Government scientists, confirming in a new study that tampon absorbency levels are the chief indicator of risk for toxic shock syndrome, are now urging that tampons be required to carry mandatory labeling of specific absorbency so women can choose the safest product.
The researchers, from the government's Centers for Disease Control in Atlanta, expressed concern about confusion created by products that are called "regular," "super" or "super plus" but whose absorbency may vary greatly from brand to brand. The government testing, and manufacturer data, showed, for instance, that some "super" products are actually significantly less absorbent than ones called "regular."
The CDC study, being published today in the Journal of the American Medical Assn., comes more than six years after a controversy over the link between tampon absorbency and toxic shock first prompted researchers in Minnesota to urge better labeling.
In the same issue of the medical journal, the head of the Ralph Nader-affiliated Health Research Group in Washington called for immediate FDA action and accused the agency of stalling on the new labeling requirements. The consumer group petitioned Thursday for FDA action to implement mandatory labeling. The FDA said it is evaluating labeling proposals and may propose some standard.
The dispute has been brewing since Rely brand tampons were driven from the market in 1980 after they were identified as a cause of a sudden rash of cases of the sometimes fatal syndrome.
In the study to be published today, the CDC team reported that a new evaluation of tampons and toxic shock found that absorbency alone--independent of the type of material from which tampons are made--is the major indicator of toxic shock risk. Tampon users face a 37% increase in toxic shock risk for each gram of absorbency of the tampons they use. Users of tampons currently on the market have between about four times and 57 times the risk of getting toxic shock as women who do not use tampons.
For that reason, the researchers concluded, women should be encouraged to pay greater attention to absorbency ratings of tampons they buy. But inconsistencies in the way tampons are labeled make such consumer judgments difficult, they said, because \o7 regular\f7 , \o7 super\f7 and \o7 super plus\f7 "are not equivalent across tampon brands.
"At this time, the strong association of absorbency with the risk of illness would suggest that, as a public health measure, the preferential use of low-absorbency tampons is likely to reduce the risk" of (toxic shock), the new study observed. "Because labeled tampon absorbencies are not standardized, a standardized absorbency classification should be included in the labeling."
In a telephone interview, Dr. Claire Broome, a member of the CDC research team, noted that users of the highest absorbency tampons may be exposed to 10 times the risk of toxic shock as women using the least absorbent. But, she cautioned, because the overall risk of toxic shock to women nationwide remains quite small, "it is something to be concerned about but also to keep in perspective." Overall, two out of every 100,000 women in the country contract toxic shock each year, she said.
For women, she said, selection of a tampon "is a trade-off between reducing a very low risk and convenience. I think it's a rare enough disease that informing consumers that there's a risk and trying to make safer tampons are reasonable public health responses.
"What you would like to have is a public that is aware this disease can occur and aware that, by choosing to use tampons, they are increasing their risk. The counterbalancing statement is that it can be a very severe disease and it occurs in previously healthy individuals."
Dr. Michael Osterholm, an epidemiologist with the Minnesota Department of Health who led a study that identified tampon absorbency as the key factor responsible for toxic shock, said the new CDC study adds new emphasis to criticism he has directed at the FDA for six years. In a telephone interview, Osterholm noted that he had supported mandatory labeling standards since 1981.
"In 1981, (government scientists) said the problem was Rely," Osterholm said. "And we were the group (the Osterholm research included scientists in Minnesota, Wisconsin and Iowa and was officially called the Tri-State Study) that kept saying it was not just one brand of tampons, it was all high absorbency tampons."
Devising a System
Osterholm said formalizing the definitions of existing tampon labeling terms--an approach suggested by some tampon makers--might work, but that the terms would still be confusing. A system of absorbency-level numbering like that used for sunblock strength in suntan lotion products would be better, he said.