On March 13, 8 days after the announcement of his resignation, Gottlieb released a statement in which he introduced some important measures aimed at containing the appeal of vaping among young people.
These measures concern the sale of flavored liquids and follow what was anticipated by Gottlieb himself in November. It seems that the time of the much feared flavor ban is coming.
Previously, the FDA placed the PMTA deadline at August 2022 for ENDS already on the market on August 8, 2016. In addiction, no enforcement was applied while the application was under review.
Now, a new compliance policy is introduced. This new approach doesn’t apply to tobacco-, mint-, and menthol-flavored ENDS products which remain under the previous indications. Some evidence actually may indicate that these flavors are not so appealing to youth while may meet the tastes of adults trying quitting smoke.
The modified compliance policy of flavored vaping products (other than tobacco-flavored, mint-flavored, and menthol-flavored) is outlined in a draft guidance, which FDA intends to finalize as soon as possible. In this document, FDA discloses how it “intends to prioritize enforcement regarding the lack of marketing authorization against flavored ENDS products” that are sold in ways easily accessible for youth (both for retails or line shops).
Even products that appeal to minors or are particularly attractive to them (by the use of particular images in marketing or by the use of social media) will be the object of particular attention by FDA.
The FDA is expecting that this approach will lead to withdrawal of the market of some flavored products.
In addition, for the flavored products that will remain on the market, manufacturers are expected to submit PMTA by August 8, 2021 (one year earlier than previously proposed deadline). With a yet not defined standard-base regulations, these could be a huge problem for small manufacturers: who can afford very high cost for a PMTA per product with no guarantee of approval?
The new policy outlined will condemn producers and professionals in the sector to a difficult survival.