Entries Tagged as FDA
Last week, I mentioned the Cigar Rights of America had introduced a bill in the House to keep the FDA out of our humidors. Now there is a Senate companion bill in the hopper.
Folks I cannot stress how important this legislation is. Earlier this month, a piece in Barrons went over all the FDA issues. You know how everyone is excited about the possibility of Cuban cigars coming into the U.S.? Well if the FDA gets its way they will never make it to our shores.
Mitch Zeller, the head of the FDA’s Center for Tobacco Products, stresses that the recent proposal “will allow us to propose further regulatory action on these and yet-to-be-conceived tobacco products.”
THE FDA HAS MADE SCANT EFFORT to understand the cigar industry. It concedes that it has little idea how many small handmade-cigar manufacturers exist in the U.S. and exporting countries. The agency estimates that compliance with the new regs will cost each small manufacturer up to $759,000 initially and another half-million dollars a year. The Small Business Administration’s Advocacy Office protested that the proposed regulations fail to discuss the costs of the proposed rule on many potentially affected small entities. If the new rules are finalized, many, if not most, small cigar producers will be driven out of business.
The Obama anti-tobacco campaign is driven by zealotry, not science. The FDA is part of the Department of Health and Human Services, which is carrying out a “strategic action plan” with “the bold vision of a society free from tobacco-related death and disease.”
The proposed anti-cigar regulations are based on the principle that the feds have moral and legal authority to prohibit any behavior they decree is harmful. As this principle gains ground, the government can consider bans on caffeine, junk food, and other allegedly addictive substances. But there will never be a Federal Register notice on the perils of total subjugation to imperious bureaucrats.
This commentary nails it. One of the only hopes we have is to get Congress to approve the legislation it now has. We have tried twice before, but now there is a new Congress and one that possibly is more agreeable to our plight.
The legislation needs more co-sponsors and needs to move. You can help by contacting your Congressman and Senator. Let them know you smoke cigars and vote. I don’t care if you have done this before, you need to do it again. CRA makes it easy, just go to the website and enter your zipcode. Please do it today.
cigar laws · FDA
When the FDA tobacco control act was written for cigarettes, products under its jurisdiction were supposed to have been on the market by February 15, 2007. Any product after that date had to go through mounds of paperwork to be justified. When the FDA started deeming cigars and e-cigs to come under its purview this year, the agency was keeping to the Feb 2007 date. Trouble is there were virtually no e-cigs on the market and think about all the new cigars that have come out since then. (Last year alone we had Nica Rustica, Kentucky Fire Cured, San Cristobal Revelation, Star Crossed by Romeo, CAO Flathead, and El Centurian just to name but a very few.) To this end, House Speaker John Boehner, Majority Leader Kevin McCarthy and Commerce Chair Fred Upton have written to HHS Secretary Sylvia Burwell requesting a change in the date for the newly deemed products.
[M]ost e-vapor products did not exist at that time,” the House Republicans wrote to Burwell. “FDA did not even consider e-vapor products to be tobacco products until 2011.”
The leaders wrote that “[a]s a practical matter, many newly deemed products could be removed from the market” if the 2007 date is not changed.
While the letter is primarily aimed at e-cigs, it does acknowledge that cigars could also be impacted by the 2007 date. The lawmakers are suggesting the new date be April 2014 or whenever the regulations go into effect. If the FDA changes the date for all the newly deemed products that would at least be a start.
cigar laws · cigar news · FDA
Recently in a cigar store, I was asked if I favored the legalization of marijuana. I said no. When asked why, I simply said that pot smokers are hypocrites. They will light up a joint, but then hack and cough if one were to light up tobacco around them. If all the people in favor of legalizing pot backed tobacco smokers as well…it would be a different story.
A public opinion survey put out last week supposedly shows that the majority of Americans support the legalization of marijuana. 39 percent of the 450,000 surveyed show they strongly support the legalization, while another 19 percent somewhat favor it.
Jennifer Sikora, a spokesperson for CivicScience, explained to The Huffington Post that although the survey was online, the company uses browser cookies to keep respondents from answering the question more than once. In order to further hedge against a person answering the same question multiple times, the question is part of a pool of more than 1,000 rotating questions on multiple websites to further decrease the possibility that a respondent might happen upon the same question again. Still, Sikora says, there is a very small percentage of respondents who do repeat the answer (after all, cookies can be deleted), but the 453,653 U.S. adults in this survey are unique.
The question was “would you support or oppose a law that would legalize, tax and regulate marijuana like alcohol?” 23 states and the District of Columbia have legalized pot for medical uses and Colorado and Washington have legalized it for recreational use. However, Washington and Colorado have bans on smoking tobacco. Do they seem to think that all pot users will eat it? After all, smoke is smoke.
