Wednesday, September 10, 2014

Everyone Agrees: FDA Should Eliminate Pre-Market Review for Electronic Cigarettes, At Least Until Effective Date of Regulations

In three separate sets of comments submitted to the FDA regarding the proposed deeming regulations, three major players in the e-cigarette space have offered the identical piece of advice for the agency:

Do not apply pre-market review requirements for electronic cigarettes, at least until the effective date of the final regulations.

Here is what each of the three companies/associations had to say regarding this issue in their submitted comments:

1. Altria Client Services (on behalf of Nu Mark): "Nothing in the FSPTCA [Family Smoking Prevention and Tobacco Control Act] requires FDA to engage in all-or-nothing deeming for all purposes. Rather than deem an entire class of tobacco products categorically subject to the FSPTCA for all purposes, FDA has multiple options for proceeding in a reasoned, scientifically sound, and incremental manner. For example, FDA should exercise its statutory authority to deem e-vapor products commercially marketed before the Final Rule for certain purposes under the FSPTCA. Such products would be subject to age restrictions, warning labels, and disclosure requirements, without subjecting them to premarket authorization. Only those e-vapor products commercially marketed after issuance of the Final Rule would be subject to ... premarket authorization."

2. Lorillard: "FDA should exercise enforcement discretion not to require premarket review of electronic cigarettes introduced into United States commerce on or before the effective date of the final deeming regulation.

3. American E-Liquid Manufacturing Standards Association: "FDA should use the effective date of the final rule for the Deeming Regulations as the new "Grandfather Date" for e-cigarettes and e-liquid products and model the substantial equivalence requirements for these products based on the Section 510(k) pathway for medical devices."

The Rest of the Story

All three of these entities have offered common sense advice with which I wholeheartedly agree. In fact, this advice may be the single most important change that I recommend in the proposed deeming regulations.

As currently proposed, the deeming regulations will require virtually every e-cigarette product on the market to submit a pre-market review application, in which the company must demonstrate that the introduction of the product into the market is beneficial for the public's health. The data required to demonstrate this is complex, as it requires a consideration of not only the benefits of the product to intended users (adult smokers), but also the consequences of the product's availability in the market to others, such as nonsmokers and youth. The complexity and burden of this requirement makes it unfeasible for most e-cigarette companies, which are small and do not have adequate resources for such an undertaking. The result would be to pull tens of thousands of products from the market and constrict the market severely. In addition, it would create an absolute bureaucratic, nightmarish mess.

Instead, as Altria Client Services, Lorillard, and AEMSA have all recommended, the FDA should scrap the requirement for pre-market review of electronic cigarettes, at least until the effective date of the final regulations. After that time, applications for new products would be required, unless they could show substantial equivalence compared to a product already on the market (as of the final regulation effective date).

Actually, I would go one step further. I don't see a need for pre-market review of new electronic cigarette products, as it is the older ones which pose the most concern and the product quality has improved with innovation and time. Moreover, such requirements would stifle innovation. Instead, if I were the FDA, I would simply establish a set of safety standards that all products must meet. These standards would address issues such as battery safety, quality of ingredients used, type of ingredients used, temperature regulation, quality and safety of metal parts, and child-safety of packaging.

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