On his way out the door, departing FDA Chief slaps vaping with harsher regs
The head of the U.S. Food and Drug Administration (FDA) may have just resigned his post, but he appears to want to go out with a bang rather than a whimper. On March 13, Dr. Scott Gottlieb announced his latest proposal to implement harsher vaping regulations in a last-ditch attempt to curb teen vaping. While the regulatory proposal is still in the draft stages, Gottlieb wants to limit the sales of flavored vapor products to only age-restricted venues.
This would mean that gas stations, convenience stores, and even pharmacies would be strictly prohibited. However, they could still offer these items but only if they commit to keeping them stored in a separate room that is inaccessible to underage consumers.
How will the new regulations affect online sales?
Gottlieb’s proposal doesn’t stop at conventional brick-and-mortar shops. He also takes a last-minute swipe at certain e-commerce stores with prior histories of selling to minors. According to the FDA press release, many of these repeat violators are at risk of being shut down permanently by the FDA. Meanwhile, the remaining online retailers must implement proper age-verification tools if they want to continue selling their products.
“Our proposed policy provides examples of circumstances that we’ll consider – for example, if flavored ENDS products are sold in locations where minors can enter at any time (e.g., the entire establishment or an area within the establishment); or, for online sales, if the products are sold without an appropriate limit on the quantity that a customer may purchase within a given period of time, and without independent, third-party, age- and identity-verification services that compare customer information against third-party data sources, such as public records. We’re also specifically seeking comment on, among other things, whether there are new technologies that can help prevent youth access at retail locations and intend to consider the use of those tools when we finalize the guidance.?
FDA Chief Gottlieb also wants to restrict the quantity of vapor products that an individual consumer can purchase in a single visit, either online or through a proper age-restricted venue. The current draft guidance of the regulations does not make clear what these limitations will be, but the public has a 30-day window to respond and offer input before the regulations will be implemented.
A general overview of the new regulations focusses on the following issues:
- Retail establishments where "minors are able to enter at any time" are to be heavily restricted.
- Online retailers with documented histories of selling to minors may be shut down permanently.
- Websites must place limits on the amount of vapor products being purchased.
- E-commerce stores must independently verify the age of their customers before purchase.
- The flavor restrictions will not apply towards tobacco, mint, and menthol flavors.
- The flavor restrictions will apply to the cigar industry, as well.
FDA Chief Gottlieb also notes in his press release three likely outcomes of the new regulatory actions:
- He expects “that some flavored e-cigarette products will no longer be sold at all.”
- He expects that other flavored products will continue to be sold but “only in a manner that prevents youth access.”
- Since the flavor restrictions will also apply to cigars, many of these products will also disappear from the marketplace.
FDA flavor restrictions receive mixed reviews
Many within the vaping community is understandably up-in-arms. And by initial outward appearances, the convenience store chains are, too. The American Lung Association is also upset but for vastly different reasons. A spokesperson for the organization, Erika Sward, told USA Today,
“FDA continues to nibble around the edges and that will not end the epidemic.”
The notoriously anti-vaping Campaign for Tobacco-Free Kids (CTFK) also believes that the new regulatory proposal is not going far enough. According to Business Insider, the CTFK “criticized the latest step for not focusing on Juul specifically or applying to menthol and mint e-cigarette flavors.” CTFK President Matthew Myers issued the following statement.
"With Juul and other mint- and menthol e-cigarettes still widely available, it is doubtful the FDA's new policy will stem the tide of youth e-cigarette use."
But Juul has already banned the selling of their flavored vaping products in these same locations that Gottlieb wants to restrict. The flavors are still readily available for purchase on a website that already implements FDA-approved age-verification software. And quite notably, Juul executives seem to be somewhat on-board with the new FDA proposal, at least initially.
FDA officials also considered modifying its regulatory approach to hookah products within the content of the draft guidance. But regulators were unsure if placing further restrictions on hookah flavors would produce any positive or negative effects on teen vaping, if any effect at all.
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