WASHINGTON -- David Sley wants to sell cigarettes. An aspiring entrepreneur who works in the financial sector in Chicago, he saw an opportunity a few years ago to create his own brand, Hestia Tobacco. He lined up investors and made arrangements with a manufacturer to produce the cigarettes.
What he didn't count on was the difficulty in getting his product through U.S. Food & Drug Administration's new tobacco regulations and approval process.
The Atlantic chronicled Sley's quest and the overall process.
The entire cigarette industry has been brought to a standstill by the FDA, forbidden from introducing any new products since March 2011, said the report. Tobacco companies contend that the agency's actions rest on uncertain scientific and legal grounds.
The Tobacco Control Act of 2009 granted the FDA pre-market review: New cigarettes cannot be introduced without an order from the agency. The law provides two routes to approval. One route is for completely new tobacco products and requires a highly detailed review. The other is for products that are "substantially equivalent" to those already on the market.
The latter option has become a source of contention between applicants and the FDA, the publication said. Citing an Associated Press report, it said that 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 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," the report said, "to an approval process that progresses glacially, presents vague standards and makes no promise of reaching a conclusion."
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, he told the magazine. 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.
Though unable to meet all of the FDA's demands, Sley responded as best he was able and beseeched the agency to rule on his case by December 2012. "We want a license to fail," he wrote to one of the regulators reviewing his application, "the freedom to see if consumers want this product. We're just asking for the ability to market our product, and see if it sells. Currently, we remain unable to do so."