worst. Defendants admit that "consumers cannot make interbrand comparisons on the basis of labeling statements about absorbency." (Px. 7 at 2.) They also admit that FDA's Director of the Center for Devices and Radiological Health confirmed that a "labeling regulation is necessary to assure that consumers can make meaningful interbrand comparisons with respect to absorbency." (Px. 9.) Nevertheless, despite the overwhelming evidence to the contrary, defendants argue that plaintiffs and this Court should defer to its schedule. It also insists that it has done much to enable women to reduce and even eliminate the risk of contracting Toxic Shock Syndrome.
This Circuit states, and defendants readily concede, that an "agency's discretion is not unbounded." Cutler, 818 F.2d at 896. Defendants still claim that deference is proper here and infer that plaintiffs deferred to the FDA's schedule by failing to bring this litigation sooner. This argument, although imaginative, is unreasonable as a claimant's failure or delay in bringing a suit cannot be viewed as condoning an agency's action or inaction. Certainly, the conduct of non-profit organizations, such as plaintiffs, cannot excuse or justify an agency's unreasonable delay in issuing an important regulation.
Defendants cite its promulgation of 21 C.F.R. § 801.430 (1982) as evidence that it was aware of its duty to inform women of the link between tampon usage and TSS. Albeit, the agency did take some action but it was wholly insufficient to thoroughly fulfill its obligation to the public in this instance. Even though a part of § 801.430 advises women to use tampons with the minimum absorbency needed to control menstrual flow, defendants admit that women cannot make an informed choice regarding absorbency amongst brands based on the present labeling. Whatever light defendants argue § 801.430 sheds on TSS is considerably dimmed as women are not armed with adequate information to make informed choices. Defendants cannot claim to have sufficiently carried out its duty to the public while admitting that a tampon absorbency regulation is necessary, on the one hand, yet failing to issue the regulation on the other.
Defendants argue that the Food, Drug, and Cosmetic Act does not impose any duty on the FDA to regulate tampon labeling via notice and comment rulemaking. Again, our Circuit has spoken in this area as "once the FDA [has] elected to respond to its legislative directive . . . the APA impose[s] an obligation to proceed with reasonable dispatch." Cutler, 818 F.2d at 895 (emphasis added). Once an agency decides to take a particular action, a duty to do so within a reasonable time is created.
As late as 1984, defendants decided that a regulation standardizing tampon absorbency information was necessary. Since then, on several occasions the FDA planned to require consistent tampon absorbency labeling. Yet it was not until September 23, 1988, that it finally issued a proposed regulation, 53 Fed.Reg. 37,250 (Sept. 23, 1988), followed by a reproposed regulation on June 12, 1989. 54 Fed.Reg. 25,076 (1989). In deciding that a regulation was necessary, the FDA took on the duty to promulgate one in a reasonable time. It cannot hide behind the argument that no duty to do so existed.
Defendants took an unreasonably long period of time to issue a proposed regulation. In fact, for defendants to issue a regulation in the midst of a litigation, is a tactical move to thereby make the issue moot. In Environmental Defense Fund v. E.P.A., 271 U.S. App. D.C. 349, 852 F.2d 1316, 1331 (D.C.Cir. 1988), our Circuit found that even though the Agency was now conducting the required studies, its history of delays and missed deadlines necessitated a court imposed schedule. See Public Citizen Health Research Group v. Brock, 262 U.S. App. D.C. 218, 823 F.2d 626 (D.C.Cir. 1987); Telecommunications Research & Action Center v. F.C.C., 242 U.S. App. D.C. 222, 750 F.2d 70 (D.C.Cir. 1984).
This Court does not view the issue as being moot. The proposed regulation was published on September 23, 1988 and defendants issued a reproposal regulation on June 12, 1989. As it now stands, a final regulation will probably be issued no sooner than the end of this year.
Given that defendants have known of this health danger for over seven years, this delay in issuing a tampon absorbency regulation is wholly unreasonable and unacceptable.
As this Circuit Court stated: "We have seen it happen time and time again, . . . action . . . for the protection of public health all too easily becomes hostage to bureaucratic recalcitrance, factional infighting, and special interest politics. At some point, we must lean forward from the bench to let an agency know, in no uncertain terms, that enough is enough." Public Citizen Health Research Group v. Brock, 262 U.S. App. D.C. 218, 823 F.2d 626 (D.C.Cir. 1987).
Unnecessarily, women are unknowingly subjecting themselves to Toxic Shock Syndrome simply because defendants proceed to drag their feet in promulgating a regulation standardizing tampon absorbency labels. Certainly, this delay has existed for more than enough years. Even though defendants are in the process of drafting a final regulation, this Court finds that a more than seven year delay in issuing a regulation impacting on women's health is certainly an unreasonable delay. In fact, waiting until the end of this year for a final regulation or for a regulation to take effect is also an unreasonable amount of time considering the nature of the disease. Therefore, this Court finds that defendants have unreasonably delayed in promulgating a regulation standardizing tampon absorbency labeling.
After analyzing all of the comments that it had received in response to the proposed regulation on standardized labeling for tampon absorbency,
the FDA decided in mid-June:
. . . the agency's initial proposal [was] to use a system of letters to represent absorbency ranges and not to standardize currently used terms of absorbency (e.g. regular, super, and super plus), [now] the agency has decided to repropose amendments to § 801.430 that would replace the letter designations with six absorbency terms that are different from currently used terms . . . . FDA is also now proposing to require that the applicable new term of absorbency be placed on the principal display panel(s) of tampon packages . . . . The agency believes that the reproposed amendments would ensure truthful, accurate, and nonmisleading labeling and would facilitate interbrand comparisons of tampon absorbency.