And what of regulation? It occurs to me that marijuana is a drug. Isn’t the name of the federal agency that intends to put cigars out of business the Food and DRUG Administration? They seem to have no interest in pot, but are more concerned about nicotine.
At the end of last month, the FDA and CDC put out a release that was very deceptive. They don’t want e-cigs, nor any other form of tobacco because, I think, it hurts pharmaceutical sales of Nicotrol, Nicorette, Chantix and the like. The National Youth Tobacco Survey massaged the data to get results that could be exploited.
Intention to smoke conventional cigarettes was 43.9% among ever e-cigarette users and 21.5% among never users.
“The increasing number of young people who use e-cigarettes should be a concern for parents and the public health community, especially since youth e-cigarette users were nearly twice as likely to have intentions to smoke conventional cigarettes compared with youth who had never tried e-cigarettes.” said Rebecca Bunnell, Sc.D., M.Ed., Associate Director for Science in CDC’s Office on Smoking and Health and the lead author of the study.
Carl Phillips takes the report to task on several points:
So what did they find? They reported that according the 2013 NYTS, 263,000 never-smoking American youth, grades 6-12, had ever tried one puff of an e-cigarette. The lies start here. They describe this as “used e-cigarettes” even though no rational person would interpret “use” to mean “tried one puff ever”... It is also worth noting that this is far lower than the roughly 5% of the “youth” in the population who are of legal age to buy cigarettes, cannabis where it is legal, and e-cigarettes where they are age-restricted.
Further, the quarter of a million number comes from the kids who EVER tried a puff, not just in 2013. As for the percentage of “youth” that had intentions to use e-cigs, well they had to juggle the numbers. When asked if they would smoke, the choices were basically definitely yes, probably yes, probably no and definitely no. The FDA CDC decided that anything other than a definite no was intention to smoke. Really? This is the kids of “science” we are up against. Liars.
cigar laws · FDA
One thing is pretty clear about the FDA…no matter what they rule, there will be court cases. For one thing, Altria—the cigarette maker Philip Morris—is concerned that the FDA control may force them to change the name of one of the best selling cigar brands. Altria owns John Middleton Co., which makes the Black and Mild brand. Middleton dates back to 1856 and it has almost a third of the U.S. cigar market.
Under the Food and Drug Administration proposal, cigar makers would have to remove descriptions like "light," ''mild," ''medium" or "low" from their products, raising a unique question about the fate of Black & Mild.
The descriptions were banned for cigarettes under a 2009 law because many smokers wrongly thought they meant the products were less harmful than "full-flavor" cigarettes. Cigarette makers have since replaced those words with colors such as gold, silver, blue and orange on such brands, which usually feature different filters and milder-flavored blends.
The company contends that forcing it to change the name would be unconstitutional.
"Neither FDA's regulatory authority or the First Amendment allows the FDA to ban words such as mild for cigar and pipe tobacco regardless of the context," said Altria spokesman David Sutton. "Here, when the word is part of a longstanding and well-established trademark like Black & Mild, such a ban would violate basic constitutional guarantees."
But, of course, constitutionality matters to the government. See Washington Redskins owner Daniel Snyder for confirmation.
cigar industry · cigar laws · FDA
The FDA is going through the comments now and last week in talking with Glynn Loope about the comments submitted, he told me that on the last day the Cigar Rights of America group delivered about 40 pounds of letters. Yup, the old fashioned pre-Internet kind on paper, not electronic. That is a lot of letters from cigar smokers and is a good thing. Loope says the CRA is drafting another letter for consumers to send to Congress. Yes there still is a way to stop this, via Congressional action. (This is an election year after all.)
In the meantime, Florida’s Attorney General gets a pat on the back. Pam Bondi wrote into the FDA to say she thinks they are overdoing it. Unfortunately she was alone.
Bondi’s letter was separate from a letter signed the same day by 29 other attorneys general that implored the FDA to make the proposed regulations even stronger, particularly in regard to electronic cigarettes
Bondi said the FDA should consider the economic impact of what it is doing. (Remember it already has put people in San Antonio out of work when Finck’s cigar factory closed and I doubt there is much call for cigar makers in Texas anymore.) Bondi is concerned that J.C. Newman in Tampa would have to cease its manufacturing in that city.
“This 119-year-old premium cigar company with 130 employees is truly unique in this industry and should not be regulated in the same manner as the nation’s largest cigarette companies,” Bondi wrote on Friday, the deadline for submissions on the federal plan.
Florida’s Senators also have been involved.
U.S. Sen. Bill Nelson, D-Fla., and U.S. Sen. Marco Rubio, R-Fla., have requested an exemption to the new rules for companies that don’t mass-produce cigars, such as J. C. Newman. The FDA is already considering an exemption for premium cigars that are handmade. J.C. Newman uses vintage machines.
