On January 10, 2012, a group of thirteen tobacco companies sent the U.S. Food and Drug Administration (FDA) a letter requesting a meeting and a detailed list of recommendations for good manufacturing practice regulations. On May 2, representatives from these tobacco companies met with the FDA to present their recommendations.

These efforts by the tobacco industry sought to compel the FDA to fulfill certain duties it has under the Family Smoking Prevention and Tobacco Control Act (TCA). The TCA, enacted in 2009, requires the government to implement regulations that assure that “the methods used in, and the facilities and controls used for, the manufacture, preproduction design validation[, …] packing, and storage of a tobacco product conform to good manufacturing practice, or hazard analysis and critical control point methodology.”

On March 19, 2013, the FDA responded by opening a docket to receive public comments on these proposed regulations. On May 20, the Tobacco Control Legal Consortium (now the Public Health Law Center) submitted a comment offering critiques of the industry’s proposal.

Among other issues, the Consortium noted that the tobacco companies proposed using an individual risk standard, rather than the “public health standard” that the TCA requires the FDA to use. Under the TCA standard, the FDA’s actions regulating tobacco must only be taken if they are “appropriate for the protection of the public health.”

The Consortium also noted that the regulations failed to explain how the FDA will enforce and penalize violations. The Consortium pointed out the tobacco industry’s long history of deception as well as its avoidance of meaningful regulation and suggested that it was not in the interests of public health to leave enforcement to self-policing by the industry.

The final regulations took effect on July 22, 2013.

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