Thursday, April 24, 2014

FDA's Proposed Electronic Cigarette Deeming Regulations: The Good, the Bad, and the Ugly

This morning, the FDA finally released its draft deeming regulations for electronic cigarettes. Here is my initial take on these draft regulations from a public health perspective. I have divided my analysis of the 241 pages of provisions into three sections: the good, the bad, and they ugly.

The Good

1. The regulations ban the sale of electronic cigarettes to minors, both in person and via the internet.

The ban on the sale of electronic cigarettes to minors is a critical aspect of the proposed regulations. If properly enforced, it will help keep these products out of the hands of minors. An additional benefit of this provision is that it will obviate the need for every city and town council in the nation to enact its own e-cigarettes sales restrictions.

2. The regulations do not ban the sale of electronic cigarettes to adults via the internet.

A ban on the sale of electronic cigarettes to adults via the internet would have been devastating to the bulk of the electronic cigarette market and would have placed an immediate limit on the potential for growth in this market.

3. The regulations do not ban the use of flavorings in electronic cigarettes.

Many anti-smoking groups and advocates have been pushing for a ban on the use of flavorings in electronic cigarettes. Such a ban would have devastated the industry, as the flavors are a key aspect of what makes these products competitive with tobacco cigarettes. In addition, the flavors make e-cigarettes distinct from tobacco cigarettes and make it much less likely that people who switch to these products will return to regular cigarettes. In addition, youth who use flavored electronic cigarettes are most likely less inclined to initiate smoking because once they are accustomed to the flavors, cigarettes would seem extremely harsh.

4. The regulations do not ban or restrict e-cigarette advertising or marketing to adults.

Many anti-smoking groups and advocates have been calling for a ban on all e-cigarette advertising. This would of course have been devastating to the industry and would have given tobacco cigarettes an unfair advantage in the marketplace. The FDA decided to defer any decision on marketing restrictions at this time. It is likely that the agency will revisit this issue in the future, but with more time, the FDA can craft marketing restrictions that balance the desire to protect youth from this advertising with the need for e-cigarette companies to be able to reach adult consumers.

5. The regulations do not immediately pull any e-cigarette products from the market.

One of my fears in advance of the release of the regulations was that they would require substantial equivalence determinations for most products currently on the market an would pull some products from the market pending such determinations. Instead, the agency decided to allow all existing products to remain on the market, giving them two years to apply for FDA approval. In addition, new products can enter the market for the next two years without pre-approval from the agency.

If a product submits an application for a new product approval or substantial equivalence determination within the allotted 24-month period, it will not be taken off the market while the review of the application is pending.

The Bad

1. The regulations do not limit the marketing of electronic cigarettes to youth.

There does need to be some restriction on the marketing of electronic cigarettes to youth. The FDA deferred a decision on marketing restrictions at this time. However, it is important that the agency does revisit this issue and that it craft restrictions that carefully balance  the desire to protect youth from this advertising with the need for e-cigarette companies to be able to reach adult consumers.

2. The regulations require pre-approval (or substantial equivalence determinations) for all new electronic cigarette products.

This provision is going to present a huge obstacle to innovation in this category. The newer products tend to be safer and more effective, so it makes no sense to allow the older products to remain on the market while requiring pre-approval for the newer and better products. The implications of this regulation is going to depend on the evidence that the agency requires to approve these applications. A stringent interpretation of the regulations will put a huge dent in electronic cigarette innovation and could limit the expansion of the market. In addition, this provision is going to place an undue burden on smaller companies and give a huge advantage to larger companies, including the tobacco companies that have entered the e-cigarette market.

3. The regulations require pre-approval or substantial equivalence determinations of almost all existing electronic cigarette products.

This provision is going to wreak havoc with the industry. The agency is determined that it cannot extend the grandfather date beyond 2007. This means that any product not on the market as of 2007 (which includes almost all electronic cigarette products) must either obtain a new product approval or a substantial equivalence determination. Given the snail's pace at which the FDA has processed cigarette substantial equivalence determinations, this could result in a literal quagmire of pending applications for the more than 250 brands of e-cigarettes currently on the market.

The Ugly

1. The regulations apply section 911 (the modified risk product provisions) to electronic cigarettes.

This is a complete disaster and is not in the interest of protecting the public's health. In fact, this provision is going to harm the public's health. It is going to require manufacturers to implicitly lie about the intended purpose and relative safety of their products.

Sadly, the agency concluded that it is not sure that e-cigarettes are any safer than tobacco cigarettes. The FDA states: "Many consumers believe that e-cigarettes are "safe" tobacco products or are "safer" than cigarettes. FDA has not made such a determination and conclusive research is not available."

That the FDA is not sure whether smoking is any more hazardous than vaping does not say a lot for the agency's scientific standards.

This provision is going to undermine the public's appreciation of the health hazards of smoking and prevent companies from telling consumers the truth: that e-cigarettes are a lot safer than tobacco cigarettes.

In addition, this is going to force companies to rely on other methods to pitch their products, such as using sexy models, emphasizing that e-cigarettes can be used where tobacco cigarettes are allowed, and relying on celebrity endorsements. The FDA is literally forcing e-cigarette companies to lie about their products and instead of pitching them as safer alternatives to smoking, to pitch them with non-health-related benefits.

Under this provision, an electronic cigarette company cannot even inform consumers that the product does not produce smoke because such a claim would be considered a "reduced exposure" claim under the Tobacco Act.


Overall Summary

All in all, the deeming regulations are a disaster. However, they are not as much of a disaster as they could have been. The positive side is that internet sales, marketing to adult consumers, and flavors are still allowed and that no products will immediately be taken off the market. The negative side is that new products will require pre-approval, virtually every product on the market will require a substantial equivalence determination (if not a new product approval), and that manufacturers will be forced to implicitly lie about the intended purpose and relative safety of the product by not being allowed to correctly point out that these products are much safer than tobacco cigarettes.

At the end of the day, while there are some positive aspects to these regulations, it is clear that science is not playing much of a role in the process. That does not bode well for the potential of electronic cigarettes to seriously challenge the combustible tobacco market, and thus to save hundreds of thousands of lives.

1 comment:

Blogger said...

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