Understanding FDA Regulations

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.

Option 1 maintained current definition of cigars according to tax code – Large Cigar (any cigar weighing more than 3 lbs per 1,000 units) and Little Cigars (any cigar weighing less than 3lbs per 1,000 units). Option 1 did not provide for any distinction between traditional/premium hand made cigars and those mass-market, mass-produced. Despite significant differences in price, use, manufacturing and material composition, traditional cigars and mass-market cigars would be treated in the same manner.

FDA’s Option 2 actually recognized the varietals of “cigar” products on the market and seemingly understood the distinction between not only the cigar products themselves, but also the industry that manufactures and supports them. Under Option 2, a Traditional/Premium Cigar is one that:

  1. Is wrapped in whole tobacco leaf;
  2. Contains a 100% leaf tobacco binder;
  3. Contains primarily long filler tobacco;
  4. Is made by combining manually the wrapper, filler, and binder;
  5. Has no filter, tip, or non-tobacco mouthpiece and is capped by hand;
  6. Has a retail price (after any discounts or coupons) of no less than $10 per cigar (adjusted as necessary every 2 years, effective July 1st, to account for any increases in the price  of tobacco products since the last price adjustment);
  7. Does not have a characterizing flavor other than tobacco; and
  8. Weighs more than 6 pounds per 1000 units.

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:

Retailers Regulatory Compliance Timeline

Manufacturers & Importers Regulatory Compliance Timeline

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.

Family Smoking Prevention and Tobacco Control Act
Proposed Deeming Rule 
Final Deeming Rule
Federal Food Drug & Cosmetics Act (Current CFR)

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