US House to Investigate FDA's Tobacco Regulation Program

On March 28th, the House Oversight and Reform Committee of the United States launched an investigation into the Food and Drug Administration's Center for Tobacco Products (CTP). The chairman of the committee, Republican Representative James Comer of Kentucky, made the investigation public.

In a letter addressed to FDA Commissioner Robert Califf, Congressman Comer outlined several reasons for an investigation, mostly based on criticisms of the agency's tobacco regulation program by the Reagan-Udall Foundation. The evaluation found numerous flaws in CTP's processes and communication with stakeholders and the public.

Recently, the Reagan-Udall Foundation conducted an evaluation of the CTP and found that...

There is no clear definition of the fundamental elements of its tobacco and nicotine regulation plan, which promotes market uncertainty and allows unsafe and unregulated products to proliferate.

Therefore, the House Oversight and Accountability Committee is seeking documents and information regarding CTP activities to achieve transparency and ensure that CTP is performing its required functions.

The committee has requested that the FDA provide:

FDA staff's comments on the Reagan-Udall assessment; all communications with the White House and the Department of Health and Human Services (HHS) regarding tobacco or nicotine policies; documents and correspondence between FDA and the Centers for Disease Control and Prevention (CDC) regarding CTP policies; communication documents between FDA and "public health advocacy groups" regarding CTP policies; all documents regarding the "appropriate for the protection of public health" standard and specific analytical processes; enforcement work documents of FDA's removal of illegal tobacco or nicotine products from retail locations.

In the coming months, the committee will hold public hearings that may offer an opportunity for the electronic cigarette industry and consumer rights advocates to explain how the FDA's confusing regulatory process is harming small businesses and individuals who use low-risk nicotine products. The hearings may also address how the agency is responding to political pressure from anti-smoking youth organizations, Congress, and the White House.

Comer pointed out deficiencies in the FDA's enforcement ability, and urged the agency to release a list of authorized products and products currently under review for retailers to reference. He also called on the FDA to allocate necessary resources and promptly remove from the market those products that are most appealing to underage users.

References:

Congressman Comer investigates FDA's tobacco and nicotine regulatory programs characterized by ambiguity.

The House Oversight Committee has announced that it will investigate the regulations enforced by the FDA pertaining to tobacco.