FDA update – April 1, 2011

FDA to require ‘substantial equivalence’ for new tobacco products

The U.S. Food and Drug Administration announced today that certain tobacco products introduced or changed after Feb. 15, 2007 must be reviewed by the agency. The Family Smoking Prevention and Tobacco Control Act, which became law June 22, 2009, granted the FDA regulatory authority over tobacco products. This law is meant to ensure that new tobacco products are evaluated by the FDA before they are cleared to enter the marketplace. In FDA guidance agency outlines a pathway for marketing a product whereby the company marketing the product must prove that it is “substantially equivalent” to products commercially available on Feb 15, 2007 under the section 905(j).

Substantially equivalent means the products must be the same in terms of ingredients, design, composition, heating source and other characteristics to an existing, single predicate product or have different characteristics, but not raise different questions of public health.

The FDA “suggests” that manufacturers submit a vast amount of information in 905(j) reports, including side-by-side comparisons of each new product with its predicate with respect to:

• Ingredients and their levels
• Design features and other materials; description of the heating source and composition
• Harmful and potentially harmful constituents.
• Consumer Perception Studies - data comparing consumer perceptions with respect to the new tobacco product and the predicate that could affect initiation, cessation, frequency of use, patterns of use, smoking behavior, and perceptions of harm or addictiveness.
• Clinical data - data comparing the biomarkers of exposure and biomarkers of potential harm and human toxicity of the new tobacco product as compared to the predicate tobacco product. summary of all pivotal studies should be submitted including final approved study protocols, statistical analysis plans, any modifications to the study(ies), raw data, analysis platforms, and full reports.
• Abuse liability data - Abuse liability can be assessed by studies, such as animal models of conditioned place preference, drug discrimination and self-administration, and human behavioral pharmacology studies that assess self-administration and subjective effects of the new tobacco product.
• Toxicology data - Comparisons between the new tobacco product and the predicate tobacco product can be assessed by studies, including nonclinical studies such as in vitro and in vivo mutagenicity and clastogenicity studies, general toxicology studies that include hematological, clinical chemistry, and histopathological endpoints, toxicology studies designed to specifically address cardiac, respiratory, and reproductive/developmental toxicity and studies to assess the carcinogenic potential.

Any questions on this new FDA rule please email us at info@mdiconsultants.com and Ref: SE Tobacco.