A Brief History of the 1938 Food, Drug and Cosmetic Act: Part 3

Shortly after S. 2800 died in committee, Senator Copeland (newly reelected, no thanks to FDR) began drafting yet another food and drug bill, this time without the input of Tugwell or the FDA. In January 1935, Copeland introduced his new reform measure, S. 5, into the Senate. Concessions made to industry in this bill were even heavier than those in Copeland's previous drafts.

Requirements for drug labeling were considerably more lenient; formulas merely had to be filed with the Secretary of Agriculture, which would avert label disclosure. The list of diseases prohibited from advertising was shortened, and FDA seizures for misbranding were limited to 3 actions on a single product. Products that varied from the recognized Pharmacopeia standard were also permissible.

Once again, FDA leadership recognized Copeland's new draft as a general improvement on the 1906 law and a realistic compromise. S. 5, like its predecessors, also had the reluctant support of the all-important women's organizations and professional pharmaceutical groups. However, the AMA found the bill too weak. The more militant consumer groups were also unhappy with S. 5, as were proprietary drug manufacturers—whose Congressional lobbyists would become instrumental in the new bill's fate.

Public hearings in March of 1935 portended the early passage of S. 5, and the bill was reported out of committee on the 22nd, despite opposition efforts from Senators Josiah Bailey (D-NC) and Joel Bennett Clark (D-MO). The 2 senators' obstructive efforts were probably informed by their respective state's interests. North Carolina was the home of the Vick Chemical Company, maker of VapoRub; the Lambert Pharmaceutical Company, of Listerine fame, was located in Missouri.

On April 1, S. 5 came up for Senate debate, and Copeland expected a speedy vote. However, Bailey and Clark had other ideas. In an attempt to gain opposition support, the 2 senators extended the debate for 8 days, arguing for 1) modified definitions of "misbranding" and "adulteration" that would significantly undermine the FDA's right to seize products and 2) the FTC's continued control over advertising. The former argument was carried in a bill amendment that, to Copeland's frustration, was passed by the Senate on April 8.

The 2 sides now viewed this juncture of S. 5's journey through the Senate as a legislative flash point. To avoid further compromise on the bill, Copeland was ready to call for a vote; Bailey and Clark wanted to return the bill to committee to attack the advertising issue. To the relief of reformists, the tension was defused by procedural maneuvering on an unrelated bill, and S. 5 was placed in limbo back on the senatorial calendar—but at least it was safely out of the hands of a dickering committee.

A compromise on the Bailey amendment—instigated by FDR with Tugwell's influence—would be reached between Copeland and the opposition the following month. Multiple seizures of a product by the FDA would by allowed if there was "probable cause" that the product was "imminently dangerous." But the FDA and women's groups remained disheartened by the compromise, because the existing 1906 law stipulated no such restrictions. Nevertheless, these proponents of reform continued to support the passage of S. 5, while hoping to strengthen the seizure language before the bill became law.

On May 28, 1935, Copeland's S. 5 was brought to a vote and passed by the Senate. The bill was now at the mercy of the House.

Chief source: Jackson CO. Food and Drug Legislation in the New Deal. Princeton, NJ: Princeton University Press; 1970.

Photograph of Royal S. Copeland from the Biographical Directory of the US Congress.