The Office of Management and Budget (OMB) from the White House edited language is the proposed FDA rules for tobacco products. This move may limit the agency's power to regulate cigars and e-cigarettes.
The OMB is responsible for analyzing the policy's economic implications, carefully studying the FDA draft that included the banning non-face-to-face cigar and e-cigarette sales or online sales. After analyzing the potential consequences of these proposed regulations to the U.S. economy, the OMB deleted language in the proposed regulations that describe how the new rules would benefit public health enormously.
"It is routine for agencies to make changes to their draft rules during the course of OMB review," OMB spokesperson Emily Cain said. "The goal is to maximize the effectiveness and benefit of the rules we complete." She said that as with all rules, the OMB ensures that the policies are efficient, based upon the best available evidence and well-designed to achieve objectives.
OMB also removed different health concerns despite of recent Senate hearing on e-cigarette safety. The body removed the requirements that mandate reviewing the makers' poor quality control, toxic ingredients and variable nicotine content and chemical called diethylene glycol which is used in e-cigarettes. The FDA said that diethylene glycol can cause mass poisoning in some products including cough syrup and painkiller acetaminophen.
The OMB changed the policy in that the prohibition only applies to vending machines. The body also modified the two-part rule that separates the unregulated from the regulated into a two-option rule that exempts premium tobaccos.
Cost-benefit analyses were also removed including the premium cigar exemption that calculated the manufacturers' savings from $1 million to $3 million. It cost public health from $32.6 million to $34.2 million, though. It also deleted a section where the FDA estimated the number of lives the regulation would save as well as those lives' values. The "welfare gain" from a reduced number of cigarette smokers would be $16 million to $52 million, according to the DFA. The OMB also removed an analysis on the health improvements that would come from discouraging the public from smoking through warning labels.
