The relevant regulations under § 352(f)(1) which were in effect at the time this seizure was made (January 30, 1962) are found at 21 C.F.R. 1.106(a)(1) and read:
'Drugs and devices; directions for use
'(a) Directions for use may be inadequate by reason (among other reasons) of omission, in whole or in part, or incorrect specification of:
'(1) Directions for use in all conditions for which such drug or device is prescribed, recommended, or suggested in its labeling, or in its advertising disseminated or sponsored by or on behalf of its manufacturer, packer, or distributor, or in such other conditions, if any there be for which such drug or device is commonly and effectively used.'
All of these interpretations indicate that adequate directions within the meaning of the statute require at the very least a recitation of the diseases or conditions for which the drug is prescribed. Since the labeling of the seized articles did not contain this information the Government's case is complete.
The articles seized under the monition in this case are condemned for misbranding, and claimant will be enjoined in accordance with the Government's prayer for injunctive relief in the amended libel. Carlton Fredericks is not a party to this proceeding nor did he testify upon the trial. Moreover, his contract to promote the sale of claimant's products has been terminated. The scope of the injunctive relief to be granted to the Government in this case shall not, by its terms, extend to Carlton Fredericks or any of his activities.
This opinion shall constitute this Court's Findings of Fact and Conclusions of Law as required by F.R.Civ.P. 52(a).
Libelant may present a draft of decree conforming with the views herein expressed.