The FDA Tobacco Products Scientific Advisory Committee
(TPSAC) met on February 6 and 7 to
consider smokeless manufacturers’ advertising and marketing claims that their
products are safer than cigarettes (making them modified risk tobacco products,
or MRTPs).
Altria, whose U.S. Smokeless Tobacco Company subsidiary
sought MRTP status for its Copenhagen snuff product, was the clear winner, as
the committee approved the statement, “Switching completely to this product
from cigarettes reduces risk of lung cancer.” (here)
Clearly, Altria seeks to underscore the message that their
form of smokeless tobacco, which is placed in the mouth and not inhaled, eliminates
the risk for lung cancer that is high with cigarette use. This obvious but important distinction was endorsed
8-0 by the TPSAC panel, with one abstention.
Swedish Match, the other company pursuing an MRTP
application (that is now almost five years old), was not as fortunate. The panel rejected their claim that “Using
General Snus instead of cigarettes puts you at a lower risk of mouth cancer,
heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”
As I commented two months ago, “The term ‘lower risk’ is an
understatement, as the risk is almost zero” (here),
but the diseases weren’t the problem.
Some TPSAC members thought that approval would send the message to kids
that snus was “safe.” Brian King, a
deputy director at the CDC Office on Smoking and Health, expressed concern
about future unknowns: “…just because [snus usage] is low now we have to
completely dismiss what the relevance could be in the future.” he said. “My
response to that is one word: Juul.” (here)
King also said that Swedish Match’s “continued absence of
any youth data is preposterous to me.”
He seemed to be faulting the company for not surveying teens about snus
products, even though, as the company pointed out, such research could run
afoul of a ban on teen marketing.
Panel member Ken Warner supported the Swedish Match
application. “I think the health
(benefits) are really clear compared to smoking -- more so than for any other
smokeless tobacco product. My sense is
that if this is not approved, it might be the death knell for the [MRTP]
process because we would be basically saying you can't get anything through
this process.”
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