Tag Archives: FDA

Stogie News: FDA Rules on Cigars Due Soon

27 Jul 2010

I know it has been said before, but FDA regulation of cigars is on the way. On April 26 the FDA published a notice in the Federal Register (Vol. 75, No. 79, Pg. 21794) of intent to regulate cigars under the so-called “Family Smoking Prevention and Tobacco Control Act” passed by Congress and signed into law by President Obama.

Cigars had originally been excluded from the law, passed in 2009, but the law also allowed for the FDA to come back later and establish regulatory authority over cigars at a later date. The specific language of the notice related to cigars is below:

147. CIGARS SUBJECT TO THE TOBACCO CONTROL ACT

Legal Authority: 21 USC 301 et seq, The Federal Food, Drug, and Cosmetic Act; PL 111–31, The Family Smoking Prevention and Tobacco Control Act

Abstract: The Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act) provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. Section 901 of the Federal Food, Drug, and Cosmetic Act, as amended by the Tobacco Control Act, permits FDA to issue regulations deeming other tobacco products to be subject to the Tobacco Control Act. This proposed rule would deem cigars to be subject to the Tobacco Control Act and include provisions to address public health concerns raised by cigars.

According to the notice, the FDA should have published a proposed rule in June 2010. At the time of this writing, a proposed rule has not yet been published. So what does all of this mean for the cigar industry? The best way to get some indication of what we can expect is to look at the regulations already in place for cigarettes and the policy reasons behind those regulations.

On June 22, some new restrictions (21 Code of Federal Regulations §1140.1-1140.34) went into effect for cigarettes and smokeless tobacco. Among them is a prohibition on distribution of free samples, prohibition on advertising in newspapers and magazines, prohibition on advertising on billboards and posters, and a prohibition on the sale or distribution of clothing or other non-tobacco items bearing the logo, motto, or other identification of a particular brand.

All of these regulations could easily be adopted for cigars. The regulations mentioned above would seriously change the atmosphere at many of the cigar events I have attended, many of which featured free samples and clothing with cigar purchases.

The only way to combat these intrusions is to speak up and be heard. So be sure to join Cigar Rights of America and contact your representatives as appropriate.

Patrick M

photo credit: FDA

Stogie News: FDA Tobacco Committee Faces Ethics Questions

10 Jun 2010

The Food and Drug Administration (FDA) Advisory Committee created to give recommendations about FDA regulation of tobacco, including cigars, is under fire for multiple conflicts of interest among some of its members.

Citizens for Responsibility and Ethics in Washington (CREW), a watchdog group, sent a letter earlier this week to the inspector general of the Dept. of Health and Human Services asking for an investigation into appointments made by the FDA to the Tobacco Products Scientific Advisory Committee (TPSAC).

TPSAC was created under the Family Smoking Prevention and Tobacco Control Act which puts tobacco products under FDA oversight. Last Fall the FDA sought comments on expanding its authority to include cigars. A recommendation by the TPSAC would be the likely first step towards regulation of cigars, which would be extremely damaging for the cigar industry and the choices of cigar smokers.

In its letter to the inspector general, CREW raised issues about Drs. Neal Benowitz and Jack Henningfield, two members of the committee who have financial conflicts of interest based on their ties to pharmaceutical companies that make smoking cessation products. Both have also made substantial money as expert witnesses in cases against the tobacco companies who they are now charged with regulating.

CREW Executive Director Melanie Sloan noted, “TPSAC panel members are barred from having financial ties to cigarette companies. Common sense dictates they shouldn’t have ties to pharmaceutical companies that make smoking cessation products either.”

In a statement to the New York Times, an FDA spokesman responded to the charges by noting “tobacco cessation drugs are not regulated by the Center for Tobacco Products.” But that doesn’t address the conflict raised due to Benowitz and Henningfield’s financial interest in getting smokers to quit smoking and use the products they stand to profit from.

In addition, the doctors conflict of interest suggests that both are in violation of President Obama’s highly-touted ethics policy, signed immediately after he took office. That policy bars “every appointee in every executive agency” from participating in “any particular matter involving specific parties that is directly and substantially related to [the appointees’] former employer or former clients, including regulations and contracts.”

The FDA ethics office did not respond to multiple questions from StogieGuys.com about whether the apparent conflicts of interest constitute a violation of the Obama executive order on appointees’ ethics commitments.

Patrick S

photo credit: FDA

Stogie Commentary: Tell ’Em What You Think

22 Dec 2009

A common complaint among cigar smokers is that elected officials and government leaders don’t listen to them. Well, here’s a chance to easily get your thoughts before the U.S. Food and Drug Administration as  the  bureaucracy considers how to implement its recently granted control over tobacco.

