It’s Official; The FDA Wants to Treat E Cigs Like Analogs

The ping pong sensationalist argument over e-cigarettes has reached its first landmark: the Food and Drug Administration recently released its regulatory proposal governing e-cigarettes as smokeless tobacco products. In a press release dated April 24, 2014, the FDA included e-cigarettes among other tobacco-related products that it wants authority over in implementing the 2009 Family Smoking Prevention and Tobacco Control Act.

Food and Drug Administration LogoThe actual rule reads as follows:

… makers of newly deemed tobacco products would, among other requirements:

  • *Register with the FDA and report product and ingredient listings;
  • *Only market new tobacco products after FDA review;
  • *Only make direct and implied claims of reduced risk if the FDA confirms that scientific evidence supports the claim and that marketing the product will benefit   public health as a whole
  • *Not distribute free samples.

In addition, under the proposed rule, the following provisions would apply to newly “deemed” tobacco products:

  • *Minimum age and identification restrictions to prevent sales to underage youth;
  • *Requirements to include health warnings; and
  • *Prohibition of vending machine sales, unless in a facility that never admits youth.

The FDA proposes different compliance dates for various provisions so that all regulated entities, including small businesses, will have adequate time to comply with the requirements of the proposed rule.

The current proposal is open to public comment for 75 days, i.e., until July 9. To submit comments electronically, head to the proposed rule’s regulation.gov page.

Notably, the FDA is looking for public input about how products like e-cigarettes should be fully regulated under the agency’s oversight. It cites “many public health questions” and the absence of tobacco combustion as the cause for the mostly vague designation of e-cigarettes.

The rule has no affect on marketing or accessories of a deemed tobacco product. That means that, for now at least, the FDA would be regulating e-liquids with nicotine and flavorings, as well as the cig-a-like units sold side-by-side with cigarettes. Keep in ind that marketing will ultimately be regulated, potentially taking away: online sales, television commercials, sports sponsorships and more.

Interestingly, despite the heavy attention e-cigarettes have been receiving in relation to the new regulations, it’s just one of a handful of other tobacco-based products that aren’t yet under FDA authority, such as cigars. The proposed products that are to become “subject to FDA regulation are those that meet the statutory definition of a tobacco product, including currently unregulated marketed products.”

Most of the products on the list make sense since they involve actual tobacco combustion. However, two are notably different, and both are smoking-cessation products – e-cigarettes and nicotine gel.

Smoking-cessation aids are specifically regulated as medical products by the FDA’s Center for Drug Evaluation and Research. The listing for smoking-cessation aids does not discuss those aids – even the ones containing nicotine and other traces of tobacco byproducts – as tobacco-based products. The FDA does provide a specific list named Recognize Tobacco in its Many Forms, which includes e-cigarettes but does not include nicotine gel or other smoking-cessation aids.

It’s hard to say whether that indicates that the FDA intends to move forward with regulating e-cigs the same way it regulates tobacco-burning products, or if the listing is due only to the fact that it describes e-cigarettes as the cig-a-like units containing “tobacco flavorings.” FDA regulation of designated therapeutic aids would not change with the new rule. The rule also would not affect the three five-year studies the FDA contracted last fall.

As of the date this article was written, only 85 comments have been received.

One Comment

  1. Zella

    As an alternative to stopping smoking, tobacco
    users can switch to powered cigarettes. All the contents of these e-cigs are approved by doctors to be okay for consumption. The new e-cigs however
    offer a clean smoking experience with no cigarette smell
    or stained teeth at the end of it.

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