- FAMRI Center
White House significantly weakened FDA's proposed rules for cigars and ecigs
The FDA posted marked-up copies of the deeming rule that it submitted to President Obama's Office of Managment and Budget showing the changes that OMB made.
Toni Clary and Sharon Begley from Reuters did an excellent job of highlighting the key changes; their story is here.
Key changes they describe include:
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."
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. And it deleted a similar analysis for the improvements in health that would come from dissuading people from smoking cigars, such as through warning labels.
The "welfare gain" from reducing the number of cigar smokers, FDA calculated, would be $16 million to $52 million.
Similarly, OMB modified or deleted FDA concerns about the safety of e-cigarettes, including manufacturing quality.
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.
Here are the documents that FDA posted:
Notice of Proposed Rulemaking
FDA’s original NPRM - http://www.regulations.gov/contentStreamer?objectId=090000648175db1a&disposition=attachment&contentType=pdf
FDA’s original NPRM with OIRA’s edits in red - http://www.regulations.gov/contentStreamer?objectId=090000648175db1c&disposition=attachment&contentType=pdf
Regulatory Impact Assessment (cost-benefit analysis)
FDA’s original RIA - http://www.regulations.gov/contentStreamer?objectId=090000648175db1b&disposition=attachment&contentType=pdf
FDA’s original RIA with OIRA’s edits in red - http://www.regulations.gov/contentStreamer?objectId=090000648175db1d&disposition=attachment&contentType=pdf