Cole-Bishop Update, The Vape Clarification Act
After months of fear and uncertainty following the official rollout of the federal Food and Drug Administration's "deeming regulations" that seemed at one point destined to send the vape world back to the veritable dark ages of vaping technology (read: 2007), it appears some relief may be in sight.
Last week, Congressmen Tom Cole (OK) and Sanford Bishop (GA) introduced a bill they're calling the FDA Deeming Authority Clarification Act of 2017.
The crux of the Act is to classify vapor products in their own category – while still falling under the authority of an existing law giving the FDA authority to regulate vape liquids and gear as tobacco products, it properly recognizes that a different approach to regulation is needed as opposed to a blanket regulation lumping vape mods in with combustible tobacco products.
The biggest factor is the "predicate date" under which new products must comply with federal regulations. Though they just took effect in August 2016, the FDA sought to apply its restrictions retroactively to every product introduced since 2007, when vaping was in its infancy. If the new law passes, the FDA will have to revise its deeming regulations as related to e-cigarettes and accessories, with the restrictions only applicable 21 months after their final release. Not only would this allow virtually all modern technology to continue production without the costly onus of submitting pre-market applications for slight variants of a product.
The bill also sets out some common sense regulations, including warning labels on products, a ban on sales to minors, a ban on advertising in outlets that target youth, and a requirement for all sales to be conducted in-person (with a carve-out for online sales, this means that e-cigarette vending machines will not replace the mostly phased-out cigarette machines).
While certainly a welcome development, enthusiasm at this point must be tempered – similar provisions, either in bill form or as amendments to omnibus spending bills, have been tried several times since 2015, before the deeming regulations were even finalized. To date, none have been successful, though we'll continue to watch with much interest.