Drinking and Smoking

Public interest groups and Rep. Henry Waxman held a Food and Drug Administration anti-centennial press conference on Capitol Hill this morning. Friday marks the 100th anniversary of the passage of the Pure Food and Drug Act, a product of Upton Sinclair's muckraking expose of Chicago's meatpacking plants in The Jungle. The event was something of a disappointment -- not in the content of the presentations, which justifiably took the FDA to task for failing to protect the American public from unsafe drugs and food -- but in the turnout. Only a handful of reporters attended, and not a single one had a question after the presentations ended.

Rep. Waxman gave more details from his staff's excellent report documenting the collapse of enforcement activity at the agency over the past five years. Dr. Michael Jacobson, executive director of the Center for Science in the Public Interest, retold the long, sad story of how the Center for Food Safety and Nutrition has repeatedly failed to regulate food additives like transfats and salt, which literally kill tens of thousands of Americans each year because of their prevalence in the U.S. diet.

But the most eye-opening presentation came from Dr. Sidney Wolfe, the long-time director of Public Citizen's Health Research Group. Sid, as everyone who knows him calls him, has waged a 35-year campaign against unsafe drugs and dietary supplements. He's a one-man regulatory agency constantly on the prowl for violations of the nation's drug safety laws, which he promptly brings to the attention of the agency that is supposed to be doing that job.

So I shouldn't have been surprised when Sid showed up at this press conference with several outrageous anecdotes about regulatory failure. All in a week's work for him, I guess. Here's just one:

In December 2001, the FDA declared nicotine-containing gum, patches or drinks to be drugs in response to a petition from the National Center for Tobacco-Free Kids and former FDA Deputy Commissioner William Schultz. That means anyone who wants to sell them must get the agency's approval, unlike dietary supplements which are exempt from the safety and efficacy requirements of the nation's drug laws.

Could you imagine what might happen if nicotine-laced drinks could be sold as a dietary supplement? Sure, some people might buy them as a way to cut down on smoking. But if those drinks were sold over-the-counter (to kids perhaps?), they would hook the users on nicotine. That would be the first step on the road to taking up smoking, which is, after all, just another way to get one's nicotine fix.

Turns out that companies are out there peddling nicotine-laced drinks over the Internet, a clear violation of the nation's drug laws. Don't believe me? Click here. Four milligrams of "purified nicotine infused in pure grade water with a hint of lemon flavoring." Perfect for airports, restaurants, bars, movie theaters, sporting event, public buildings and at work -- all the places where smoking is now prohibited.

Is the company lying when it says the FDA has classified this drink as a dietary supplement, Wolfe asked. Or has the FDA reversed its 2001 ruling? Under "either scenario," Wolfe said, "the FDA is, again, extremely negligent in its responsibilities to enforce the laws and regulations. . . Where is the FDA?"

Under David Kessler's leadership in the 1990s, the FDA led a relentless battle against the tobacco industry and wracked up huge victories. Under this administration, companies peddling tobacco starter-sets get a wink and a nod.

Posted by gooznews at June 27, 2006 10:30 PM