Ending its 27-year stranglehold on proposals for federal pure food and drug legislation, Congress passed the Pure Food and Drug Act and its companion bill, the Meat Inspection Act, on June 30, 1906. An unprecedented convergence of consumer, scientific, and industrial support in 1906 prompted such action; most industries even planned for it, hoping regulation would restore the competitiveness of their products on weak foreign and domestic markets. The ways in which these interests converged, and the reasons therefore, suggest a change in their relationships to each other and with the federal government as America headed into the twentieth century.
President Roosevelt called the conditions revealed in the special commission's report "revolting." In a letter to Congress, he declared, "A law is needed which will enable the inspectors of the [Federal] Government to inspect and supervise from the hoof to the can the preparation of the meat food product."
Passage of the Meat Inspection Act opened the way for Congress to approve a long-blocked law to regulate the sale of most other foods and drugs. For over 20 years, Harvey W. Wiley, chief chemist at the Department of Agriculture, had led a "pure food crusade." He and his "Poison Squad" had tested chemicals added to preserve foods and found many were dangerous to human health. The uproar over The Jungle revived Wiley's lobbying efforts in Congress for federal food and drug regulation.
Roosevelt signed a law regulating foods and drugs on June 30, 1906, the same day he signed the Meat Inspection Act. The Pure Food and Drug Act regulated food additives and prohibited misleading labeling of food and drugs. This law led to the formation of the federal Food and Drug Administration (FDA).
The two 1906 laws ended up increasing consumer confidence in the food and drugs they purchased, which benefitted these businesses. The laws also acted as a wedge to expand federal regulation of other industries, one of the strategies to control big business pursued by the progressives.
In 1981, the Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) issued regulations based on the Belmont Report. DHHS issued Code of Federal Regulations (CFR) Title 45 (public welfare), Part 46 (protection of human subjects). The FDA issued CFR Title 21 (food and drugs), Parts 50 (protection of human subjects) and 56 (Institutional Review Boards).
In addition, certain federally sponsored and much privately sponsored research is subject to the regulations of the Food and Drug Administration (FDA) at 21 CFR Parts 50 and 56. FDA regulations confer protections on human subjects in research when a drug, device, biologic, food additive, color additive, electronic product, or other test article subject to FDA regulation is involved. FDA regulations and the provisions of the Common Rule are largely congruent, although some significant differences exist.
A pure food and drug bill would probably not have passed in 1906 without Wiley's unceasing commitment. A doctor and a chemist, he recognized early the need to regulate the adulteration of food and later joined the crusade for pure drugs.
Spearheaded by Harvey Washington Wiley, the Pure Food and Drugs Act of 1906 launched the federal regulation of food and drugs in the United States. Wiley is often lauded as a champion of public interest for bringing about a law that required healthful ingredients and honest labeling. Clayton Coppin and Jack High demonstrate, however, that Wiley was in fact surreptitiously allied with business firms that would benefit from regulation and moreover, that the law would help him build his government agency, the Federal Bureau of Chemistry.
We examine three theories of Progressive Era regulation: public interest, industry capture, and information manipulation by the federal bureaucracy and muckraking press. Based on analysis of qualitative legislative histories and econometric evidence, we argue that the adoption of the 1906 Pure Food and Drugs Act was due to all three factors. Select producer groups sought regulation to tilt the competitive playing field to their advantage. Progressive reform interests desired regulation to reduce uncertainty about food and drug quality. Additionally, rent-seeking by the muckraking press and its bureaucratic allies played a key role in the timing of the legislation. We also find that because the interests behind regulation could not shape the enforcing agency or the legal environment in which enforcement took place, these groups did not ultimately benefit from regulation in the ways originally anticipated.
The Food and Drug Act of 1909 prohibited interstate commerce in misbranded or adulterated foods, drinks, and drugs. Of its many amendments, some involved product labeling and advertising. In 1938 Congress repealed parts of the 1909 act and enacted the Food, Drug and Cosmetic Act, which, in part, granted the Federal Trade Commission (FTC) oversight of advertising associated with products regulated by the FDA with the exception of that for prescription drugs. The act also forbade false therapeutic claims for drugs.