We’ll see how this plays out.
cigar industry · cigar laws · FDA
Well the comment period is now closed for the FDA’s proposed rule to take over cigars. We don’t know how many were in favor and how many were on our side yet. But the final count was 75,735, which is about 15,000 more than we had at the start of last week. Since the FDA has to look at every comment, figure it will take them about 6 months to go through all of them. Realistically, the FDA is going to do what it wants to do no matter what. So now we sit and wait. I thank those of you who did put in your comments, and as for those who didn’t, well when cigars are gone you only have yourselves to blame.
The other side is not resting…they are continuing their push for regulation of premium cigars. According to an inaccurate report by Bloomberg:
“We know that premium cigars have health risks, they cause cancers they have cardiovascular implications and so on,” Gregg Haifley, associate director of federal relations with the American Cancer Society’s Cancer Action Network, said in an interview. “Why should a product that has known disease health consequences be exempt from a factual scientific warning label?”
There are 3,639 types of cigars that would be affected by the proposal, 3,276 of which are made in other countries, according to an economic analysis by the FDA.
The groups want the premium cigar makers to have only one year to file an application to sell their products instead of the 2 years the FDA proposes. For all 3,639 cigars and that doesn’t include what came out this year at the trade show. And I am sure the FDA will get right on that approving them...
Oh the inaccurate part? In the story’s third paragraph it talks about Imperial Tobacco as the owner of Davidoff. Guess the reporter and the anti’s don’t know Davidoff is a separate company. Nice fact checking.
By the way, in Hawaii there is a preview of things to come. Starting July first, the state got rid of self-service for cigars, unless the shop bars anyone under 18 from going in. It is not that much of a problem because there are very few walk-in humidors in the state and the under 18 ban is a way out. But look for the FDA to implement a very similar rule everywhere once they gain control.
So What Now?
There is still something you can do about this…urge your Congressmen and Senators to support HR 792 and SB 772, which would exempt premium cigars from the FDA’s clutches. As of now, there are 162 sponsors and co-sponsors for the House bill and 16 for the Senate version. We need to do better. Write and call your Congressional delegation to be certain they get involved. Even if these bills do not pass this session, the more sponsors we get will get the FDA’s attention. After all, the FDA gets its money from Congress. You can go to the Cigar Rights website to get information on the bills and how to contact your representatives.
cigar laws · FDA
The FDA says it uses science for its rulings. But does it? Nope not a whit. Take the e-cig deeming. You would think there is research on e-cigs to back up the agency’s proposal. Not so much. You see the FDA is spending $270 million of your money on research into e-cigs. The research is underway and the regulations could happen within the year.
“Final results may not be available before 2018, researchers leading the FDA-funded projects told Reuters. That timetable, which has not been reported before, underscores how the slow pace of science is contributing to a regulatory vacuum, allowing e-cigarette makers to sell their products virtually unchallenged.”
Note the editorial comment above…emphasis mine. So then why are they doing it? Big Pharma. The International Tobacco Growers Association has outlined the reasons for this and the WHO tobacco control agenda. IGTA chief executive Antonio Abrunhosa:
"This is big war. Pharmaceutical companies always dream of replacing each cigarette with nicotine patch. They have been campaigning very heavily against tobacco for many years. They fund heavily for the campaign against tobacco," Abrunhosa alleged while talking to reporters.
"We are poor farmers, we cannot fight with big companies. They have millions of dollars. But we have millions of people on our side," he added.
While this fight goes on, the retailer trade group is still wrestling with definitions of premium cigars…how much should it weigh, what size, what price and who should be exempt. To me this is the equivalent of re-arranging deck chairs on the Titanic. Just leave cigars alone. All cigars.
An example is the Quesada Petit cigar introduced last month at the trade show. It is little and weighs almost nothing, yet it is hand made out of all tobacco and it is even long filler! The price about a buck. Hand made and long fill make that a premium cigar to me, but others disagree.
Then what about the premium cigars that J.C.Newman makes in Tampa? They are machine made and would not get an exemption. That could kill the last cigar factory in “Cigar City” because the FDA would have to review all “new” products.
“The gatekeeping role includes requiring cigar manufacturers to spend thousands of hours, according to an FDA analysis, to test new products before submitting an application to sell a single new brand or size of cigar. New packaging on an existing cigar also would require FDA approval, and the tightened manufacturing practices could prohibit J.C. Newman’s vintage equipment.”
Remember we have already lost one factory--Finck Cigar Manufacturing in San Antonio. There are those in the cigar industry who think they can work with the FDA. Nothing could be further from the truth. If cigars are deemed to be under FDA control, in addition to most likely banning walk-in humidors (no self service) the agency would have to approve all new products. How does that work out? Not great. Just last week, the Wall Street Journal editorialized how skin cancer is one of the most easily preventable diseases in the U.S. with melanoma killing one person per hour.
