July 11, 2015

Stanton A. Glantz, PhD

Republicans move to block limited FDA action on e-cigs for more years: Will Obama fight them?

Although 15 months ago FDA released its proposed “deeming rule” that would give FDA authority to regulate e-cigarettes and other harmful tobacco products, the final rule has still not been issued, and these unregulated nicotine products remain on the market to addict kids and other new users, and to keep current and dual users addicted.  
 
While the final rule will likely have little practical effect on controlling the exploding e-cigarette use, especially among kids, it does take the first tiny first step to controlling the unfettered marketing of e-cigarettes and other new tobacco products.  So the e-cig industry (which includes the major cigarette companies) is worried that even the minimal restrictions that the final rule would impose would curtail the development and marketing of e-cigs, vaporizers, snus, and the next generation of heat-not-burn traditional cigarettes.
 
A technicality in the law allows the introduction and marketing of new tobacco products by claiming they are “substantially equivalent” to existing products that are grandfathered, i.e., those products that were marketed as of February 15, 2007; products that are not substantially equivalent to grandfathered products can not legally be marketed until they demonstrate that they are appropriate for the protection of the public health and receive premarket authorization from FDA. (Sections 910 and 905(j) of the Family Smoking Prevention and Tobacco Control Act).  This means that all e-cigs and other new tobacco products that are currently on the market would be illegal unless and until they can obtain premarket authorization, since these products were not being marketed as of February 15, 2007.
 
The FDA could use this fact to effectively reign in the wild west marketing of e-cigarettes in exchange for allowing them to remain on the market. 
 
On July 8, 2015, the Republicans in Congress moved to make sure that the FDA doesn’t do anything meaningful to regulate e-cigarettes for a very long time.  The House Appropriations Committee passed an appropriations bill that does not allow funding to implement the substantial equivalence regulations with a February 15, 2007 grandfather date.  Instead, funding would be permitted for substantial equivalence regulations only with a start date 21 months after the effective date of the final deeming rule.     In other words, this bill allows all the e-cigs and other new products that are currently on the market to remain on the market, and their manufacturers do not have to file any papers demonstrating their public health impacts.
 
In addition to establishing a new policy that defeats the intent of the Tobacco Control Act, the Appropriations Committee also recommended that the FDA carve out special protections for so-called “premium cigars”, incorrectly stating that they are somehow less harmful and addictive and distinct from other products, especially regarding youth perceptions, when cigar use has been increasing among youth as cigarette use decreases.  Also, the Committee recommended that FDA consider the “benefits of harm reduction” when evaluating the deeming rule regulations. 
 
This bill represents yet another move by the e-cigarette and cigarette industry to harness politics to prevent FDA to do its job and use its authority to protect public health.  If Congress is truly interested in reducing harm to youth and adults who are becoming or staying addicted to nicotine in e-cigarettes and other new tobacco products, they should let FDA do its job and control their rampant marketing.
 
The question is:  Will President Obama block the bill or allow it to move forward and protect the tobacco companies?
 
(Lauren Lempert helped prepare this blog post.)

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