IPCPR Legislative | FDA Toolbox DEV
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Your FDA Toolbox

 

As of August 8, 2016, the FDA  finalized the so called “Deeming Rule” and extended authority over the regulation of cigars and pipes, placing unfair and unwarranted burdens on premium cigar and pipe tobacco manufacturers and retailers across the country.

To meet help our retailers meet these new challenges, IPCPR has designed the FDA Toolbox. Here you’ll find a one-stop shop for the resources you’ll need to not only understand, but meet your new obligations under the FDA’s regulatory regime. Below you’ll find information on what your new requirements and deadlines are as a retailer, industry and FDA guidances on how to remain in compliance and a whole host of other materials to help you as a professional tobacconist meet these new challenges head on.

Questions? Concerns? Interested in Getting Involved?  Let Us Know!

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UNDERSTANDING FDA REGULATION

New Requirements and Deadlines under the Deeming Rule that Every Retailer Should Know

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 IPCPR and other industry stakeholders with the FDA, the proposed rule included two distinct options on how to define premium cigars. Despite continue intensive engagement with the FDA, HHS, Obama Administration and Congress, and despite thousands of comments submitted by industry and 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.

Option 2: 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 percent 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.

New Requirements for Retailers Under FDA Deeming Rule

As of 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 too dense to review in depth here . But IPCPR has listed the major new requirements our tobacconists must meet or will need to meet over the coming years. We’ve also hyperlinked those issues for which IPRPC has produced guidances for retailers.

 

  • FDA Compliance checks
  • Age Verification Requirements
  • Warning Label Requirements for Packaging and Advertising
  • Prohibition on Sampling
  • Re-Classification of “Manufacturer”
  • Reporting & Testing Obligations for new “Manufacturers”
  • Limitation of available stock for retail
Compliance Timeline and Deadlines for Retailers & Manufacturers

IPCPR wants to help make sure you understand and follow the regulations set forth by FDA.  Click the button below and take a look at the compliance timeline developed by the IPCPR Legislative Team.

FDA Compliance Timeline
Statue and Regulations - TCA and the Deeming Rule

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 it’s 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

IPCPR, CAA and CRA File Lawsuit Against FDA

Following the May 5th, 2016 publishing of the final rule, IPCPR, along with two other major cigar and tobacco industry associations filed suit against the FDA. In addition to 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 main issues highlighted in the complain is listed below.

 

View Full Lawsuit Filing Here

Frequently Asked Questions

Since implementation of the Deeming Rule, IPCPR has received a multitude of questions from tobacconists about what they now need to do. Our Tobacconist FAQ document can be found here. If you have a question that you couldn’t find the answer too, we encourage you to click the “Contact IPCPR” button listed above and our staff will be happy to get back to you!

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COMPLIANCE HUB

Stay Informed & Stay in Compliance

IPCPR Guidance for Retailers and Industry

Age Verification Best Practices

Warning Plans (For Manufacturers)

Warning Plans (For Retailers)

Warning Letter Responses

FDA Guidance Documents For Retailers
FDA Compliance Webinars
IPCPR Comments + Communications
IPCPR Seminar Recordings

  2016  FDA Webinar for Retailers


    2016 Government Affairs Briefing

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