Estee Lauder, Inc. v. United States Food & Drug Administration

How courts have described this case

Verbatim parenthetical descriptions written by other courts when citing this decision. Ranked by citation-network relevance.

• concluding that language in the agency’s letter—requesting that the plaintiff “advise [the FDA]” if it was “unwilling to make the changes identified in [its] letter”—“was by its very nature informal and advisory”
• “If a product is both [a cosmetic and a drug], it must comply with the stricter requirements applicable to drugs.”
• “by its very nature the [FDA regulatory letter was] informal and advisory,” and did not constitute final agency action
• “The Commissioner’s determination on a citizen petition is final agency action subject to judicial review.”
• the decision to classify a product as a “food additive” is a fact-based determination and judicial review pri- or to final agency action would “deny the [FDA] the full opportunity to apply its expertise and to correct errors or modify positions in the course of a proceeding”
• exemption 5 inapplicable to materials discussing prior agency decisions

Source: CourtListener parenthetical corpus (CC0).