The White House’s Office of Management and Budget has made changes that significantly weaken the language that detailed Health Risks for Cigars. This marks the second agency in less than a weak to express concerns over the proposed FDA regulations outlined in the Deeming Document. Last week the Small Business Administration sent a letter to the FDA claiming they underestimated the impacts of regulation to small business.
The changes by the OMB are marked-up here.
These changes in regards to premium cigars include:
1. Clarifying the proposed regulations have two options, one of which would exempt premium cigars. The exemption is now more clearly defined as an option in the proposal.
2. Deleting language in terms of how the FDA calculated how many lives would be saved by regulating cigars
3. Deleting an analysis by the FDA in terms of the health improvements from discouraging cigar use through such actions as large warning labels.
4. The OMB did a significant recalculations around the cost and benefits of the two options proposed. As noted in a story by Reuters, the OMB deleted an analysis showing that exempting premium cigars from the proposal stating that large warning labels would save 1 – 3 million, but incur costs of 32.6 to 34.2 million.
5. In terms of the prohibition of “non face to face” sales, the language was changed to specifically impact vending machines. Prior to this change, the language could have left the door open for a ban on internet sales.
There were no changes to the OMB made as to what the definition of a premium cigar is, where the controversial point as been the $10.00 minimum. It is routine process for FDA proposals to be submitted to the OMB for approval, denial, or modification