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Gottlieb Tells Congress FDA Will Base E-Cig Regulations on Science
#1
Gottlieb Tells Congress FDA Will
Base E-Cig Regulations on Science

-Competitive Enterprise Institute-
Michelle Minton • May 26, 2017


Democrats like to portray their party as the “party of science.” Yet, when it comes to harm-reducing tobacco alternatives that offer millions of smokers a chance to quit their deadly habit—Dems may as well be a pitchfork-wielding village mob. Luckily, for public health, the newly appointed Food and Drug Administration (FDA) Commissioner Scott Gottlieb is not as fearful of innovation.

Yesterday,  Gottlieb testified before the House Appropriations Committee. During the hearing, members asked Gottlieb about his financial ties to the vaping industry, his interest in keeping kids off tobacco, and his commitment to preserving a rule implemented by the Obama FDA, which would regulate electronic cigarettes more stringently than actual cigarettes.

Their major concern revolved around Gottlieb’s plans to implement the FDA’s “Deeming” rule, which classified non-tobacco products, like e-cigarettes, as “tobacco.” While the Tobacco Control Act (TCA) enacted by Congress in 2009 gave the agency power to regulate the industry, it also grandfathered in products on the market prior to 2007. When the FDA—without any input from Congress—decided to include e-cigarettes under the definition of tobacco products, it did not change this grandfather date. This means that all vaping devices and liquids will need to submit and be awarded a pre-market tobacco product application (PMTA), a process that could take years—with no guarantee the agency will approve any applications—and cost hundreds of thousands of dollars per application.

Almost all of the research into e-cigarettes shows they are less harmful than traditional tobacco products—because the nicotine-liquid is heated and not burned—are effective smoking-cessation devices. This is why Reps. Tom Cole (R-Okla.) and Sanford Bishop (D-Ga.) offered an amendment to the recent omnibus spending bill that would not weaken the FDA’s ability to regulate e-cigarettes—as some Democrats have argued—but merely change the grandfather date so that e-cigarettes currently on the market could stay on the market without needing to file a PMTA.

Ranking member Nita Lowey (D-N.Y.) declared that e-cigarettes are addictive and a “gateway for teenagers to use tobacco.” Sitting shoulder-to-shoulder with her colleague Rep. Bishop, whose bipartisan bill she gleefully killed less than a month ago, Lowey demanded Gottlieb “stand with science” and commit to “fully implementing the deeming rule, including through the courts, if need be.”

Not falling for Lowey’s insinuation that “big tobacco” is behind efforts to alter the deeming rule, Gottlieb answered that any decisions he makes on tobacco harm-reduction will be “science-based” and designed to ensure they are “maximally achieving the public health goals set out by Congress.” He added that he will not “preside over a period of time when teenage smoking went back up in this country. As a cancer-survivor and a physician that’s not going to be my legacy.”  

Apparently unsatisfied with Gottlieb’s dedication to relying on actual evidence to make decisions, Lowey asked him “as a father, would you be comfortable with your children having such easy access to e-cigarettes and other flavored tobacco products?” Just as easily, Gottlieb could have asked that if she, as a mother, was concerned about her children having even easier access to caffeine, since caffeine is also a central nervous system stimulant, both contain carcinogens, and—as research has shown—there are essentially no differences in the withdrawal symptoms of abstaining from nicotine versus caffeine.

Gottlieb’s actual answer to Lowey’s appeal to emotionalism was more diplomatic. “As a father I’m not comfortable with any child being started on a nicotine product,” he told the Committee. Had I been able to offer Gottlieb a follow-up question, I would have asked whether he’d be more comfortable with his kids smoking cigarettes, which kill about half of those who develop the habit, or e-cigarettes, which have about 95 percent fewer harmful and potentially harmful ingredients.

A 2013 meta-analysis of research by the German Cancer Research Center found that the vapor emitted from e-cigarettes contained a comparable amount of harmful and potentially harmful constituents as ambient air. According to that same study, the FDA received only 42 reports of “adverse events” from e-cigarettes between 2008 and 2013. Compare that to the 97 reports the agency received related to just three types of soda (Coke, Diet Coke, Mountain Dew) in that same period.


[Image: FDA%20post%20chart.png]

I don’t expect the mountain of evidence showing the relative safety of e-cigs or the nor the many studies showing e-cigs are an effective means for smokers to reduce or quit smoking, will ever convince some anti-smoking advocates like Rep. Lowey of how reckless it would be to destroy the e-cigarette market. Luckily, Commissioner Gottlieb seems far more inclined to actually examine the evidence and make his decisions based on objective data before making policy decisions that could affect the lives of millions of Americans.
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