Court Hands FDA a Deadline for Tampon Absorbency Rules
Federal court, accusing the Food and Drug Administration of endangering women’s health, has given the agency until Oct. 30 to issue rules requiring tampon manufacturers to place uniform absorbency ratings on labels.
The decision, in U.S. District Court here, was a victory for consumer groups that have been demanding absorbency ratings since a 1981 study found that using the most absorbent types of tampons increased the risk of toxic-shock syndrome, a rare but potentially fatal infection.
Judge Barrington D. Parker’s ruling, released Tuesday, called the FDA’s delay in ordering revisions of tampon labels “wholly unreasonable and unacceptable.”
The agency “has been lethargic in responding to and carrying out its legal obligation, and thus has failed to adequately inform and protect the public on this important health issue,” Parker said.
Manufacturers currently label tampons “super,” “regular” or “junior,” but such descriptions give the buyer no basis for comparing one brand’s absorbency against another’s. A “super” tampon made by one manufacturer may be less absorbent than another firm’s “regular” one.
Since 1982, the FDA has advised women to use tampons with “the minimum absorbency needed,” but the question of how to provide a means of judging a product’s absorbency has engendered a seven-year dispute among FDA officials, manufacturers and consumers.
Among the points argued were whether absorbency should be rated on a numerical scale and if the agency should require that terms such as “super” or “regular” correspond to specified absorbency levels.
Not until last September did the FDA propose new rules for tampon labeling. In January, it said it would issue final rules by April. Then in June it “reproposed” yet another version.
An FDA spokesman said the agency was “reviewing the decision” and would not comment further.