PCA & CRA Joint ANPRM Comment
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Option 1 vs. Option 2: How We Got Here
In 2014, the FDA issued it’s proposed rule deeming new tobacco products for regulation. As a direct result of heavy engagement by the PCA (nee IPCPR) and other industry stakeholders with the FDA, the proposed rule included two distinct options on how to define premium cigars. Despite continued intense engagement with the FDA, HHS, Obama Administration and Congress, and despite thousands of comments submitted by our industry and by individuals in support of Option 2, the FDA ultimately selected Option 1 and published their final rule in May of 2016.
FDA Deeming Rule: New Requirements for Retailers
On August 8th, 2016, premium cigar and pipe tobacco retailers found themselves beholden to a whole new host of onerous requirements. At 500+ pages, the deeming rule is far too long and dense to review in depth here. But the PCA has listed the major requirements tobacconists must comply with currently or in the near future.
Compliance Timeline + Deadlines for Retailers & Manufacturers
To help you understand and follow the regulations set forth by FDA, we have provided compliance timelines and deadlines for:
TCA and the Deeming Rule: Statute and Regulations
The legislative foundation for the FDA’s deeming rule is the Family Smoking Prevention and Tobacco Control Act of 2009. This is where the FDA derived its statutory authority to “deem” new products. The resulting proposed rule and final rule, published in 2014 and 2016 respectively, are included below.
PCA, CAA & CRA File Lawsuit Against the FDA
Following the May 5th, 2016 publishing of the final rule, the PCA [IPCPR], along with two other major cigar and tobacco industry associations, filed suit against the FDA. In addition to the PCA (IPCPR), The Cigar Association of America and the Cigar Rights of America joined in the legal action. Filed in the District Court for the District of Columbia, the suit calls for a declaratory injunction to “vacate, set aside and enjoin the enforcement of the final rule” because it is violates numerous federal statutes as well as the federal rulemaking process. A summary of key issues highlighted in the complain is listed below.
View Full Lawsuit Filing Here