Tuesday, June 17, 2014

New Study Demonstrates Why FDA's Proposed Regulatory Approach to E-Cigarettes Makes No Sense

A new study published today in the journal Tobacco Control demonstrates why the FDA's proposed regulatory approach for electronic cigarettes makes no sense. In fact, the new research shows why the FDA's approach would be a complete bureaucratic nightmare, while not actually protecting the public's health.

(See: Zhu S-H, et al. Four hundred sixty brands of e-cigarettes and counting: implications for product regulation. Tobacco Control. Published online ahead of print on June 17, 2014.)

In this study, the authors study attempted to determine the number of electronic cigarette products on the market, both in terms of the number of different brands and the number of different flavors. Using comprehensive internet searches, the researchers found as follows:

"By January 2014 there were 466 brands (each with its own website) and 7,764 unique flavors. ... Newer brands offered more flavors per brand (49 vs. 32) ... ."

The Rest of the Story

The basic framework that the FDA has proposed to regulate e-cigarettes is that every product on the market (except a very few that were already on the market as of February 2007) must submit a new product application. These applications must demonstrate to the FDA that the introduction of the product to the market is appropriate for the public's health.

Because products are substantially equivalent only if they pose no different issues of public health, and because flavorings can affect product efficacy and safety, it is probable that every different flavor of every different brand must submit a separate application. Thus, at a minimum, there are going to be at least 466 x 49 applications, or 22,834 required applications.

The FDA's Center for Tobacco Products simply does not have the capacity to review 22,000 new product applications. After all, it has taken more than 4 years for the agency to even begin to process the more than 3,500 substantial equivalence applications submitted by tobacco companies, and as of this date, there are still thousands of those applications pending. It is easy to see that the proposed deeming regulations would create a bureaucratic nightmare.

Moreover, the proposed regulations do nothing to directly regulate product safety. For years to come, we would still have exploding batteries, leaking cartridges, and packaging that is not child-proof. After all, it is going to be a minimum of one year before the regulations are promulgated, another two years before the applications are due, and probably 5-6 years before the 22,000 new product applications can be processed (and that is only if the FDA acts in an unprecendentedly speedy fashion). So we're talking 8-9 years before we see any meaningful safety improvements.

Instead of this insane regulatory approach, the FDA should scrap the requirement for product applications and should simply promulgate basic safety standards that ensure minimum, uniform requirements for product safety. If the agency allows for a 12-month grace period, we could expect to see these requirements actually take effect within two years.

The safety standards should focus on the following issues:

1. Battery safety and overcharge protection;
2. Packaging (leak-proof cartridges and child-proof containers);
3. Basic manufacturing standards;
4. Pharmaceutical-quality ingredients in e-liquids;
5. Quality control for stated nicotine levels; and
6. Regulation of heating temperature and protection against overheating and dry puffs.

In addition to ensuring basic safety, such regulations would also address issues such as the presence of formaldehyde in some e-cigarette brands and would regulate the product to minimize the known harmful by-products which have been identified in some e-cigarettes. These by-products are avoidable. We know this because some brands on the market (such as Vuse and NJOY) have been tested and shown to have no detectable/quantifiable levels of any hazardous byproducts.

As the agency learns more about these products in all their diversity, the basic safety standards could be enhanced.

I can only hope that this new study will help the FDA realize the folly of its proposed approach to electronic cigarettes and develop a new set of regulations that directly set standards for the safety of the product.

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