In August 2017, the FDA had announced a major shakeup to the agency’s policy on e-cigarettes which included the de-nicotinization of cigarettes, and a PMTA deadline delay. Following that announcement, the FDA had issued a guidance titled Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule, in order to formalize and explain this deadline extension.
Following this, many public health and harm reduction advocates were finally able to breathe a sigh of relief. The agency on the other hand, had become the recipient of mounting pressures from the other end, and a number of health groups including the American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association and Campaign for Tobacco-Free Kids and Truth Initiative even sued.
Gottlieb pressured to close in on vaping companies
FDA Commissioner accused of FUELING the alleged rise in teen vaping, due to the PMTA delay.
Meanwhile last week, U.S. Rep. Nita Lowey once again criticized FDA Commissioner Scott Gottlieb for the delay, saying that it was a “big, big whopping mistake” and that it helped fuel the alleged rise in teen vaping.
“The FDA’s decision to take its foot off the gas while thousands of products have entered market has led to the epidemic we face today,” said House Appropriations Chairwoman Lowey, D-N.Y., at a hearing last Wednesday.
Gottlieb explained that the agency is trying keep a balance between making the products inaccessible for youth and keeping them available for adults who want to quit smoking. “We’re trying to thread a public health needle here where we preserve some element of the availability of these products for adults while foreclosing them for kids, or at least really dramatically curtailing the availability of kids to access these products,” he said.
In recent months, the FDA has launched several efforts in an attempt to fight teen vaping, saying that vaping amongst minors has become an epidemic. Last September, the agency released a campaign which points out that while e-cigarettes deliver addictive nicotine, the toxins in the devices could have unexpected negative health effects.
Are the FDA’s actions justified?
On the other hand, many public health experts who view vaping as an excellent harm reduction tool, have spoken up in response to the FDA’s harsh stance and claims, saying that the agency is exaggerating the risks of e-cigarettes, and that the agency’s efforts are unjustified. Public health expert Clive Bates added that the actual data which would support the FDA’s actions, have not even been released yet.
“..the partial release of data does not provide justification for FDA’s policy. This is because the data required to understand underlying changes in the pattern of tobacco use has been withheld. In other words, the data to create alarm has been released, but the data required to understand if the alarm is justified and the policy is sound has not been released,” said Bates in a blog post.
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