Wednesday, April 26, 2017

A Major Embarrassment for the FDA: Congressman to Introduce E-Cigarette Regulatory Bill Tomorrow

According to multiple sources, Representative Duncan Hunter (R-CA) will introduce legislation tomorrow in the House of Representatives that will create a new regulatory framework for electronic cigarettes and vaping products. The bill is titled “The Cigarette Smoking Reduction and Electronic Vapor Alternatives Act of 2017.”

Briefly, here is what the bill would do, in order of importance:

1.     The FDA would be precluded from regulating electronic cigarettes under the same framework as tobacco cigarettes. Thus, the bill would put an end to the requirement for e-cigarette companies to submit pre-market tobacco applications and would not apply modified risk provisions to vaping products.
2.     The bill would set up a distinct regulatory framework for electronic cigarettes, under the jurisdiction of the FDA’s Center for Tobacco Products.
3.     The bill would establish safety standards for e-liquids and vaping devices that would go into effect one year after the enactment of the legislation. These standards include:
a.       Immediate adoption of the e-liquid standards developed by the American E-Liquid Manufacturing Standards Association (AEMSA);
b.       Subsequent adoption of the e-liquid standards being developed by the American National Standards Institute (ANSI) once they are established;
c.       Immediate adoption of battery safety standards set by the International Electrotechnical Commission;
d.       Immediate requirement for short-circuit protection for the heating element;
e.       Battery overcharge protection;
f.        Battery discharge protection; and
g.       Tracking of all devices by serial and lot numbers.
4.     The FDA would be required to review any subsequent e-liquid standards established by AEMSA or ANSI and adopt such standards if they are deemed to be appropriate for the protection of the public’s health.
5.     The FDA would be authorized to promulgate regulations to prevent marketing of vaping products to minors.
6.     The FDA would be required to conduct a health safety assessment comparing the risks of different tobacco products as well as vaping products and submit this report to Congress.
7.     The FDA’s Center for Tobacco Products would be renamed the “Center for Tobacco Products and Tobacco Harm Reduction.”

The Rest of the Story

This is critical and much-needed legislation that would put an end to the lunacy going on with the current regulation by the FDA of cigarettes and e-cigarettes. Right now, the FDA regulates e-cigarettes much more stringently than real cigarettes, putting an almost insurmountable obstacle in front of the development and marketing of electronic cigarettes – all to the advantage of the real, maximum harm, tobacco cigarettes. The current regulations will decimate the electronic cigarette industry, removing 99% of vaping products from the market and eliminating much of the competition faced by cigarettes for the nicotine market. This legislation would finally put an end to such nonsense.

It makes perfect sense to carve out a separate regulatory framework for electronic cigarettes that is separate from that for real cigarettes. This is something I have been calling for repeatedly during the past five years, and it is gratifying to see this potential approach finally seeing the light of day.

The most interesting aspect of this story is what an embarrassment it is for the FDA. While the FDA has had regulatory jurisdiction over electronic cigarettes for the past seven years, it has not established a single safety standard for these products. It has watched scores of people being injured by exploding batteries and done nothing. Even worse, the agency has actually prohibited companies from repairing this defective battery problem because any such change would render the product a “new tobacco product,” meaning that it could not be marketed without pre-approval – a process that would take years and is prohibitively expensive for all but the largest of companies.

Now, in one fell swoop, Representative Hunter and co-sponsors are stepping in establishing almost immediate safety standards (that go into effect in one year) that not only regulate battery safety, but also regulate all aspects of e-liquid manufacturing. This is something that the FDA could have and should have done years ago. But it has been too busy developing its prohibitory approach to e-cigarettes rather than actually working to protect the public’s health by assuring the maximum safety of e-cigarettes being used by millions of Americans.

This bill is not perfect, but it is a superb start and with a couple of amendments could be ideal. Here are the two major changes that I believe are necessary:
1.     The FDA should be given authority to set additional safety standards, beyond the e-liquid standards established by AEMSA and ANSI and the battery standards outlined in the bill. This is critical because we don’t know what safety features will be uncovered as research into e-cigarette safety continues and evolves. The FDA needs the flexibility to establish additional safety standards as they are warranted.
2.     The statute should explicitly address what claims are allowed and disallowed in e-cigarette marketing; in particular, what claims represent therapeutic claims and what claims are allowable without making a product subject to regulation as a drug or device. Specifically, I would like to see language that allows companies to truthfully inform their consumers that vaping is much safer than smoking and that it can be effective in helping many smokers to quit. Neither of these should be considered to be drug claims and should be allowed as long as they are accurate.

Please note that this commentary pertains to the merits of the legislation. I am not commenting on the political strategy, the wisdom of introducing this bill at the same time as the Cole-Bishop rider is considered, or other political concerns. I defer to others who know more about the political climate than I do.

But from purely a public health policy perspective, this legislation makes sense. It needs to be strengthened by allowing the FDA to set additional safety standards and by explicitly allowing reduced risk and smoking cessation claims. However, it is a great start to correcting the lunacy of today's federal regulation of electronic cigarettes.

2 comments:

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