As defined by the Supreme Court in 1942 in Valentine v. Chrestensen, commercial speech is expression involving the economic interests of the speaker and its audience. In Valentine, the Court ruled that the First Amendment did not protect purely commercial advertising. But during the 1970s, the Court began to extend some protection to commercial speech, but less than it was giving to political speech. The First and 14th Amendments protect truthful and informative commercial speech, but government can regulate misleading and deceptive advertising.
Judith Haydel. 2009. Food and Drug Administration [electronic resource]. The First Amendment Encyclopedia, Middle Tennessee State University (accessed Feb 09, 2023). -amendment/article/813/food-and-drug-administration
For those already addicted, however, the protection afforded by the 1906 act and by subsequent amendments was short-lived, for in 1914 Congress passed the Harrison Narcotic Act, which cut off altogether the supply of legal opiates to addicts. As a result, the door was opened wide to adulterated, contaminated, and misbranded black-market narcotics of all kinds. The heroin available on the street in the United States today, for example, is a highly dangerous mixture of small amounts of heroin with large and varying amounts of adulterants. The black market similarly distributes today large quantities of adulterated, contaminated, and misbranded LSD and other drugs. The withdrawal of the protection of the food-and-drug laws from the users of illicit drugs, as we shall show, has been one of the sign)ficant factors in reducing addicts to their present miserable status, and in making drug use so damaging today.
The Food and Drug Administration (FDA) is one of the oldest consumer protection agencies in this country. Since 1979, it has been part of the Department of Health and Human Services. It regulates products that account for over one fourth of all consumer spending. The FDA protects the public from unsafe foods to drugs and from medical devices to cosmetics. It also protects the rights and safety of patients in clinical trials of new medical products and monitors the promotional activities of drug and device manufacturers. The FDA even regulates the labeling of all packaged foods and the safety of the nation's blood supply.
Is your baby keeping you up at night? Calm him down with this soothing syrup laced with moderate amounts of opium! Do you have a problem with your heart, kidney, or stomach? Why not just take this remedy that will cure you like magic. Are you balding or losing hair? Wipe on some of this special potion and just like that you will be cured. Would you like to see what is being put inside your food? Too bad, because we are not going to share our secret. But wait, it gets better. Would you like to try this bottle of ketchup preserved with formaldehyde (the same chemical used to treat warts)?
All of these scenarios seem ridiculous, even absurd by today's standards. But prior to the Pure Food and Drug Act of 1906, all of these products and practices were in place. The Pure Food and Drug Act was the first legislation in the country that sought to regulate pharmaceuticals and food products by requiring truth-in-labeling on products, creating inspectors of the drug and food manufacturing process, and creating a list of 10 dangerous drugs that had to be labeled at all times.
Upton Sinclair was referred to as a ''muckraker'', someone who investigated the ''muck'' of society and brought it to light so that society would reform. In 1906, the publication of The Jungle by Upton Sinclair brought to public knowledge two major sets of issues. Firstly, the struggles of factory workers in an unsafe and unsanitary environment. Secondly, the unsanitary conditions and practices of factories, which contributed to the deleterious conditions of food and drugs throughout the country, specifically in the meat-packing industry. The Jungle was one of the most significant factors in President Theodore Roosevelt's decision to muscle through the passage of the Pure Food and Drug Act in 1906. He read passages from the book to Congress; what they heard motivated them to pass the Act.
After reading The Jungle, and because of his progressive stance which was already concerned about the behaviors of business owners and industrialists, Roosevelt was determined to learn for himself the conditions of food and drug creation, transportation, and marketing. He was put off by the socialist argument presented at the end of Sinclair's book, but he enlisted the Agriculture Department to investigate the facts behind Sinclair's novel. When he read the Neill-Reynolds report, which stated that conditions in the factory were even worse than Sinclair reported, he strongly supported the Beveridge Amendment to the Agricultural Appropriations Bill, which legislated broad reforms in the meat-packing industry. 2b1af7f3a8