Carl Brandenfels v. Margaret M. Heckler, Secretary of Health and Human Services

We affirm the decision of the Commissioner of the Food and Drug Administration withdrawing approval of petitioner’s new drug application.

FACTS

Brandenfels Scalp and Hair Applications and Massage is an aqueous solution of 0.25% sulfanilimide and an aqueous solution of 1.5% lanolin. The labeling reviewed by the Food and Drug Administration’s (FDA) scientific panels claimed that the treatment tends to soften the scalp, to remove dandruff scales, and to aid the scalp and hair generally. The treatment consists of topical applications of the solutions accompanied by massage along the arteries leading to the scalp. It has been marketed since the 1940’s and is sold principally by mail. As per the requirements of the 1938 Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., the treatment was found to be safe by FDA in 1948.

Brandenfels was the subject of a Post Office investigation in 1946 for alleged misrepresentation of his treatment’s effectiveness. The proceeding was dismissed without prejudice in 1958.

In compliance with the 1962 amendments to the Act, petitioner in 1964 filed with the Bureau of Drugs four volumes of evidence in support of the efficacy of his treatment. Such…