FDA tobacco regulation

Yesterday, Obama signed into law a deceptive FDA “tobacco regulation” bill that will undermine public health in the long run by protecting cigarette manufacturers against competition from less deadly tobacco products (which is why the nation’s largest cigarette maker supported the bill). As Bill Godshall of Smoke Free Pennsylvania notes, the bill “protects the most hazardous tobacco product (cigarettes) from market competition by the least hazardous (smokefree) tobacco products, as it:

* bans all new and recently introduced smokefree products, while keeping cigarettes on the market.
* deceives consumers to believe that smokefree tobacco products are just as hazardous as cigarettes
* prohibits industry from telling smokers that smokefree products are less hazardous than cigarettes . . .

“Cigarettes are 100 times deadlier than smokefree tobacco products, but 85% of smokers incorrectly believe that smokefree tobacco products are just as hazardous as cigarettes. By switching to smokefree tobacco/nicotine products, smokers reduce their health risks by nearly as much as by quitting all tobacco/nicotine, and millions have already done so.”

Patrick Basham calls the new law “an epic public health mistake.” As I noted earlier, FDA regulation may actually undermine public health by making it harder to market to smokers other tobacco products, like snus, that are not as lethal as cigarettes. As Jacob Sullum notes, the law will require snus “to carry a warning that it ‘is not a safe alternative to cigarettes,’” even though “there’s no question that snus is far less hazardous than cigarettes.” And to even “introduce a ‘modified risk product,’ a manufacturer has to convince the FDA not only that the product will ‘significantly reduce harm and the risk of tobacco-related disease to individual tobacco users’ but also that it will ‘benefit the health of the population as a whole, taking into account both users of tobacco products and persons who do not currently use tobacco products.’”

The Examiner earlier described how the bill would reduce competition in the tobacco industry and enrich the biggest cigarette company at the expense of consumers and competitors alike. Although the bill is supported by the most well-funded anti-smoking groups (which indirectly receive money from Big Tobacco through the $246 billion Master Settlement Agreement), the bill’s “most important ally” is “the largest cigarette maker in the world.”

In other news, the FDA is blocking importation of so-called “E-cigarettes,” which are infinitely less dangerous than cigarettes because they do not emit any smoke. “If the FDA were to succeed in banning or restricting e-cigarettes, which are already illegal to sell in Australia and Hong Kong, the potential health risks to American smokers looking for a tar-free and less offensive cigarette alternative would be enormous.”

The Senate has just passed the FDA tobacco regulation bill by a 79-to-17 vote. The bill now goes to President Obama, who has said he will sign it. The bill has odd and counterproductive provisions. Curiously, the bill would deny companies’ protection against “tort liability — even if they rigorously follow every FDA rule.”

As I noted earlier, FDA regulation may actually undermine public health by making it harder to market to smokers other tobacco products, like snus, that are not as lethal as cigarettes. As Jacob Sullum notes, the law will require snus “to carry a warning that it ‘is not a safe alternative to cigarettes,’” even though “there’s no question that snus is far less hazardous than cigarettes.” And to even “introduce a ‘modified risk product,’ a manufacturer has to convince the FDA not only that the product will ‘significantly reduce harm and the risk of tobacco-related disease to individual tobacco users’ but also that it will ‘benefit the health of the population as a whole, taking into account both users of tobacco products and persons who do not currently use tobacco products.’”

In the Washington Examiner, Tim Carney wrote earlier about how the bill would reduce competition in the tobacco industry and enrich the biggest cigarette company — Philip Morris — at the expense of consumers and competitors alike. Although the bill is supported by leading anti-smoking groups (which indirectly receive money from Big Tobacco through the $246 billion Master Settlement Agreement), the bill’s “most important ally” is “Philip Morris, the largest cigarette maker in the world”:

“Philip Morris stands to benefit from this regulation in many ways. First, all regulation adds to overhead, and thus falls more heavily on smaller firms. Second, restrictions on advertising help Philip Morris’ Marlboro, a brand everyone already knows, by keeping lesser-known brands in the shadows. (Existing restrictions on advertising have already helped Philip Morris in this regard, with an added benefit spelled out in Altria’s annual report: ‘Marketing and selling expenses were lower, reflecting regulatory restrictions on advertising and promotion activities. … ‘) Finally, if the bill passes and the FDA gets added control over the industry, Philip Morris, more than any of its competitors, will have access to those bureaucrats and agency heads making the decisions.”

Federal regulation often backfires. A classic example is the 2007 child-safety law, the CPSIA, which was based on junk science. It shut down countless thrift stores and entire industries, resulting in children’s books being thrown out and pulled from library shelves by the thousands. It harmed poor people and special-needs kids. It rendered many ordinary bicycles illegal and made motorcycles more dangerous to children.

But it is now being used by Congress as a blueprint for a misguided law, the Food Safety Modernization Act of 2009, that would put small food producers and farmers’ markets out of business in the name of food safety.

The Supreme Court earlier rejected the FDA’s unilateral attempt to regulate tobacco, making clear that such regulation must receive Congressional approval, in FDA v. Brown & Williamson Tobacco Corp. (2000).

Congress is about to enact a bill to subject tobacco to FDA regulation. Mark Berlind notes one anomalous feature of the bill: it would deny companies’ protection against “tort liability — even if they rigorously follow every FDA rule.” We wrote earlier about how FDA regulation might actually undermine public health by making it harder to market to smokers other tobacco products, like snus, that are not as lethal as cigarettes.

As Jacob Sullum notes, the law will require snus “to carry a warning that it ‘is not a safe alternative to cigarettes,’” even though “there’s no question that snus is far less hazardous than cigarettes.” And to even “introduce a ‘modified risk product,’ a manufacturer has to convince the FDA not only that the product will ‘significantly reduce harm and the risk of tobacco-related disease to individual tobacco users’ but also that it will ‘benefit the health of the population as a whole, taking into account both users of tobacco products and persons who do not currently use tobacco products.’”

In the Washington Examiner, Tim Carney wrote earlier about how the bill would reduce competition in the tobacco industry and enrich the biggest cigarette company — Philip Morris — at the expense of consumers and competitors alike. Although the bill is supported by leading anti-smoking groups (which indirectly receive money from Big Tobacco through the $246 billion Master Settlement Agreement), the bill’s “most important ally” is “Philip Morris, the largest cigarette maker in the world”:

“Philip Morris stands to benefit from this regulation in many ways. First, all regulation adds to overhead, and thus falls more heavily on smaller firms. Second, restrictions on advertising help Philip Morris’ Marlboro, a brand everyone already knows, by keeping lesser-known brands in the shadows. (Existing restrictions on advertising have already helped Philip Morris in this regard, with an added benefit spelled out in Altria’s annual report: ‘Marketing and selling expenses were lower, reflecting regulatory restrictions on advertising and promotion activities. … ‘) Finally, if the bill passes and the FDA gets added control over the industry, Philip Morris, more than any of its competitors, will have access to those bureaucrats and agency heads making the decisions.”

Federal regulation often backfires. A classic example is the 2007 child-safety law, the CPSIA, which was based on junk science. It shut down countless thrift stores and entire industries, resulting in children’s books being thrown out and pulled from library shelves by the thousands. It harmed poor people and special-needs kids. It rendered many ordinary bicycles illegal and made motorcycles more dangerous to children.

But it is now being used by Congress as a blueprint for a misguided law, the Food Safety Modernization Act of 2009, that would put small food producers and farmers’ markets out of business in the name of food safety.