The Food and Drug Administration (FDA) has the authority to…
The Food and Drug Administration (FDA) has the authority to regulate medical “devices.” 21 U.S.C § 321(h) defines a device as “an instrument, apparatus, implement, machine, contrivance, … or other similar or related article, … which is intended to affect the structure or any function of the body … and which does not achieve its primary intended purposes through chemical action within or on the body.” FDA Commissioner R.K. Fennedy issued an Interpretive Statement (“the Fennedy Statement”) on February 1, 2023 in which he stated that some types of clothing are “devices” subject to regulation by the FDA. Specifically, he states, “clothing that restricts or alters the shape, function, or movement of the body in unnecessary or unhealthy ways” can be regulated or banned by the FDA. Prior to the Fennedy Statement, the FDA had never claimed authority over ordinary clothing items, but for many years it has regulated medical-grade items worn on the body, such as compression socks, knee braces, and posture-control garments. Commissioner Fennedy then initiates a notice-and-comment rulemaking process to create regulations for body-restrictive clothing. The FDA first proposes a rule that would ban the sale without prior FDA approval of tight pants, undergarments, and swimsuits for men because their long-term use can lower sperm count. They include the findings of many studies showing the effects of tight clothing on sperm count. Despite the scientific evidence provided, the proposed rule generates huge resistance from the men’s fashion industry and from the public in general. The FDA is flooded with comments opposing the proposed rule, most of them focused on the value of individuals making their own fashion decisions, not about countering the scientific evidence. Faced with this backlash, the FDA decides to scale back its plan. When the final rule is issued on August 5, 2023 (“The Underwear Rule”), it reaffirms all the studies that were in the initial notice, but bans only the sale of “brief-style underwear for men” without prior FDA approval, and does not mention pants or swimsuits at all. You are a clerk for a judge on the 6th Circuit Court of Appeals. Due to a backlog of cases, you have been given the materials for three related cases together. These cases are identical on the facts, and differ only in the dates they were filed and the legal arguments that were available to the FDA and the companies at those different times. FDA v. Alpha: In January 2023, the FDA brought an enforcement action in federal court against Alpha Underwear Co. for marketing a device (i.e., brief-style men’s underwear) without seeking FDA approval. At that time, neither the Fennedy Statement nor the Underwear Rule had been issued. Therefore, the FDA argued ONLY that brief-style men’s underwear is a device under the Act based on the statue alone (21 U.S.C. § 321(h)). Write a memo for your judge analyzing the merits of the FDA’s case under the statute alone, making sure to discuss any applicable judicial doctrines in addition to the statutory interpretation question. FDA v. Bravo: In March 2023, the FDA brought an enforcement action in federal court against Bravo Underwear Co. for marketing a device (i.e., brief-style men’s underwear) without seeking FDA approval. This case was filed after the Fennedy Statement, but before the rulemaking. Write a memo for your judge analyzing whether the Fennedy Statement makes a difference to the outcome of the case, and if so, in what way(s). You do not need to repeat the analysis you did in the Alpha case, and you may refer back to it if you want to. FDA v. Delta: In December 2023, the FDA brought an enforcement action in federal court against Delta Underwear Co. for marketing a device (i.e., brief-style men’s underwear) without seeking FDA approval. This case was after the Underwear Rule was issued in the August 5 rulemaking, so the FDA argued that Delta was in violation of this regulation, not the statute directly. Write a memo for your judge analyzing the case under the relevant framework for administrative law cases PRIOR TO the Loper-Bright You do not need to repeat the analysis you did in the Alpha and Bravo cases, and you may refer back to them if you want to. Several months later, your judge is about to put the finishing touches on her opinion in the FDA v. Delta case. Unfortunately, before she can publish it, the Supreme Court decides Loper Bright Enterprises v. Raimondo, which made substantial changes to court review of administrative law cases. Write a memo for your judge explaining how she should change the FDA v. Delta opinion in light of Loper Bright. You do not need to repeat any prior analyses, and you may refer back to them if you want to.