The process is relatively simple. Just go to this page and follow the instructions to input your comments. Before doing that, though, you should read about the process. That’s easy, too. Visit this page on FDA.gov and you’ll find links to the notice in the Federal Register and commentary from the FDA on tobacco regulation.

The IPCPR, in a recent release, had “talking points” you might find helpful. I’ve reproduced them below, with permission. Cigar Rights of America has also issued talking points for cigar smokers, but I urge you not to copy your comments from another source.  Use your own words to express your own opinions. Thoughtful, polite, and concise individual comments always carry more weight. The deadline for public comment is Dec. 28.

You might also want to send a copy of your comments–with a brief explanatory note–to your Senators and Representative. You’ll find their contact information here and here. Even though they’re not currently directly involved, I think it’s good to take every opportunity to let them know how you feel. When it comes to elected officials, personal letters are more effective than emails.

One point to remember is that the current law does not explicitly include cigars and pipe tobacco. To do so would require hearings, though it wouldn’t require new legislation. But one of the aims is to attack under-age smoking, and “little” cigars and mass-produced cigars–particularly flavored ones–are often enmeshed in that effort. So, it couldn’t hurt to voice your views now.

IPCPR Suggested Talking Points

— Congress recognized the fact that cigars and pipe tobacco do not pose the same public health concerns as the tobacco products outlined for regulation. FDA needs to recognize this important distinction as it implements the Tobacco Act.

— Flavored cigarillos are manufactured and marketed to only adults, as is premium cigar tobacco, and should remain as a legal adult choice product.

— Kids don’t smoke tobacco pipes; pipe smoking is an adult activity; there has not been a single study that has indicated any issue with kids smoking tobacco pipes.

— Cigar and pipe consumers have the right to purchase and enjoy flavored premium products just as they have the right to purchase and consume flavored alcoholic spirits and other flavored alcoholic products.

— Because of their artisan nature, origin, and construction, cigars are far different from cigarettes and are not consumed in the same way.

— Cigars are a mature, adult social experience.

— As most cigar and pipe tobacco businesses are owned and operated by small business owners and their families, further regulation will prove burdensome and overwhelming.

— Simply because a product is flavored does not mean it is intended for, or marketed to, children.

— For centuries, pipe tobacco has been flavored to create a wide variety of taste profiles enjoyed by adults.

George E

photo credit: FDA.gov

Stogie Commentary: The Neverending War on Tobacco

3 Nov 2009

You’ll find no simpler product, and in my opinion no simpler pleasure, than a fine handmade cigar. Made from meticulously grown tobacco, expertly blended and constructed, the fine cigar is a luxury that can be enjoyed for an hour at a time, yet can be had for just a few dollars.

Statue LibertyAnd that makes it even more of a shame that government is waging a war—naturally, an undeclared and unconstitutional war—against tobacco. Punitive taxes, trade restrictions, government-funded phony science, massive regulatory schemes, state-created cartels, violations of property rights, even free speech restrictions—you’ll find them all in government’s attempts to stop people from enjoying this simple plant. As in other wars, government attacks indiscriminately, making no distinction between small, family-owned cigar companies and “Big Tobacco.”

State attacks on tobacco can be found throughout history. Rodrigo de Jerez, one of Christopher Columbus’ sailors, was thrown in jail for seven years by the Spanish Inquisition for smoking the “Devil’s weed,” which he brought back with him to Europe after Columbus’s historic 1492 journey.

Since that time, governments have excommunicated, slit the lips of, and even poured molten lead down the throats of those who defied smoking bans. Despite being a pack-a-day cigarette smoker in his youth, Hitler came to consider smoking a Jewish habit and had the Nazi government launch an all-out campaign against tobacco.

Back then, America sent its boys to war with a pack of cigarettes as part of a soldier’s daily rations. Today, our tobacco policy more closely resembles that of Nazi Germany. Even the U.S. military, which defeated the Axis with cigarettes blazing, announced this summer it was considering a total smoking ban.

Our head of state today was also once a pack-a-day smoker. And while President Obama still sheepishly admits to smoking the occasional cigarette, that hasn’t stopped him from leading the largest expansion yet of the war on tobacco. One of his first acts of office was signing into law a historically high tax hike on tobacco—federal cigarette taxes jumped from 39 cents to $1 a pack, while taxes on handmade cigars increased a staggering 750 percent. Cigar factories have already begun to close, as hundreds, if not thousands, of jobs are lost.

Only a few months later, Obama signed a bill into law that puts tobacco under the regulatory jurisdiction of the Food and Drug Administration, meaning that, among other regulatory hoops, new cigarette products will have to be approved by FDA bureaucrats, even though it will be illegal for cigarette companies to highlight FDA approval in their advertisements. Flavored smokes are now banned, and all cigarette advertisements will be black and white and text only—hardly the robust free speech our founders envisioned when they penned the First Amendment.

