When Congress gave the FDA regulatory authority over tobacco
in 2009, it specified that manufacturers wanting to sell a new product must get
a “substantial equivalence” (SE) order demonstrating to the FDA that the product
has the “same characteristics as a predicate tobacco product [i.e. on the
market before February 15, 2007]; or has different characteristics than the predicate
tobacco product but…does not raise different questions of public health.” (here)
Copenhagen brand moist snuff has been available in the U.S. since
1822. The U.S. Tobacco Company (UST) had
17 different styles of the brand, including 5 pouches and 4 with wintergreen
flavoring on the market in 2007.
It's worth examining UST's SE application submitted on
November 13, 2015 for a variant to be called Copenhagen Bold Wintergreen
Pouches. According to the Troutman
Sanders law firm blog (here):
“The Copenhagen Bold [WG Pouches] SE submission compared the
new product, a portioned smokeless tobacco in pouches with a grandfathered product
in the same format (pouched smokeless tobacco) but containing different
tobacco. UST had considered using a
different grandfathered product – a loose tobacco product with the exact same
blend and formula as Copenhagen Bold – but the FDA discouraged UST from doing
so because the grandfathered product was in a different format. At the FDA’s suggestion, UST designated the
grandfathered loose tobacco product with the exact same tobacco blend and formula
as Copenhagen Bold as a ‘surrogate’ product.”
Despite the company’s acquiescence in using its loose
wintergreen snuff as the predicate product, the FDA denied the SE on July 13,
2017. UST’s appeal of that decision was
denied by the agency on January 2, 2018. The company sued the FDA on February
2, seeking to overturn the agency’s action. The filing is available here.
This lengthy, so far futile attempt to gain marketing
approval for a simple variation of a moist snuff product that is associated
with nearly zero health risks underscores the broken state of the FDA review
process.
To be clear, my criticism of FDA is not intended to further
the interests of any company, but rather to advance the health interests of American
smokers who should be encouraged to switch to safer smoke-free cigarette
substitutes. Limiting the market entry of potentially attractive cigarette
alternatives reduces the chance that smokers will give up their dangerous
habit.