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The White House’s Office of Management and Budget made changes to the rules proposed by the Food and Drug Administration (FDA) for regulating tobacco products, deleting restrictions that might have prevented online sales of e-cigarettes. The rules proposed by the FDA on April 24 would subject the $2 billion industry to federal regulation for the first time.
E-cigarettes are battery-powered cartridges filled with liquid made up of propylene glycol, flavouring and nicotine that when heated creates an inhalable vapor. The FDA’s proposal would ban the sale of e-cigarettes to people under the age of 18 and vending machine sales, though it did not restrict flavoured products or TV advertising or outright prohibit online sales. Because the flavoured e-cigarettes are very attractive to children, public health advocates believe they will initiate a new generation and serve as the gateway for all smoking products, yet too much remains unknown about the long-term health impact of these devices.
Additionally, the Office of Management and Budget weakened language indicating the FDA’s concerns about the safety of both cigars and e-cigarettes. Currently the FDA has the authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco, but until it issues and finalizes new rules, it lacks the authority to regulate other smoking products such as electronic cigarettes, cigars, pipe tobacco, certain dissolvable gels and water pipe tobacco.
“Once the proposed rule becomes final, FDA will be able to use powerful regulatory tools such as age restrictions and rigorous scientific review of new tobacco products and claims to reduce tobacco-related disease and death,” the agency reported.
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 said. “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.”