CTP Held Public Hearing on Manufacturing Rules

On April 12, 2023, the Food and Drug Administration’s Center for Tobacco Products (CTP) held an online public hearing regarding its recently released proposed rule on “Requirements for Tobacco Product Manufacturing Practice.” This public hearing was scheduled when the CTP issued the proposed rule on March 10.

The hearing began with introductory comments by CTP Director Brian King. In addition to welcoming the participants and audience to the hearing, King noted that the CTP has been designing this proposed rule since 2011. Following King was Matthew Brenner, CTP senior regulatory counsel. Brenner summarized the proposed rule and highlighted the definitions of a “finished tobacco product” and a “bulk tobacco product” with regard to the rule. Emil Wang, senior advisor for manufacturing and regulatory policy at the CTP’s Office of Compliance, concluded the introductory session by detailing the timeline of the proposed rule. The proposed rule’s 180-day public comment period is between March 10 and Sept. 6, 2023. The effective date for the regulation would be two years after the final rule is published in the Federal Register. For small manufacturers (those manufacturers with fewer than 350 employees), the effective date for the regulation would be six years after the final rule is published in the Federal Register.

The public comment session featured the following scheduled participants (in order):

• James O’Reilly—professor of public health policy at the University of Cincinnati. O’Reilly called the proposed rule “comprehensive” and noted that the CTP needs to add another $100 million in additional staff to properly enforce this rule. O’Reilly also called on the CTP to coordinate with other federal agencies, such as the Environmental Protection Agency, to handle foreign chemical imports that relate to this rule.
• Drew Newman—JC Newman. The premium cigar maker representative highlighted four items: flexibility is required as each tobacco product differs from one another; recordkeeping is lengthy and costly; qualifying suppliers such as tobacco leaf growers will be difficult; and batch coding for final products will prove very difficult for the premium cigar industry.
• Hiuyu Shi—e-cigarette manufacturer from Shenzhen, China. Shi noted that foreign components will be very difficult to regulate and monitor. One example was the difference in water quality between nations.
• Laura Searcy—National Association of Pediatric Nurse Practitioners. Searcy supports the proposed rule.
• Gabby Kaife—Boutique Cigar Association. Kaife is against the proposed rule.
• Jason Hodge—former smoker and current vaper. Hodge is against the proposed rule.
• Joshua Habursky—deputy executive director of the Cigar Association. Habursky is against the proposed rule.
• Meredith Berkman—Parents Against Vaping. Berkman supports the proposed rule.
• Maham Akbar—The Truth Initiative. Akbar supports the proposed rule.
• Connor Fuchs—Campaign for Tobacco-Free Kids. Fuchs supports the proposed rule and notes that the timeline is too long and should be shortened.
• Mark Anton—e-cigarette/vapor product manufacturer. Anton believes that sections of the proposed rule conflict with previous statements by the CTP. Also, he believes that the burden has been shifted from the regulator to the manufacturer.
• Patrick Murphy—vice president of scientific and regulatory affairs at Reynolds American Inc. (RAI). Murphy calls for further refinement and guidance to the proposed rule. He calls for more clarity in several sections and better processes that are product dependent. RAI will forward its notes in a written comment.
• Michelle Paige—tobacco chemist. Paige discussed storage conditions and stability issues regarding electronic nicotine-delivery system liquids. Further product standards are needed in this area.
• Sammy Hamdouche—Lucy, manufacturer of oral nicotine products. Hamdouche called the regulation onerous for small manufacturers such as his company. Further labor for his company and their suppliers could eliminate parts or potentially all of their business. Costs could be 10-fold for these processes for his company. Predetermined acceptance criteria could be one solution. The CTP has wide latitude to make this rule more flexible, but Hamdouche is not optimistic.
• Ron Tully—tobacco industry consultant. Tully believes that the proposed rule should recognize manufacturers of different products and sizes. Small manufacturers could face financial disaster with this rule.
• Pamela Ling—professor at the University of California at San Francisco. Ling supports the proposed rule. She also calls to strengthen the section of the rule regarding storage procedures and shelf life.
• Pamela Granger—anti-tobacco activist. Granger supports the proposed rule.

The public comment session featured the following unscheduled participants (in order):

• Jason Hodge concluded his earlier
• Delores Orlando—Florida Smoke-Free Organization, nicotine product manufacturer. Orlando is against the proposed rule.

On May 18, 2023, the CTP’s Tobacco Product Scientific Advisory Committee will meet the discuss the proposed rule on “Requirements for Tobacco Product Manufacturing Practice.”