We're Officially a Tobacco Product!

I was tossing around ideas for two very different posts, but yesterday something really big happened, so those ideas will have to wait.

Yesterday, April 25, 2011, the FDA announced that it would not appeal the Supreme Court’s decision that electronic cigarettes should not be classified as a combination drug/drug delivery device. Instead, they issued this letter, http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm252360.htm , stating that they would pursue regulations for electronic cigarettes as a tobacco product.

Now this is both a win for electronic cigarettes and a complete game changer. I spent a good portion of yesterday evening researching FDA procedure and watching the message boards for reactions from eCig users. Many people are really scared of what this means. Personally, I’m shifting between optimism and fear. There are a lot of unknowns out there, but I keep reminding myself how pessimistic users must have been in 2009 when the FDA started seizing shipments.

The first thing I gravitated to was the FDA link for “Overview of the Family Smoking Prevention and Tobacco Control Act.” This act went into effect on June 22, 2009, giving the FDA the ability to regulate tobacco products. Here is a link for the timeline of what has happened and will happen because of this act: http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm237052.htm. For those who don’t want to point and click, here are some basic bullet points:

        - 6/09: Obama signed the Act

        - 9/09: Banned flavored cigarettes other than menthol

        - 6/10: Banned misleading words like “light” and “mild” on tobacco products

        - 10/10: Published a proposal to restrict non-face-to-face sales, such as the internet

---------- Still to come… ---------------------

-            - 6/11: Require tobacco products to use color graphics depicting negative health consequences of use.

-             - 10/11: Publish determination for restrictions on internet and other non-face-to-face sales

-             -   4/12: Publish regulations for advertising for internet and other non-face-to-face sales (note that the last point won’t eliminate all internet sales and will give a minimum of 4 years to internet companies to change their sales practices)

-            - 4/12: Establish a list of harmful ingredients by brand and sub-brand

-            - 4/13: Publish the above list in common words to be understood by the public

-            - 4/15: Submit a report to congress asking that the minimum age to purchase be raised

Many people didn’t make it through the legalese (I barely could) to find things like the minimum 4 years before internet companies must shut down their non-face-to-face sales, as well as an extensive appeals process in which they can prove that they have put up safe guards against selling to minors and therefore should be exempt from the regulation.

Another big fear is that this will eliminate all vapor flavors other than tobacco and menthol. However, the ban on flavors applies only to cigarettes, not to pipe tobacco, cigars, smokeless tobacco, or other tobacco products. Right now it appears that eCigs will go into the smokeless tobacco category, which has much lower restrictions. The higher restriction category that cigarettes fall into was required to list specific tobacco products and give a way to amend the list through a process. Although eCigs use cigarette in the name, it is not on the list and therefore is not currently in the highly restricted category.

Next, people fear that the nicotine content will be restricted to the point of elimination. But that cannot happen now that eCigs have been declared a tobacco product. Although the FDA has the right to limit the amount of nicotine, it must be done across all tobacco products, not just one category. They are not allowed to eliminate nicotine from any product. Therefore we may find that the specialty e-liquids that contain three- or four-times the nicotine of regular cigarettes could be banned, but your average pre-filled cartridge or e-liquid contains no more than 18mg or 24mg, which is still within the range of some full-flavor cigarettes.

Finally, everyone fears that absurd taxes will be placed on the cartridges and e-liquid, making it too expensive to be a viable alternative. However, until eCigs are put into the same restrictive category as cigarettes, the taxes won’t be nearly what smokers are used to paying. Current federal tax on a pack of cigarettes is $1.01. Tax on a package of pipe tobacco is just under 18 cents. Chewing tobacco is just over 3 cents. And snuff is just over 9 cents. Many states currently do not tax non-cigarette tobacco products.

Don't mistake me as being overly optimistic. There are still some issues that could cause trouble. There is a clause that the FDA referenced in their letter stating that any product marketed before February 15, 2007 and not modified since that date will be grandfathered into this act. Any product that is not grandfathered is considered a "new" tobacco product and may be required to submit for premarket authorization. Since eCigs are such a new concept, they have been modified several times since that date. It will likely come down to another court battle to establish whether those modifications eliminated their right to be grandfathered. The letter also mentioned that tobacco products cannot be marketed in conjunction with any other FDA-regulated products, including food, drugs, cosmetics, etc. That could mean that even if flavored vapors are not eliminated, they could be put under such heavy restrictions on advertising and marketing that no one would know that a flavor is supposed to be strawberry since they can’t advertise it as such. Finally, there is a clause that prevents a claim of “reduced harm” except with a marketing order from the FDA. In that case, how do you explain what eCigs are without stating the simple fact that they eliminate most of the harm caused by combustible cigarettes?

No matter what, the FDA must now wade through its own red tape to do anything. Unless something unexpected happens, we won’t see any restrictions for at least a year, probably closer to two. During that time, this ruling will allow sales of electronic cigarettes in any establishment that already sells tobacco products, including gas stations, grocery stores, and specialty stores. This will open up opportunities for American factories, giving a quality option better than China. Since the FDA is no longer stating that eCigs are a dangerous drug/drug delivery device, you’re likely to begin seeing reports on the news, talk shows, and radio. Word will spread quicker than ever. And the more word gets out, the more support it will have and the less likely the FDA can do something ridiculous to prevent it.

So the bottom line is that the fight isn’t over, but we’re at least now in a real fight instead of battling unsubstantiated and ridiculous claims. The best way for you to help is to keep the word spreading to smokers far and wide. The more vapers we have, the more likely that bully FDA will just give up and find something else to pick on.