But like so much expansion of the government, the war on tobacco is hardly a one-party issue. FDA regulation of tobacco has been a pet issue of Republican Sen. John McCain for well over a decade. And McCain’s 2008 presidential primary rival Mike Huckabee told an audience that, if elected, he would sign a national smoking ban if one made it to his desk.

In the one area where Obama has made comments that are welcome to cigar smokers, normalizing relations with Cuba, politicians of both parties have joined to stall any steps towards ending the embargo that was signed into law by President Kennedy over 48 years ago. Famously, the night before approving the embargo, Kennedy sent his press secretary, Pierre Salinger, around DC to buy 1,200 of his cherished Cuban H. Upmann cigars. Presidential hypocrisy on tobacco, it seems, is not a new phenomenon.

Armed with government-funded research, a well-funded group of professional lobbyists continues to agitate for more restrictions. In the states and in local government, they push smoking bans for public parks, bars, restaurants, apartment buildings, and even personal cars. On the federal level, they push for more taxes, further restrictions on advertising, and prohibitions on mail-order tobacco. If the current campaign for government-run healthcare succeeds, expect a slew of new regulations under the guise of keeping health cares costs down.

One anti-smoking law nearly always leads to another. In San Francisco, after a smoking ban pushed smokers out of bars and onto the sidewalk, the mayor proposed an additional tax on cigarettes to clean up the cigarette butts the exiled smokers created. Elsewhere, after cigar smokers reacted to smoking bans in bars by creating private clubs, politicians “closed the loophole” by extending the ban to the clubs.

Despite this onslaught, cigars are experiencing something of a renaissance, with quality and variety as good as ever. Today the best non-Cuban cigars, usually from Nicaragua, the Dominican Republic, or Honduras, are as good as Cuba’s top smokes. Innovative blenders are creating new cigars with all the complexity and subtleties of the world’s finest wines.

In the past year, cigar makers (and consumers) have organized to fight the ever-expanding threat to their business. Leading cigar maker Rocky Patel told me, “Every night I go to bed and I worry about the government putting us out of business.” Another maker, Nick Perdomo of Perdomo Cigars, called the government his “biggest competitor.”

The problem is government doesn’t merely compete. It destroys with taxes, regulations, and other infringements of liberty. All of which make every cigar you smoke a small act of defiance against big, oppressive government. I recommend defying often, and with a strong spirit in your other hand.

[This article originally appeared in the Fall Issue of the Young American Revolution, the quarterly magazine of Young Americans for Liberty.]

Patrick S

photo credit: ELCivics.com

Stogie Commentary: Protecting Our Cigars from the FDA

27 Oct 2009

When first signed into law, Food and Drug Administration (FDA) regulation of tobacco seemed by many to be a distant threat to cigars. The apparent consensus was that the bill was targeting cigarettes and, if it any threat to handmade premium cigars existed, it would be many years before the impact would be felt.

Lately, however, cigar makers who would be most impacted, along with retailers and consumers, have started to recognize the serious and immediate threat that FDA oversight poses to handmade cigars.

This was brought to a head when, nearly simultaneously, reports started surfacing that the FDA was sending agents into cigar shops to investigate the need for further regulations, and that a House Committee was investigating “flavored” cigars. Of course, I would be remiss if I didn’t point out that StogieGuys.com has been warning about FDA regulation the entire time the bill was being considered and being signed into law.

Part of the confusion over the impact of the FDA bill—called “The Family Smoking Prevention and Tobacco Control Act” by its proponents—is that the bill does two different things which at first glance seem somewhat in conflict. First, the legislation authorizes the FDA to regulate all tobacco, with the only major restriction being that the FDA cannot create an outright prohibition on tobacco products without an additional act of Congress. Second, the bill instructs the FDA to use that authorization to regulate cigarettes, including a ban on flavored cigarettes (except for menthol).

While focusing on the second provision of the bill, many in the cigar industry failed to recognize that by authorizing FDA regulation of any tobacco products, the bill now puts the fate of the handmade cigar industry in the hands of unelected FDA bureaucrats. This puts cigars behind the eight ball, where opponents of cigars no longer need to pass any additional legislation to subject the industry to extremely restrictive regulations that would include bans on most advertising and a burdensome FDA product approval process.

Since repeal of FDA oversight isn’t a realistic option with the current makeup of Congress (and frankly it would be a tough sell under any Congress we’re likely to see in the next decade), the current strategy should focus on differentiating handmade cigars from other products. Unlike small machine-made cigars and cigarettes, handmade cigars aren’t “manufactured”—they’re crafted. For example, blends are often tweaked from year to maintain an overall flavor even when the tastes of the tobaccos in the blend change due to climate or other factors.

