White House Weakens Proposed Deeming Regs
OMB edits ease language on health risks, regulation of premium cigars, e-cigarettes
WASHINGTON --The White House's Office of Management and Budget (OMB) has put its own spin on the U.S. Food & Drug Administration's (FDA) proposed deeming regulations. According to a Reuters report, the OMB, tasked with analyzing the potential economic consequences of the proposed regulations, specifically looked to weaken or outright omit some of the language detailing health risks and restrictions on premium cigars and electronic cigarettes.
These changes were chronicled in documents published in the Federal Register and included the following:
- Changing the original proposed two-part cigar rule (one for traditional tobacco products, one for tobacco products that previously not been regulated) to a "two-option" rule, one of which would exempt premium cigars.
- Removing FDA analysis that showed exempting premium cigars from a proposal to require large warning labels would save manufacturers $1 million to $3 million but run up $32.6 million to $34.2 million in public health costs.
- Removing FDA calculations on how many lives might be saved from the proposed cigar regulations, including a "welfare gain" of $16 million to $52 million from dissuading people to smoke cigars through warning labels.
- Changing the FDA's proposed "prohibition of non-face-to-face sales (e.g., vending machines)" of e-cigs, which suggested the possibility of an online sales ban, so that it only applied to vending machines.
- Deleting language regarding electronic cigarette manufacturing concerns, specifically a proposal that the FDA would review e-cigarette cartridges for evidence of poor quality control, variable nicotine content or toxic ingredients.
In response to the OMB's changes, FDA spokesperson Jennifer Haliski said the agency does not comment on changes to a proposal during the review process. She encouraged interested parties to express their views through the August 8 deadline for public comments.
"All comments will be carefully considered as the final rule is being developed," she told Reuters. "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."