In June 2009, President Obama signed the Family Smoking Prevention and Tobacco Control Act, a law that gave the U.S. Food & Drug Administration (FDA) the authority to regulate all tobacco products. Previously, the agency had regulated cigarettes and smokeless tobacco through various pieces of legislation passed by Congress, but cigars, pipe tobacco and the burgeoning e-cigarette and vapor market had not been subject to FDA regulation.
As part of the Tobacco Control Act, FDA established the Center for Tobacco Products (CTP) in order to handle the regulation of tobacco products, including those it now had the authority to regulate.
In April 2014, FDA announced its long-expected Deeming Regulations, a draft of the proposed regulations for cigars, pipe tobacco, e-cigarettes/vapor products and other tobacco products. In it, FDA outlined two options for cigars.
Under Option 1, FDA would regulate all cigars just as it would other tobacco products. This would mean cigars would need FDA approval, be subject to warning label restrictions, free samples would be barred and all cigar manufacturers would pay user fees.
Alternatively, the agency laid out Option 2. Under this path, FDA would exempt premium cigars—those that met an FDA-established definition that included a $10 retail price minimum, no characterizing flavors and weight restrictions—while regulating all cigars. It asked both the public and industry to provide comment on all parts of the proposed regulation, including which pathway it should take, before it finalized its decision and enacted the rule.
It should be noted, FDA did not create the exemption path as Option 2. It originally proposed a slightly looser set of restrictions for premium cigars, but not a full exemption. The White House Office of Management & Budget (OMB), which oversees the economic impact of agencies like FDA, changed Option 2 to include a full exemption as part of the draft.
In early May 2016, FDA announced its finalized rules. It included Option 1, the regulation of all cigars, along with a few other changes. Those regulations are set to begin on Aug. 8, 2016.