FDA/FTC Warning Letter Gives Marketer of Dietary Supplement Touted as Preventing Swine Flu 48 Hours to Take Corrective ActionOctober 16, 2009
By Ricardo Carvajal –
In an unusual step, FDA and FTC have issued a joint warning letter to the internet marketer of a dietary supplement promoted as helpful in preventing swine flu, seasonal flu, and colds. According to the letter, the product “has not been approved, cleared, or otherwise authorized by FDA for use in the diagnosis, mitigation, prevention, treatment, or cure of the H1N1 Flu Virus,” and is both adulterated and misbranded. In addition to threatening seizure and injunction, the letter threatens a referral for criminal prosecution if there is a failure to take corrective action. Following a determination by the Secretary of Health and Human services that swine flu poses a public health emergency that “has the significant potential to affect national security,” FDA provided Emergency Use Authorization for certain unapproved or uncleared swine flu related products – but not for the product at issue.
The letter further states that the FTC Act requires claims that a product prevents H1N1 infection to be supported by “well-controlled human clinical studies,” and prohibits health claims that are not supported by “rigorous scientific evidence.” The letter notes that violations can result in an injunction or Administrative Order that can require restitution for consumers.
The 48-hour time frame afforded for a response to a joint agency action is a standard part of recent warning letters to companies selling illegal products for prevention of swine flu, and shows that there is a high level of concern surrounding the marketing of these products at both FDA and FTC (also see FDA's recent press release regarding illegal H1N1 drugs marketed on the internet here). Marketers of products high on the agencies’ priority lists had better take note.