The latter option has become a source of contention between applicants and the FDA. As first reported by Michael Felberbaum of the Associated Press, since
2009 the agency has received about 3,500 substantial equivalence reports. Approximately 115 employees work on reviewing them. And to date they have issued
exactly zero rulings.
Products introduced before March of 2011 have been allowed to enter the market provisionally, although the agency may order their removal at any time. The
approximately 500 products submitted for review since then, however, are hostage to an approval process that progresses glacially, presents vague
standards, and makes no promise of reaching a conclusion.
Hence David Sley's complaint. Sley, 28, works in the financial sector in Chicago. A few years ago he saw an opportunity to compete with Natural American
Spirit cigarettes, a formerly independent brand now owned by Reynolds American. Sley created his own brand named Hestia Tobacco, lined up investors, and
made arrangements with a manufacturer to produce the cigarettes. What he didn't count on was the slog of getting his product through the FDA's
Sley's first contact with the agency came in November 2010 with an email seeking advice on what a small business must do to get market approval. This was
the beginning of more than two years of communication, during which the agency was often slow to provide needed information, or never provided it at all.
His frustration has driven him to reveal the entirety of this correspondence, presenting the first inside look inside look at how the FDA handles
applications for new cigarettes.
Simply getting approval for the Hestia Tobacco brand name required multiple inquiries over an entire year. Sley first asked about the acceptability of
Hestia, an allusion to the Greek goddess of the hearth, in October 2011. Seven more inquiries with three different FDA employees followed before he finally
received word in October 2012 that the agency would allow it.
Also in October 2011, Sley asked whether his plan to age tobacco in cedar, a common practice in the cigar industry, would violate the Tobacco Control Act's
ban on characterizing flavors. David Ashley, director of the Office of Science at the FDA's Center for Tobacco Products, replied by merely quoting the
statute without clarification. Despite multiple follow-ups, Sley still has not received an answer. In an interview in February, Ashley said that he had not
thought about the question. A spokesperson for the FDA has declined any further comment on the issue.
Then there is the substantial equivalence report, which Sley submitted in June of 2012. A new product is considered substantially equivalent to an existing
product if it has the same characteristics, "characteristics" legally defined as "materials, ingredients, design, composition, heating source, or other
features." The law also allows for a finding of substantial equivalence when a product differs in characteristics but raises no new questions of public