Friday, January 13, 2012

FDA Sends Warning Letter to Website to Cease & Desist: It Doesn't

@skypen posted this tweet recently: "Interesting warning letter for flu med for false claims via web, twitter & facebook," which I found in the ePharma Pioneer Club Forum.

What I found interesting about this letter is that it addressed an issue more serious than the typical "false claims" letter that Rx pharma companies sometimes receive. This letter pointed out that a product ("Triple Flu Defense") was being "promoted for conditions that cause the product to be a drug" subject to FDA regulation. "Triple Flu Defense," however, never submitted a new drug application to the FDA for marketing approval. Hence the letter.

FDA pointed out that several unsubstantiated efficacy claims were made, such as:
  • “Relieves Flu Symptoms” 
  • “Eases Flu Vaccine Side Effects” 
  • “…[T]his product is of inestimable value in the prevention and mitigation of influenza.” “Triple Flu Defense can also be used to alleviate side effects from the flu vaccine.”
In addition, said FDA, the website "includes claims in the form of testimonials that establish the intended use of your product as a drug. Examples of these testimonials include the following:
  • “It really works. My husband didn’t take the formula and got sick and I didn’t. It has no side effects.” 
  • “I have been around people with the flu and haven’t gotten sick since taking Triple Flu Defense.” 
  • “I had been sick for a week with the flu and thought I was never going to feel better. I took two doses of Triple Flu Defense and felt a lot better. It works great.” 
  • “I'm one of the few people I know who didn't get the flu this past year because of Triple Flu Defense!”  
  • “I took Triple Flu Defense during the season. I didn’t get sick all winter.”
Pretty amazing claims!

When I accessed the Triple Flu Defense Web site (here), I expected to see that it had been taken down in response to the FDA's waring. After all, the FDA sent the letter via UPS overnight on December 14, 2011 and demanded action within 15 days. But it's almost a month later and all the claims are still there (see screen shot; click to enlarge and read the claims).

In contrast, when Rx Web sites are cited for violations by the FDA, the offending pages are gone by the time you learn about the letter!

1 comment:

  1. Good post, interesting subject.

    I blogged about the recent FDA warning about how the 'flu jab is best adminstered, which might be of interest:


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