The rules rule

The US Food and Drug Administration, which has come under criticism for its cumbersome processes and which is fighting a lawsuit over its August 2017 Guidance Document, Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule, says it is spotlighting tobacco regulations as part of its Understanding Tobacco Regulation and Guidance series.
In a note issued through its Center for Tobacco Products, the FDA said that in 2009, the Family Smoking Prevention and Tobacco Control Act (TCA) amended the Food, Drug, and Cosmetic (FD&C) Act, establishing FDA’s authority to regulate the manufacture, distribution, and marketing of tobacco products. ‘FDA implements the FD&C Act by issuing regulations (commonly referred to as rules) and guidances,’ the statement said. ‘A regulation is a government statement that carries out or explains a law or policy. Regulations can also describe the agency’s organization or procedures. FDA regulations are created through a formal notice-and-comment rulemaking process and have the full force and effect of federal law.’
The FDA said it went through a number of steps that invited participation from the public as it considered, developed, and finalized a regulation.
For instance, the agency might choose to issue an Advance Notice of Proposed Rulemaking (ANPRM) before issuing a proposed rule. An ANPRM, the FDA said, was a document published in the Federal Register that generally described the regulatory action the agency was considering, explained the underlying issues, and asked for public comment on specific questions.
A Proposed Rule (also known as a Notice of Proposed Rulemaking or NPRM), meanwhile, was an official document published in the Federal Register that announced the agency’s proposal of a new rule or regulatory change. It explained the need and authority for the proposed rule and the issues involved, and it provided also a period for the public to comment. A proposed rule and accompanying public comments shaped the final rule.
A Final Rule was a regulation published in the Federal Register that explained the basis for the rule, described and responded to public comments received on the proposed rule, explained any changes from the proposed rule, contained a variety of analyses of the rule’s potential impacts, and provided a specific date on which the rule became effective. A final rule was law.
A more detailed overview of the federal rulemaking process is available here. And it is possible to explore FDA’s searchable list of ANPRMs, proposed rules, and final rules here.
The FDA included information in its statement on its ‘public health mission’.
‘As a science-based regulatory agency, FDA examines areas of its legal authority under the FD&C Act and prioritizes issues for rulemaking in accordance with the agency’s public health mission,’ it said. ‘FDA’s traditional “safe and effective” standard for evaluating medical products does not apply to tobacco products. When FDA develops certain regulations, the TCA requires the agency to apply a public health approach that considers the effect of the regulatory action on the population as a whole, not just on individual users, with respect to initiation and cessation of tobacco use. FDA also considers the impact of the regulation on the regulated tobacco industry.’
In addition, the FDA said, when considering a new tobacco regulation there were many other factors involved in the process, ‘some of which may include the following’:

• ‘New technologies or data related to the issue;
• Subject matter expertise, research findings and recommendations of agency staff;
• ‘Concerns arising from accidents or other health risks affecting the public;
• ‘Recommendations from congressional committees or federal advisory committees;
• ‘Requests from other agencies;
• ‘Petitions from interest groups, corporations, and members of the public;
• ‘Lawsuits filed by interest groups, corporations, states, and members of the public;
• Presidential directives.