FDA Warns 5 Ecig makers for violations of FDCA

Friday the FDA sent warning letters to five electronic cigarette makers citing various violations of the Federal Food, Drug, and Cosmetic Act (FDCA). These violations stem from unsubstantiated health claims made by these companies in their marketing and poor manufacturing practices.

Let me say first however, none of the brands featured on this site were among them and only one of them, Gamucci, has ever been listed in our brand index.

None of this is really that big of a surprise. The FDA has been saying all along they will go after ecig makers who make health claims or claim the Ecig is a great way to stop smoking before they receive FDA approval as a smoking cessation product. While many ecig users, aka Vapers, are very steadfast in their assertions that electronic cigarettes are the greatest way to stop using tobacco ever invented, some manufacturers and distributors don't grasp that legally they just can't say that in their marketing without formal studies and scientific proof. 

The medical community has decided that nicotine is a pharmacological agent, addiction to nicotine is a disease and that withdrawal from nicotine is a medical condition. Therefore anything that claims to treat, mitigate or in any way affect ones smoking habits or addiction to nicotine must fall under their rules for marketing and have clear clinical proof to back up any of those claims. If you sold suckers or toothpicks and said "helps you quit smoking", you would also fall under these rules and run the risk of your suckers and toothpicks being classified as drugs by the FDA. Silly? Perhaps. But that's the way it is, and it could be argued, with good reason.

Sadly, ecig marketers and makers have been increasingly claiming that ecigs are "healthier", "safe", "will help you quit smoking". Over the past year dozens of ecig companies and hundreds of marketers have popped up on everything from email and search results to television and radio commercials claiming all sorts of things in direct violation of the FDCA. The FDA had to do something, that is, after all, their job.

One company, E-cig Technology went so far as to include vitamins in their ejuice, a move that has recently gotten companies like Coca Cola and other soft drink makers in hot water with the FDA. But E-cig Technology didn't stop there, they also included other drugs like the unapproved E-Rimonabant to "to help users lose weight and combat their smoking addiction" and even E-Cialis (tadalafil) to "improve sexual capacity for men who suffer with ED". So what did they expect the FDA to do? See the FDA's letter to E-cig Technology

When you claim ecigs are a smoking cessation product or even go so far as to include actual drugs, one of which is not even approved for use in the US (Rimonabant) while the other the FDA even claims is actually amino-tadalafil, not tadalafil, in your ecigs, of course the FDA is going to slap you down. And rightly so.

Companies like this are literally ruining the industry. I'm such a believer in ecigs that it actually angers me to see all these ads claiming "Safe, Healthy, quit smoking, No Carcinogens" and I won't even touch on my feelings of companies who put actual weight loss or ED drugs in their products. But each time I've tried to out some of these companies here on this blog I've been threatened with lawsuits I just can't afford to fight. So, I'm actually glad to see the FDA nailing some of them, particularly E-Cig Technology.

I will stop here though and take exception to the fact that in most of these letters the FDA has chosen to quote comments left by customers as proof that the products are marketed as a smoking cessation product. Using this mindset, if users of canned peaches wrote on the peach canners site that they "had not picked up a cigarette since I began eating peaches" that might qualify the peaches as a drug or drug device intended to help someone quit smoking.

Ecigs are marketed as a smoking alternative, so of course if people switch they have quit using tobacco, but by the FDA and other non smoking groups own admission, these people are still addicted to nicotine and therefore are still technically smokers suffering from the same disease. There is no smoking cessation by saying "I quit using tobacco" if the disease is addiction to nicotine. You can't have it both ways FDA. Is smoking tobacco the disease or the use of nicotine?

I understand that from the FDA's point of view any claims are fair game and I do agree that even those manufacturers who are very careful not to make any claims will allow comments by customers expressing their success at quitting tobacco use with their ecigs to allude to their effectiveness, but again, they never technically quit smoking and customer comments are not claims by the manufacturers. Neither is the reporting of medical studies or news reports in support of ecigs.

In the case of Johnson Creek the FDA includes a quote from their news section regarding a study done by the University of Auckland called "Effect of an E-Cigarette on Cravings and Withdrawal, Acceptability and Nicotine Delivery: Randomised Cross-Over Trial" as proof that Johnson Creek ejuice is a drug. Basically they are saying any of us that point to any study that the FDA claims they are "unaware of" is a health claim in violation of the FDCA and any time a customer says "I quit using tobacco the day I bought your product" then ecigs instantly become a drug that cured their disease. If nicotine addiction is the disease smoking cessation drugs are supposed to cure, then ecigs clearly are not meant to treat the disease.

In the end, it's all going to boil down to Nicotine. The FDA says nicotine is a drug as long as it's not derived from burning tobacco of course, in which case it would not actually be a drug but rather a tobacco product, one they know kills but are unable to ban or significantly regulate.

Now, what does all this mean for the industry and the other makers? Well, that has yet to be seen. Michael Levy of the FDA's Center for Drug Evaluation and Research told a news briefing "We have not made a decision to remove all e-cigarettes from the market," and further went on to say ""We are interested in finding out whether e-cigarettes can be proven safe and effective. That is why we sent out the letter to the Electronic Cigarette Association."

The letter to the Electronic Cigarette Association again asserts their intention to regulate ecigs as a drug and a drug device under the FDCA and invited ecig makers to "work in cooperation with the agency toward the goal of assuring that electronic cigarettes sold in the United States are lawfully marketed." This letter also outlined the steps that must be taken to start the New Drug Application Process, what types of information and studies would need to be conducted and outlined some of the manufacturing standards the FDA expects for drug manufacturing.

Now, a federal judge already ruled last February that ecigs are not a drug device and interestingly enough the FDA's appeal to that decision is scheduled to be heard by the federal court of appeals in about two weeks leading many in the industry to wonder if this is a last ditch effort by the FDA to entice some maker to file an NDA giving them something to show the court that says "see, they admit they are a drug" or is the FDA so confident of victory that they decided to jump the gun and start classifying ecigs as drugs now? We shall see.

Many E-cigarette makers and vapers in general argue that if ecigs are a drug, then cigarettes are also a drug and should be held to the same standards. As the FDA mentions in these letters "nicotine withdrawal is a medical condition" and "smoking is a disease" so then why are cigarettes not classified as a drug device too since the reason people smoke is to use nicotine or avoid withdrawal? Well, that is a great argument and I look forward to what the courts have to say on that. Right now though, cigarettes are protected by law to not be classified as a drug delivery device. Right or wrong, that's just how it is.

But whether ecigs are ultimately found to be tobacco products or drug devices it seems these five companies were indeed in violation of the FDCA either way because of their marketing claims, manufacturing standards and, of course, the addition of actual drugs and vitamins into their products.

Each company has 15 days to respond to the FDA and I'll pass on more information as it becomes available.

See FDA Press Release on Citation of 5 Ecig companies in violation of the FDCA › to read the letters for yourself.