This morning, FDA released a new “advance noticed of proposed rulemaking” (or “ANPRM”, because we need an acronym for everything) which outlines FDA’s intent to regulate the labeling, packaging and child-proofing of e-liquid.
The bulk of meaning to be gathered from this document comes in a series of questions, seeking public comment on how FDA should treat e-liquid and other novel products that use tobacco-derived nicotine. In the first section asking for comment, FDA is inquiring on what warnings should be given on e-liquid bottles, whether they should be broad or specific, and if specific what “dangers” they should specify about the e-liquid product. In my mind, the use of the word “dangers” could range from the danger of keeping e-liquid in range of children and pets (which nearly all e-liquid manufacturers currently cover) to potential dangers that they may feel are associated with nicotine use.
The rest of this section on e-liquid labeling gets into specifics like whether or not Poison Control numbers should be printed on labels, or if certain fonts or colors should be used in the warning
The final section of this release gets into child-proofing e-liquid, something that the vape community and industry is nearly unanimously in favor of. FDA is asking specifics here, as to what child-proofing should be used and how to determine what child-proofing is sufficient.
Unfortunately, this release gives zero information on FDA’s plans to regulate how vapor products are marketed on the label, in terms of flavor names and colors. Such information would be extremely powerful at this juncture, with concern and controversy continuing to mount in the vaping community regarding the use of things like recognizable cartoon characters, candy and cereal brands on e-liquid bottles.
What we can gather is that FDA is absolutely going to take some action on both nicotine warnings and bottle child-proofing, something that anyone paying attention has likely assumed all along. Most of all, anyone with any concern for vaping, especially those with a stake in this industry should absolutely reply to this document with comment for any questions they can provide on. Though it doesn’t look like this particular proposal is currently available online for comment, when it does become available it should be accessible on the Search box of Regulations.gov by searching for “Docket No. FDA-2015-N-1514” (without quotes).