FDA’s regulation of tobacco products: misplaced authority

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On June 22, 2009, the Family Smoking Prevention and Control Act was signed by President Obama, amending the Food, Drug, and Cosmetic Act.  This historic piece of legislation created within the FDA the Center for Tobacco Products and thus granted the FDA authority to regulate tobacco products.

FDA is tackling this as a public health issue, with a goal to use as a public education tool the scientific knowledge that will be gained from the requirement that the tobacco manufacturers report the contents of tobacco products.

Video with Laurence Deyton, Director of the FDA Center for Tobacco Products

One one hand, this may be viewed as a step in the right direction, by such groups as the American Heart Association and American Lung Association.

However, the tobacco industry is surprisingly mixed in its response to this change in regulation.  Large tobacco producer Altria supports the regulation, which may be viewed as improving the image of tobacco products overall.  Other tobacco companies view this regulation negatively, based upon the new marketing restrictions, control of products, and requirements that companies fully disclose the contents of tobacco products.  In addition, associations such as the International Association of Pipe Smokers advocate for individuals’ right to smoke.

A major concern is that FDA’s new authority to regulate tobacco products could lead to a perception among the public that tobacco products are safe.

FDA’s regulation of tobacco is in conflict with the main function of the FDA: protecting the health of Americans by ensuring marketed drugs are safe and effective, and that food is safe for consumption; there are huge, negative implications of the FDA’s regulating a product (alongside FDA’s primary responsibilities of approving for marketing other products intended to improve the health of the public) that, if used properly, causes disease.

In addition, this new authority given to the FDA increases the strain on an already underfunded agency, and impacts negatively the pharmaceutical industry, others involved with the development and marketing of health related products, and, ultimately, the public.

Overall, one of the primary agencies responsible for improving the health of the nation should not be tasked simultaneously with regulating a product that causes disease (without the authority to ban the product altogether, which should be- and may be- the ultimate goal).

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5 Responses to “FDA’s regulation of tobacco products: misplaced authority”

  1. dauerbach100 Says:

    I find the contention that having the FDA involved in the regulation of tobacco products possibly leading to public perception that tobacco products are safe to be without merit. The public has a long held and deeply ingrained perception that tobacco products are not safe. Further, the FDA regulates literally thousands of drugs that are known to be extremely dangerous. Does anyone really think that chemotherapeutic drugs are safe for general use? As tobacco companies attempt to produce new products that they intend to have the public and smokers in particular believe are safer (not safe) the FDA can now intercede and have a say in what claims the tobacco manufacturers can and cannot make.

  2. drtyjenkins Says:

    This is such a great subject. The Family Smoking and Prevention Act was riddled with controversy. The very fact that is was championed by Phillip Morris makes one suspect particularly when you study industries response to decreasing cigarette sales in the US – step marketing in developing countries were we are not seeing exponential increases in use of tobacco with the subsequent health consequences. Tobacco industry has seats on the FDA’s scientific advisory panel! The bill bans candy flavorings but does not require the FDA to eliminate menthol which is the brand that is heavily marketed to African-Americans and Latinos. There is also no mandate to eliminate toxic gases. I am really looking forward to advertising that says “This cigarette is FDA approved!”

  3. markamarino Says:

    I have to say that this is one of the few times I’ve heard a public health student or faculty disagreeing with the FDA regulating tobacco products, as many thought this was a huge public health victory. I commend you for your bold stance but I disagree with your argument. First, I do not have the same definition about the role of the FDA. It sounds like you are taking a very literal interpretation of their title to mean that they should only be focusing on regulating safe and effective food and drugs. Under previous administrations this may have been the case, but I would encourage you to read the New England Journal of Medicine article by the #1 and #2 FDA Commissioners who have a much broader approach to the agency and its role in public health – http://www.nejm.org/doi/full/10.1056/NEJMp0903764. Second, even if I do agree with your literal food and drug interpretation, what would you call tobacco? Is it not a legal consumable good and shouldn’t each consumer have it’s government regulate its use as it regulates all other consumable goods? Finally, if not the FDA than who? Tobacco proved that they cannot regulate themselves, and the FDA is quite literally the only federal agency that would have the capacity and the regulatory power to tackle such a job short of creating a whole new bureaucratic agency – an option no one particularly likes. I agree with dauerbach100 who said that I’m pretty sure everyone and their mom now knows tobacco isn’t safe, so the idea that there would be some huge confusion with the FDA now regulating it is a bit of a stretch. In your video of Laurence Deyton, Director of the FDA Center for Tobacco Products, he even mentions that the three main functions of this new center is focused on preventing people from using tobacco in the first place. This is the first time that a dedicated agency has ample resources available to educate people about tobacco, control its use, and understand its effects on the human body. We should all embrace this as a victory for the entire country, because the agency responsible for improving the health of a nation finally has the ability to control the nations number one killer.

  4. aliceytsai Says:

    As a tobacco control advocate, I welcome the decision that FDA gets to regulate tobacco products. Because if it’s not the FDA, who has the “regulatory” authority? It is definitely NOT the CDC because it’s only an agency that provides health recommendations and does not have any regulatory power.

    A major challenge in tobacco control worldwide has been the dealing of tobacco industry’s various tactics and enormous investment in branding and advertising. In dealing with such challenge, many tobacco control measures in developing countries are carried out through smoking bans led by the Ministry of Health or the government itself (http://news.bbc.co.uk/2/hi/americas/4761624.stm). The law enforcement sometimes gets involved with the severity of tobacco smuggling in countries like China or Thailand (http://tobaccocontrol.bmj.com/content/13/suppl_2/ii104.full).

    In the US, tobacco products have not been rigorously regulated partly because of government’s failure to ratify the international treaty known as the Framework Convention on Tobacco Control, which was signed and ratified by 168 countries to date (http://www.who.int/fctc/about/en/). Industry sponsorship and American politics are unavoidable factors in such inaction.

    With the Family Smoking Prevention and Control Act, the United States will be able to better regulate tobacco products in protecting the nation’s health. In regards to FDA’s authority in banning the tobacco product, if treated as a drug, the FDA DOES have the authority to limit tobacco product sales on the market based on known drug side-effects and long-term health effects–which should not be old news to the government and public alike. Let’s not forget the other role of the FDA in addition to the determination of drug safety is to also protect the public from false advertisement of drugs such as the Virginia Slims that implies women can stay thin by smoking. In addition, the FDA has the power to place more effective warnings on cigarette packages rather than a mere statement of “smoking is harmful to your health,” which has known to be ineffective to smokers.

    In sum, this Act provides legitimacy for the FDA to get involved in tobacco control and I’m 100% supportive of the FDA as the regulatory agency of tobacco products in the US.

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