Dose of History – A Brief History of Drug Advertising and Regulation

Prior to 1906, the medicine market looked very different than it does today. Prescriptions were not necessary and patients were generally able to self-medicate without consulting a doctor or pharmacist. The actual contents of medicines were not always known to the buyer as the manufacturers were not obligated to make their proprietary formulas public. As a result, the composition of many solutions on the market during this period have been lost to time. However, it was quite common for these medicines to contain opiates, alcohol, and other intoxicants. Drugs of this kind were called “patent medicines” and were often distinguished from drugs compounded and sold by a trained pharmacist. Although they had existed since the 17th century, the patent medicine industry boomed in the late 1800s largely due to the growth of mass media. Patent medicine manufacturers were some of the most aggressive advertisers in newspapers and magazines and often relied on this advertising and name recognition to win over customers. Advertisements were also distributed by mail, and most medicine could be purchased via mail.

There was almost no legislation restricting how these advertisements were conducted, meaning that many medicines were advertised with little concern for how effective they actually were. Many advertisements feature rather outlandish claims–for instance, one advertisement for “Dr. Hand’s Remedies for Children” describes its effects as “magical” and claims it “instantly relieves the babe” of all pain and bowel issues. As this ad suggests, mothers were a fairly common target for patent medicine advertisements, and imagery of shrieking infants turned calm by a certain remedy figure prominently.

As the patent medicine industry grew, so did the movement against it. Most pharmacists had long scorned the patent medicine industry for its lack of professional oversight and its perceived delegitimization of the occupation of pharmacy. The late 19th century also saw the growth of the Progressive movement, which sought to redefine the role of the federal government to provide better protection for consumers. Concurrent with the development of the Progressive movement was the growth of the Temperance movement, which blamed the patent medicine industry, in particular its advertising directed towards mothers, for the creation of alcoholics and addicts from an early age. These political and cultural movements culminated in the passage of the Pure Food and Drug Act in 1906, which set up standards of quality which would be enforced by the federal government.

The Pure Food and Drug Act also resulted in significant changes in labelling and advertisement. It required certain substances such as cocaine, heroin, and chloroform to be listed on the label if the medicine contained them. The act also prohibited drugs which misrepresented their contents to consumers and, in theory, provided consumers some protection against false claims made in advertising. Some medicine manufacturers took advantage of this act and spun it as an unofficial endorsement of purity from the federal government in their advertisements.

For the next thirty years or so, the country would operate under the Pure Food and Drug Act as the only piece of federal legislation regulating drug advertisement. Despite the lack of new regulation, the early 20th century remained a period of significant change for drug advertising. The political and moral backlash against patent medicines led to their gradual decline to the advantage of the pharmaceutical industry. One article published by the American Medical Association in 1919 advises against the use of patent medicines, demonstrating a conscious effort to consolidate authority of the administration of medicine to medical professionals. This drive continued into the 1930s, with the National Association of Retail Druggists publishing pamphlets criticizing self-medication and encouraging pharmacists to write more prescriptions. Of course, patent medicines did not simply cease to exist–arguably, they still exist in some form in the modern day–but their prominence in the medical market was steadily diminishing.

This shift towards professionalization of the drug industry was reflected in advertising. By the 1930s, advertising for certain drugs such as antibiotics were directed exclusively to pharmacists. These ads appeared in trade magazines and medical journals that the general public was unlikely to read. However, restrictions on these advertisements were still rather lax. There were no requirements to note the potential side effects or dangers of the drugs. Moreover, there was no oversight for how the drug was advertised, meaning that a drug could be advertised for a purpose that it wasn’t really well suited for. Amphetamines, for instance, were often billed as appetite suppressants and antidepressants, and advertising for them does not note the risk of psychosis. As a result, cases of amphetamine psychosis would see a significant rise in the mid-20th century until the prescription of amphetamines was regulated under the Controlled Substances Act of 1970. Many drugs which were considered less “heavy-duty”, such as cough syrup and aspirin, were still advertised to consumers. This type of advertising was commonly printed on the backs of matchbooks, a practice which continued well into the 1950s.

An ad for St. Joseph’s Aspirin printed on the back of a matchbook from the Edward Kremers Research Library and Archive.