Unless the FDA recognizes this, innovation in the industry is likely to be stifled, particularly for smaller boutique cigar makers who can’t afford the testing that an FDA approval process would include. Splitting handmade cigars from machine-made cigars would be a positive step towards protecting the innovation that has brought us so many of the great cigars that have come to market in recent years. It would also have the added benefit of stalling implementation of regulations until further FDA studies are completed.

The ultimate goal should continue to be to free handmade cigars entirely from the chains of FDA oversight. However, until that is possible, organizations like the International Premium Cigar and Pipe Retailers Association (IPCPR) and Cigar Rights of America (CRA) should focus on protecting cigars as best as possible through the FDA by creating a “handmade cigars” designation that would recognize the unique characteristics of our beloved premium cigars.

Patrick S

photo credit: FDA

Stogie News: Flavored Cigarette Ban Hits, Cigars Next?

22 Sep 2009

Today, the first provision of the so-called “Family Smoking Prevention and Tobacco Control Act”—a bill that gives the Food and Drug Administration sweeping powers to restrict the manufacturing, marketing and sale of tobacco products—goes into effect. The provisions make flavored cigarettes illegal, something anti-tobacco activists say will help stop minors from buying cigarettes.

The ban exempts menthol-flavored cigarettes but includes such “adult” flavors as coffee and whiskey. The menthol exemption is thought to be the result of lobbying by Altria, the world’s largest cigarette maker, which supported the bill as a way to protect its market share.

The new law, however,  has evoked other responses besides cheers from the nanny state crowd. Small tobacconists are bracing for a decrease in sales. As Manhattan smoke shop owner Sami Mohammed told NPR, “It’s destroying us—it’s rocking the smoke shops. It’s killing us, banning all flavored cigarettes,  as well the increase on taxes.”

Cigar Rights of America board member and Orlando cigar shop owner Jeff Borysiewicz told the Orlando Sentinel he’ll lose between $100,000 and $150,000 in sales annually due to the ban. “They say the different flavors appeal to children,” he told the paper. “Applying that logic you might as well ban piña coladas and strawberry daiquiris.”

Ban Leading Regulators to Target Cigars

In response to the law, some flavored cigarette makers, such as clove maker Djarum, have introduced little cigars with the same flavors designed to replace the now prohibited cigarettes. This has already led anti-tobacco lobbyists to call for the ban to be extended to cigars.

The FDA has issued a letter asserting that it may treat flavored cigars as if they were cigarettes. That move should worry makers of flavored or infused cigars including Drew Estate, CAO, General Cigar, and Altadis, all of whom make both flavored and non-flavored cigars.

Patrick S

photo credit: Stogie Guys

Stogie Commentary: Free Speech for Tobacco

10 Sep 2009

There I was, enjoying a relaxing Labor Day weekend of golf, cigars, barbecue and camaraderie, when I read an editorial so horrible, so anti-tobacco and anti-freedom, that it required a response. The New York Times took to it’s hallowed pages to write “Big Tobacco Strikes Back,” an editorial against a lawsuit filed by tobacco companies seeking to challenge new restrictions on advertising created by the recent bill that subjects tobacco to the jurisdiction of the FDA.

flaglightersThe title itself speaks to the problems with the article. “Big Tobacco” may not be a mom and pop operation, but those entrepreneurs are up against something far bigger—the federal government. So if it’s “Big Tobacco,” who are they striking back against? “Colossal Government”?

And then there’s the issue of who is actually suing to advance their free speech rights. While you wouldn’t know it from the editorial, the “tobacco companies” at issue don’t include the largest cigarette company in the world, Altria.

Altria, with its 40% plus market share in cigarettes, was a key supporter of the FDA regulation bill. The company knows that the bill’s advertising restrictions will protect its dominant market share. Those restrictions includes bans on sponsorships for sporting events, bans on ads using anything other than black text on a white background, and a ban on advertising products as “light” or safer, even if truthful.

The Times, and the anti-smoking lobbyists who no doubt inform its opinion, take the position that advertising of tobacco products can be banned if children might be exposed to it. Never mind that the ads target adults; it would be virtually impossible to advertise to adults without some exposure by children. Perhaps even worse, their opposition to tobacco companies informing consumers of how to reduce the harms caused by smoking leaves smokers in the dark about ways to reduce risks. (As to any false claims that cigarette companies might make, surely there are enough trial lawyers looking for a payday to ensure that companies don’t lie about their products.)

The editorial’s view isn’t compatible with the Constitution’s protections of free speech, enshrined in the First Amendment. After all, a corporation is just a group of shareholders who all have the right to tell their fellow citizens about their legal product. Which is why the editorial amounts to nothing more than a screed against companies attempting to assert their guaranteed constitutional rights.

Which brings me to cigars. While we cigar enthusiasts aren’t always pleased with cigarette companies, we should support this effort to overturn the FDA’s free speech ban. It isn’t just a hypothetical that cigars will be the next target. They already are.

Patrick S

photo credit: Amazon