The 1938 Food, Drug, and Cosmetic Act

In September and October 1937, a raspberry-flavored liquid sold as Elixir Sulfanilamide killed 107 people, many of them children, according to FDA's timeline of food and drug law². The deaths were spread across 15 states, from Virginia to California. The solvent that made the drug drinkable was diethylene glycol, a chemical FDA's own account of the episode describes as “normally used as an antifreeze.”

Nothing in federal law at the time required anyone to test a new medicine for safety. The manufacturer's lab checked the mixture for “flavor, appearance, and fragrance,” FDA's 1981 history of the incident¹ says, and shipped it. “Selling toxic drugs was, undoubtedly, bad for business and could damage a firm's reputation, but it was not illegal,” the account notes.

Within a year, Congress passed the Federal Food, Drug, and Cosmetic Act, and President Franklin Roosevelt signed it on June 25, 1938. The law required drugs to be shown safe before they were sold, and it remains the statute under which FDA regulates drugs today, generics included.

How FDA tracked down the elixir

The American Medical Association received reports from physicians in Tulsa, Oklahoma, on October 11, 1937, that an unfamiliar sulfanilamide product was linked to deaths. Its laboratory identified diethylene glycol as the toxic ingredient and issued public warnings. A New York physician learned of the deaths on October 14 and notified FDA headquarters, and an inspector from the agency's Kansas City station confirmed that eight children and one adult had died after taking the product.

By then the manufacturer had sent 633 shipments around the country. Its first recall telegrams, FDA's account¹ says, asked for the product back without saying it was lethal, and a stronger message went out only at FDA's insistence. Practically the agency's entire field force of 239 inspectors and chemists was assigned to the search, working through shipping records, pharmacy sales slips and prescription files. Of 240 gallons made and distributed, 234 gallons and 1 pint were recovered.

FDA's legal footing was thin. Under the 1906 Pure Food and Drugs Act, the agency could seize the product only on a charge of misbranding, because “elixir” implied an alcohol solution and the product contained none. Had it been labeled a “solution,” the account¹ says, no charge could have been made. FDA Commissioner Walter Campbell called it “a technical and trivial charge of misbranding” and said the episode showed the need for a law requiring “that all medicines placed upon the market shall be safe to use under the directions for use.”

A bill that had stalled for five years

Reform was already in Congress. A bill to overhaul the 1906 law was introduced in the Senate in 1933 and stalled, according to FDA's centennial history⁶. FDA had tried to build support with an exhibit of dangerous products that were legal under the old law, which a reporter dubbed “The American Chamber of Horrors,” the agency's history of the 1938 act³ says. The bill languished for five years until the sulfanilamide deaths, which, in FDA's words, “propelled the bill itself through Congress.”

As FDA's timeline² describes it, the 1906 act did not prohibit false therapeutic claims, only false statements about a drug's ingredients or identity. A 1912 amendment banned false therapeutic claims made with intent to defraud, a standard the agency called difficult to prove.

What the new drug section required

Section 505 of the 1938 act⁵ barred the interstate sale of any “new drug” unless an application for it was in effect. The application had to include full reports of investigations showing whether the drug was safe, a full list of components, a statement of composition, a description of manufacturing methods, facilities and controls, samples on request, and the proposed labeling.

FDA's review clock was short. An application became effective “on the sixtieth day after the filing thereof” unless the government postponed it, for no more than 180 days after filing. If FDA did not act, the application took effect on its own, a point FDA's centennial history⁶ also makes. The act's misbranding section required “adequate directions for use” and warnings against unsafe use, and it let the government exempt drugs from the directions requirement by regulation when they were not needed to protect public health.

Drug advertising was left out of the act. FDA's history³ notes that a separate law gave the Federal Trade Commission jurisdiction over it.

What the law set in motion

Applications poured in. According to FDA's history of the act's amendments⁴, more than 6,000 new drug applications were filed in the first nine years, and 13,000 by 1962. Within two months of passage, FDA began identifying drugs, the sulfas among them, that could not be labeled for safe use by patients on their own and would require a prescription. That dispute was settled by the Durham-Humphrey Amendment of 1951.

Safety was the only standard in 1938. In 1962, after thalidomide, Congress added a requirement to show effectiveness and ended automatic approval, through the Kefauver-Harris Amendments. The abbreviated application that generic drugs use today, described in how a generic drug gets approved, sits in section 505(j) of the same 1938 statute.

Diethylene glycol after 1938

The solvent did not go away. In a 2023 guidance on testing high-risk drug ingredients⁷, FDA lists a string of later poisonings in which manufacturers used contaminated glycerin or similar ingredients without full identity testing.

Under the guidance, drug manufacturers must test representative samples of each shipment of each lot of glycerin, propylene glycol, sorbitol solution and similar ingredients for diethylene glycol and ethylene glycol, and must find no more than 0.10 percent before using them. FDA recommends sampling every container in a lot, citing wide variability from drum to drum. Those rules sit within the manufacturing standards explained in GxRadar's CGMP guide, and the 2008 heparin contamination is a later example of an ingredient problem that reached US patients.

The 1938 law in today's recall records

Recalls of adulterated or misbranded drugs still rest on the act's definitions. FDA's enforcement data, published through openFDA⁸, list 212 drug recall records between July 30 and October 28, 2026, including 19 in Class I, the category for products with a reasonable chance of causing serious harm. GxRadar keeps the full series on its recalls page, and how drug recalls work explains the classes.