The Food and Drug Administration Needs to Tread Lightly With Any New Regulations

David Williams

August 30, 2011

The federal government is obsessed with controlling behavior, and despite President Obama’s call to repeal $1 billion worth of regulations, the federal government is also obsessed with regulating businesses, large and small.  One program that symbolized the obsession with controlling behavior was the creation and the expansion of the Communities Putting Prevention to Work (CPPW) program funded by the Centers for Disease Control (CDC) (see previous blog post).  Now, as part of an all-out assault on one industry through regulation, the federal government has its sights on new smokeless tobacco products.

Smokeless tobacco comes in many forms and most are probably most familiar with chewing tobacco or snuff.  But there are two new forms of smokeless tobacco that show quite a bit of promise for smoking cessation, e-cigarettes and nicotine lozenges.

E-cigarettes provide an opportunity to enjoy the cigarette experience without the harmful effects of smoke and have been used extensively by people to stop smoking.  According to the Western Daily Press in the United Kingdom, “Pete, 61, has puffed up to 100 fags per day since he was a schoolboy aged only 11. For most of his life, he went through a full packet of 20 before 10am and another two packets during his working day. He would then smoke up to 40 after work and at his local pub near Bridgwater.”  The article also notes that, “He now uses Nicolites electronic cigarettes, which contain nicotine – and ‘smoke’ like real fags – but contain no harmful tar or toxins.”

A battle brewing in the United States is one involving flavored dissolvable tobacco lozenges.  On one hand you have tobacco companies looking for new safe and legal products.  On the other hand you have influential interest groups and certain members of Congress who are reluctant to give tobacco companies any slack and assume that anything these companies do can’t be good.  So far, the Food and Drug Administration (FDA) has not regulated this new form of smokeless tobacco but this lack of government intervention may only be a result of timing rather than philosophy since these products are new to the market.  It does appear that a group of Senators including Sens. Scott Brown (R-Mass.), Jeff Merkley (D-Oregon), Tom Harkin (D-Iowa), Barbara Mikulski (D-Md.), Ron Wyden (D-Oregon), Bob Casey (D-Pa.), Al Franken (D-Minn.), Michael Bennet (D-Col.), Jeff Bingaman (D-N.M.),  Richard Blumenthal (D-Conn.), Frank Lautenberg (D-N.J.), and Bernie Sanders (I-Vermont) will be asking the FDA to “look into” regulating these new products.

The group sent a letter to the FDA questioning why the FDA has not yet regulated this new product.  Trying to use an old scare tactic, the letter read, “The group noted that dissolvable tobacco poses very clear health risks, particularly for children. In April 2010, the medical journal Pediatrics found that dissolvable tobacco products can poison and ultimately cause death in children….Medical experts estimate that ingesting 10 to 17 Orbs could kill an infant.”  The major flaw in this argument is that the product will not be sold over the counter and will be an age-restricted item.  This crusade appears to be more directed at the companies rather than the product.

Congress and the FDA should tread very lightly as they regulate new smokeless tobacco products because the opponents of these products may actually be doing more harm than good.  According to a July 22, 2011 article in the Wall Street Journal, “Some see the product as an important alternative to cigarettes. Elaine Keller, representing the Consumer Advocates for Smoke-Free Alternatives Association, said cigarette-smoking adults are able to switch to less hazardous alternatives when they can’t stop using nicotine completely. Mr. Keller, in FDA testimony, said her group doesn’t have ties to the tobacco industry.”

Taxpayers and consumers would be better served if the FDA would be honest about the potential benefits of these new smokeless tobacco products rather than succumbing to cheap scare tactics.

In a struggling economy it is important to allow all companies to be as innovative as possible and government needs to step out of the way to allow that to happen.  Consumers and taxpayers benefit when the government takes a light regulatory touch.