On September 9th, 2010, the FDA issued letters to 5 electronic cigarette companies. They also sent a letter to the Electronic Cigarette Association. There has been a lot of confusion among vapers and e-cigarette suppliers about what the letters mean. So we decided to write a blog post looking at each letter and what the FDA is saying.
In the letter the FDA once again re-stated it’s position that:
FDA has determined that the electronic cigarette products addressed in the warning letters described above, and similar products, meet the definitions of both a drug and device under the Act and the definition of a combination product in 21 C.F.R. Part 3, with a drug primary mode of action.
This is the position that the FDA has taken as soon as they had a position. They go on to ask that the industry work with them to make the e-cigarette a new drug and drug delivery device. It’s nice of them to ask, but as a pharmaceutical product, 99% of the small American businesses who sell electronic cigarettes would be out of business as they could not possibly afford the new drug application fees. This would also mean that e-cigarettes could only be sold in pharmacies which would not allow the product to fairly compete against tobacco cigarettes and other tobacco products. And lastly, the FDA is currently in a Federal lawsuit the specifically deals with the classification of the electronic cigarette.
The FDA lists what they consider to be health claims, including claims that electronic cigarettes can help users quit smoking, made by this company. The FDA states:
As presently labeled and promoted, these electronic cigarette and cigar products, and their components marketed by your firm violate provisions of the Federal Food, Drug, and Cosmetic Act (the Act).
Although the FDA used some customer testimonials as proof (which a Judge has already said is not permissible as evidence of intended use), they do have a leg to stand on as this company has an electronic cigarette kit named “Nicotine Withdrawal Program” and states “Our new program is designed to naturally and slowly wean your body off of the nicotine cravings by slowly decreasing them.” This is obviously a claim that e-cigs can help the user quit smoking and the FDA is right, in this case.
In this case, the FDA notes that the company in question is putting lobelia, a herbal remedy/dietary supplement into e-cigarette liquid. They note that the company is making numerous claims that their products can help users quit smoking, such as “The product provides smokers quick and effective relief for a number of conditions commonly attributed to tobacco use.” In this case, we again agree that the FDA is in the right.
This one seems less clear as the website the FDA cited is no longer live. What we don’t agree with is the FDA attempting to use links as proof of health claims. I can’t believe any judge would accept resource or news links as a health claim. It brings up the question, if I link to a news story, then the page I linked to changes, am I responsible for the new content on that page? Giving users links to learn more about a topic is not marketing material, in my opinion.
This is an easy one. The FDA is right. This company is making numerous health claims about quitting smoking and they are putting other things such as Cialis and vitamins into the e-liquid. It is companies like this that gives the electronic cigarette industry a bad name.
In this case, the FDA mostly cites customer testimonials and linked news articles for evidence of health claims. The actual promotional material from the company that the FDA cites is ambiguous. It is unclear whether the statements could actually be considered health claims. For instance, the FDA cites this statement: “Most people who smoke, do so because they enjoy the tactile, emotional and physical sensations. E-smoking provides pleasures similar to those commonly associated with traditional smoking” To me, this is not a claim about quitting smoking, but rather about how much e-smoking is like actual smoking.
The FDA goes on the cite manufacturer standards not being met. However the standards they cite are based on a new drug. And without health or smoking cessation claims, the electronic cigarette is not a new drug, and therefore the manufacturing standards cited are not relevant.
Aren’t Standards and Regulations Good?
Yes, proper regulation is good. This isn’t about no regulation, it’s about reasonable regulation. Regulations that eliminates the current market and hands the industry over to large pharmaceutical companies is unacceptable. Regulation that keeps the electronic cigarette from fairly competing with tobacco cigarettes is unacceptable. Regulations that establish safe manufacturing processes, allows small American businesses to continue operating, allows the electronic cigarette to compete fairly with tobacco cigarettes, and allows for product innovation are exactly what we want. All of this is possible, including some sort of taxation, provided the FDA is willing to work with the current industry and abandon it’s notion that they can unilaterally categorize a product based on a few supplier claims.