During the first session at the Society for Research on Nicotine and Tobacco we heard from Lawrence Deyton, the doc in charge of implementing the Family Smoking Prevention and Tobacco Control Act, which puts the tobacco industry under FDA regulation.
While the beginning of his speech was more of a pep-talk, there were a few interesting bits of info. One of the not-very-surprising items was that the FDA will have different standards for tobacco will be different than for the other drugs they review. Although some of us had wanted the FDA to deem there was no safe level of tobacco use, therefore pull it off the markets, it’s pretty obvious now that FDA will not do that. FDA will instead act with regulatory actions.
There were 5 Key features of the act he wanted to point out from the policy:
- The act mandated ceasing the selling of fruit or other spice-flavored cigarettes – which has already has been implemented. As most of us know, this does not include Menthol, which sucks because menthol tends to be used most in the most disparate populations.
- Act requires the creation of a Tobacco Product Scientific Advisory Committee. They will look at things like “the use of menthol with children or minority” One thing that made me go “YIKES”: Three non-voting members from tobacco companies, including growers. However, most will be docs. I’m personally afraid that the non-voting members will be some of the best speakers tobacco companies will find. I used to be a non-voting member on the Board of Education, and while I advocated for voting rights, there’s a great deal of influence that comes with simply sitting on a board of any sort. And why would FDA want to take any guidance of any tobacco industry people? Alright, put that on my “does not compute” column.
- Establish good manufacturing practices. But good to who? Good tobacco marketing practices for the population would be NO marketing. I have a feeling that they are going for “good for all” type of agreement. Right, as if tobacco companies need any extra help.
- Requires manufactures to report ingredients, including nicotine, and risks in engaging in products.
- Authorizes FDA to put larger warning statements on packs (1 of 9) an on smokeless tobacco products (1 of 4). They will be large and have color graphics. I wonder if there’s a place to look at them?
The doc stated if tobacco companies don’t stay in line, FDA will investigate and ensure compliance. They have already issued 25 letters already. Yes, you read right, a “letter”,
Finally, the doc ended by saying what they are working on immediately:
- Reissue the 1996 rule that advertising shouldn’t be to youth
- Enforce requirement that companies using light low mild must put in applications with FDA. Applications?! Seriously? Isn’t there enough data out there to show that these are misleading titles?
- Will research if certain words, colors, etc. may mistakenly signal that certain tobacco products are safer. (see my commentary above)
Essentially, at the end the Doc wanted to make sure that we understood that FDA has to follow science and he stated “the success of our efforts will be ultimately determined by the quality of our science.”
He also encouraged for researchers and tobacco control experts around the country to give ideas to FDA through dockets they develop to get community input. You can find them at http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM173455
During the question and answer the Doc did made it clear that Nicotine Replacement Therapy will not be regulated by the same group that will regulate tobacco. NRT will be regulated as a drug delivery. He could not share much about e-cigarettes because there is a pending lawsuit.
For more information about the Family Smoking Prevention and Tobacco Control Act visit http://www.fda.gov/TobaccoProducts/default.htm