## Facts

- The United States filed an in rem seizure and condemnation action against quantities of tablets labeled “Decholin,” each containing 250 mg dehydrocholic acid.
- The product was marketed for over-the-counter use for “Indigestion,” “After Meal Discomfort and Fullness,” “Excessive Belching,” and “Constipation,” and its label warned consumers to consult a physician if symptoms persisted or if severe pain, nausea, or vomiting occurred.
- The government alleged the product was misbranded because it was a prescription-only drug under 21 U.S.C. § 353(b)(1)(B) and therefore could not lawfully be sold OTC.
- The government’s main safety rationale was that self-treatment of gastrointestinal symptoms could mask serious underlying disease and delay diagnosis and treatment.
- Expert testimony indicated physicians would not prescribe Decholin to treat obstructions or organic disease, but its use in those conditions would not itself cause harm; experts also suggested seriously ill patients would likely seek medical care despite OTC use.
- The case was presented on cross-motions for summary judgment by the United States and the claimant (the manufacturer/successor in interest).

## Issues

1. Whether Decholin was “not safe for use except under the supervision of a practitioner” under 21 U.S.C. § 353(b)(1)(B) due to toxicity, potential harmful effects, method of use, or collateral measures necessary to its use.
2. Whether the possibility that OTC use could delay diagnosis of serious underlying conditions, without proof of material toxicity or direct harm from labeled use, sufficed to require prescription-only status.
3. Whether disputed expert evidence concerning toxicity and medical practice precluded summary judgment condemning the drug.

## Decision

- The court denied the government’s motion for summary judgment.
- The court declined to classify Decholin as prescription-only as a matter of law on the summary-judgment record.
- The court treated the government’s diagnostic-delay theory as insufficiently supported to establish that the drug was unsafe for unsupervised use.
- The court found the expert submissions reflected conflicting or unclear factual bases on toxicity and clinical rationale, making summary disposition against the claimant improper.

## Legal Principles

- Under 21 U.S.C. § 353(b)(1)(B), prescription-only status requires a showing that, because of toxicity, other harmful potential, method of use, or necessary collateral measures, a drug is not safe for use except under practitioner supervision.
- A remote or theoretical possibility of harm does not, by itself, establish that a drug is unsafe for OTC use within § 353(b)(1)(B).
- Alleged “diagnostic delay” from self-treatment may be relevant, but it must be supported by substantial evidence showing unsupervised use is unsafe in practice, not merely that symptoms could reflect serious disease.
- Where expert evidence is conflicting or depends on disputed facts (including toxicity and clinical reasons for prescribing practices), condemnation or prescription-only classification should not be ordered on summary judgment.

## Conclusion

The court refused to condemn Decholin on summary judgment because the government did not establish that the product was unsafe for OTC use under § 353(b)(1)(B); speculative diagnostic-delay concerns and contested toxicity evidence did not justify treating the drug as prescription-only as a matter of law.


United States v. An Article of Drug Labeled “Decholin”, 264 F. Supp. 473 (E.D. Mich. 1967)