Click to Enlarge

The FDA held another media briefing on electronic cigarettes yesterday to inform the world that it sent letters to 5 electronic cigarette vendors warning them that they are in violation of the U.S. Federal Food, Drug and Cosmetic Act (FDCA).

This is a bold move by the agency considering that Smoking Everywhere has already sued the FDA with some success for trying to detain their electronic cigarette imports based on accusation of FDCA violations.

Also, I find the FDA’s decision to target only 5 companies unfair.  There are several other large e-cig distributors out there I can think of that could be accused of the same violations outlined in the warning letters the FDA sent, but I will not out them here.  Why did the FDA only send letters to these 5 companies though?

During the briefing held yesterday an FDA representative also announced that it sent a letter to the Electronic Cigarette Association (ECA). In this letter Janet Woodcock, M.D. advised former congressman and ECA President, Matt Salmon, that “[The] FDA intends to regulate electronic cigarettes and related products in a manner consistent with its mission of protecting the public health.”

I guess they intend to protect us only 5 companies at a time?   Or, are they testing the waters first before they scale up operations to contact e cig companies in larger groups?

I have listened to the media briefing, read ALL of the letters the FDA sent out yesterday and have been following the FDA’s actions including pending litigation and studying the applicable laws on this story for over a year now.

But, before I really go into the analysis I want to emphasize this point:

This news is NOT ALL BAD!

Sure it could have been better, but there are some good things to be gleaned from the FDA’s actions AND statements made during yesterday’s briefing by Michael Levy who works for the FDA’s Center for Drug Evaluation and Research (CDER).

So, follow me here.. I will cover the good stuff first.

Electronic Cigarettes are NOT Being Banned or Taken Off the Market

First, these 5 warning letters do NOT indicate a pending ban on ALL electronic cigarettes.  In fact, Levy said:

This action only concerns the 5 companies that got warning letters …

He also said in the briefing that the FDA will continue to evaluate the marketers of e-cigarettes on a case by case basis further adding:

We have not made a decision to remove all e-cigarettes from the market.

This is yet another bold statement since the case of Smoking Everywhere v. FDA is beginning to establish at least some legal precedence that the FDA doesn’t have the authority to make such a sweeping decision.

But, do these statements suggest that the FDA could be warming up to electronic cigarettes as long as they don’t make unsubstantiated claims?

Warning Letters: Smoking Cessation Claims Subject E Cig Product to FDCA Compliance

The FDA sent the warning letters to the following 5 companies:

• Gamucci America (Smokey Bayou, Inc.)
• E-Cig Technology, Inc.
• E-CigaretteDirect, LLC
• Johnson Creek Enterprises, LLC
• Ruyan America, Inc.

The letters the FDA sent were all very similar in nature with the FDA citing claims that, “As presently labeled and promoted” all 5 company’s products are drugs in violation FDCA because they have not been approved by the New Drug Application (NDA) process required by the FDCA.

A few of the companies were also warned for additional reasons including , “violations of good manufacturing practices,” and, “using the devices as delivery mechanisms for active pharmaceutical ingredients like rimonabant and tadalafil” the FDA said in its letter to the Electronic Cigarette Association.

More specifically Johnson Creek Enterprises LLC was singled out for violations of “good manufacturing practices” the FDA discovered while touring their facility in Wisconsin.

Also, E-Cig Technology Inc. is the company singled out for marketing products containing rimonabant and tadalafil (Cialis) which are drugs used for weight loss and erectile dysfunction. Rimonabant is not currently approved for use in the U.S.

And finally, Ruyan American was singled out for marketing products containing lobelia, an herbal remedy that is rumored to reduce nicotine craving.

FDA Electronic Cigarette Media Brief Q&A

I was impressed by the tenacity of the journalists asking questions at the media brief. There were a couple of questions that got asked more than once in slightly different ways for clarification because Levy’s answers were a bit vague.

Questions from Michael Felderbaum (Associated Press), Daniel J. DeNoon (Web MD), Jennifer Corbett (Dow Jones), and Emily Walker (MedPage Today) shared the same theme. They all wanted to know:

Will other e cigarette products stay on the market or get similar warnings? Will electronic cigarette companies not making smoking cessation claims be warned or allowed to conduct business as usual?

Levy stated that the FDA has not decided to remove all e cigarettes from the market and also repeated twice that smoking cessation claims were considered evidence that the intended use of the e-cig products in question were as a drug, but that it was not the only evidence considered.

In a follow up question Malcolm Spicer (Elsevier Business Intelligence) asked what other evidence was used in determining that that the products were drugs subject to FDCA compliance.

Levy deferred to the warning letters stating that they contain specific examples of evidence used in their decision to warn each company.

Good News or Bad News?

My analysis? Well, I may be optimistic, but to me this sounds like good news! Other electronic cigarette companies should be able to at least look at these 5 warnings as an example of what NOT to do and maybe even as a gold standard later down the road if these companies are able to appease the FDA “drug lords.”

Except..

If you examine the warning letters closely you notice the FDA quotes news, media, and testimonials in the body of the warning letters in order to establish “intended use.” E cigarette companies have no control over what these third parties are claiming in most cases.

I find this outrageous that the FDA could expect electronic cigarette distributors to totally control how other un-affiliated parties reference their products.

