The White House’s Office of Management and Budget (OMB) reportedly edited language in the FDA’s proposed rules for tobacco products that may weaken and limit the agency’s ability to regulate e-cigarettes and cigars, according to published documents cited by a Reuters news article.
According to Reuters, documents published Tuesday in the Federal Register reveal that the OMB significantly weakened language detailing health risks from cigars and deleted restrictions that might have prevented online sales of e-cigarettes. The OMB also weakened language detailing the FDA’s concerns about the safety of e-cigarettes and deleted text that described how the FDA rules would have enormous public health benefits by preventing thousands of Americans from taking up cigar smoking.
The OMB analyzes potential economic consequences of federal policy, such as the FDA-proposed regulations.
From the Reuters article:
In its draft, the FDA had proposed “prohibition of non-face-to-face sales (e.g. vending machines).” That would have opened the door to a ban on online sales. But OMB edited the sentence so that the prohibition refers only to vending machines.
In another significant change, OMB turned the FDA’s proposal as it relates to cigars from a two-part rule – one for traditional tobacco products and one for products that have not previously been regulated – into a “two-option” rule, one of which would exempt “premium cigars.”
The cigar industry, backed by some members of Congress, had lobbied OMB heavily for such an exemption. In a December 2013 letter to FDA Commissioner Margaret Hamburg and Sylvia Mathews Burwell, who was director of OMB at the time and is now Secretary of Health and Human Services, 24 Republican lawmakers asked that premium cigars be exempt.
“As you know,” they wrote, “premium cigars are a niche product with an adult consumer base, much like fine wines. The majority of people who enjoy a cigar do so occasionally, often in social or celebratory settings.”
OMB also deleted an FDA analysis showing that exempting premium cigars from a proposal to require large warning labels would save manufacturers $1 million to $3 million but incur costs to public health of $32.6 million to $34.2 million.
The White House office also deleted an extensive section in which the FDA calculated how many lives would be saved by regulating cigars, as well as the value of those lives.
It deleted FDA draft language saying it would review electronic cigarette cartridges to respond to evidence of poor quality control, variable nicotine content or toxic ingredients such as diethylene glycol, a chemical that the FDA said has caused mass poisonings in products such as the painkiller acetaminophen and cough syrup.
According to the FDA webite, the agency currently regulates cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco. As of April, the FDA has proposed new regulations that would bring electronic cigarettes, cigars, pipe tobacco, certain dissolvables that are not “smokeless tobacco,” gels, and water pipe tobacco under their authority.