White House Intervenes With Changes to the FDA Ecig Regulation Proposal
On the heels of the FDA’s proposal for new electronic cigarette regulations, it seemed that ecigs might be doomed to an uphill battle for survival. However, the vaping community had an unexpected victory this week when the White House stepped in to intervene. After reviewing the FDA’s initial ecig proposal, White House officials made immediate changes to significantly weaken the language and delete some restrictions.
It all began when the White House’s Office of Management and Budget (OMB) analyzed the full impact of the FDA’s proposal. After studying the potential economic consequences, officials took steps to delete portions of the proposal and weaken the language in other sections.
The original proposal was published in April, creating a lot of concern among ecig users. The FDA initially wanted to ban sales of electronic cigarettes to people under age 18 and put an end to vending machine sales. The proposal also called for ecig manufacturers to undergo an extensive review and approval process, which could potentially cost millions of dollars and shut down thousands of small operations, leaving big tobacco companies at an unfair advantage.
Some public health officials criticized the FDA, calling for more stringent regulations specifically with the restriction of flavored e-liquids. Others also encouraged the FDA to ban or heavily restrict Internet sales, arguing that age verification was not reliable online. The original proposal draft called for “prohibition of non-face-to-face sales” with an explanation given that this would be targeted at vending machines. However, OMB felt that the wording left room for the FDA to shut down online ecig sales in the future so they edited the wording to be specific to vending machines, thereby protecting online ecig sales from potential shut down.
OMB also deleted and modified some of the FDA’s comments about the potential safety concerns related to ecigs and manufacturing standards. Originally, the FDA proposal said it would review ecig cartridges to investigate quality control and look for variable nicotine contents or even toxic ingredients like diethylene glycol. OMB also deleted this portion of the proposal.
Emily Cain, a spokeswoman for OMB, explained that the office always conducted an extensive review of all regulation proposals and made changes as needed. She said the goal is “to ensure that the regulations through which agencies implement policies are efficient, well-designed to achieve their objectives, and based upon the best available evidence.” She insisted that the White House routinely intervenes on proposals like this one. “It is routine for agencies to make changes to their draft rules during the course of OMB review. The goal is to maximize the effectiveness and benefit of the rules we complete,” she said.
The FDA has not publicly responded to the White House’s changes, but spokeswoman Jennifer Haliski said the period for public comments will stay open until August 8. “All comments will be carefully considered as the final rule is being developed,” she wrote in an email. “As the science base continues to develop for these products, the agency has the ability to take additional regulatory actions designed to further minimize the public health burden of tobacco use in this country.”
You can view the edited ecig proposal here by clicking under “Supporting Documents”. What are some other areas of the proposal that you want to see changed before the regulations are officially released?
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