Ads Prompt FDA to Warn 3 Makers of Dental Rinses
The Food and Drug Administration has warned the makers of Listerine, Plak Attack and Plax that if they continue to advertise the dental rinses as preventions for plaque and gum disease, the agency might seize the products or get a court order barring distribution.
Although such advertising has boosted sales significantly of so-called anti-plaque products, some experts have questioned their effectiveness.
The FDA started sending warning letters to several makers of dental rinses and toothpastes last July. Some voluntarily complied with the FDA request to change advertising and package labels, but “some decided they were going to fight,” FDA spokesman Michael Shaffer said Friday.
Three manufacturers recently received a second “regulatory letter” from the FDA warning that the agency is prepared to take action against them.
The law does not allow over-the-counter products to make claims to prevent plaque and gingivitis until the FDA approves a standard formula, he said. To create a standard, the manufacturers must give the FDA proof that certain combinations of ingredients are effective--a process that can take years. Once a standard is set, other manufacturers can make similar claims in their advertising and on their labels if they have the same ingredients.
The bacterial gum disease gingivitis can destroy gums and the supporting structure of teeth in the mouth. Plaque is a buildup of bacteria and debris that can lead to gingivitis and tooth decay. As the law stands, gingivitis is a disease that must be diagnosed by a dentist and treated by prescription drugs, Shaffer said.
$20 Million in Sales
The recent regulatory letters raised slightly different issues with each manufacturer.
In a letter to Harvey Vechery, president of Key Brands Research Laboratories of Irwindale, which sells Plak Attack, the FDA said, “We also are not aware of any evidence that would establish that the combination of ingredients in Plak Attack is generally recognized as safe and effective for the treatment, and or prevention of plaque.”
Vechery, who projected Plak Attack sales of $20 million this year, said his attorneys were reviewing the FDA letter and the company has decided to make some labeling changes. “We are going to comply with the FDA. I’m not going to fight it,” he said.
Warner-Lambert Co., the Morris Plains, N.J., maker of Listerine, said it will continue to challenge the FDA’s position. Listerine’s claims of preventing gingivitis and plaque buildup are supported by the American Dental Assn.’s “seal of acceptance,” said Barry Cohen, director of public communications. The company received the seal, he said, because of 22 clinical trials supporting its claims.
Listerine Formula Questioned
“The ADA is not going to treat lightly anything they put their name on,” he said. The ADA seal is greatly responsible for a boost in Listerine sales expected to reach “well above” $100 million in 1989, he said.
Additionally, Cohen said Warner-Lambert does not need to heed the law because it advertised Listerine as effective in preventing plaque and gingivitis before the law went into effect in 1975.
In a letter to Listerine, the FDA said Warner-Lambert violates the law because it has not submitted information that a Listerine with the same formula that claimed to prevent plaque and gingivitis was on the market before the law went into effect.
The FDA also said Plax, made by Oral Research Laboratories of New York, violates the law because it claims to prevent plaque. Oral Research couldn’t be reached for comment Friday.
