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FDA Suspends Deeming Regulations On Vapor & Cigar Products

 

The Trump Administration has suspended the Food and Drug Administration’s deeming regulations on the vapor industry, which gave the FDA the ability to regulate all vapor products, reports  theGazette.com.  

Read more on the FDA’s PMTA Approval Process

Court filings revealed by the Justice Department opened the book on the suspension, which occurred Monday night in Washington, DC and Alabama. These moves have come at a great time for the vapor and tobacco industry as many companies have been launching legislative efforts in order to have the FDA roll back their onerous regulations.   Read more on The Vapor Industry’s Congressional Allies & Their Fight to Save Vaping

Attorneys of the Justice Department rallied together with pro-vapor groups and challenged the FDA’s rule and requested an additional three-month delay in two different cases to give the new lead at the Health and Human Services “additional time to more fully consider the Rule and issues raised in this case.”

Due to this request, FDA officials have announced the agency will be postponing the deadlines that were established under the rule set for May 10th or later.

 

Due to the postponement, the following is now going to take effect:

 

- Cigar manufacturers (who were also under the same rules as e-cigarettes) no longer have to turn in their proposals for adding addictiveness warnings on their products.

- E-Cigarette & cigar manufacturers will no longer need to submit information on the ingredients contained in their products by August 8.

- Interstate commerce of products including the label of “light”, “low” or “mild” will no longer be banned.

 

Parts of the rule still in effect:

 

- Vapor and tobacco products are banned from sale to anyone under the age of 18

- Giving away free vapor/tobacco products & samples is also still banned

 

Not All Are Rejoicing In the Rule’s Postponement

 

The president of the Campaign for Tobacco-Free Kids, Matthew Myers, stated that the legislative jockeying reveals just how much the vapor and cigar industry wants to wage a war on a rule that public health officials feel is critical to the health of the public.

“From a pure public-health standpoint, there’s been no factual change from the overwhelming public record that prompted promulgation of the rule,” Myer’s stated. “The administration’s decision yesterday means that the public will continue to lack the information on what products are on the market, what effect they’re having and what’s in them.”

Though Trump’s Administration has not yet revealed what it will ultimately do with the 2016 deeming regulations, the decision to side with the vapor industry shows the huge shift from Obama-era policies. Officials who are pro-vapor are optimistic that the administration will have a lighter hand on the overall judgement of the rule due to the many congressional allies that have come forward to help in their fight.

Several officials of Trump’s Administration have ties to the vapor and tobacco industry. Chad Readler, whom had represented R.J. Reynolds at the law firm Jones Day before he joined the Justice Department, is now the acting assistant attorney general for the civil division. Readler was included on a March 1st brief that had asked the U.S. District Court for the Middle District of Alabama Northern Division for an extension in a case that involved the FDA’s deeming regulations.

Scott Gottlieb, the newly confirmed head of the FDA, had served on the board of the e-cigarette firm Kure until May 2016. He had kept stock in the company, but pledged to sell if he received Senate confirmation—which occurred just last week. Gottlieb had also stated he would not have a voice in matters that involve Kure for a year after his resignation from their board. Indicating that his recusal period will end during this month.

 

Relief for the Vapor Industry

 

Obama’s administration vigorously defended the FDA’s deeming regulations siding with anti-vape proponents who feel that vaping is only creating a new health threat for the nation’s youth. Arguing that nicotine is still highly addictive and that vaping appeals to adolescents due to the available sweet e-liquid flavors. 

“Vaping has evolved into an industry that’s targeted at our children,” Merkley said, stating that becoming addicted to nicotine “can have lifelong health impacts.”

TVECA’s chief political officer, Keith Nelson, said that the health impacts of long-term vaping is premature due to the fact that the vapor industry is still new and that the studies on the health impacts of vaping that have been conducted are, “somewhat premature, because this is a nascent industry.”

Nelson did mention though that since the time the FDA’s deeming regulations have come into effect, two major vapor companies, NJOY and Electronic Cigarettes International Group Ltd have gone bankrupt. Which isn’t a far-fetched outcome as the rule had also required e-cigarette manufacturers to conduct, on their on dollar, “not just health-based research but behavioral research and psychological research on the impact of your product and all the combinations of these products.” 

“The numbers start to add up,” Nelson said. “The industry needs some relief.”