URGENT: Write the FDA

June 5, 2017

The FDA is trying to smother the handmade cigar industry. We need your help. WRITE TODAY!

The Food and Drug Administration is making it harder and harder for family-owned, handmade cigar companies to produce and sell their products. The new rules are unnecessary and highly political, and they will drive companies out of business, leaving you with fewer choices in your humidor, changing the cigar industry forever. 

It needs to stop. 

Write the new FDA commissioner, Dr. Scott Gottlieb, and President Donald Trump. Let them know how you feel. Tell them handmade cigars deserve an exemption from FDA control. It's time to deregulate the handmade cigar industry and let this small, artisanal and venerable business continue without government interference. 

SAMPLE LETTER

Copy-and-paste this sample letter and let your voice be heard. 

I am protesting the FDA's over-regulation of the handmade cigar industry. Keep this family owned and artisanal industry intact and leave handmade cigars alone. 

WRITE NOW: 

FDA Commissioner Dr. Scott Gottlieb

Email address:

President Trump

Contact information: whitehouse.gov/contact/

Vice President Michael Pence

Contact information: whitehouse.gov/contact/

Health and Human Services Secretary Thomas Price

Email address:

Click here to read Marvin R. Shanken's letter to FDA commissioner Dr. Scott Gottlieb.

 

 

FDA Extends Final Rule Compliance Deadlines by 90 Days

May 2, 2017

By Andrew Nagy - Cigar Aficionado

The cigar industry has been given a 90-day extension to comply with future FDA rulings. Yesterday, the U.S. Food and Drug Administration announced that it is extending and deferring enforcement of all future compliance deadlines under its controversial Final Deeming Rule for three months. 

The three-month extension applies only to deadlines set for May 10, 2017, or later, and includes all newly regulated tobacco products, among them premium cigars. It also pushes back the starting date for the joint cigar industry lawsuit, from August 30 to sometime in October. 

The extension pertains to major deadlines such as manufacturer submission of future cigar warning label plans, registration and listing, health documents, Substantial Equivalence exemption request and applications, Premarket Tobacco Product Applications and Harmful and Potentially Harmful Constituent reports. 

The deadline stay was the result of a compromise between the three major lobbying groups that represent he premium cigar industry--the Cigar Association of America, the Cigar Rights of America, and the International Premium Cigars and Pipe Retailers Association--and the U.S. Department of Justice, which is representing the U.S. Department of Health and Human Services, the overseer of the FDA, in multiple lawsuits that challenge the agency's Final Deeming Rule. 

Members of the premium cigar industry had been hoping for an extension to FDA compliance. It came about via an unlikely source, after the Department of Justice asked Judge Amit P. Mehta of the U.S. District Court for the District of Colombia to push back the deadlines in the joint cigar industry lawsuit by three months "to allow new leadership personnel at the Department of Health and Human Services to more full consider the issues raised in this case and determine how best to proceed." The cigar industry attorneys agreed to this request, so long as the FDA agreed to delay all future compliance dates by three months. 

Therefore, the trial for the joint cigar industry lawsuit, which had previously been pushed back to August 30, won't begin until sometime in October, depending on when Judge Mehta sets the date. 

"The fact that is was the federal government that asked for the delay suggests that it is just as uncertain as to how FDA regulation should apply to premium cigars as all of us in the cigar industry," said Drew Newman, general counsel of J.C. Newman Cigar Co., based in Tampa, Florida. 

The delay also means that the cigar industry lobbying groups have additional time to continue their efforts to help pass legislation that would exempt premium cigars from FDA regulation. Also, the extension offers smaller cigar companies, many of which may not be able to absorb the costs of compliance, a three-month reprieve. 

"Hopefully this begins the process of a long-term dialogue with the new Department of Health and Human Services," said Glynn Loope, executive director of the Cigar Rights of America. "While this suspension of the rule is positive on the immediate demands of the regulations, it is also an opportunity for us to continue our message to Congress and the new administration as to the threat that these regulations pose to the industry." 

The FDA's decision to delay its deadlines affects one immediate provision: cigar warning plans. Originally, all retailers, manufacturers, distributors and importers were supposed to submit their warning plans to the FDA by May 10, but the new deadlines is now August 10, 2017. 

"We are very happy that the government has extended the implementation of FDA regulation by three months," said Newman. "Because there is so much uncertainty about FDA regulation throughout the premium cigar industry, this deplay will give all of us some much needed time to continue to work together and address them."

