Letter to to the Hon. Daniel Levinson, Inspector General of the U.S. Department of Health and Human Services - Investigate Potential Leak of Confidential Information on E-Cigarette Regulations

Letter

On Wednesday October 28, an organization known as the Tobacco Vapor Electronic Cigarette Association (TVECA) posted a document on the organization's website alleged to be the first portion of proposed rule FDA-2014-N-0189, "Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products." This confidential proposed final rule, more commonly known as the Deeming Rule, was transmitted from the Food and Drug Administration to the Office of Management and Budget on October 19, 2015, and is expected to establish FDA authority over a range of tobacco products, including novel tobacco products entering the market since passage of the Family Smoking Prevention and Tobacco Control Act in 2009.

I would be very concerned to learn that TVECA gained access to confidential information about federal policymaking on such critical issues ahead of the public. I am writing to request that you conduct an investigation into authenticity of the document posted by TVECA, and how this important public health document came into the possession of the trade association at this stage of the regulatory process.

The partial document posted by TVECA appears to be the table of contents of the pending final Deeming Rule. The document sets out that FDA deems that cigars should be regulated in the same manner as cigarettes and asserts authority to regulate e-cigarettes and vape shops. The document further sets out an outline of requests for additional regulations that would apply to the newly deemed products, including a ban on flavored tobacco products and nicotine exposure warnings.

In April 2014, FDA issued a proposed rule deeming non-drug e-cigarettes as tobacco products subject to its regulation. The proposed rule would also bring cigars, pipe tobacco, waterpipe (hookah) tobacco, and other novel products like nicotine gels under FDA's regulatory authority. After two rounds of public comment, and over 18 months, FDA sent the final rule to the Office of Management and Budget (OMB) for regulatory review.

The premature disclosure of this unverified but confidential information during a period when the regulation remains under review by the Executive Branch is of serious concern. Given the public health importance and sensitive nature of this pending FDA regulation, I believe it is critical that an independent investigation be undertaken to ascertain the origins of this potential leak. Thank you for your prompt attention to this matter.

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