In 1961, Florida doctor Richard A. Brunson began selling a nasal spray to doctors in his state that he claimed would cure asthma, a large number of allergies, migraine headaches, and skin allergies. The product, called Alergimist, was marketed in two forms, for over-the-counter use and as a prescription drug. The two versions had the same ingredients, consisting of amino acids, their constituent parts, and other chemicals -- about ten ingredients in all. The only difference was a slightly higher concentration of acetylcholine and so-called “amino acid derivatives” in the second product.

A year before, the doctor’s company, the Brunson Corp., had filed a new drug application (NDA) with FDA for the preparation but in the filing claimed that the product was exempt from requirements for new drugs because it had been marketed since 1936 – before the 1938 Food, Drug, and Cosmetic Act. After FDA rejected the NDA, Brunson went ahead and marketed the product in Florida anyway.

In June, 1963, FDA obtained a temporary injunction to bar Alergimist from being shipped in interstate commerce, asserting that it was a new drug that lacked FDA approval based on evidence of safety and effectiveness. In October, 1964 another federal judge issued a permanent injunction to prevent distribution of both forms of Alergimist, noting the company’s failure to establish the pre-law “grandfather” status of their preparation. The company nevertheless continued to try to advertise and market its drug. That too would meet with legal resistance

Immediately after the permanent injunction was issued, the Better Business Bureau of Greater Miami sent alerts to local print and broadcast media about Alergimist. The company responded by suing the Bureau because, they claimed, the BBB action interfered with their ability to buy advertising. The company continued to publish a broadside in some outlets addressing the “Truth About Alergimist” (with a slight alteration in the drug’s name, perhaps thinking this might allow them to evade the injunction).