products found to be contaminated with prescription pharmaceuticals, including an erectile dysfunction drug and a diabetes drug.