This request for comments represents a welcome departure from FDA’s prior treatment of First Amendment concerns in the context of product advertising, labeling, and promotions. Over the past decade, FDA has aggressively restricted the information that can be disseminated by manufacturers regarding the health benefits of foods, drugs, and dietary supplements. In doing so, the agency has essentially ignored the substantial body of Supreme Court precedent protecting the commercial use of factually accurate information about products and services. Manufacturers wishing to use unapproved health information were often forced to file suit in federal court. FDA’s policy has been less than satisfactory, both for manufacturers and consumers. Even after agency speech restrictions were found unconstitutional, FDA would continue to pursue its restrictive policies, either by devising new explanations for banning the speech at issue, or by refusing to undertake the court-ordered administrative actions in a timely fashion. These delaying tactics have necessitated years of litigation, which in some instances has continued long after the speech restrictions at issue were initially determined to violate the First Amendment. Further, the agency has construed each decision to narrowly apply only to the specific speech at issue.
In effect, FDA had been content to flout the First Amendment, and continue banning a considerable volume of product information, defying the affected parties (manufacturers or consumers) to undertake the lengthy litigation necessary to vindicate their rights. The chilling effect of this policy has deprived the public of a wealth of potentially beneficial product information.
There is, however, a notable exception to this attitude—FDA’s stand against mandating certain statements on bioengineered foods and related products. As described below (pages 8-11), on many occasions, FDA has resisted petitions to require mandatory labels on such products. FDA’s denials of these petitions have been based on scientific grounds; specifically, on FDA’s view that the information at issue was not material. In fact the First Amendment adds further support to these agency actions. The First Amendment not only protects truthful speech; it also protects the right of manufacturers to be free from mandated speech unless there are compelling reasons for such mandates.
CEI applauds FDA’s effort, through this request for comments, to proactively and comprehensively modify its policies to comply with First Amendment jurisprudence. As will be discussed below, this body of precedent requires several changes in FDA’s treatment of manufacturer requests to use product information.
This body of precedent may also require changes in FDA’s interpretation of its underlying statutes. FDA states that it “intends to defend the [Food, Drug, and Cosmetic Act] against any constitutional challenges ….” 67 FR 34,943. Nonetheless, FDA has a duty to construe that act in a manner that will avoid First Amendment issues to whatever extent possible. The Supreme Court has noted its “prudential desire not to needlessly reach constitutional issues and [its] assumption that Congress does not casually authorize administrative agencies to interpret a statute to push the limit of congressional authority.” Solid Waste Agency of Northern Cook County v. U.S. Army Corps of Engineers, 121 S. Ct. 675, 683 (2001). FDA should do likewise.