Warnings Inching Closer

The extended period to comment on the U.S. Food and Drug Administration’s (FDA) proposals for graphic health warnings ends today.

The 2009 Family Smoking Prevention and Tobacco Control Act (TCA) directed the FDA to issue regulations requiring that cigarette packages and advertisements include new health warnings with text statements and color graphics depicting the negative health consequences of smoking.

The original regulations published by the FDA in 2011 were challenged in court by several tobacco companies and vacated in August 2012 on First Amendment grounds.

The agency has since reworked its proposed warnings and FDA officials think the current draft regulation and revamped photos will stand up to further First Amendment challenges.

“The FDA believes the proposed warnings would survive judicial scrutiny because they advance the substantial government interest of promoting greater public understanding of the negative health consequences of smoking and are factual, accurate, and not unduly burdensome,” an agency representative told MedicineNet in an e-mail message.

Following a lawsuit by public health groups, a judge in March directed the FDA to publish the proposed rule by August 2019 and issue a final rule in March 2020. The warnings would be required to appear on packages and in advertisements 15 months after a final rule is issued, which means U.S. smokers could be looking at graphic health warnings in 2021.

As of Nov. 27., the FDA had received 288 comments to its proposed rule on graphic health warnings.