Next Up for Potential FDA Regulation: E-Liquids

SILVER SPRING, Md. — While the tobacco industry still awaits the final deeming rule on electronic cigarettes, the Food and Drug Administration (FDA) is now taking steps to regulate e-liquids.

Last week, the agency issued "an Advance Notice of Proposed Rulemaking (ANPRM) seeking comments, data, research and/or other information related to nicotine exposure warnings and child-resistant packaging for liquid nicotine, nicotine-containing e-liquid(s) and potentially for other tobacco products including, but not limited to novel tobacco products such as dissolvables, lotions, gels and drinks."

The 60-day public comment period began July 1.

The FDA made the move after evaluating data and science related to the risks, especially to infants and children, from accidental exposure to nicotine, including exposure to liquid nicotine and nicotine-containing e-liquid. According to the agency, the increase in the use of electronic nicotine devices — such as e-cigarettes — which often use liquid nicotine and nicotine-containing e-liquids, has coincided with an increase in calls to poison control centers and visits to emergency rooms related to liquid nicotine poisoning and other nicotine exposure risks. 

Its assessment of these recent trends has led the agency to seek additional information on whether, based on the acute toxicity of nicotine (up to and including nicotine poisoning), it would be appropriate for the protection of the public health to:

• Warn the public about the dangers of nicotine exposure (especially due to inadvertent nicotine exposure in infants and children); and/or
• Require some tobacco products to be sold in child-resistant packaging.

The American Vaping Association (AVA), however, is questioning the agency's bid to regulate e-liquids when it has yet to finalize the deeming regulation for e-cigarettes.

"The FDA is jumping the gun by moving on this issue before the deeming regulation has been finalized," said Gregory Conley, president of the AVA. 

At the 2015 NATO Show in April, Mitch Zeller, director of the agency's Center for Tobacco Products, said the FDA was targeting the month of June to release a final deeming rule — a timeline that has now passed.

Reflecting on the timing of the ANPRM, 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. Measures should be taken to keep all nicotine-containing products, including pharmaceutical products like the nicotine gum, out of the hands of children," he said.
 
Warning labels present distinctly different issues than child-resistant packaging, according to Conley. "Poorly designed warning labels have the capacity to mislead adult smokers on the relative risks of vaping vs. tobacco smoking," he said. "Any proposed warning must be thoroughly tested to ensure that it only imparts factual information."

The AVA pointed out that this is the first time the FDA has formally signaled its intent to set product standards for vapor products.