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FDA issues rules on tampon absorbency; manufacturers are now required to follow uniform labeling and testing guidelines in producing and packaging tampons.

FDA Issues Rules on Tampon Absorbency

In late October, the Food and Drug Administration (FDA) released final rules that will require tampon manufacturers to label their products to reflect newly-adopted standardized terms to describe tampon absorbency.

Under the rule, terms such as "regular" and "super" will have to comply with specific absorbency levels and all products will have to be designed so that they fit into one of four specified absorbency levels. To determine the category their products fall into, manufacturers will also be required to follow a standardized, FDA-approved test to measure fluid absorbency. Manufacturers will have until March 1, 1990 to produce products that comply with this final rule.

Need for Regulation

This regulation represents the culmination of nearly eight years work. Since the first cases of toxic shock syndrome were reported in the late 1970's, and linked to the use of highly absorbent tampons, the FDA has been working to protect consumers from risks associated with use of tampons that may have absorbency levels that are too high for an individual's needs.

In fact, since 1982 the FDA has advised women to use tampons with "the minimum absorbency needed." The problem has been, though, that there were no standardized terms being used by manufacturers that consumers could rely on to make an informed choice. Without standardized terms, instances were reported where one manufacturer's "super" tampon was actually less absorbent than another's "regular" tampon.

The FDA Action

Starting in 1982 the FDA began to seek voluntary standards to address the issues of absorbency, testing and labeling. In June, 1984, these efforts led to FDA's release of a "talking paper" regarding proposals for consistent tampon labeling. Nothing much happened for several years until, on April 25, 1988, the FDA released a proposed rule on the issue. Based on comments to that proposed rule, however, the FDA deemed that significant changes be made and determined that a "reproposal" would be necessary. That reproposed rule was published on June 12, 1989.

While all this was going on, a consumer rights group, the Public Citizen Health Research Group, had filed legal suits in federal court in an effort to speed FDA action. In the end, it was the courts that ultimately required the timing of the FDA's final rule.

In an Aug. 28, 1989 decision handed down from the U.S. District Court for the District of Columbia, Judge Barrington Parker ruled that the FDA had "unreasonably delayed" issuing a regulation and required that a final regulation be adopted no later than Oct. 30, 1989.

The Final Regulation

In complying with Judge Parker's rule, the FDA issued a final regulation that requires manufacturers to produce tampons that fall into one of four standardized categories: junior, regular, super and super plus. Products will also have to be labeled to reflect the category into which they fall.

Each of these four categories is to have a corresponding, standardized absorbency rate. The absorbency rate for "junior" is to be less than six grams of fluid, "regular" is to be six to nine grams of fluid, "super" will be nine to 12 grams of fluid, and "super plus" will be 12 to 15 grams of fluid.

The regulation does not include a term for tampons with absorbency ranges of 15 to 18 grams or more because, according to the regulation, the FDA is unaware of any currently available products that fall into such a category. The regulation states that any products with these ultra-high absorbency levels will have to have a premarket notification submitted to FDA before the products could be approved for public sale.

To standardize the way that absorbency rates are determined, the regulation also includes a test that manufacturers must conduct to demonstrate grams of fluid absorbed. This test is described in detail in the final regulation and basically involves pumping Syngyna fluid (a combination of sodium chloride, certified reagent acid fuchsin and distilled water) into a tampon until the tampon is saturated. The tampon is weighed both before and after the test to determine the number of grams it has absorbed.

Exemptions and Alternative Tests

The only exemption the FDA will allow from these final regulations is for tampons intended to be dispensed by a vending machine. In comments to the proposed version of the rule, it was pointed out that a requirement to label vending machine tampons would not be practical, or necessary, since consumers must purchase whatever single product is available in a particular vending machine. The FDA apparently agreed with this.

The FDA also agreed with numerous letters it received on the issue of standardized testing procedures. According to the regulation, the FDA recognizes that individual manufacturers might want to use test methods that differ from those outlined in the final rule. For this reason, the FDA will allow use of alternative test methods if the manufacturer is able to submit convincing evidence that the alternative method(s) will yield test results that are equivalent to the results obtained under the FDA's test.
COPYRIGHT 1989 Rodman Publications, Inc.
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1989 Gale, Cengage Learning. All rights reserved.

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Title Annotation:Capital Comments
Author:Mayberry, Peter
Publication:Nonwovens Industry
Date:Dec 1, 1989
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