Filtered Out

Buried in the proposed tobacco agreement is a clause which, while claiming to increase the FDA's authority, actually restricts it.

| Wed Sep. 17, 1997 2:00 AM EDT

P resident Clinton is calling for sweeping changes in the proposed tobacco settlement. But there's a major problem with it that neither Clinton nor anybody else is talking about: Freon. The EPA says you can't put it in air conditioners. But you may be smoking it. And, thanks to a little-noticed clause of the proposed settlement that calls for a "safety assessment of ingredients," the FDA could have a tough time doing anything about it. According to tobacco industry documents, it's just one of hundreds of ingredients used in cigarettes along with tobacco.

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The FDA currently has the full authority to regulate what's in cigarettes, including additives. The agency won that power in April when a federal court ruled the FDA had the ability to regulate cigarettes as "nicotine delivery devices" (the ruling is currently being appealed). The court case, widely hailed for giving the FDA the authority to regulate nicotine, also gave them another, far less noticed, power: The authority to regulate other ingredients in cigarettes as they would any food products. Until the decision, the FDA couldn't get the tobacco industry to disclose the ingredients in cigarettes, let alone regulate their safety. Now the agency has full regulatory power over cigarettes. And the burden is on the industry to prove that additives are safe.

Under the proposed settlement, the industry would have five years to provide the FDA with ingredient lists and clinical proof of the safety of each additive. The FDA would then have only 90 days to review the industry supplied data and approve or reject each additive. If the FDA does nothing within 90 days, the additive would be deemed safe. That includes benzene, chromium, or any one of at least 43 compounds in cigarette smoke found to be carcinogenic by a 1989 Surgeon General's report. This for an industry, of course, that does not exactly have a stellar record of non-biased research.

Dr. Greg Connolly, Director of the Massachusetts Department of Public Health's Tobacco Control Program, calls the proposed restrictions "idiotic." "What [the tobacco industry] will do is come in and drop [a list of] 599 additives on the FDA's lap and expect the agency to do a turnaround in 90 days. It took the FDA 12 years to approve Olestra. It plays into the hands of the tobacco industry. It's foolish."

In an interview with the MoJo Wire, an FDA official who spoke on the condition of anonymity pointed out, "In this area the agreement does not give us any authority we currently lack. What's different about the settlement [from the FDA's existing authority to regulate cigarettes] is that we only get 90 days to consider a safety review and if we don't come to a decision, the ingredient is deemed safe anyway."

The agreement, in short, only limits the FDA's powers to regulate additives.

So how did the Attorneys General and the public health group that was also involved in the tobacco settlement drive such a bad bargain?

The leading Attorney General in the proposed settlement, Mike Moore of Mississippi, didn't return multiple phone calls. Nor did the Center for Tobacco-Free Kids, the only public health group represented in the deal.

But one official familiar with the talks says, "The AGs, especially Mike Moore, went in as lone cowboys.

"They went into the negotiations without any staff support. Meanwhile the tobacco industry had an army of aides and lawyers. Most of these guys [AGs] are former county prosecutors, they don't know about federal regulations. In that atmosphere, they were bound to get hoodwinked. And this 'safety assessment clause' is a great example. It's the most one-sided aspect of the whole agreement."

Says Stan Glantz, professor at the University of California at San Francisco, and author of The Cigarette Papers says, "The FDA already has jurisdiction over tobacco. What's happened is that the deal reduces the FDA's authority below what it is today. That to me is no great shakes."

And the FDA isn't the only agency that would have its authority restricted. Following a now-familiar pattern, the tobacco industry has snuck a preemption clause into the agreement. The provision would preempt state laws regarding additives, which are often much tougher than the proposed agreement. Massachusetts and Minnesota both have legislation that would force tobacco companies to release detailed lists of all the ingredients in their cigarettes, by product and by amount. The Massachusetts law is scheduled to be enacted in December.

But the proposed agreement makes it clear that the FDA regulations would supersede, and effectively cancel out, state laws. Says Dr. Connolly, who helped craft the Massachusetts law, "The tobacco industry negotiators knew exactly what they were doing. Right now, in terms of regulating cigarette ingredients, the states can exceed the FDA's authority. That was a hard-fought battle in the courts. We won. And now we're going to lose it."

The tobacco industry, of course, is none too enthusiastic to see those state laws take effect. The industry has fought for years to keep the lists of additives under wraps. They claim they're trade secrets and refuse to publicly disclose the ingredients. The tobacco industry is required to submit a list of additives yearly to the Department of Health and Human Services, where it is held in a secret file. The last time the public got ahold of the list, in 1994, 599 separate ingredients showed up.

What are the dangers of cigarette additives? As Elizabeth Whelan, President of the American Council on Science and Health (ACSH) says, "Ultimately, the really dangerous stuff in cigarettes is tobacco and nicotine. But burning and inhaling added things like chocolate and licorice doesn't help."

Chocolate and licorice are both flavoring additives to cigarettes. They make cigarettes taste better. There is also evidence that both are carcinogens when burned. But flavorings aren't the only extra ingredients in cigarettes. Chemicals used in their manufacture also show up in the final product. As for Freon, industry documents explain how it can be used as a "puffer" to reduce the amount of tar in cigarettes. Unfortunately, Freon, besides being a major contributor to the depletion of the ozone layer, has another potential side effect: When burned, it can turn into phosgene, a poisonous gas used in World War I.

While many additives are dangerous in and of themselves, some are also used to increase the kick of nicotine. Take ammonia, which causes "respiratory inflammation." The tobacco industry says it uses the chemical as a flavoring. But according to tobacco industry documents leaked to the Wall Street Journal, ammonia is used to boost the amount of nicotine a smoker inhales. Nicotine treated with ammonia is absorbed into the bloodstream faster than non-treated nicotine. The result is that people who smoke cigarettes "boosted" with ammonia end up more addicted to nicotine.

Cassandra Welch, spokesperson at the American Lung Association, says "nicotine is already addictive in its natural state, to 'boost' it makes it much more addictive."

Representatives from the major tobacco companies refused to discuss whether any of the above ingredients are in cigarettes, citing "trade secrets."

How then should the loophole regarding additives be fixed?

According to Glantz, if it ain't broke, don't fix it. "I don't see why we need this agreement. Everything about it favors the tobacco industry. The state cases are being settled on terms very favorable to public health. I think the federal government should just stay out of it.

"Clinton coming is demanding stronger youth smoking penalties and full FDA powers to regulate nicotine. Tobacco will scream bloody murder, and then cave in. Everybody will say this is a great victory. And then all the other bad provisions will go through, the additives 'safety assessment' being one of them."

Additional reporting by Rachel Burstein.