Biotics Research Corporation v. Margaret Heckler, Sec'y Etc., Seroyal Brands, Inc. v. Margaret Heckler, Sec'y Etc.

Biotics Research Corporation (Biotics) and Seroyal Brands, Inc. (Seroyal) appeal from district court orders dismissing their complaints for injunctive and declaratory relief against the Food and Drug Administration (FDA). We are asked to decide whether a “regulatory letter” in which the FDA states that a firm has violated laws it administers and threatens enforcement action constitutes a final agency determination ripe for judicial review under the Declaratory Judgment Act, 28 U.S.C. §§ 2201-2202 . We find that it does not and therefore affirm.

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Biotics manufactures and distributes tablets labeled “Interferon-Plus.” Seroyal distributes and markets a product labeled “ ‘Raw’-Thyroid Tablets.”

Following an investigation, the FDA sent regulatory letters to Biotics and Seroyal stating that they were violating certain enumerated federal statutes and threatening enforcement action if they did not initiate corrective measures. The letter to Biot-ics stated that its product “Interferon-Plus” was a “biological product” and a drug and that the firm was in violation of section 351(a) of the Public Health Service Act, 42 U.S.C. § 262 (a), and various subsections of section 502 of the Food,…