In April, the FDA released their official proposal for electronic cigarette regulation, but this week the White House intervened by weakening the initial regulation proposal and deleting sections that could potentially be damaging to the economy. In the initial proposal, the FDA said they would ban sales to anyone under age 18 and eliminate ecig vending machines. All ecig manufacturers would also be required to undergo an extensive review period to get approval for continued sales. Many feared that the review process could be so expensive that small ecig businesses would have no choice but to shut down, leaving big tobacco companies in control of the entire ecig industry.
After reviewing the FDA’s proposal, White House officials from the Office of Management and Budget (OMB) stepped in with immediate changes to significantly weaken the regulations and prevent vague wording from leaving room for the FDA to act unjustly in the future. It’s a small, but significant victory for the ecig movement!
The world’s reaction to the FDA proposal has been mixed with some claiming that it is a balanced approach and others arguing that it is too vague and could turn disastrous in the future. Some health advocates argued that the FDA should take a more strict approach and ban flavored e-liquids and online sales, arguing that the Internet was not conducive to reliable age verification.
In the first draft of the proposal, the FDA called for “prohibition of non-face-to-face sales” and then added a note to explain that this phrase meant to target vending machines. Many ecig supporters feared that the wording left room for the FDA to come in later and ban all online sales, citing this one phrase in the regulations. When OMB officials reviewed the proposal, they also felt that it was too vague and edited the section to specifically say that vending machines were prohibited, giving future protection to online ecig businesses.
The White House also deleted and heavily edited a section where the FDA speculated on potential safety concerns and lackluster manufacturing standards. The original proposal included plans to review ecig cartridges and further investigate quality control concerns such as variations in nicotine or the potential inclusion of toxic chemicals like diethylene glycol. The OMB completely deleted this section, which was based largely on old research that has been disproven in subsequent studies.
OMB spokeswoman Emily Cain said the White House regularly reviews all regulation drafts and makes changes when needed to insure efficient policies based on the best scientific evidence. “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.
At this time, the FDA has not issued any public response to the changes from OMB, but spokeswoman Jennifer Haliski said that public comments are still welcome until August 8. “All comments will be carefully considered as the final rule is being developed,” she said. “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.”
This summer, we will continue to watch as the regulatory process continues. We will keep you updated with any changes. You can see all the OMB changes to the proposal here.
What areas of the proposed ecig regulation are most concerning to you? Are there other important changes that need to be made?