FDA Issues Guidance on Tobacco and Nicotine

Following the Reagan-Udall Foundation's assessment of the Center for Tobacco Products, the Food and Drug Administration commissioner outlined proposed actions for tobacco and nicotine products.

After being challenged, and even continued, by public health stakeholders for the slowness of its procedures, the Food And Drug Administration (FDA) is now keen to show that it is fully mobilized on the issues of tobacco and nicotine. An evaluation of the FDA's Center for Tobacco Products (CTP) has since been conducted and delivered on December 19, 2022 by the Reagan-Udall Foundation[1]Based on this assessment and internal feedback, FDA Commissioner Robert Califf and CTP Director Brian King presented their outlook for action on tobacco and nicotine products in the months and years ahead on February 24.[2]A five-year action plan should be unveiled at the end of 2023.

Strengthening of accreditation actions and regulatory sanctions

In charge of tobacco products since 2009, the FDA's authority was extended in 2022 to all nicotine products. The FDA and CTP officials first recalled the extent of the work accomplished by the CTP in terms of accreditations, in particular the rejection of millions of non-regulated e-liquids and the approval of several e-cigarette devices limited to tobacco flavors. The CTP's action in this area, which has increased significantly since the procedures initiated by public health stakeholders, should be further strengthened in the coming years.

Although it cannot take legal action, the FDA has also reaffirmed its legal mission and should strengthen it. Since January 2021, it has sent more than 550 warning letters to vaping manufacturers who illegally marketed their products. In mid-February 2023, the CTP even imposed financial penalties for the first time on vaping manufacturers who kept their products on sale despite a warning from the FDA. While the majority of manufacturers comply with the FDA's injunctions, the growing number of illegal situations has led the FDA to develop actions in partnership with the Department of Justice (DOJ) and collaborations with other institutions (US Custom and Border Protection, US Postal Service, Federal Trade Commission, etc.).

A diversification of legal procedures

Noting that legal actions are systematically initiated by tobacco and vaping manufacturers to prevent or simply delay the application of public health measures, the FDA says it also wants to explore approaches "alternatives" to criminal action. Among the incentive measures aimed at "educate the industry" and to ensure greater transparency, the CTP is considering, for example, better technical support for manufacturers, as well as putting online the list of products that have been the subject of a warning.[3]The CTP also promises to communicate better on the agenda of measures it is carrying out, and to take better account of the opinions of public health stakeholders, particularly in terms of the scientific evaluation of products.

The CTP also wants to introduce a new "tax" on tobacco and nicotine products. Brian King argued that the proliferation of tobacco and nicotine products required an increase in the resources of this institution to carry out its missions, with millions of products still to be assessed. Finally, the CTP will maintain its information campaigns aimed at the general public, its campaign entitled "The True Cost" having been applauded and awarded.

Public health actors still need to be convinced

Although they appear encouraging, the statements by FDA and CTP officials do not contain any truly strong measures. Pending the action plan on tobacco, they seem to respond more to the criticisms that these administrations are subject to. Public health actors have thus regretted that 2022 has seen little progress in the fight against smoking. They also deplored that the warnings and procedures initiated against manufacturers selling their products illegally affected small manufacturers more than the multinationals that dominate the market. The credibility of the FDA will therefore depend on its ability to keep its stated commitments.

Keywords: FDA, CTP, Reagan-Udall Foundation

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