The three-month extension means that the following provisions from the Final Deeming Rule, which were set to take effect on May 10, 2018, have been pushed back to August 10, 2018: 

  • Rotational cigar warning statements on product packages and advertisements;
  • Point of sale warning statement requirements for cigars sold individually without packagaing. 

Moreover, the deadlines for the following premarket review requirements have also been pushed back: 

  • Compliance period for manufacturersto submit a Substantial Equivalence Exemption Request (original deadline of August 8, 2017 is now November 8, 2017);
  • Compliance period for manufacturers to submit a Substantial Equivalence Application (original deadline of February 8, 2018 is now May 8, 2018);
  • Compliance period for manufacturers to submit a Premarket Tobacco Product Application (original deadline of August 8, 2018 is now November 8, 2018);

The deadlines for the following provisions from the FDA's Final Deeming Rule have also been extended:

  • Ingredient listing (original deadline of August 8, 2017 is now November 8, 2017. For small-scale manufacturers, the original deadline of February 8, 2018 is now May 8, 2018);
  • Harmful and Potentially Harmful Constituents (original deadline of August 8, 2019 is now November 8, 2019);
  • Tobacco products label information (original deadline of May 10, 2018 is now August 10, 2018).

Agreement Reached on Suspension of Regulations

May 1, 2017

WASHINGTON, D.C. - Since July 15, 2016, Cigar Association of America (CAA), Cigar Rights of America (CRA), and the International Premium Cigar and Pipe Retailers Association (IPCPR) have been pursuing litigation in federal court against the United States Food and Drug Administration (FDA), challenging the FDA's May 10, 2016 Rule deeming cigars and pipe tobacco to be tobacco products subject to FDA regulation. 

In the context of the litigation, the FDA has announced an extension of upcoming compliance deadlines under the deeming rule. Specifically, on May 1, 2017, the United States Department of Justice advised the United States District Court for the District of Columbia that the FDA will extend and defer enforcement of all future compliance deadlines under the Rule for three months, and that it plans to issue guidance to that effect. 

The United States Department of Justice informed the court that new leadership at the United States Department of Health and Human Services wish additional time to more fully consider the issues raised in the Rule. For example, the deadline for submission of product listings, previously June 30, 2017, will now be September 30, 2017. The three month extension applies to all future scheduled deadlines whether they fall in 2017, 2018, or later. 

IPCPR Chief Executive Officer Mark Pursell stated, "This is certainly good news for our retail and manufacturing community, given the nature of the rules the industry is facing, and the uncertainty they create. This gives everyone, the industry and the administration alike, time to revisit the regulation, to determine the best path forward."

Cigar Rights of America Executive Director Glynn Loope added, "This extension speaks to the questions raised in the suit, and the recognized need by the new administration to review the nature and impact of the proposed regulations. It spans both ends of Pennsylvania Avenue, and a courthouse in between."

The associations will collaborate on conveying additional information to the industry as it becomes available. A notice is expected to be published in the coming days further memoializing FDA's extension of compliance deadlines under the Rule. 

Thousands of Fuente Cigars Stolen

Letter from A. Fuente & Co. Inc. 

April 7, 2017

To our customers, 

On April 3rd we learned that an entire 40-foot ocean container load of our cigars was stolen before it reached our Tampa warehouse. I was stunned--this has never happened to us in over a century of business. 

Unfortunately, we can't replace the hundreds of thousands of cigars that were stolen, and this loss will cause more shortages of Fuente cigars this year. We will allocate our cigars in a fair manner to all, and we thank you for your patience, understanding and support as we work through this shortage. 

We will ocercome this latest challenge, just as we have others. We have been expanding our factory in the Dominican Republic for the last two years, and we hope to increase production in the future. Our entire team is ready to put in extra effort to recover from this loss, and provide you with the highest quality cigars. You can be confident that we will never rush our production and aging process to get cigars onto the market; we will protect the quality of our product and your confidence in Fuente cigars. 

We are doing everything we can to recover the cigars, and I ask for your help. If anyone offers you Fuente product other than your trusted salesman, please contact the Miami-Dade Police Department, Telephone #305-4-POLICE (305-476-5423). WE want to get the cigars our of the hands of thieves, and into your hands for your loyal customers. We appreciate any help you can provide. 

-Carlito Fuente