On this page:
- What Is a Tobacco Product Standard?
- What Is the Process for Developing a Product Standard?
- What Gives FDA the Authority to Set Tobacco Product Standards?
A tobacco product standard is a rule that sets requirements for how a tobacco product can be made. It is based on rigorous evaluation of scientific evidence and FDA’s determination that the product standard is appropriate for the protection of the public health. For example, a product standard could include reducing or eliminating certain ingredients or chemicals in tobacco products or limiting nicotine levels of tobacco products.
Tobacco product standards are a powerful regulatory tool because they have the ability to significantly reduce tobacco-related disease and death by addressing the addictiveness, toxicity, and appeal across a whole product category.
The 2009 Family Smoking Prevention and Tobacco Control Act (or TCA) established two tobacco product standards, known as “Special Rules”:
- A product standard to prohibit cigarettes with characterizing flavors other than tobacco or menthol, such as fruit and chocolate, which are known to appeal to youth and young adults.1
- A product standard prohibiting the use of tobacco containing a pesticide chemical residue that is at a level greater than is specified by any tolerance applicable under Federal law to domestically grown tobacco.
“Special Rules” are rules set forth by Congress in statute, as opposed to rules FDA may issue through the notice-and-comment rulemaking process.
A product standard is a rule, and therefore developing a product standard requires FDA to follow the notice-and-comment rulemaking process.
The rulemaking process typically starts with identifying a need for a rule, gathering information for a proposed rule, and writing a proposed rule (known as a Notice of Proposed Rulemaking or NPRM). Once the proposed rule is reviewed by the appropriate departments and agencies (e.g., HHS, OMB, and others), it is published in the Federal Register and made available for public comment. The public usually has 60-90 days to submit comments on the proposed rule. Public comments may include data, research, or other information, pointing out parts of a proposed rule that may be confusing or suggesting different wording.
CTP then reviews all public comments, analyzes the issues raised and prepares a final rule that provides the basis and the purpose of the rule. The final rule also responds to public comments and provides an effective date for the rule. The final rule is published in the Federal Register and made publicly available. It becomes legally binding and must be followed like a law.
Section 907 of the Federal Food, Drug, and Cosmetic Act gives FDA the authority to propose and adopt, through notice-and-comment rulemaking, tobacco product standards. Once effective, these product standards have the full force of the law and must be adhered to.
1. U.S. Department of Health and Human Services (USDHHS). A Report of the Surgeon General: Preventing Tobacco Use Among Youth and Young Adults: We CAN Make the Next Generation Tobacco-Free (Consumer Booklet). Atlanta, GA: US Dept of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2012.