In 1937, over 100 people died after taking an unsafe drug. The pharmaceutical company had formulated a liquid version of a well-known product. The new antibiotic, Elixir Sulfanilamide, was tested for flavor, appearance, and fragrance — but not safety. The first batches of the product were sent out in September. In October, the first fatalities appeared. To the modern audience, one of the most shocking things about this story is that the manufacturer did nothing illegal. At the time, there were no safety requirements. In fact, the only charge the U.S. Food and Drug Administration (FDA) could bring against them was that the product was misbranded.¹

Even before this tragedy, it was generally acknowledged that new legislation was needed. The deaths of so many over something completely preventable were the proverbial final straw. Consequently, President Franklin D. Roosevelt, signed the Food, Drug and Cosmetic Act of 1938 (FD&C Act) into law.

Before the FD&C Act

The problems that led to the sulfanilamide incident weren’t new or unknown to the government. Neither were the problems limited to drugs. In 1906, Upton Sinclair’s novel “The Jungle” horrified readers with its accounts of the unsanitary conditions in Chicago meat-packing plants. The public outcry led to President Franklin D. Roosevelt signing the 1906 Food and Drug Act. This was a step forward in that it required that foods and drugs be truthfully labelled and meet standards for purity and strength. However, it placed the burden of proof on regulators. They had to prove that a manufacturer intended to defraud consumers before they could take action against them.²

New legislation was clearly needed. An effective way to illustrate this is with a brief look at dangerous products being sold at the time that the FDA had no authority to remove.

• Dinitrophenol: Sold as a weight-loss product, it caused fatal blood disorders, cataracts, and other serious side effects. As a cosmetic, it was beyond the scope of the 1906 law.
• Koremlu: Meant to reduce body hair, it contained a rodenticide that caused neuromuscular damage, respiratory problems, blindless, and permanent hair loss. “One 26-year-old woman reportedly lost her teeth, eyesight, [and] ability to walk.”
• Lash Lure: A cosmetic that contained a toxic dye that could cause eyebrow and eyelash loss, vision impairment, and blindness.
• Othine: A product that removed brown spots and lightened skin — using mercury. Side effects included bone deterioration, tooth loss; neurological, pulmonary, and renal damage; and death.³

The above list is just a sample of products that the FDA warned the public about but couldn’t remove from the market. Products ranged from deceptive and only harmful to your wallet, to those containing known toxins.

Raspberry-Flavored Antifreeze

Experimenting with different delivery forms isn’t bad. It can help consumers that have trouble swallowing pills and help children more easily take medicine. If you’re reading this, odds are you’re at least somewhat familiar with the complexity of designing such a product. And all the paperwork that goes along with it. In 1937, this product development was quite a bit different.

First, pharmaceutical salespeople from S.E. Massengill Co. reported that there was a demand for a liquid version of sulfanilamide, a drug used to treat streptococcal infections. The company’s chief chemist and pharmacist, Harold Cole Watkins, dissolved sulfanilamide in diethylene glycol, gave it a raspberry flavor, and after testing it for flavor, appearance, and fragrance, the product was sent out. Without further testing, Watkins unintentionally failed to realize that diethylene glycol is antifreeze and is poisonous. But, as the examples above show, this was not the first product to include a poison and not the first one to cause death.

It was what finally pushed the Food, Drug, and Cosmetic Act through Congress and got the bill onto FDR’s desk. He signed it on June 25, 1938, empowering the FDA with a further reach and more enforcement abilities. Among other things, it gave FDA authority over medical devices and cosmetics, required premarket approval of drugs, proof of drug safety, and prohibited false therapeutic claims. Amendments to the act gave the agency the authority it has today (such as requiring proof of drug efficacy).

Conclusion

People don’t like being told what to do. We bristle at rules. We don’t like authority figures. But, as much as we hate admitting it, regulations and regulators are necessary. The FD&C Act is one such example. It’s not exaggerating to say that before 1938, every time you bought a product you took your life into your hands. Now consumers know the drugs they purchase have been tested for safety and efficacy. They know the ingredient list on a food product is a complete list. And you can have confidence in the COVID-19 vaccine you just received.

It’s surprising that pharmaceutical companies were able to develop vaccines and get authority to distribute them so quickly from the FDA. Fortunately, as technology has developed, the agency has accepted and encouraged the use of digital tools in regulated industries. This meant that companies using that technology could move at a speed that would’ve been impossible with paper systems, while prioritizing patient safety. With advances in technology, particularly cloud computing and advanced analytics, companies have the flexibility to develop their products quickly while ensuring compliance.

Sources

1. “Sulfanilamide Disaster,” Carol Ballentine, U.S. Food and Drug Administration, June 1981.
2. “80 Years of the Federal Food, Drug, and Cosmetic Act,” U.S. Food and Drug Administration, July 11, 2018.
3. Supra note 2