Tag Archives: FDA

News: Cigar Groups Push Back Against Impending FDA Cigar Regulations

12 Dec 2013

IPCPR and CRA sent a letter to the Obama Administration’s Office of Management and Budget (OMB) to argue against impending regulation of cigars by the Food & Drug Administration (FDA). The OMB is currently evaluating rules proposed by the FDA.

In 2009, President Obama signed into law the so-called “Family Smoking Prevention and Tobacco Control Act,” which required the FDA to regulate cigarettes. The bill also authorized the FDA to regulate other types of tobacco, but doesn’t require such regulation.

The nine-page letter makes the case that there is “no public health basis to conclude that premium cigars should be regulated by FDA under the Tobacco Control Act.” It states there is no legal basis for such regulation because there is no evidence that premium cigars are addictive or used by young people.

The letter notes the Tobacco Control Act gives the Food & Drug Administration “the authority to address issues of particular concern to public health officials, especially the use of tobacco by young people and dependence on tobacco,” and also should “continue to permit the sale of tobacco products to adults in conjunction with measures to ensure they are not sold or accessible to underage purchasers.”

It then goes through the scientific research, especially the National Cancer Institute’s Monograph 9, which is the most comprehensive overview of the health effects of cigar smoking. As explained in the IPCPR and CRA letter, the 248-page monograph demonstrates that handmade cigars are not addictive when used properly.

The letter, which can be read below, makes the case that if the FDA and OMB apply the law in a scientific manner, the FDA should not create any new regulations for handmade cigars. Further, should the FDA attempt to regulate handmade cigars, the arguments in the letter are likely to be the same arguments in any legal challenges to FDA regulation.

Patrick S

photo credit: N/A

News: Over a Year and a Half Later, White House Still Silent on FDA Cigar Petition

26 Nov 2013

Why does the Obama White House refuse to answer a petition regarding the forthcoming Food & Drug Administration (FDA) regulation of cigars, when it has answered numerous other petitions that were filed more recently and had fewer signers?

wtpIn 2011, the Obama White House announced We The People. The concept was simple. “Individuals will be able to create and sign petitions seeking action from the federal government on a range of issues. If a petition gathers enough signatures, White House staff will review it, ensure it is sent to the appropriate policy experts, and issue an official response.”

Originally the threshold for an official response was 5,000 signatures within 30 days, but later it was raised to 25,000 signers, and more recently to 100,000. For the most part it worked as intended. According to WHPetitions.info, which tracks the 235 petitions that have reached the required threshold, 209 (88%) have received the promised response, with an average wait time of just 69 days.

But not all petitions have been answered in a timely fashion, including one about cigars. On April 11, 2012, Jeff Borysiewicz, owner of Corona Cigar Co. in Orlando, filed the petition asking the President to order the FDA to not use its discretion to regulate handmade cigars:

Dear Mr. President:

The FDA is considering the creation of regulations for the premium cigar industry. These regulations will jeopardize over 85,000 American jobs, destroy America’s “mom and pop” premium cigar retailers and manufacturers, and risk over 250,000 jobs in Latin America that produce cigars, impacting the economic/political stability in the region.

We hope you will stand up for small businesses that dot Main Street America and recognize that premium cigars are enjoyed by adults, are not addictive, and therefore do not conform to the Congressional intent of the Family Smoking Prevention & Tobacco Control Act.

Tell the FDA to leave our premium cigars alone. With this nation’s more pressing issues, harming my simple ability to enjoy a cigar should not be a priority of the government.

Cigar consumers, grassroots activists, websites, cigar sellers, and manufacturers soon banded together to promote the petition. By April 25, it reached the 25,000 signatures needed to qualify for an official response from the administration. Before the 30-day deadline ended, the petition collected nearly 39,000 signatures.

While the average response has taken just over two months, 19 months have passed and the Administration has not yet issued any answer to the 39,000 people who signed in favor of protecting cigars. Only one other petition has been pending longer.

