Experts Seek Strict Labels for Tampons

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.

Dispute Brewing

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 regular , super and super plus “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.

The labeling system proposed in the FDA petition by the Nader group, and in the editorial, written by Dr. Sidney Wolfe, would create such a numbering system. The system is a modification of one already considered by an industry group but never established as a standard because an attempt to develop such a voluntary system collapsed in 1985 when Tambrands, Inc., manufacturer of the leading brand, Tampax, refused to endorse labels having specific absorbency ratings.

The consumer group made the observations in an editorial in the journal that represented the first time the AMA’s official publication had invited the Nader group to contribute an opinion article.

In the proposed rating system, lower absorbency rating numbers would signify lower absorbency, but also low risk of toxic shock. High numbers would denote tampons with maximum absorbency but correspondingly heighted toxic shock danger.

Broome said she was “supportive of the utility of (a) labeling system” like that proposed by the consumer group. She said the CDC research team had shared its findings with the FDA even before publication of the AMA journal article.

The FDA said a working group that has been considering possible tampon labeling standards for some time is expected to make recommendations soon. Agency sources said, however, that the FDA is most likely to endorse labels that permit tampons to fall within an absorbency range that would become the official definition of regular , super and super plus .

Tampons on the market today are capable of absorbing a range of from about six grams of liquid to about 17. Tampon users generally rely on existing labels to distinguish comparative absorbency, but the new CDC study--and other data supplied by tampon manufacturers--indicate that the nomenclature used now does not truly define absorbency, permitting extreme consumer confusion.

Less Absorbent

According to CDC and manufacturer data, for instance, a Playtex “super plus” is less absorbent than an OB “super.” A Kotex “regular” is less absorbent than a Tampax “super” but an OB “regular” is the same as a Playtex “super.” Tampax “regular” absorbs more than four grams less than the same classification of OB.

Through a spokesman, Tambrands said it has not changed its position that absorbency numbering would, itself, confuse women. The company has held out for the approach the FDA may propose. Manufacturers would be required only to maintain absorbency within a range of levels for each type.

“We don’t think it’s wise for manufacturers to be in a horsepower race,” said Paul Konney, a Tambrands vice president. “If you put a single number on the package the way sunscreen manufacturers do, the normal tendency of the consumer is to want the bigger number.”

However, research studies at the time of the Rely crisis indicated--among women in California and Tennessee, in particular--that consumers were quick to develop awareness of the implications of greater and lesser absorbency.

OB, manufactured by Johnson & Johnson, now includes numeric absorbency ratings on the front of all its packages and Playtex includes the information on the backs of boxes.

Questioned a Decision

The CDC team also questioned a decision by tampon manufacturers in 1985 to withdraw highly absorbent products made of the synthetic fiber polyacrylate from the market. The decision was prompted by a $10-million product-liability judgment entered against Playtex, Inc., in a toxic shock case. Tampons today are made of cotton and rayon.

The litigation appeared to create the impression, the CDC researchers concluded, that the artificial fiber was the cause of toxic shock when, in fact, absorbency alone now appears to be the villain. Toxic shock syndrome is a sudden disease that can quickly deteriorate into kidney failure and other symptoms of organ system compromise and is fatal in 8% to 15% of all cases. Unrecognized before this decade, toxic shock gained sudden public attention in 1980 when the Rely crisis developed.

In that year, 812 cases were reported nationwide. After Rely was withdrawn at the end of a flurry of media reports of a developing “epidemic,” the number of cases dropped dramatically. But in the years since, toxic shock has remained on the public health scene--with between 200 and 250 cases are reported each year.