The OMD and the FDA: Will e-cigs be banned in the U.S.?


Office of Management and Budget Director Shaun Donovan
(Courtesy Govexec.com)

Many in the U.S. vaping community have heard of the FDA, but few know of the role that the White House Office of Management and Budget (OMB) plays in the anti-vaping movement.  There are nine steps involved with the federal regulatory process of any product.  OMD approval is the eighth step, with the ninth being the publishing of the finalized regulations in The Federal Register

The FDA is already successfully in completing seven of the nine steps needed to regulate vaping products.  In April of 2014, the FDA sent their latest updates to the OMB for approval, but the proposed regulations were sent back for recommended revisions.  The FDA offered two options of regulatory restrictions, neither of which was approved by the OMD. 

Option 1:

Attempted to grant FDA regulation of all tobacco cigarettes, cigars, loose pipe tobacco and snuff, hookah tobacco, nicotine gums and gels, electronic cigarettes, nicotine enhanced e-juices, and other dissolvables.  Notable exceptions included any accessories of tobacco products, such as lighters, cigar cutters, cigarette and cigar cases, and hookah accessories. 

Option 2:

Offered the same regulations as Option 1, with another exception for premium cigars.

Had one of these options been approved by the OMD back in 2015, then all of the related categories of products would be subject to the same regulations as Big Tobacco.  If a $2-per-pack tax were to be placed on tobacco cigarettes, for example, e-cigs and e-juices would face a similar financial burden, as well.  Luckily for the vaping community, the OMD did not immediately sign off on the deal, but this doesn’t mean the battle is over.  The next round of FDA proposals could be either less or more severe, depending on the 2014 OMD recommendations which remain clouded in mystery.

Is an agreement between the OMD and the FDA in the near future?

According to Nato News, there are nine separate regulations under consideration that would affect the vaping industry in the following ways, if approved:

  1. Manufacturers would be required to register all related products with the FDA. There would likely be a fee involved and perhaps a lengthy approval time.
  2. Manufacturers would be required to also submit a list of all ingredients of each product.
  3. Manufacturers would be prohibited from using terms like “light,” “mild,” and “low” in their marketing campaigns.
  4. Manufacturers would be prohibited from offering free samples.
  5. Manufacturers would be required to complete a premarket tobacco application (PMTA) for all new products, and the FDA can regulate how, when, and in what manner that these new products can be offered to the public.
  6. Manufacturers whose products are determined to be misbranded or tainted would face certain FDA enforcement actions.
  7. Minimum age to buy tobacco products would remain at 18-years of age, but recent news stories of Hawaii and California attempting to raise the smoking age to 21 might cause a change in this regulation.
  8. All related categories of products would be required to display a health warning: WARNING: This product contains nicotine derived from tobacco. Nicotine is an addictive chemical.”
  9. Retailers cannot sell products through vending machines, unless the machines are located in an adult-only establishment.

It is important to note that this list of nine regulations is the old version of the FDA guidelines, and it is unclear as to why the OMD did not approve them.  As anti-vaping lobbyists continue to be more vocal, many fear that the next revisions of proposed regulations might ban vaping completing in the United States.  As strange as this might sound to the average vaper, similar legislation is already active in Quebec, Canada. 

In this northern province, even selling e-cigs and vaping products online will be illegal in just a few short months.  The Canadian Vaping Association (CVA) is currently trying to get Quebec Bill 44 deemed unconstitutional by the courts.  The U.S. may suffer a similar fate because the only thing standing in the FDA’s way is government approval by a single agency – the OMB.

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