|Decision deadlines near FDA schedule
By Linda Abu-Shalback Zid
CSP Daily News
ROCKVILLE, Md. — Following the release of an annotated version of the Tobacco Products Scientific Advisory Committee’s (TPSAC’s) report on menthol, the next few weeks will be a flurry of activity for the FDA Center for Tobacco Products (CTP), notably with a conclusion expected today about which new warning messages and images will be required for cigarette packaging.
Also this week–90 days after the March 23rd deadline of the TPSAC report–the CTP is slated to update the industry on its progress regarding its review of the science surrounding menthol cigarettes. According to the CTP website, “The FDA recognizes the strong interest in this issue among all stakeholders and will continue to communicate the steps the FDA is taking as it determines what future regulatory actions, if any, are warranted.”
Dates to watch include:
Warning Labels by June 22
The FDA issued a proposed rule to modify the required warnings that appear on cigarette packages and in cigarette advertisements. The warnings include nine new text warning statements accompanied by color graphics depicting the negative health consequences of smoking.
The Family Smoking Prevention and Tobacco Control Act requires the FDA to issue final color graphics by Wednesday. It also specifies that the requirement for the new health warnings on cigarette packages and advertisements will take effect 15 months after issuance of the final rule. The nine textual statements are:
- WARNING: Cigarettes are addictive.
- WARNING: Tobacco smoke can harm your children.
- WARNING: Cigarettes cause fatal lung disease.
- WARNING: Cigarettes cause cancer.
- WARNING: Cigarettes cause strokes and heart disease.
- WARNING: Smoking during pregnancy can harm your baby.
- WARNING: Smoking can kill you.
- WARNING: Tobacco smoke causes fatal lung disease in nonsmokers.
- WARNING: Quitting smoking now greatly reduces serious risks to your health.
Compliance Training June 28
At 1 p.m. eastern time, June 28, the CTP will host a webinar to provide retailers with FDA compliance training information on “Smokeless Tobacco Product Packaging and Advertising Requirements.” Click here
for more information.
Menthol Discussion July 21
In the morning, TPSAC will discuss proposed editorial changes to its menthol report and consider additional oral and written comments from the public. “The committee will consider and deliberate on proposed changes to the report and adopt amendments that constitute the advice of the committee,” according to CTP website.
Dissolvable Tobacco July 21-22.
In the afternoon these dates, TPSAC will initiate discussions on dissolvable tobacco products. The discussions will begin the process for TPSAC’s required report to the Secretary of Health and Human Services “regarding the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children,” according to the CTP website. “The final report should take under consideration (1) the risks and benefits to the population as a whole, including users and nonusers of tobacco products; (2) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and (3) the increased or decreased likelihood that those who do not use tobacco products will start using such products.”