Azim Chowdhury in the Tobacco Reporter on upcoming FDA reg.s - esp. substantial equivalence &c.

[Roger_Lafayette]

I scanned this quickly while putting together today's media summary, and I'm not sure it contains any new info. Look forward to any comments from those of you who know a lot more than me (Bill?):

http://www.khlaw.com/webfiles/What_To_Expect.pdf

 

[Bill Godshall]

Azim's article correctly points out what I've been saying since 2011, and what I presented at FDLI last year, and will present again at next month's FDLI annual conference. The unfortunate (or fortunate) fact is that the FDA deeming regulation would once again ban ALL e-cigs.

This is not a matter of opinion or talking points (which is all the news media cares about and reports), but rather this is a matter of federal law.

The only way that FDA wouldn't issue cease and desist orders, product seizures and worse (under the deeming regulation) is if the FDA chooses to NOT enforce various provisions of the law (kinda like how Obama chose to NOT enforce various provisions of Obamacare, and how Eric Holder chose to NOT enforce various federal laws banning {OTHER STUFF} in states that have legalized it).

This appears to be the regulatory goal of Altria, njoy, FIN/ecig, blu, TVECA and other e-cig companies that have publicly endorsed the FDA regulation of e-cigs (as all of them are fully aware that the deeming regulation would ban all e-cigs).

But whenever a federal agency decides to NOT enforce a law, the corporations who benefit from that policy decision are then forever indebted to that agency (and its political bosses) and must grovel, plead and/or bribe the agency (and/or its political bosses) to retain its nonenforcement policy every year in the future (as otherwise the agency or its political bosses could rescind the nonenforcement policy at any time).

I staunchly oppose that type of (lets ban it, but just not enforce it) type of lawmaking and law enforcement (as it just breeds corruption and encourages bribery of government officials).



There are two inaccurate statements in Azim's article. One is his claim that e-cigs don't deliver nicotine very effectively (citing Eissenberg's deeply flawed study of folks who had never used an e-cig).

He also inaccurately stated that the Feb 15, 2007 date was included the original FSPTCA legislation, which was introduced by Waxman and Kennedy in 2004 (after they negotiated and agreed on a deal with Philip Morris, CTFK's Matt Myers and GSK's Mitch Zeller).

In fact, the 2004 and 2005 FSPTCA bills had grandfather dates of 2/15/04 and 2/15/05 respectively, and the 2007 FSPTCA bills contained the 2/15/07 date (as the sponsors moved the grandfather date up each time they introduced a new bill).

But in 2009, both Kennedy's and Waxman's FSPTCA bills kept the 2/15/07 date due to lobbying by the ANTZ (because they wanted the soon-to-be enacted FSPTCA to ban the new smokefree products the Reynolds, Altria, Star and other tobacco companies were developing and test marketing at that time (i.e. Camel Snus/Orbs/Strips/Sticks, Marlboro Snus/Moist Snuff and Skoal Snus, Star's flavored Ariva and Stonewall lozenges and Ariva and Stonewall BDL, etc.).

 

[aikanae1]

There's a lot of "I hope they will do this instead" messages in that piece, and his opinions do sound reasonable but overly optimistic. We've already seen that science, logic, or concern about public health haven't carried much weight with regulating e-cigs. He doesn't address the impact on taxes or other market variables.

What I do like is his statements are well-referenced and quotable. Overall it would be a good short statement to give to someone in doubt about their safety and what regulations they deserve. "No junk" as you say.

Mitch Zeller, the director of the FDA’s CTP, has publicly acknowledged that e-cigarettes and products that only contain nicotine do not create the same health risks compared to their tobacco-combusting alternatives. Zeller has been advocating for an agency wide “comprehensive nicotine regulatory policy” that recognizes that different nicotine-containing and nicotine-delivering products pose different levels of risk to the individual.19

A recent, much publicized survey by the Centers for Disease Control and Prevention (CDC) indicated that the percentage of students from grades six through 12 that had used an e-cigarette doubled to 6.8 percent from 3.3 percent in 2012. It has subsequently been revealed, however, that nine out of 10 high school students in that survey who reported vaping in the previous month were already cigarette smokers, suggesting that the increase in e-cigarette use is a positive step toward harm reduction.20 Moreover, despite concerns that e-cigarettes could lead to an increase in youth smoking, new data are demonstrating that youth smoking rates reached a record low in 2013.21 This is in line with the CDC’s announcement last year that the overall U.S. smoking rate has declined for the first time in several years (to 18 percent of the population down from 20–21 percent).22 It is unclear whether the sudden decrease in cigarette smoking and the corresponding increase in e-cigarette vaping is merely coincidence, but it is certainly hard to ignore.23

He does acknowledge the vaping industry will be crushed if alternate grandfathering regulations aren't established.

If the original Feb. 15, 2007, grandfather date remains applicable to e-cigarettes, the biggest potential hurdle remains obtaining the necessary information on a grandfathered/predicate product that was on the market before the grandfather date. As most e-cigarette companies had not yet entered the market, few will have access to such data.

Maybe that should be a focus on the federal level?

 

[Sikko]

There's another big problem with the ban but not enforce model.

States will see that and start enforcement on their own. I can't see that if the FDA bans it the states would be willing to look the other way. Not with all the assaults on vaping we are currently fighting.

 

[aikanae1]

I've seen a couple of estimates that up the world wide market to $3.5 billion currently and expected to be $5 billion by 2015. That's huge for an unregulated industry. Everyone wants in on that.

 

[rothenbj]

Bill, speaking of other stuff and e cigs in relation to the Federal government and specifically the FDA. We lived through the FDA's lose to the e cig industry when the courts ruled that as long as they weren't being marketed as a drug and drug delivery system to treat a disease (as if stopping smoking is treating a disease).

However, the FDA remains completely silent when states are approving the use of unapproved drugs to treat a variety of illnesses from sleep problems to cancer. I'm not objecting to that stance by the states or general legalization, but I find the lack of proven "safe and effective" and all the "we just don't knows" confusing.

 

[twgbonehead]

I've seen a couple of estimates that up the world wide market to $3.5 billion currently and expected to be $5 billion by 2015. That's huge for an unregulated industry. Everyone wants in on that.

You meant to say "under-taxed" not "unregulated", right?

 

[aikanae1]

Nope. According to someone with a background in economics, the ecig industry is considered a grey market largely because of it's size (> billion) and lack of regulation. News to me.

 

[AegisPrime]

There are two inaccurate statements in Azim's article. One is his claim that e-cigs don't deliver nicotine very effectively (citing Eissenberg's deeply flawed study of folks who had never used an e-cig).

I believe one of Dr. Farsalinos' studies actually confirmed this Bill - e-cig delivery of nicotine was in the region of 40% of that delivered by regular cigarettes (per puff) with more time needed for the nicotine to get into the bloodstream. This was likely based on earlier-gen hardware though so the results using 3rd-gen devices may well be much improved (though still unlikely to match cigarettes).

This was at the crux of his argument for nicotine strengths in excess of 20mg being made available in the EU.