Patrick S

photo credit: White House

Commentary: Which Side is Big Tobacco On?

18 Apr 2013

Those who hate all tobacco are constantly trying to equate premium cigars with “Big Tobacco,” which they view as an an evil not seen since the Galactic Empire in Star Wars (a long time ago in a galaxy far, far away).

Which should, but won’t, make them feel a bit uncomfortable about being on the same side as Big Tobacco when it comes to FDA regulation of cigars. A recent article in The Hill makes it clear that when it comes to the bill to stop the FDA from expanding its oversight to include premium handmade cigars, the biggest of cigarette companies stands with the tobacco control groups that detest everything about Big Tobacco:

Cigar companies are going up against tobacco giant Altria, the parent company for Philip Morris USA, which backs expanded FDA oversight and opposes Posey’s legislation. “We believe cigars are a product that are made for adults, have health issues related to them, and have tobacco. We believe the FDA asserting its jurisdictional authority over them is appropriate,” said David Sylvia, a spokesman for Altria.

Altria, it’s worth noting, originally supported the original FDA bill to regulate tobacco because, according to Forbes, the bill “solidifies the position of the producer with the greatest market share—Altria—which makes 50% of all cigarettes in the U.S.”

If Big Tobacco is the unmitigated evil that anti-tobacco zealots say they are, then maybe they need to re-examine their position, which is now the same as the Marlboro Man.

My own view of so-called Big Tobacco is more nuanced. First off, I believe cigarettes, like cigars, should be a legal product which adults should be free to choose to consume. I’d concede that there was a time when the largest cigarettes companies probably misled the public about the health effects of their products. But that doesn’t change the fact that tobacco is and should be a legal product in a free society, or that every smoker now understands that there are serious risks to smoking, especially cigarettes. (In fact, studies suggest smokers overestimate the health effects of smoking.)

Which brings me back to the politics of Big Tobacco, cigars, and the FDA. If cigarette companies’ position is that the bill stopping the FDA from regulation cigars should be opposed because all tobacco should be free from FDA oversight and they want cigar smokers as an ally in that fight, then I’d have some sympathy.

In fact, ultimately I agree with that position while realizing that in the short term it is politically impossible. So the best position right now is articulated by Glynn Loope of Cigar Rights of America to The Hill: “When Congress passed the original Tobacco Control Act, it was really to address two primary points: youth access to tobacco and chemical addition. Premium cigars don’t meet that criteria.”

But that’s not the position of Philip Morris USA, which is the quintessential “Big Tobacco” company. Philip Morris lobbied for the FDA bill, which apparently they feel is best for their bottom line by stifling their competitors, and now they are seeking to force cigars under the same onerous regulations.

All of which is a long way of saying, the next time you talk with someone who opposes the “Traditional Cigar Manufacturing and Small Business Jobs Preservation Act” to repeal the FDA’s authority to regulate cigars, feel free to ask them why they are taking the side of Big Tobacco against the little guy.

Patrick S

photo credit: FDA

Cigar News: The FDA is Two Small Steps from Banning Handmade Cigars

7 Mar 2013

Jacob Grier (writer, cocktail expert, cigar smoker, and a friend of this site) has a must-read article at The Atlantic‘s website about the FDA’s approval process, or lack thereof, for new tobacco products. Essentially, the FDA is supposed to be “regulating” cigarettes but instead is blocking all new products from reaching the market.EPCAging-room

The article describes the impossible delays and bureaucratic hurdles (over 1,000 new products are pending review but none have been approved) thrown up by the FDA under it’s authority under the Tobacco Control Act of 2009, particularly the story of Hestia Tobacco, which tried for over a year to get FDA approval for a new organic cigarette. And while the focus of the article is on cigarettes, a careful reading of Grier’s piece contains some grave warnings for cigars.