“One reason is that the Food and Drug Administration refuses to approve superior prevention technologies. The FDA last blessed a new sunscreen in 1999. Eight new chemical ingredient applications are awaiting regulatory decisions—three of them since 2002, and another three since 2005.”
As for the Tobacco office itself, Senator Richard Burr of North Carolina cited a GAO report on the FDA’s approval process in tobacco which relies on Substantial Equivalence (SE).
“According to Burr, the GAO report concluded that since 2009, the FDA has collected more than $1.1 billion in tobacco user fees. However, as of now, the agency has only made final decisions on 17 tobacco products out of the 3,788 total SE submissions in the three years since the FDA received the first SE submission in June 2010. “
Bottom line, this is serious and more needs to be done quickly. Get involved and make sure your friends are involved as well. Contact your Senators and Representatives to back the bills, which would prohibit the FDA from regulating cigars. And then get every cigar smoker to rise up and literally flood the FDA with comments this week. After Friday, it will be too late.
cigar industry · cigar laws · FDA
Stop posting pictures of what cigar you smoked or are smoking. Because if you don’t get busy your cigar days will soon be gone. We are in the last hours to submit comments to the FDA on its deeming proposal that would bring cigars under its control. To date, the FDA website shows only 66,000+ comments on the proposed rule. Now considering not only cigars would come under the FDA, but so too would e-cigs, which don’t even contain tobacco nor emit smoke, and there are by estimates millions of e-cig users, that comment number is pathetic. To give you an idea, when the Federal Communications Commission called for comments on the so-called net neutrality issue, there were more than a million comments. Of those 66,000 you can bet many are from the anti side, although the Sunlight Foundation says as of July 18 slightly more than half come from our side. But then again another 11,000 comments have come in since that report. We still have to do better.
Late last week the Campaign for Tobacco Free Kids put out a release saying 17.4 million Americans smoke cigars every day. (I bet most don’t even know about the FDA actions. I met a couple of retailers at the trade show who did not know!) What does that mean to the Campaign? Regulation of course.
“This study shows that cigar smoking is a serious public health problem that must be addressed through strategies such as Food and Drug Administration regulation of all cigars and taxation of cigar products at the same rate as cigarettes.”
The other side wants absolutely no exceptions. Remember the FDA didn’t want one either, it was the Office of Management and Budget that suggested the option for premium cigars and removed the ban on anything other than face-to-face sales, which would have shut down Internet cigar sales. That did not make the anti’s happy.
"The part of the proposal we are deeply troubled by is the sweetheart deal for the cigar industry," Erika Sward, assistant vice president for national advocacy at the American Lung Association.
The campaign also is working hard lobbying medical groups to get on board.
"We oppose any amendment that would interfere with the current rulemaking process, prevent a science-based decision-making process, and place a broad category of cigars beyond the reach of FDA," said the May 27 letter, which was crafted by the Campaign for Tobacco-Free Kids and signed by more than 30 medical organizations. "An amendment to exclude certain types of cigars would prevent FDA from implementing even basic common-sense rules such as requiring manufacturers to report what ingredients are contained in their products."
The last day for comments on the FDA rules is this Friday August 8th. If you haven’t done so, go directly to the FDA site, or reach it through the Cigar Rights site. I would suggest the FDA stay away from ALL cigars. Be sure to tell all your friends and make certain your tobacconist knows. And make sure they submit their comments.
cigar industry · cigar laws · FDA
We got the 30 day extension for comments to the FDA, and we will most likely need all that time. But recently the state of Florida is fighting back at the FDA. Last month, I wrote about one cigar manufacturer who was moving production offshore—Finck in San Antonio. Now the J.C.Newman company in Tampa is involved in the death match.
Tampa was once home to more than 150 cigar factories but today only one remains, the Newman factory. While Newman is known for its Cuesta Rey and Diamond Crown cigars in the Dominican Republic , it also makes machine made cigars. The Newmans have enlisted some help in the form of Florida’s Governor and Lieutenant Governor.
The duo wrote to the head of the FDA a couple of weeks ago, urging an exemption for the Newmans. The letter cited Tampa’s history as cigar city and said the new FDA regulations will put undue and excessive burdens on the family.
To require these companies to charge $10 for a premium cigar would unnecessarily inhibit future sales. Making matters worse, these artificial price floors only apply to small, family-owned businesses while big tobacco companies are unaffected. In addition, requiring FDA approval for each new size, shape or brand would require upward of 5,000 hours of testing at the company’s expense – a massive burden for a company like J.C. Newman, which simply does not have the financial bandwidth of national cigarette companies that have long incorporated these kinds of requirements into their bottom line.
They ask for an exemption for premium cigar companies…which is different than excluding premium cigars since the Newmans do make the machine products. Remember to get your testimony in as well.
cigar laws · FDA