Following a tragic incident which resulted in the deaths of over 100 people, the Food, Drug, and Cosmetic Act (or the FDCA) supplanted the Pure Food and Drug Act in 1938. This act is important in the history of drug regulation for requiring FDA approval before drugs went to market, but it would not have a significant effect on drug advertising directly. However, later amendments to this act would formalize the distinction between prescription and over-the-counter drugs in the 1950s, which further contributed to the split between advertising directed at consumers and advertising directed at professionals. As regulation tightened, it became increasingly common for pharmacies to sell non-medicinal products such as tobacco, candy, and cosmetics. This was hardly an unprecedented development–soda fountains were a common fixture at pharmacies since the 19th century–but a larger and larger share of drugstore real estate was being consumed by non-medical merchandise.

 A photo depicting children purchasing candy at a drugstore, from the American Institute of the History of Pharmacy : Drug Topics Photograph Collection at the University of Wisconsin Digital Collections.

By the 1960s, the FDA had become the main regulatory body presiding over drugs and pharmacy. Congress still played a significant role in drug regulation–the Controlled Substances Act being a significant example–but the regulation of advertisement was well within the FDA’s domain. Consequently, from this point on it is difficult to speak of specific pieces of legislation which contributed to a rapid change in pharmaceutical regulation. Still, guidelines for drug advertising changed significantly in the 1960s and 1970s. For instance, advertisers were now obligated to provide a “brief” summary of potential dangers and side effects of the advertised drug. One ad for valium published in the 1980s demonstrates these changes: the backside contains a full page of text describing instructions for use, potential side effects, proper dosages, and more. 

Interestingly, the prevailing trend of advertising to pharmacists and doctors rather than consumers reversed in the 1980s. The first instances of direct-to-consumer advertising (or DTCA) for prescription drugs occurred in the 1980s, but televised advertisements were prohibitively expensive for most manufacturers. In 1997, pressure from other branches of government and pharmaceutical companies caused the FDA to ease restrictions on these ads, effectively opening the floodgates for televised drug adverts which are now ubiquitous in television and print media. Nowadays, DTCA remains a booming industry with drug manufacturers spending around $6 billion annually on it. 

Since its inception DTCA has been quite controversial. Most countries do not allow it, with New Zealand and the United States being the only exceptions. The opinions of medical professionals, pharmaceutical manufacturers, and the general public vary wildly. Recently, however, it has become a major target for the FDA. In September of 2025, the FDA announced a crackdown on deceptive advertising and subsequently sent cease-and-desist letters to several major pharmaceutical companies as part of the Trump administration’s “Make America Healthy Again” campaign. The effects of this crackdown are yet to be seen, but it is proof that the conversation surrounding drug advertisements remains very much alive. 

This Dose of History was brought to you by AIHP Intern, Leo Ryan.

Bibliography:

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Carpenter, Daniel. “The Ambiguous Emergence of American Pharmaceutical Regulation, 1944–1961.” In Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA, 118–227. Princeton University Press, 2010. http://www.jstor.org/stable/j.ctt7t5st.10.

“Combatting Self-Medication”. National Association of Retail Druggists, c. 1936. https://cdm17532.contentdm.oclc.org/digital/collection/krf_coll/id/1249/rec/262.

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“Part I: The 1906 Food and Drugs Act and Its Enforcement.” U.S. Food and Drug Administration. Last revised April 24, 2019. Accessed September 16, 2025. https://www.fda.gov/about-fda/changes-science-law-and-regulatory-authorities/part-i-1906-food-and-drugs-act-and-its-enforcement.

“Prescription Drugs: Medicare Spending on Drugs with Direct-to-Consumer Advertising”. Government Accountability Office, 2021. https://www.gao.gov/products/gao-21-380.

“Publications Dealing with the Nostrum Evil and Quackery.” Journal of the American Medical Association, February, 1919. https://cdm17532.contentdm.oclc.org/digital/collection/krf_coll/id/150/rec/39.

Rasmussen, Nick. “America’s First Amphetamine Epidemic 1929 – 1971: A Quantitative and Qualitative Retrospective With Implications for the Present.” American Journal of Public Health 98, no. 6 (June, 2008): 974–985. https://pmc.ncbi.nlm.nih.gov/articles/PMC2377281/#sec1.

“FDA Launches Crackdown on Deceptive Drug Advertising”. FDA, September 9, 2025. https://www.fda.gov/news-events/press-announcements/fda-launches-crackdown-deceptive-drug-advertising