The FDA finally released a proposal to regulate electronic cigarettes under its authority to control tobacco products. Most major news outlets are already covering the proposal, but here’s the quick and dirty on what they hope to do. In general, the proposal is not as nasty to the e-cig market as one might have expected. Advertising, flavors, and internet sales are not banned — as some thought possible.
I’d like to drill down on two pieces of the proposal however. Disclaimer: This is an opinion. Take it as nothing more.
The most significant piece requires companies submit an application for all technology and products released since February 2007. The FDA will review these applications and determine whether the products should be allowed on market. This effectively applies to all up to date electronic cigarettes. This application must happen within 2 years and the FDA will review the application at whatever pace it wants.
This is perhaps the single worst part of the proposal. It affords the FDA the ability to drown the e-cig market in red tape and drag its feet on approvals. Though it appears products can be marketed and sold while acquiring approval, it requires companies take a leap of faith and invest in marketing, infrastructure, distribution, and more for a product that the FDA may come back and say We decided you can’t sell that anymore.
And if you think the FDA might actually, diligently respond to applications, let us not forget that just last year it patted itself on the back for approving two new tobacco products and rejecting 20 while hundreds were still awaiting review.
It seems likely that the date will get pushed forward in negotiation — probably to whenever the regulation officially becomes active. Perhaps it’s even the FDA’s goal to use that date as a bargaining chip. But if this rule exists at all, it hamstrings technological advancement in the industry moving forward. E-cigs are technology, and encouraging improvements could mean safer, less harmful, and more reliable products in months rather than decades. Instead, companies are encouraged to stick with the technology they have and never improve it.
But there is one bit that offers hope. The new regs state that manufacturers will be required to provide scientific evidence to substantiate any claims they make that e-cigs are safer than tobacco cigarettes. This may sound silly. Most experts agree that there is no question on this fact; electronic cigarettes are safer than tobacco cigarettes. And the FDA certainly could push for a ludicrously high standard to prove lower harm. However, this does mean that the FDA accepts some nicotine products are potentially safer than others and is open to allowing companies to make this claim.
For once, e-cig companies may be able to accurately state that electronic cigarette use is safer than smoking. The FDA might try to require long-term research — say, 50 or 100 years worth because Hey, that’s what we have for smoking. If dragged into courts over this (or if they drag someone else into courts over this) fact, they’d be hard pressed to convince the courts that e-cigs are not safer than tobacco cigarettes. We could end up seeing health claims the moment the regulations go into effect. That, to me, is promising.
You can read more proposal coverage by The Wall Street Journal, CNN, and more. They spend a good chunk of time just talking about what e-cigs are and why the FDA is involved in the debate.
Here’s the major pieces of the proposal:
FDA review of products released or updated since February 2007
- Sales banned to anyone under 18
- No ban on ads
- No ban or Internet sales
- No ban on the use of flavors
- Manufacturers will be required to disclose the chemicals
- Distribution of free samples banned
- New health warnings will note that the nicotine they contain can be addictive
- Evidence required from companies that claim e-cigs are healthier than tobacco cigarettes
This list comes from the e-cig industry trade group SFATA (The Smoke Free Alternatives Trade Association). They’re likely to be in government halls arguing for sensible regulation alongside CASAA (Consumer Advocates for Smoke Free Alternatives) really soon.