FDA Considers Setting Product Standards on Vaping Products in Unprecedented Decision

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FDA Approved Regulations on E-Cigs and Vaping Products

Washington, D.C. – The FDA has formally announced its intention to publish an Advanced Notice of Proposed Rule-making (or ANPRM for short) regarding vapor products. This will be the first time the FDA has announced intentions to set product standards for such products. The American Vaping Association, which is an advocacy group that speaks on the potential benefits of vaping products, has expressed concern regarding the FDA’s plans.

According to this document released by the FDA, they are seeking comments on requiring the use of child resistant packaging and prominently displayed nicotine exposure warnings on all vapor and e-cigarette products. Typically, the FDA does not have the authority to create any such rules until a deeming regulation that classified vaping and e-cigarette products as “modified risk tobacco products” had been passed. The FDA has made the unprecedented move of releasing this ANPRM before the deeming regulation had been passed. Currently, vaporizers and e-cigarettes remain largely unregulated, and the benefits and risks of vaping have been a subject of debate for many years.

Although in favor of the use of child resistant packaging, Gregory Conley, the head of the AVA, expressed concern over requiring nicotine exposure warnings. “If warning labels are badly designed, they can give false information about the risks of vaping versus tobacco smoking,” Conley said. “We want to make sure that any proposed warning gives accurate information.” He then went on to add “Why the FDA would even inquire about putting these warnings on vapor products when they haven’t fulfilled their duty to require prominently displayed warnings on combustible cigarettes is beyond me. Every month, the FDA seems to do progressively less to combat combustible cigarettes which are many times more dangerous than vapor products.”

It should also be noted that currently, the following states have already passed legislation that require all e-liquids to be sealed in child resistant packaging:

  • Minnesota
  • New York
  • North Dakota
  • Connecticut
  • Arkansas
  • Indiana
  • New Mexico
  • Oregon
  • Nevada
  • Tennessee
  • Texas
  • Virginia
  • Wyoming

Interestingly, the language that was used in the legislation for each state is very similar to the federal Poison Prevention Packaging Act.

The AVA continues to proactively support measures to block all attempts by the FDA to require vaporizers and e-cigarettes to undergo the same pre-market approval process as normal cigarettes, citing concerns that the process could cost companies millions of dollars, which may put some of the smaller manufacturing companies out of business. Those that can afford to remain in compliance would need to pass the cost on to the consumer in the form of higher prices on vaping products and e-liquids.

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  • Ali Esmaili
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