Toilet Goods Ass'n, Inc. v. Gardner
| Toilet Goods Association, Inc. v. Gardner | |||||||
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| Argued January 16, 1967 Decided May 22, 1967 | |||||||
| Full case name | Toilet Goods Association, Inc., et al. v. Gardner, Secretary of Health, Education, and Welfare, et al. | ||||||
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Toilet Goods Association, Inc. v. Gardner, 387 U.S. 158 (1967), was a case heard before the United States Supreme Court. It held that judicial review of a regulation's validity was inappropriate because the controversy was not ripe for adjudication, in that it was not clear whether or when an inspection would be ordered and what reasons the Commissioner would give to justify his order, no primary conduct was affected, and no irremediable adverse consequences flowed from requiring a later challenge to the regulation by a Manufacturer who refused to allow inspection.
Facts
Toilet Goods Ass'n are an organization of cosmetic manufacturers accounting for 90% of annual American sales in the field.
The commissioner of the FDA promulgated a rule that, in relevant parts, stated:
"(a) When it appears to the Commissioner that a person has:"
"(4) Refused to permit duly authorized employees of the Food and Drug Administration free access to all manufacturing facilities, processes, and the formulae involved in the manufacture of the color additives and intermediates from which such color additives are derived; he may immediately suspend certification service to such person and may continue such suspension until adequate corrective action has been taken."[1]
Holding
Justice Harlan delivered the opinion. "In determining whether a challenge to an administrative regulation is ripe for review a twofold inquiry must be made: first to determine whether the issues tendered are appropriate for judicial resolution, and second to assess the hardship to the parties if judicial relief is denied at that stage."
Whether the issues were appropriate for judicial resolution
No. The regulation only states the commissioner may order an inspection, and a permit may be refused.
Whether there was an excessive hardship on the parties
No. Unlike other cases, the failure to comply with the rule resulted in, at most, a suspension of a certification. No fines, seizures of goods, or the possibility of criminal liability was present.
See also
References
- ↑ 28 Fed. Reg. 6445-46; 21 C.F.R. § 8.28