Through the vaporization of text in the proposed regulations on classification of tobacco products, the White House's Office of Management and Budget eliminated language that would have given the FDA the ability to restrict the online sales of e-cigarettes and would have highlighted the health risks associated with smoking cigars, according to a report from Reuters.
After lobbying by members of Congress, an effort that included pleas from 24 Republican lawmakers, the OMB has converted the language in the FDA's proposal from a pair of rules on classifying cigars to a couple of options.
"Option 2 of the proposed rule would extend the Agency's 'tobacco product' authorities to all other categories of products, except premium cigars and the accessories of a proposed deemed tobacco product, that meet the statutory definition of 'tobacco product' in the FD&C Act," stated the proposal's summary.
The OMB also removed FDA commentary that stated exempting the manufacturers of premium cigars from issuing warning labels would save the industry between $1 million and $3 million, while driving up public health costs as high as $34.2 million. The document was also ammended to eliminate FDA estimates stating the U.S. could gain between $16 million to $52 million by using warning labels to discouraging individuals from smoking cigars.
Also up in smoke was the FDA's effort to use broad language on the regulation of vending machine sales. Left as it was originally drafted, the classification of "non-face-to-face" sales would have given the FDA the ability to regulate mechanically and electronically assisted sales -- as web servers are machines, the FDA would have received authority over the Internet sale of e-cigarettes.
Emily Cain, a spokeswoman for the OMB, stated that the OMB headed up a review process to ensure that the regulations where clear in achieving their intended goals.
"It is routine for agencies to make changes to their draft rules during the course of OMB review," Cain stated. "The goal is to maximize the effectiveness and benefit of the rules we complete."
The period for comments on the FDA's regulations will close July 9. However, Jennifer Haliski, an FDA spokeswoman, stated that commenting would continue until Aug. 8.
"All comments will be carefully considered as the final rule is being developed," stated Cain. "As the science base continues to develop for these products, the agency has the ability to take additional regulatory actions designed to further minimize the public health burden of tobacco use in this country."
