Subscribe to read this article in its entirety.

FDA is Coming to a Tobacco Product Manufacturing Plant Near You
Author: John H. Lauterbach

SUMMARY
The US Food and Drug Administration is coming to a tobacco manufacturing plant near you. You may not be near one of the large cigarette factories that once dotted the southeastern states, but you may be near one of the many smaller tobacco product-manufacturing plants or one of the manufacturers of components of tobacco products that FDA wants to regulate. FDA has concluded that all such operations are in its purview, including those producing products that may have uses that do not include tobacco and tobacco products. FDA’s authority comes from the Family Smoking Prevention and Tobacco Control Act (FSPTCA), signed into law on June 22, 2009 (Public Law 111-31). Much of what FDA has done to date has involved enforcement of statutes related to flavored cigarettes and reporting of ingredients. However, other statutes give FDA power to deal with adulterated and/or misbranded products, and at a later date, to set testing standards and regulations for good manufacturing practices (GMPs). This article summarizes the current situation and outlines the opportunities for scientists skilled in GXP and validation to contribute to this new area of product regulation.

Subscribe to read this article in its entirety.