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History

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FDA’s regulation of premium cigars in America began over a decade ago.

It took eight years from the time that FDA gained the authority to regulate premium cigars for the agency to actually begin regulation. The following is a quick summary of the most important events from that time until Aug. 8, 2016, the date FDA began regulating cigars in the U.S.

2007

The very beginning

On Feb. 15, 2007, Sen Ted Kennedy, D-Mass., introduced S.625 in the 110th Congress. That bill, the Family Smoking Prevention and Tobacco Control Act, would radically change the regulation of tobacco products in the U.S. In 2000, the Supreme Court ruled in a 5-4 decision that Congress had not given FDA the authority to regulate tobacco products. The Tobacco Control Act was introduced to not only give FDA the authority to regulate cigarettes but also other tobacco products like cigars.

It would establish a division within FDA—the Center for Tobacco Products—to regulate tobacco. In addition, it would require tobacco companies to disclose all the ingredients used in their products, as well as seek approval whenever those would change. It also gave FDA the authority to regulate other tobacco product categories like cigars, pipe tobacco and hookah and shisha tobacco. At this time, the government was largely only regulating cigarettes, roll-your-own and smokeless tobacco.

Kennedy’s bill would fail to pass in the 110th Congress.

2009

The Tobacco Control Act Passes

In May 2009, Sen. Kennedy once again introduced the Tobacco Control Act, this time to a new Congress and with a new president. Barely one month later, President Barack Obama signed H.R. 1256 into law.

While FDA had gained the authority to regulate cigars, it hadn’t decided how to regulate cigars.

Instead, most were focused on something called SCHIP. In February, the government had passed a law that would ensure every child—no matter of their financial status—would have access to health care. To fund this program, the federal excise taxes on tobacco products was increased. For cigars, that meant the maximum taxes increased from 4.875 cents per cigar to 40.26 cents.

2010-2013

The Calm Before the Storm

For the next handful of years, it was clear that FDA was planning on regulating cigars, but it wasn’t clear in what manner.

Trade organizations like the Cigar Association of America (CAA), the newly-formed Cigar Rights of America (CRA) and the International Premium Cigar & Pipe Retailers’ Association (IPCPR) introduced bills which would limit FDA’s power, most notably bipartisan-backed bills that would exempt cigars from regulation.

Simultaneously, the same groups began lobbying the White House Office of Management and Budget (OMB), an agency which must approve all FDA regulations, to limit the impact of FDA’s regulations.

In 2013, Mitch Zeller, the head of CTP, commented that he heard from the cigar industry and its claims that premium cigars were different and said the agency would consider that in the upcoming regulations.

April 2014

FDA Unveils Its Plan for Regulations

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 banned 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 and Budget, an executive agency that must approve FDA rules, changed Option 2 to be a full exemption.

 

May 5, 2016

The Regulations Announced, FDA Chooses Option 1

On May 5, 2016, FDA announced its deeming regulations.

The agency chose Option 1, regulating cigars the same as other tobacco products.

Last Updated: March 11, 2019.

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