Tag: graphic warnings

  • FDA Halts Packaging Enforcement for 15 Months

    FDA Halts Packaging Enforcement for 15 Months

    Credit: Bilitster

    The U.S. Food and Drug Administration has provided guidance on the “Tobacco Products; Required Warnings for Cigarette Packages and Advertisements” final rule that established new required health warnings for cigarette packages and advertisements.

    Specifically, the FDA has issued guidance to the tobacco industry that describes the agency’s enforcement policy for the final rule. The final rule was issued in March 2020 and was challenged in the U.S. District Court for the Eastern District of Texas. In December 2022, the District Court struck down the rule.

    The government appealed the decision and in May of 2024, the U.S. Court of Appeals for the 5th Circuit reversed the District Court’s decision. This reinstated the final rule, causing the rule to now be in effect. The plaintiffs’ petition for a review by the Supreme Court review is pending.

    “The new guidance for the agency’s enforcement policy states that the FDA intends to exercise enforcement discretion and generally not enforce requirements of the final rule for 15 months, or until December 12, 2025,” an FDA release states. “With respect to products manufactured before December 12, 2025, the FDA also intends to exercise enforcement discretion and generally not enforce the rule’s requirements for these products for an additional 30-day period, or until January 12, 2026.”

    The pause aligns with the 15-month compliance period originally contemplated by the Family Smoking Prevention and Tobacco Control Act.

    The FDA chose 15 months to provide an orderly transition period; this aligns with the 15-month compliance period originally contemplated by the Family Smoking Prevention and Tobacco Control Act, before that timing was disrupted by litigation.

    The final rule also requires the industry to submit a plan and obtain FDA approval for the random and equal display and distribution of required warnings on cigarette packages and the quarterly rotation of required warnings in cigarette advertisements.

    The agency’s guidance recommends that entities that do not already have approved cigarette health warning plans submit such plans as soon as possible, but in any event, within five months or by February 10, 2025. Entities that previously submitted cigarette plans to the FDA do not need to resubmit their plans unless they wish to make changes.

    The public can provide comment on the guidance in the docket at regulations.gov. 

  • Graphic warnings on cigarette packs due in the Philippines

    Health groups in the Philippines have reminded the government and the public that graphic images and warning texts should be printed on the labels of all tobacco products by Nov. 5, in compliance with the Graphic Health Warnings (GHW) Law, according to a story in the Philippine Daily Inquirer.

    Sections 6 and 15 of the GHW Law, or Republic Act (RA) No. 10643, give tobacco manufacturers no more than one year from the issuance of the initial set of templates to comply with the printing requirements, according to a statement issued jointly by HealthJustice, Southeast Asia Tobacco Control Alliance and New Vois Association of the Philippines. Irene Reyes, managing director of HealthJustice, said the department of health published the templates in November 2014.

    “The World Health Organization Framework Convention on Tobacco Control, to which the Philippines is a party, mandates governments, within three years of entry into the agreement, to pass and implement a law requiring tobacco products to carry effective health warnings,” Reyes said.

    Under RA 10643, which was signed into law by President Aquino last year, all tobacco products in the Philippines must display a photographic warning accompanied by text printed on 50 percent of principal display surfaces, such as the front and back of cigarette packs. The law also prohibits the use of “misleading” terms such as “light,” “mild,” “low tar” or other words that suggest a particular variant is less harmful.

    The deadline for the Philippines to implement graphic warnings and text was September 2008, making the country seven years late in fulfilling its obligation.