Friday, December 02, 2011

The writing was on the wall...

Back in 2009 a large rift split the community. The topic of such controversy was whether or not to classify the electronic cigarettes as a tobacco product vice a drug (as seen by the health agencies), or to relabel it to an alternate form, such as: enjoying as stimulant (nicotine) not unlike enjoying a fine cup of Joe (caffeine) .
The rift caused some irreparable damage in the community amongst the principal parties, albeit both sides have achieved a certain amount of success. Neither party formulated the right approach into the classification of electronic cigarettes. On the other hand with the relatively new industry, both parties were merely pioneers with regard to the subject and debate at hand.

The reckless move in my opinion as shared by others to classify the industry with tobacco was a step backwards. Although at the time it seemed the lesser of two evils, that vaping should be seen as the use of a relatively harmless tobacco product (reduced harm product), considering the FDA had jurisdiction over the tobacco industry - a step in the wrong direction.

By doing so, and considering the case of Sotera vs FDA the unprecedented ruling of Judge Leon stated in part that the FDA had no jurisdiction to regulate over e cigarettes as they were clearly not drug delivery devices and could only regulate them if at all was as, a tobacco product. This ruling was  considered a large victory for all and the community rejoiced. Not so.

Although Judge Leon's ruling seemed favourable to the average individual, it was nothing more than a trojan horse in my opinion. It did however release Sotera's shipments held captive by the FDA (being held as drug devices), but also ensured the FDA would have freedom to legislate and regulate at will - providing the industry was regulated as a tobacco product and not a drug delivery device. Some folks say tomato other tomahto, at the end of the day it is the same fruit.

Whilst the ruling seemed favourable, it also crippled the industry by now placing the entire industry under the ruling thumb of the FDA - folks rejoiced prematurely with the ruling not totally realizing the deeper consequences of said ruling. The ruling provided but a small burst of fresh air, it was merely a stay of execution, a retreat to regroup - where once again we fall under the clutches of BT and BP manifested once again through the governing body, the FDA.

I mentioned after the ruling that such rejoice was premature. I was ridiculed for my comment. Yet here we are today with (excerpt from Bill Godshall):

<<FDA regulation to apply Chapter IX of the FSPTCA to e-cigarettes could ban many/most e-cigarette products (that contain nicotine) is because Section 910 of the FSPTCA could allow the FDA to ban some/many/most/all e-cigarette products that were not available in the US market before February 15, 2007.

Under the provisions of Section 910, manufacturers/importers (of all tobacco products that weren't on the market prior to February 15, 2007) would need to submit an application to the FDA claiming that the product is "substantially equivalent" to another product that was already on the market prior to 2/15/2007, and the FDA would have sole discretion of determining whether the product is or isn't substantially equivalent to the other e-cigarette product.

Also, Section 911 would prohibit all e-cigarette manufacturers and importers from truthfully claiming that e-cigarettes are less hazardous than cigarettes, as such a claim would render the product as a "modified risk tobacco product". Section 911 requires any company desiring to make a MRTP claim to apply to the FDA to do so, and the FDA must approve the application.

Many other provisions in Chapter IX would basically require every e-cigarette manufacturer and importer to hire a team of lawyers just to comply with the currently pending provisions (as well as comply with regulations approved in the future).>> 

Although William is no lawyer this explanation translated from the legalese surrounding this case, brakes down the case and subsequent ruling into layman's terms.

Subsequently the FDA loss their appeal on the injunction and loss the main case as well. They had the right and indicated they would appeal Judge Leon's ruling, however informed the courts days before their time limit was reached they would not be filing an appeal. Therefore, Judge Leon's ruling stands and the FDA is regulating e cigarettes as a tobacco product.

Provisions of the act (FSPTCA)
  • Creates a tobacco control center within the FDA and gives the FDA authority to regulate the content, marketing and sale of tobacco products.
  • Requires tobacco companies and importers to reveal all product ingredients and seek FDA approval for any new tobacco products. (e cigs are a "new tobacco" product)
  • Allows the FDA to change tobacco product content.
    • The ban on flavoring applies to any product meeting the definition of a "cigarette" according to section 3(1) of the Federal Cigarette Labeling and Advertising Act. This includes any tobacco that comes rolled such as cigarettes and cigars, and added to this definition in the Family Smoking Prevention and Tobacco Control Act is any tobacco with the purpose to be rolled such as rolling tobacco.
  • Calls for new rules to prevent sales except through direct, face-to-face exchanges between a retailer and a consumer. (Internet sales)
  • Limits advertising that could attract young smokers.
  • Requires cigarette warning labels to cover 50 percent of the front and rear of each pack, with the word warning in capital letters.
  • Requires FDA approval for the use of expressions such as "light, "mild" or "low" that give the impression that a particular tobacco product poses less of a health risk.
FDA achievements on FSPTCA
  • Established the Center for Tobacco Products;
  • Established the tobacco user fee program, which provides funding for FDA tobacco regulation support activities;
  • Begun to enforce the Act’s prohibition on manufacturing, distributing or selling certain flavored cigarettes, such as spice-, fruit-, and candy-flavored cigarettes;
  • Implemented new statutory authorities, under which tobacco product manufactures have registered their establishments and listed their products with the FDA, provided detailed information about product ingredients and their own research into the health effects of their products;
  • Convened a Tobacco Products Scientific Advisory Committee, which began to study the impact of the use of menthol in cigarettes on the public health;
  • Established FDA rules that limit the sale, distribution, and marketing of cigarettes and smokeless tobacco to protect the health of children and adolescents become legally enforceable139;
  • Issued provisions that prohibit the advertising or labeling of tobacco productswith the descriptors “light,” “mild,” or “low” or similar descriptors without an FDA order; and
  • Required that new, larger health warning labels for smokeless tobacco products.[
The bold text was my interpretation of the act (FSPTCA) as signed. Did we rejoice prematurely? You bet! It will be interesting to see what will develop in the months to come. Although hind sight is 20/20, we provided the FDA with the means to build our own gallows for our hanging.

    No comments:

    Post a Comment