TOB Magazine

FDA REVELATIONS

TBI:

What is top-of-mind

for you concerning the FDA?

Patel:

Some of the mass market [cigar] com-

panies are proposing that we [premium cigar

companies] go through testing, such as carbon

monoxide testing and a few others, but we feel

that we should absolutely not have to do that.

We are made differently, the humidity is differ-

ent, the combination of tobacco is different, the

climate is different, there are changes that take

place from year to year and you never have the

consistency in that kind of mapping with pre-

miums. Plus, we don’t have cigars from 10 years

ago that people can link to, it’s cost-prohibitive.

We would rather say to the FDA that our

cigars are ‟substantially equivalent” and they

don’t present a public health hazard to the pop-

ulation because nothing is that different from

cigars made pre- and post-2007. They’re the

same size, have the same amount of tobacco

and there’s no harmful effect. They need to

come up with a different ruling for us. The bur-

den is on the FDA to show that premium cigars

create a significant health problem. There’s no

data, they have no evidence that the benefit of

the deeming rules outweigh the detriment to the

industry. There’s no demonstrative science, just

arbitrary and capricious regulations that are not

relevant because they don’t rely on any data.

We are working with the Office of Man-

agement & Budget (OMB) to show them this

and that they have no evidence of any public

benefit with what they’re doing. It’s clear that

they just intend to be prohibitionists; they’re

just trying to wipe all tobacco off the face of

the market. Even though we are finally work-

ing with the OMB, we fear they are absolute

strict prohibitionists.

People are complaining that soldiers can’t

get cigars in Afghanistan and Iraq. I believe

Mitch Zeller said that it’s a soldier’s job to

shoot, not to smoke, so that’s the kind of men-

tality we are dealing with.

TBI:

What stage are you in with

the FDA? What communication

have you had?

Patel:

A few months ago, we filed a lawsuit,

that is, our industry associations—Cigar Rights

of America, the Cigar Association and the

IPCPR—are all three suing the FDA on the

compliance side because much of the deeming

regulations are arbitrary and ambiguous.

FDA told us we had 90 days in which to get

substantially equivalent cigars out (by August

8), but they didn’t give us guidance as to what

“substantial equivalence” is. All we knew is

that it had to be similar to products created

before 2007. So now we’re going to the OMB

and pushing them, saying we need clarity and

we want them to understand how these laws

actually impact the premium cigar segment.

It makes no sense. They’re not showing

any health benefit to society by doing this

and the detriment in cost to our industry to-

tally outweighs any benefit they’re trying to

claim. The government does not understand

our business, and they’re not trying to intel-

ligently make educated decisions on their

rules and rulings.

However, we have totally started the pro-

cesses to be compliant, even beyond what we

have to do. First off, if you’re a domestic man-

ufacturer, you have to register your products

with the FDA. Then, in February, everybody

has to come up with an ingredient list to the

FDA. We also started product registration—

we started it, but we don’t have to do it because

we are not a domestic manufacturer.

There’s a bill pending presently in Congress

for premium cigar exemption because we are

not habit-forming, nor are we a product that is

consumed by youth. We managed to get that

bill out of the House and now we are cautiously

hopeful that we could get it out of the Senate

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