Tampon packages should be labeled with an absorbency rating and a listing of ingredients to help protect women against toxic-shock syndrome, a government advisory panel concluded yesterday.
The Food and Drug Administration first announced in June 1984 that it was planning to require manufacturers to test tampon absorbency and grade their products according to a numerical scale, similar to that used for sunscreens.
Now, a specific test has been agreed upon, and an agency spokesman predicted yesterday that the regulation will be published early next year.
Consumer groups have urged the FDA to require absorbency ratings since 1982, because higher-absorbency tampons increase the user's risk of developing toxic-shock syndrome, a rare but potentially fatal disease.
But the question of how absorbency should be expressed on tampon labels has polarized industry and consumer groups.
At a meeting of the FDA's obstetrics-gynecology devices panel yesterday, representatives of several women's health groups argued that numerical ratings would only confuse shoppers if manufacturers continued to market tampons as "super plus," "super" or "regular" without regard to their numerical score, as the FDA's current proposal would allow.
"The 'super' of one brand is less absorbent than the 'regular' of another brand," said Sybil Shainwald, past president of the National Women's Health Network.
Consumers would prefer that " 'super' means one thing, just like low fat milk and whole milk and skim milk mean one thing," said Sarah B. Kotchian, a consumer representative on the advisory panel.
Now, labels mean different things on different brands.
"Tambrands [manufacturers of Tampax tampons] as a product line has low absorbency. Playtex as a product line has high absorbency," according to Alan Andersen, deputy director of the office of standards and regulations in the FDA's center for devices and radiologic health.
The purpose of providing an absorbency rating on the package is to allow women to choose the least-absorbent tampon needed to contain menstrual flow, in order to minimize their risk of toxic-shock syndrome, he said.
But he said tampon manufacturers have warned the agency that, if the FDA requires that terms like "super" be synonymous with high absorbency ratings, it will force manufacturers of less-absorbent tampons to reformulate their products to get the higher ratings.
Andersen said manufacturers expect that "people will use the numbers . . . [but] higher absorbency will be what they'll go after" in spite of the fact that FDA will be saying use the lowest.
"If that were to come about, that's scary," Andersen said.
"The net result would be an increase in absorbency," and therefore an increase in tampons' potential to promote toxic-shock syndrome, he explained.
He said the FDA's view is that "women are more than capable of being told about a level of absorbency and understanding that they should use the least."
Tampon industry representatives did not attend yesterday's meeting, but a spokeswoman for the Health Industry Manufacturers' Association, which represents most of the tampon manufactuers, said the association has no position on the FDA's proposal.
Current regulations governing tampons do not require that ingredients be listed on packages, nor do they impose limitations on pesticides or contaminants that might be introduced during manufacture, Andersen said.
Procter & Gamble's Rely tampons, the brand most associated with toxic shock syndrome and removed from the market in 1980, was the only brand containing polyester foam, Andersen said.
But carboxymethylcellulose, another ingredient of Rely, is still present in some tampons currently on the market, he said.
Playtex and Tampax tampons containing polyacrylate rayon were reformulated this year to eliminate that substance, after a Harvard study suggested that the ingredient might induce bacteria to manufacture more of the toxin that causes the disease.
As of June 1, the Centers for Disease Control had confirmed 2,815 cases of toxic-shock syndrome, 122 of them fatal.
So far this year there have been 52 cases reported, with four deaths, according to the CDC.
Although commonest in menstruating women, the disease has also occurred in users of contraceptive sponges and diaphragms, in nonmenstruating women, and in people with some injury-related infections.