online sales redux
The US Food and Drug Administration has been surprising everyone with the moderate character of its new deeming regulations. Not only has Tobacco Products honcho Mitch Zeller declared that the agency has "an open mind" regarding by the "continuum of harm" that characterizes the range of nicotine-containing products, but some substantive revisions have been made in the deeming documents.
This week the agency extended its deadline for comments, and also modified some language in a decidedly open-minded way.
In its provisions banning vending machine sale of electronic cigarettes (except in venues with a round-the-clock "adults-only" rule), language that could have opened the door to an online sales prohibition was removed. The earlier document used the phrase "non-face-to-face sale" while this week's revised text removes that phrase to speak specifically about vending machines only.
The revision also softens provisions regarding quality control review of electronic cigarettes by the FDA.
The revisions and deletions were made by the Office of Management and Budget, which is an administrative arm of the White House. More extensive changes in the revision had to do with exemption of certain "premium cigars" from strict regulation, a measure that was strongly lobbied by advocates for the cigar producing industry.
There is considerable speculation to the effect that the ultimate deeming rule will allow online sale of e-cigarettes if an effective age-verification mechanism can be devised. This will come as a disappointment to critics of the vaping movement, who had hoped to ban online sales. The news comes in the wake of harsh criticism from senators convinced that e-cig companies are targeting underage users when they offer vaping supplies in candy-like flavors. Of course the criticism is rendered moot if internet sales platforms can effectively demand accurate birthdate information before authorizing sales.
The adoption of an FDA stance more friendly to harm reduction could reflect a certain turning of the tide in the effort to regulate vaping supplies sensibly. Earlier on, it had seemed that the agency was aligned with some of the prohibitionist attitudes characteristic of the Centers for Disease Control. But the hearings leading up to deeming, and now the suggestions being submitted during the post-deeming feedback phase, may be producing a change of heart, and mind.
The recognition that users who are vaping to quit constitute a genuine social movement, one that is committed and passionate, has to be a factor here. This realization comes at the same time as growing array of studies demonstrates that the minimal risks of e-vapor are insignificant, and there are more and more studies studies showing that smoking cessation through vaping is real.
It is even possible to hope that Yankee open-mindedness on this issue will ultimately affect decisions about the implementation of the Tobacco Products Directive in the European Union as well.