## Facts

- The United States filed an in rem forfeiture and condemnation action under the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 334(a), against undetermined quantities of a depilatory device labeled “Depilatron Epilator Model No. DP‑206,” along with accompanying labeling (brochures and a leaflet).
- The government alleged the Depilatron devices were “adulterated” and/or “misbranded” within the meaning of the FDCA; the court did not decide whether the devices were in fact adulterated or misbranded because the matter came up on a motion to dismiss.
- The Medical Device Amendments of 1976 expanded FDCA seizure authority for certain devices by permitting seizure “without regard to interstate commerce,” codified at 21 U.S.C. § 334(a)(2)(D).
- The claimant (the device owner) moved to dismiss the complaint on two grounds:
  - The 1976 amendments were facially unconstitutional under the Commerce Clause because they allowed seizure of devices without proof that the seized devices traveled in interstate commerce.
  - A prior California state-court action involving the Depilatron device resolved “the same issues” in the claimant’s favor, and therefore the United States was barred by collateral estoppel or equitable estoppel from pursuing the federal seizure action.

## Issues

1. Whether 21 U.S.C. § 334(a)(2), as amended by the Medical Device Amendments of 1976 to allow seizure of certain medical devices without proof of an interstate-commerce connection for the seized items, is unconstitutional on its face under the Commerce Clause.
2. Whether a prior California state-court proceeding involving the Depilatron device collaterally or equitably estops the United States from bringing this federal in rem FDCA condemnation action.

## Decision

- The court denied the claimant’s motion to dismiss.
- The court held that Congress acted within its Commerce Clause authority in authorizing seizure of certain adulterated or misbranded devices without requiring proof that the particular devices seized had moved in interstate commerce.
- The court held that the prior California litigation did not bar the federal action because the required elements for collateral estoppel were not met, and equitable estoppel did not apply to prevent the United States from enforcing the FDCA in this in rem proceeding.

## Legal Principles

- Congress may regulate intrastate activities and articles when it has a rational basis to conclude that, taken in the aggregate, the regulated class substantially affects interstate commerce.
- In a broad regulatory scheme, Congress may dispense with case-by-case proof that each specific item traveled in interstate commerce if reaching intrastate items is a rational means of making the scheme effective.
- A facial Commerce Clause challenge fails where Congress could rationally determine that the regulated category of activity or articles affects interstate commerce and where the challenged provision operates as part of a larger federal regulatory program.
- Collateral estoppel generally requires that the identical issue was actually litigated and necessarily decided in the prior proceeding, and that the party to be bound (or a legally recognized privy) was a party to that proceeding.
- A state-court judgment in a state enforcement action does not, by itself, bind the United States in a later federal enforcement action under a different sovereign’s law, especially where party identity and issue identity are lacking.
- Equitable estoppel is rarely applied to block the federal government from carrying out public-law enforcement responsibilities; it requires a strong showing not present merely because a claimant prevailed in earlier state litigation.

## Conclusion

The Southern District of New York allowed the FDCA in rem seizure case involving the Depilatron Epilator to proceed, rejecting a facial Commerce Clause attack on the 1976 device-seizure amendments and holding that earlier California state-court litigation did not collaterally or equitably estop the United States from pursuing federal condemnation and forfeiture of the devices and their accompanying labeling.


United States v. Undetermined Quantities of an Article of Device . . . “Depilatron Epilator”, 473 F. Supp. 913 (1979)