In Reid v. Johnson & Johnson, the Ninth Circuit heard an appeal of one of the many state law-based consumer class actions over food labeling. A new Washington Legal Foundation Working Paper by partner Sarah Roller assesses the Ninth Circuit’s refusal in Reid to grant preemptive effect to a 2003 FDA letter of enforcement discretion. Johnson & Johnson had made certain label claims based on the 2003 letter, in which FDA sought to expand its existing health claim on phytosterols and heart disease pending final rulemaking. The Working Paper posits that by exercising its enforcement discretion in allowing additional phytosterol claims, FDA balanced the burdens of rulemaking against First Amendment commercial speech considerations and the public health benefit of valid health information reaching consumers as expeditiously as possible. In refusing to acknowledge this important role of the FDA in the area of commercial speech, the Ninth Circuit sets a precedent that threatens a wide variety of truthful, FDA-allowed claims – not the least of which are qualified health claims which rely entirely on FDA letters of enforcement discretion. The new Working Paper reviews Reid, assesses its implications, and examines where other circuits stand on preemption and FDA letters of enforcement discretion.
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