On March 8, 2023, the U.S. Food and Drug Administration (FDA) announced that it is proposing new requirements that will address the manufacture, design, packing, and storage of commercial tobacco products.
While it may appear as though the FDA is staking out greater oversight over tobacco manufacturers and benefiting public health by ensuring good manufacturing processes, this action masks the extent to which tobacco companies stand to benefit with these requirements. Indeed, tobacco companies have supported this type of regulations for years. The Public Health Law Center submitted comments to the FDA on this issue in 2013 and in 2017, when the agency last accepted public comments on proposed regulations of tobacco product manufacturing processes. In these earlier instances, the proposed regulations were based on recommended language from several tobacco companies.
One reason the Center submitted comments critical of these earlier regulations is that they subtly brought an individual risk standard into tobacco regulations instead of the “public health standard.” The Family Smoking Prevention and Tobacco Control Act requires that the FDA make its decisions about tobacco product regulation based on the public health standard, which focuses on actions “appropriate for the protection of the public health.”
The Center submitted another comment in response to the regulations proposed in 2023. Our comment underscored that the regulations could still do more to incorporate the public health standard. In addition, as with the 2013 and 2017 iterations, the 2023 proposed regulations also do not delineate enforcement mechanisms for companies that violate the regulations, suggesting that enforcement will be largely left to self-policing by the tobacco industry. Finally, the Center urged the FDA to create regulations that appreciate that tobacco manufacturing can cause environmental harms, harms that the FDA can play a role in preventing.
The FDA held a public hearing on the proposed regulations on April 12, 2023, sought the recommendations of the Tobacco Products Scientific Advisory Committee on May 18, and accepted comments on the proposed regulations through October 6, 2023.