FDA Soup: An Assortment of FDA News
The new director of the U.S. Food and Drug Administration’s Center for Tobacco Products is now on the job. It seemed as good a time as any to do a rundown of the various things going on in the world of the FDA that might matter to the electronic cigarette world.
Awareness and The American Cancer Society
The Centers for Disease Control released a study in January finding that awareness and use of electronic cigarettes in U.S. adults continues to climb. From 2010 to 2011, awareness moved from 40.9% to 57.9% and use grew from 3.3% to 6.2%. We’ll have full coverage of the report soon. Many groups and individuals are taking this as a time to call on the FDA for serious investigation into the products. The American Cancer Society’s Cancer Action Network (in short, their advocacy group) was among the most vocal.
A statement from the Action Network’s president Chris Hansen actually seems open to the possibility that electronic cigarettes might be effective cessation devices. From Hansen: “ACS CAN and the American Cancer Society are anti-smoking, not anti-smoker. We’re calling on the FDA to determine if e-cigarettes are safe for use and whether they can help youth and adults avoid actual cigarettes or quit the habit. We also urge the FDA to test these products to determine their potential as cessation aids so consumers have the best information available when deciding how to quit.”
FDA Targets Facebook Likes
Interestingly enough, Facebook likes have become such a serious marketing tool, that the FDA is now focusing some of its efforts on drug companies using them to give a spotlight to unapproved claims. Essentially, but covertly directing social groups to like a post or image or page that suggests some unapproved claim, some companies are circumventing or dodging claims standards. Culprits that could fit this M.O. would be dietary supplement sellers, drug companies, and electronic cigarette vendors.
The FDA has said it would be cracking down on companies that use testimonials to sneak in unsubstantiated claims. Facebook likes can qualify as this sort of subversive marketing.
Pfizer Settling Chantix Lawsuits
Pfizer announced through its annual report that it has settled 80% of the lawsuits associated with its smoking cessation drug Chantix. Chantix was fast-tracked onto the market in 2006 for its higher than average success assisting smokers to quit. By 2008, reports started appearing that the drug had substantial psychological side effects (the worst being suicide and suicidal thoughts). The lawsuits claimed the company knew about the side effects and released the drug into the market without proper warning labels.
The bill so far: $273 million to settle 80% of the suits. It’s unlikely it will end with the remaining 20%. Chantix has been approved in more than 100 countries. It’s been prescribed to 18 million patients worldwide (9 million in the U.S.). This will likely have a detrimental effect ease with which all future cessation products get onto the market. No matter how clean electronic cigarettes prove to be, the FDA can always claim that they don’t yet know enough to allow cessation claims.