Repeatedly during the story Hestia Tobacco founder David Sley describes attempt after attempt at getting a straightforward answer from the FDA, only to be stymied repeatedly. One passage in particular, regarding aging tobacco in cedar, has important implications for cigars:

Also in October 2011, Sley asked whether his plan to age tobacco in cedar, a common practice in the cigar industry, would violate the Tobacco Control Act’s ban on characterizing flavors. David Ashley, director of the Office of Science at the FDA’s Center for Tobacco Products, replied by merely quoting the statute without clarification. Despite multiple follow-ups, Sley still has not received an answer. In an interview in February, Ashley said that he had not thought about the question. A spokesperson for the FDA has declined any further comment on the issue.

It wouldn’t be a stretch to estimate that the vast majority of handmade cigars are “aged” in cedar in one way or another (think cedar-lined aging rooms, cedar cigar boxes, and cedar sleeves) because cedar’s qualities (especially Spanish cedar) make it ideal for storing cigars. That means that a ruling by the FDA that aging tobacco in cedar violates statutory language against “characterizing flavors” could be one step away from a near total ban on cigars.

And every indication is that other step is only weeks away. As the article notes, the FDA plans to introduce its first rules on cigars by April. Many have speculated that this could include an extension to cigars of the flavor ban that makes flavored cigarettes (other than menthol) illegal. A group of Senators even tried to mandate such a flavored cigar ban last year by attaching it to an appropriations bill.

With the FDA unwilling (after being asked multiple times over the course of 17 months) to foreclose cedar aging being a violation of the flavor ban that is central to the FDA’s tobacco regulatory regime, the coming FDA rules on cigars could leave the FDA dangerously close to banning very common practices fundamental to the creation of the premium handmade cigars you smoke.

Patrick S

photo credit: EPC

News: An Update on the FDA and Cigars

20 Nov 2012

The next step in the conflict over the FDA’s plan to regulate premium cigars is likely to come from the agency rather than Congress. An FDA spokeswoman told me that there’s no date set for issuing a proposed rule, which it first broached in the spring of 2011. “Sometime in the future,” was as close as she said she could come on the timing.

When the rule is published in the Federal Register, there will be a period for public comment, likely at least 45 days. To make sure you know what’s going on and have an opportunity to register your view when the FDA begins action, sign up for an email subscription to “This Week in CTP.”

Recent elections had an impact on the legislative efforts to stop the FDA, which we touched on earlier this month. The effects were stronger in the House of Representatives, where the bill to protect cigars (HR 1639) had bipartisan support from more than half the members. The bill’s author, Rep. Bill Posey (R-FL), won re-election and remains committed to it. I talked to George Cecala in his office, and he told me they’re continuing to educate members and to build support.

I have a call in to Sen. Bill Nelson (D-FL) who introduced the Senate version, and I’ll let you know what I hear from them.

As you’re no doubt aware by now, the likelihood of FDA regulation devastating the cigar industry is very real. I believe the efforts of cigar smokers helped build support for the legislation, and if you haven’t gotten in touch with your elected officials, there’s no time like now. Just search “1639” on Stogie Guys and you’ll find everything you need to know.

This is no time to let up. Every cigar smoker needs to stay involved and help win this fight.

George E

photo credit: FDA

Commentary: Don’t Forget H.R. 1639

30 Aug 2012

If I might borrow a phrase from June Cleaver, I’m worried about the bill. H.R. 1639, that is.

I’m concerned because I think many cigar smokers believe there’s nothing left to do on this legislation to bar the Food & Drug Administration from regulating premium cigars. I’ve heard more than once that it’s achieved a majority in Congress, the implication being that we’ve won the fight.

Sorry, that’s not true. The bill hasn’t achieved a majority of support in either the House or the Senate, according to Thomas.gov, the Library of Congress site that tracks bills.

In the House, there are 217 voting members who’ve signed on, including the original sponsor, Florida’s Bill Posey. I know you keep seeing and hearing that it’s achieved the threshold of half of the 435 members but, as I’ve pointed out before, the key is voting members. The cosponsor list includes among supporters the representative from Guam, who has no vote, and former Oregon Rep. David Wu, who resigned in 2011. No one’s signed on since Aug. 2.

