More on FDA

August 6, 2014

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.

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