Not only that, but the FDA has been repeating that electronic cigarettes are not proven “safe and effective for their intended use,” or we need evidence that these devices are “safe and effective for their intended use,” over and over like a broken record. Why? The wording is actually legalese that is written into the FDCA and is actually supposed to mean something.

Safe, Effective and Intended Use According to the FDA

“Proven safe and effective for its intended use.” Sounds like a good idea right? Not if you look at the FDA’s idea of safe and effective. If you really want to know what the FDA considers safe and effective you can look at their track record over the years.

This involves me taking the gloves off for a second here.

First, effective is just better than placebo after subtracting the margin of error in clinical trials. There are a lot of products out there just barely better than sugar pill placebos, but cause serious side effects. Big pharma makes billions from these marginally effective drugs. This is probably one reason why currently FDA approved nicotine gum, lozenges and patches are notoriously un-successful, yet the FDA calls this effective.

One example of the FDA’s idea of “safe” is a previously FDA approved drug like Viox. Viox was recalled after causing over 20,000 fatal heart attacks according to the FDA’s own analysts. Also considered safe by the FDA is a smoking cessation drug called Chantix which was found to cause suicidal thoughts or actions AFTER it was approved by the FDA. It’s OK though because the FDA updated the label for the drug and that makes is safe right?

The FDA’s idea of safe should come as no surprise to anyone when you think about it. Commercials for FDA approved pharmaceuticals always include a requisite list of side effects that make the treatment seem worse than the disease itself.

Historically, “intended use” is established by the manufacturer and / or distributor of the product by how the product is labeled and promoted and NOT by un-affiliated third parties. I say historically because there are legal precedents for how “intended use” is to be established for purposes of the FDCA. I have no problem with this except that the FDA seems to be changing the rules a bit for e cigarette products and distributors.

Can Electronic Cigarette Companies Choose Their Rules?

The FDA suggests in all the letters sent that these companies comply with the FDCA by submitting the new drug application (NDA) and going through the FDA’s process for new drugs. Any company doing this will likely need to take their product off the market for a number of years until clinical trials can be completed.

Is this only if they want to continue to make smoking cessation claims and have their product classified as a drug or device? Or, can the e cigarette companies simply change the way their labeling and marketing efforts so that their products can be classified as tobacco products subject to the same rules and regulations of cigarettes?

There are only subtle hints in the letters if any as to any course of action other than the new drug application route proposed by the FDA. Ironically I believe that none of the companies warned will take this route opting to instead change their labeling and marketing to be consistent with a tobacco product.

Hopefully the FDA will be OK e cigarette companies simply changing their labels and marketing, but I have my doubts, because if they allow e-cigarettes to be classified as tobacco products then it is conceivable that nicotine gum, candy (eh hem.. lozenges), patches etc could be relabeled and marketed as recreational tobacco products.  Which would mean that gum and candy that literally has nicotine in it will surely be targeting children and, and….  Oh no!  Whole house of cards falling..  Blanket / default “protect the children!” argument supposed to apply..

Final Thoughts

I think the FDA is engaging in some political “posturing” somewhat here because this month’s oral statements are scheduled to be made this month in front of a court of appeals in regards to the Smoking Everywhere v. FDA case.

Back in January of 2010, a federal judge granted e cig suppliers Smoking Everywhere and NJOY a preliminary injunction stating that the FDA had no jurisdiction over electronic cigarettes and could not detain electronic cigarette imports. In March of 2010 a higher court granted the FDA’s request for a stay on that preliminary injunction pending the court hearing.

Parties on both sides of the arguments have since been preparing “briefs” to submit by the court’s deadlines. Oral statements on those briefs are scheduled to be heard this month September 2010.

The stay on the preliminary injunction was granted in March of 2010. Why didn’t the FDA send the warning letters back then? Were they too busy creating their court briefs? I don’t think so because those were submitted in May and July of 2010. So, I don’t think the timing of these warning letters sent out yesterday is a coincidence.

In my opinion I believe the FDA is attempting to demonstrate to the court, in a timely fashion, how it will regulate electronic cigarette companies by making an example out of 5 different companies that each violate the FDCA in various ways. This way the FDA has some concrete examples that may not even be submitted as evidence to the case, but will be hard to ignore.

This effort may backfire severely and the FDA may even appear grossly incompetent (should be getting used to it by now) because they sent a warning letter to Ruyan America when Ruyan America reportedly hasn’t sold any e smokes containing nicotine in the U.S. in over a year contrary to what the FDA warning letter says.

I remain optimistic about the whole thing because of remarks made in the letter to the Electronic Cigarette Association where Janett Woodcock said, ”FDA invites electronic cigarette firms to work in cooperation with the agency toward the goal of assuring that electronic cigarettes sold in the United States are lawfully marketed.”

I do believe that as long as these e cigarette companies don’t make unsubstantiated claims or assert intentions to diagnose, cure, or mitigate disease such as nicotine addiction etc. etc. the FDA will see this as “lawfully marketed” and back off.

Ultimately though, I listen to what people (and government agencies) do, not what they say. One thing is clear; we will know a lot more about the FDA’s new position in about 15 days.

You can listen to the audio of the FDA media brief by clicking here.

I will transcribe it myself if the FDA doesn’t post theirs soon.