In a turn of events and some rather good news for the e-cigarette industry, the FDA’s Proposed Regulations have been weakened by the White House.
The White House’s Office of Management and Budget (OMB), a portion of the White House that analyzes the potential economic consequences of proposed regulations has made some changes to the proposed rules for tobacco products, namely cigars and e-cigarettes.
The OMB deleted language in the U.S. Food and Drug Administration’s recently proposed regulations describing how the rules describing how the rules would keep thousands of people from taking up cigar smoking and have enormous public health benefits.
According to documents published Tuesday in the Federal Register, the OMB also weakened language detailing the FDA’s concerns about the safety of e-cigarettes.
As with any rule, OMB’s office of information and regulatory affairs conducted an interagency review process 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. 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.
Anyhow, to continue on, here’s what the OMB did:
In the proposal, the FDA had proposed prohibition of non-face-to-face sales (such as vending machines). With this rule, it would have opened the door to a ban on online sales. If you’re a frequent reader of GuideToVaping, you may remember me publishing a post after the FDA released its proposed regulations, and saying that within the rules there are a lot of loop holes and that the FDA is quite the sneaky ones. That said, the OMB has edited the sentence so that the prohibition refers only to vending machines.
By the OMB making this change, it will eliminate the FDA’s loop hole to prevent online sales of e-cigarettes in the future. The FDA is smart and knows how to word things so that it doesn’t look so harsh to the public, but will then later use that same rule in the future to restrict vapers from the devices we enjoy, and by that time there will be nothing we can do about it. Thankfully OMB caught this very sentence.
The OMB also modified or deleted FDA concerns about the safety of e-cigarettes, including manufacturing quality. The OMB deleted FDA draft language saying it would review electronic cigarette cartridges to respond to evidence of poor quality control, variable nicotine content or toxic ingredients such as diethylene glycol.
Other changes were made focused on cigars, here are those changes just in case you might be interested.
- OMB turned the FDA’s proposal as it relates to cigars from a two-part rule – one for traditional tobacco products and one for products that have not previously been regulated – into a “two-option” rule, one of which would exempt “premium cigars.”
- OMB also deleted an FDA analysis showing that exempting premium cigars from a proposal to require large warning labels would save manufacturers $1 million to $3 million but incur costs to public health of $32.6 million to $34.2 million.
- The White House office also deleted an extensive section in which the FDA calculated how many lives would be saved by regulating cigars, as well as the value of those lives. And it deleted a similar analysis for the improvements in health that would come from dissuading people from smoking cigars, such as through warning labels.
From the looks of it, we may finally have some high officials on our side for once. Many online e-cigarette users throughout the vaping community are well pleased with this latest news. It would be worth the visit to the original news report to check out some of the replies from consumers in the comments section.
Original Source: White House Weakened Tobacco Regulations of FDA’s Draft Proposal