FDA Jumps the Gun on E-Cigarette Regulations

WASHINGTON, D.C. – Today, the American Vaping Association, a leading advocate for the benefits of vapor products such as electronic cigarettes, reacted to the Food & Drug Administration’s (FDA) Center for Tobacco Products’ plan to publish an Advanced Notice of Proposed Rulemaking (ANPRM) with regard to vapor products in the Federal Register tomorrow, July 1st. This marks the first occasion that the FDA has formally signaled its intent to eventually set product standards for vapor products.

Through the ANPRM, the FDA is seeking comment on the possibility of requiring child-resistant packaging and nicotine exposure warnings for products containing liquid nicotine, such as bottled e-liquids. Importantly, while the FDA can seek out information, the agency has no power to issue any proposed rule until the ‘deeming’ regulation is finalized (and possibly litigated).

“The FDA is jumping the gun by moving on this issue before the deeming regulation has been finalized,” said Gregory Conley, President of the American Vaping Association. Reflecting on the fact that the FDA had previously pledged to have the deeming regulation finalized in June 2015, only to issue this ANPRM on July 1st, Conley noted, “The timing indicates that this is more of a public relations strategy than it is the actions of a neutral regulator just collecting information.”

Conley and the AVA expressed support for child-resistant packaging that is in line with already existing federal law, but urged caution in formulating warning labels.

“Child-resistant packaging is already in use by the vast majority of e-liquid manufacturers,” said Conley. “Measures should be taken to keep all nicotine-containing products, including pharmaceutical products like the nicotine gum, out of the hands of children.”

Conley warned, however, that warning labels present distinctly different issues than child-resistant packaging. “Poorly designed warning labels have the capacity to mislead adult smokers on the relative risks of vaping versus tobacco smoking,” said Conley. “Any proposed warning must be thoroughly tested to ensure that it only imparts factual information.”

Equally concerning to the AVA is the FDA’s inaction on cigarette warning labels, which were mandated by Congress in 2009. “Why is the FDA even inquiring about placing color warnings on vapor products when they haven’t even fulfilled their duty to Congress to require graphic warnings on deadly combustible cigarettes?” asked Conley. “With each passing month, it seems that the FDA is doing less and less to combat the most lethal products on the market.”   

Currently fourteen states have laws requiring child-resistant packaging for nicotine-containing e-liquid products.* These states have almost universally mirrored language from the federal Poison Prevention Packaging Act, which provides clear language and allows for consistency between states.

The AVA continues to support proposals in the U.S. Congress that would prevent the FDA from retroactively requiring vapor products already on the market to undergo a potentially multimillion dollar “pre-market” approval process.

* Minnesota, Vermont, New York, Connecticut, Arkansas, Indiana, North Dakota, New Mexico, Nevada, Oregon, Tennessee, Texas, Virginia, and Wyoming have enacted child-resistant packaging laws. Not all laws have gone into effect. Bills in Missouri and North Carolina are awaiting action their respective Governors.   

For further analysis of data regarding calls to Poison Control Centers from vapor products, we recommend this article by Clive Bates, former head of the UK’s largest anti-smoking group Action on Smoking & Health.