FDA issued two draft guidance documents that set out the agency’s thinking with respect to new tobacco products and the requirement to either demonstrate substantial equivalence under FDC Act § 905(j) or secure premarket approval under § 910.
The draft guidance titled Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions notes that changes to the label and packaging of a tobacco product make it a “new tobacco product” requiring either premarket approval or a demonstration of substantial equivalence. Logically, FDA doesn’t intend to enforce those requirements with respect to labeling changes required by law, but the guidance discusses other circumstances under which demonstration of substantial equivalence would be needed. For example, changes in the brand name of the product, tobacco blending changes that are intended to alter the chemical or perception properties of the new product, and changes in moisture content, ingredient composition, or harmful/potentially harmful constituents would all require a submission. Even if "a supplier of a component (e.g., the filter) began using a new processing aid (e.g., an antimicrobial agent) for a sub-component (e.g., paper used for the filter's plug wrap) and the change is so minor that it is not even capable of being quantified in the finished product," that change would require a submission. Notably, the submission of a substantial equivalence report under FDC Act § 905(j) must be accompanied by an environmental assessment ("EA") pursuant to the National Environmental Policy Act. An EA is a public document that evaluates the potential risk for the product to cause significant environmental effects, focusing on environmental issues relating to the use and disposal of the product. It discusses the need for the proposal and any alternatives, of the environmental impacts of the proposed action and alternatives, and a listing of agencies and persons consulted. If potentially adverse environmental impacts are identified for an action, the EA must discuss reasonable alternative courses of action that offer less environmental risk or that are environmentally preferable to the proposed action. Most actions regarding human drugs, devices, food, and food additives are exempt from the requirement to submit an EA.
If a new product is not found to be "substantially equivalent" to a product on the market as of February 15, 2007, then it is a "new tobacco product" subject to premarket review by FDA. The draft guidance titled Applications for Premarket Review of New Tobacco Products explains the procedural and substantive requirements that apply to premarket tobacco product applications submitted under FDC Act § 910. Among other things, a PMTA must include:
- full reports of investigations of health risks posed by the tobacco product, which FDA interprets to mean both favorable and unfavorable studies regardless of whether the studies were conducted in the U.S. or abroad, and regardless of whether they complied with human subject protection guidelines;
- a “full statement of all components, ingredients, additives, and properties, and of the principle or principles of operation” of the product; and
- a “full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, where relevant, packing and installation a full description” of the product.
A PMTA must also include “information sufficient to enable FDA to make a finding that the marketing of a new tobacco product is ‘appropriate for the protection of the public health’” within the meaning of FDC Act § 910(c)(4). As this is a new standard in the FDC Act, FDA requests comment on what type of evidence should be required to satisfy the standard, as well as comment on “establishing a baseline for determining whether a new product affects the likelihood that tobacco users will quit or the likelihood that non-users will start using such products.” However, the guidance makes clear that FDA expects rigorous “well-controlled scientific investigations” that address the product’s comparative health risks, the product’s effect on the likelihood of quitting tobacco use, and its effect on initiation. In specific, FDA expects comprehensive information on product chemistry; nonclinical studies that address toxicity, abuse liability, and carcinogenicity; and human studies.