"... the FDA has finally issued guidance on the sale of flavored vaping products.
“We’re proposing to prioritize enforcement of flavored ENDS products (other than tobacco-, mint-, and menthol-flavored) that are offered for sale in ways that pose a greater risk for minors to access the products,” Gottlieb said in a statement. “For instance, we’ll consider whether the products are sold under circumstances, whether at retail or online, without heightened age verification.”
The big news is that the agency has moved up the deadline by one year for manufacturers to submit premarket tobacco applications (PMTA’s) for flavored products other than tobacco, mint and menthol — from Aug. 8, 2022 to Aug. 8, 2021.
Since the FDA has still not produced promised standards-based regulations for small manufacturers like e-liquid makers, this could amount to a death sentence for any vaping business that depends on sales of flavored e-liquid.
Most of the new requirements were part of Gottlieb’s November guidance announcement. Other components of the new guidance include:
Enforcement actions against e-liquid in packages the FDA says attract minors
Prohibit sales in establishments that allow minors entry
Quantity limits on purchases
Enhanced age verification for online sales
The FDA has already targeted e-liquid brands that use so-called kid-appealing packaging, like labels and boxes that copy candies and fruit drinks. The announcement today seems to indicate further enforcement against such practices.
Forcing flavored products into stores that prohibit entry to minors means that convenience stores will be unable to sell flavored vaping products (other than tobacco, mint and menthol), but will still be allowed to sell cigarettes, beer, liquor, and pornography. Retail trade associations have already announced that they may go to court to challenge the FDA policy.
Gottlieb says that online sellers should be using “independent, third-party, age- and identity-verification services that compare customer information against third-party data sources, such as public records.” These are services that many online vaping retailers already use.
The FDA guidance document is long and repetitive, but the evidence it contains to support flavor restrictions is weak. The agency claims that it has the evidence needed to conclude that flavored vaping products (other than tobacco, mint and menthol) are uniquely attractive to minors and not important to adults. But the studies cited are old and limited (including a 2014 survey of fewer than 400 Connecticut high school students), and the regulators ignored last year’s national survey of almost 70,000 adult vapers that clearly shows that successful ex-smoking vapers prefer fruit and dessert flavors.
EDIT:
https://vaping360.com/vape-news/77702/fda-announces-new-restrictions-on-flavored-vapes/
13 March 2019
“We’re proposing to prioritize enforcement of flavored ENDS products (other than tobacco-, mint-, and menthol-flavored) that are offered for sale in ways that pose a greater risk for minors to access the products,” Gottlieb said in a statement. “For instance, we’ll consider whether the products are sold under circumstances, whether at retail or online, without heightened age verification.”
The big news is that the agency has moved up the deadline by one year for manufacturers to submit premarket tobacco applications (PMTA’s) for flavored products other than tobacco, mint and menthol — from Aug. 8, 2022 to Aug. 8, 2021.
Since the FDA has still not produced promised standards-based regulations for small manufacturers like e-liquid makers, this could amount to a death sentence for any vaping business that depends on sales of flavored e-liquid.
Most of the new requirements were part of Gottlieb’s November guidance announcement. Other components of the new guidance include:
Enforcement actions against e-liquid in packages the FDA says attract minors
Prohibit sales in establishments that allow minors entry
Quantity limits on purchases
Enhanced age verification for online sales
The FDA has already targeted e-liquid brands that use so-called kid-appealing packaging, like labels and boxes that copy candies and fruit drinks. The announcement today seems to indicate further enforcement against such practices.
Forcing flavored products into stores that prohibit entry to minors means that convenience stores will be unable to sell flavored vaping products (other than tobacco, mint and menthol), but will still be allowed to sell cigarettes, beer, liquor, and pornography. Retail trade associations have already announced that they may go to court to challenge the FDA policy.
Gottlieb says that online sellers should be using “independent, third-party, age- and identity-verification services that compare customer information against third-party data sources, such as public records.” These are services that many online vaping retailers already use.
The FDA guidance document is long and repetitive, but the evidence it contains to support flavor restrictions is weak. The agency claims that it has the evidence needed to conclude that flavored vaping products (other than tobacco, mint and menthol) are uniquely attractive to minors and not important to adults. But the studies cited are old and limited (including a 2014 survey of fewer than 400 Connecticut high school students), and the regulators ignored last year’s national survey of almost 70,000 adult vapers that clearly shows that successful ex-smoking vapers prefer fruit and dessert flavors.
EDIT:
https://vaping360.com/vape-news/77702/fda-announces-new-restrictions-on-flavored-vapes/
13 March 2019