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By Sean Pendergast
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By Ben DuBose
Propylene glycol is a clear, viscous liquid derived from cracked petroleum. Though it is a synthetic substance, its chemical makeup puts it squarely in the same class of compounds as ethanol. And while widely believed to be less toxic, propylene glycol is absorbed and processed by the human body in the same way as ethanol, meaning that both substances cause similar reactions.
"The bottom line is," says Mark Wilson, "does the consumer have the right to know that the products they are buying are not as they are advertised? I'm not a toxicologist. I'm only saying that if it quacks like a duck, waddles like a duck and looks like a duck, why isn't it a duck?"
In 1993, when Antonio Benedi was a 37-year-old aide to former President George Bush, he had wine with his dinner one evening. Over the next four days, he took ten extra-strength Tylenol tablets. On the fourth day, he went into a coma and nearly died. A liver transplant saved his life. Benedi sued Johnson & Johnson, Tylenol's manufacturer, and won $8 million.
During the lawsuit, it was revealed that, in 1986, Johnson & Johnson had polled several hundred people, including physicians, on how they would react to an alcohol-warning label on Tylenol. About 70 percent said such a warning would damage their faith in the product's safety. Benedi's lawyers also trotted out internal Johnson & Johnson memos that advised the company's salespeople to avoid any discussion with physicians about studies that linked liver damage to the use of acetaminophen and alcohol.
Following other, similar lawsuits, Johnson & Johnson agreed to adopt alcohol-warning labels on its liquid Tylenol products. Yet, to this day, liquid Children's Tylenol contains propylene glycol as a solvent, as do other brands of acetaminophen for children. While it's uncertain if propylene glycol was a factor, acetaminophen products formulated for children were blamed for nearly 105,000 poisoning cases between 1993 and 1995, according to the American Association of Poison Control Centers.
Toxicologists say there simply isn't enough published data to know how toxic propylene glycol is. Unlike most FDA-approved chemical additives, propylene glycol has no known LD 50 -- the amount of a substance that would be lethal to 50 percent of the population.
"Take acetic acid, or vinegar," says Andrew R. Barron, a professor of chemistry and materials science at Rice University. "We know what its LD 50 is, we know what concentrations are safe to drink. Vinegars are not more acidic than they are for the simple reason that pure acetic acid is very dangerous.
"In the case of things like propylene glycol, it would be nice to know the reason it's not a problem, rather than the FDA saying, 'Oh, we just don't think it's an issue.' Well, it might be someday, so let's work it out now, not only for the consumer, but so the people who make Children's Tylenol know how much to put in and how much not to put in."
But, as Barron probably knows, he's talking about a federal agency that, though supposedly looking out for the best interests of consumers, is not known for decisive action.
In March 1984, the American Academy of Pediatrics released a policy statement noting that, while more than 700 pharmaceutical liquids contained ethanol, little was known about how the alcohol content of those medications affects children. The academy pointed out that, even though ethanol had been known to cause neuronal dysfunction, some liquid OTC medications, such as cough medicines and teething preparations, contained as much as 68 percent alcohol.
The academy concluded that while "efforts should be made to have alcohol removed from liquid preparations for children," the Food and Drug Administration should limit the amount in OTC drugs to no more than 5 percent.
Despite the academy's compelling advice, the FDA didn't establish alcohol limits in OTC products until 1995 -- 11 years later. It is impossible to know how many ethanol-induced poisonings could have been prevented had the FDA acted sooner; data on adverse drug reactions is recorded only by the active ingredients of a particular product.
But, according to the American Association of Poison Control Centers, more than 29,000 people, including two who died, were poisoned by ethanol-based mouthwash between 1993 and 1995, when the agency finally stepped in. The 1995 rule on ethanol limits its content in OTC products to 10 percent for adults, 5 percent for children under 12, and 0.5 percent for children under six.
"Apparently, there is more than a one decade delay in the FDA doing its job," says Mark Wilson. "Conservatively, there are probably tens of thousands of poisonings that occurred during that time. No one really knows."
Wilson has been butting heads with the FDA over the propylene glycol issue for years now, with little success. The FDA has never even bothered to respond to the dozens of letters Wilson has written since 1994 requesting an explanation for why the government will not recognize the substance as an alcohol.
If the feds thought Wilson would grow frustrated and quit, they were wrong. He spends 12 to 14 hours a day, seven days a week, researching propylene glycol, consulting with scientists and other experts and hounding the FDA for information he never receives. While, admittedly, he has quite a future as a manufacturer of alcohol-free drugs if the FDA ever reclassifies propylene glycol, the issue has become for him an all-consuming crusade to protect children. Pity the mother who gets into a conversation with Wilson; she's sure to get an earful about the FDA.