03/22/2018
FDA ANNOUNCES ANPRM ON FLAVORS
March 22, 2018
This week the FDA published its Advanced Notice of Proposed Rulemaking (ANPRM) entitled "Regulation of Flavors in To***co Products." This is not a surprise, as it is what FDA first announced last July. The ANPRM seeks information onwhether and how FDA should implement regulations on the use of flavors in to***co products and ENDS.
What is an ANPRM? An ANPRM is the earliest step that can be taken in a regulatory rulemaking process. Contrary to some alarming claims, the ANPRM does not proffer a proposed regulation. Rather, it asks for comments on a series of questions that the FDA will consider in evaluating whether to draft a regulation and, if so, what it should look like. After reviewing all the comments, FDA then prepares and publishes its Notice of Proposed Rulemaking (NPRM) which will then be submitted to another notice-and--comment period. Given the complexities of what is being requested, this process can take quite some time.
Here are some interesting highlights from the Commissioner's statement:
"But when it comes to flavors in non-combustible products like electronic ni****ne delivery systems or e-ci******es we recognize the issue involves additional considerations. Here, it's possible for flavors to do both harm and good."[W]e're aware that certain flavors may help currently addicted adult smokers switch to potentially less harmful forms of ni****ne-containing to***co products.I've talked to ex-smokers, who've told me that they quit ci******es altogether and that they now v**e. And they've also told me it was the flavors that helped them make that transition off combustible ci******es. Now I know anecdotes aren't the same as data. And the ANPRM specifically seeks data on this issue. But these personal stories are important to me as we shape our overall approach to smoking cessation. And it's important to me that we uphold the FDA's responsibility to consider all sides and take into account, among other things, the risks and benefits to the population as a whole.
Commissioner Gottlieb's full statement can be found here. And, the full ANPRM can beread here.
What does it all mean? It means that FDA is seriously exploring regulations on limiting flavors in both to***co products and ENDS products. It means that FDA is at the beginning stages of determining whether and how to regulate flavors. It means that our industry needs to respond with the appropriate analyses to defend flavors since, as the Commissioner recognizes, they do play a role in smoking cessation and the transition away from ci******es to lower risk v***r products.
What are we doing about it? In anticipation of this ANPRM, VTA already began assembling its team of experts to respond. Given that VTA's Board and VTA's membership is comprised of some of the largest flavor companies, distributors of open systems, and e-liquid companies in the world, and given that we represent the interests of v**e shops selling e-liquids and open systems in two dozen states, we are uniquely positioned to take on this fight.
We will be coordinating an industry response, and we'll be announcing an aggressive campaign regarding the FDA in the coming weeks. So, if your company is interested in participating with us in a full-throated scientific defense of flavors, please let us know now by sending an e-mail to us atSaveFlavors@v***rtechnology.org.
Thanks for all you do to save v***r!
Tony Abboud
Executive Director
V***r Technology Association
