Opinion ID: 7267
Heading Depth: 3
Heading Rank: 1

Heading: Agency Deference: FDA's Characterization

Text: 28 In analyzing whether an agency pronouncement is a statement of policy or a substantive rule, the starting point is the agency's characterization of the rule. 23 It is undisputed that the FDA has consistently classified the instant rule as a statement of policy. The rule is self-described as Policy, and it was promulgated as a compliance policy guide. In addition, the FDA has steadfastly insisted, both before us and before the district court, that CPG 7132.16 was intended to propound policy. 29 Further, the FDA chose to promulgate the information contained in this rule in the form of a compliance policy guide, which FDA regulations classify as an advisory opinion. 24 An advisory opinion may be used in administrative or court proceedings to illustrate acceptable and unacceptable procedures or standards, but not as a legal requirement. 25 Both of these factors--the description as policy in the CPG itself and the fact that compliance policy guides do not have binding effect--militate in favor of a holding that CPG 7132.16 is not a substantive rule. 30 But as we observed in Brown Express, Inc. v. United States, 26  '[t]he label that the particular agency puts upon its given exercise of administrative power is not, for our purposes, conclusive; rather, it is what the agency does in fact.'  27 We therefore turn now to those matters of substance.