In the Senate, where the legislation is known as S. 1461, there are but 12 cosponsors to the bill, introduced by Bill Nelson of Florida. That’s a long, long way from 51.

Adding to the pressure is the fact that Congress has only a few weeks of work left in this session. This doesn’t bode well for the chances of such specific legislation as the cigar bill winning approval, even with adequate support. Couple that with the fact that many of the names you see on the lists of supporters in both chambers won’t be back in 2013, and the fight doesn’t appear so certain.

And that last point leads to another consideration. I know some feel that the legislation doesn’t have to pass, that simply the recognition of ample Congressional support will be adequate to force the FDA to back down. I’m not one of them. There might be a tactical retreat, but they’re smart enough to bide their time and strike later.

So, once again, I’m urging all of you to see whether your senator or representative has signed on. And, if not, let them know you want their support. This is a golden opportunity and we can’t afford to settle for silver.

George E

photo credit: Stogie Guys

Commentary: Cigar Events Worth Attending and Fighting For

5 Jul 2012

Last weekend I attended Famous Smoke Shop’s Cigarnival at their year-old Leaf Cigar Bar, Restaurant, and Lounge location. The event reminded me why cigar smokers wanting to learn more about the craft of cigars should attend events, whether just a small visit by a brand representative to their local shop or a large event like Cigarnival, with nearly 1,000 attendees and two dozen or so industry representatives.

Often it’s the perks that bring people to such events. In the case of Cigarnival 2012, it was enough cigars and swag to cover the cost of the ticket ($180), not to mention the unlimited beer, lunch, dinner, and carnival show. At smaller events it’s the special event deal or free samples.

But the best part of such shows is getting a few minutes with the guys who actually make the cigars we enjoy on a daily basis, and in my experience they are always willing to spend a few minutes talking with their customers.

No question will go unanswered if you just ask. In just a few hours, I was able to talk with Pete Johnson (Tatuaje), Jesus Fuego (J. Fuego Cigars), Abe Flores (Pinar del Rio), Ricky Rodriguez and Michael Giannini (General Cigar), Sean Williams (El Primer Mundo), Jonathan Drew (Drew Estate), José Blanco (Joya de Nicaragua), Brad Mayo (Jameson Cigars) and many others. (Details about some of the upcoming projects they told me about will be coming in a future article previewing the 2012 Trade Show.)

And although I was there as press, I saw many regular cigar-loving attendees do the same. It’s one of the things about the premium cigar industry that makes it so easy to write about: The industry is small enough that with minimal effort, whether via social media or in person, anyone can converse with the guys (and gals) responsible for making their favorite smokes.

In other ways, such events showcase the very best of the cigar industry. You meet fellow cigar fans and talk about your shared passion for cigars.

The defense of cigars from meddling politicians was also on display at Cigarnival. The Cigar Rights of America (CRA) booth was busy all day signing up new members.

Later, representatives of CRA were given the stage to explain how important it is to support CRA and the bill in Congress that would stop the FDA regulatation of cigars.

Famous Smoke owner Arthur Zaretsky, who moved the store from New York to Pennsylvania to escape the oppressive New York tax regime, took the stage too, imploring attendees to contact Pennsylvania Senator Bob Casey and demand his support for the bill. He then surprised everyone, including CRA representatives, by offering to subsidize half of the cost of CRA membership for anyone who signed up at the event.

All in all, it was a pointed reminder of not only what is so great about cigars, but the challenges cigars face from government regulation and taxes. For example, if the FDA bill doesn’t pass, it wouldn’t be hard to imagine FDA regulations including a ban on samples like those handed out at the event and many similar events around the country.

So enjoy cigar events now, and fight to protect your right to enjoy them in the future by supporting CRA and contacting your representatives in support of the Traditional Cigar Manufacturing and Small Business Jobs Preservation Act.

Patrick S

photo credit: Famous Smoke