Last week, FDA’s Center for Tobacco Products issued their first regulatory action since being established by an act of Congress in 2009. An Indian company, Jash International, was instructed to cease U.S. import, distribution, and sales of four brands of bidis, a tobacco smoking product that’s rolled in the leaves of the tendu plant, instead of paper, then tied with string. The specific bidi products are sold as Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone, and Sutra Bidis Menthol Cone.
An article in The Times of India suggests that Jash International is not a particularly well-known company in its home country, so this first FDA warning might be serving as a shakedown cruise for exercising their regulatory might. The company was cited for not registering their products with the FDA, an application that would likely have been turned down anyway since bidis do not meet the standards of having a “predicate product” sold in the U.S. as of February 15, 2007. What that means is that tobacco products sold as of that date serve as the standard to which new tobacco products are compared with for “substantial equivalence.”
The FDA’s CTP order results from the authority provided under the Family Smoking Prevention and Tobacco Control Act of 2009, “to regulate the manufacture, distribution, and marketing of tobacco products to protect public health.”
Several local folks I spoke with were not aware that the FDA had regulatory authority of tobacco products, certainly not since 2009. A typical response is “Why would FDA regulate a potentially lethal product?” Indeed, use of tobacco products results in over 440,000 death per year in the U.S. alone.
In the briefest possible terms, the FDA Center for Tobacco Products takes a harm reduction approach to tobacco use in the U.S. The Act established the CTP’s mission as three-fold: 1) to prevent Americans—especially youth—from starting to use tobacco, 2) encourage current users to quit, and 3) decrease the harms of tobacco product use.
To accomplish this mission, the CTP has the authority to require tobacco companies to register their products with the FDA, disclose the content of the product, including nicotine and tar content, limit how tobacco is distributed and sold, and review new tobacco products before they are marketed. Of course, this is one activity where the FDA does not require proof of efficacy or safety. Rather, the products are being regulated to minimize their health risks for Americans who choose to continue smoking.
A major effort is directed at minimizing tobacco sales and promotion to minors, including a ban on all candy and fruit-type flavorings other than menthol. The special dispensation of menthol was a sticking point during legislative deliberations since its inclusion in cigarettes appeals disproportionate to minority groups and causes smoke to be inhaled more deeply into the lungs.
Interestingly, the Act only applies to manufactured or hand-rolled cigarettes, the tobacco used therein, and smokeless tobacco. Cigars do not fall under the Act, nor do the increasingly popular nicotine delivery devices, e-cigarettes.
However, a “Unified Agenda” statement from the FDA and the U.S. Department of Health and Human Services was published in Fall 2013 to give the CTP authority to regulate, “hookah, electronic cigarettes, cigars, pipe tobacco, other novel tobacco products, and future tobacco products.”
The Act represents the compromise from a long battle for complete prohibition of tobacco products that began with the FDA commissioner tenure of Dr. David Kessler from 1990 to 1997.
Kessler documents the history of tobacco regulation in a highly-readable and sometimes suspenseful 2002 book, “A Question of Intent: A Great American Battle With A Deadly Industry.” A Johns Hopkins-trained pediatrician with a University of Chicago law degree, Kessler was not new to politics. He had served as an advisor to Senator Orrin Hatch (R-Utah), who described him in 1991 as, “one of the brightest, most decent men I know.” Kessler had also taught food and drug law at Columbia.
Kessler is well-known to Forbes Pharma & Healthcare readers since his one of his major contributions was to accelerate the pace at which the FDA reviewed and approved pharmaceuticals. Among his accomplishment was to enable the agency to use surrogate endpoints of efficacy as the basis for approval of drugs to treat serious, life-threatening diseases. For example, an increase in CD4+ T lymphocytes was used as a surrogate marker of efficacy of HIV reverse transcriptase inhibitors instead of, say, five-year patient survival.
But Kessler also felt that if nicotine was a drug – which it is in pharmacological terms – and that the FDA regulates all chemicals that come in contact with our bodies, that the FDA should regulate tobacco products. While he was not successful at the time, his efforts carried on as social stigma to tobacco smoke grew across the U.S., even in tobacco-growing states like North Carolina (from where this post has been written).
Passage of the Family Smoking Prevention and Tobacco Control Act of 2009, garnered both bipartisan support, the endorsement of the American Cancer Society and American Heart Association, as well as the endorsement of major tobacco companies. The Act continues to raise concerns as to the ethics of a regulatory safety agency should continue to allow sales of products know to still be the leading cause of death in the United States.
But the Center for Tobacco Products also allows for training and development of policies in this arena. In fact, interested mid-career investigators might care to apply for the third class of FDA-CTP-Institute of Medicine fellowships in tobacco regulatory science. You have one week to send your application in – the deadline is March 3, 2014. Application information is here.
Source: Forbes Business