The Federal Food, Drug, and Cosmetic (FD&C) Act has a wide-ranging impact on the industries it regulates, as well as significant influence on consumers’ health and quality of life. It can be hard for us to imagine today that it was once perfectly legal in America to sell dangerous products, misleadingly packaged products, and drugs that could be ineffective at best and deadly at worst. The FD&C Act and its amendments changed all that.
What is the Food, Drug, and Cosmetic Act of 1938?
The Food, Drug, and Cosmetic Act of 1938 promotes public health and safety by addressing how the products covered by this law — most foods, food additives, dietary supplements, drugs, medical devices, tobacco products, and cosmetics — must be developed, manufactured, tested, labeled, promoted, and/or distributed.
Although the language in the act is purposely broad, giving the government discretion over implementing regulations and guidelines, it authorizes the Food and Drug Administration (FDA) to undertake such actions as:
- Approving new drugs, certain medical devices, and food additives
- Inspecting venues that manufacture, process, pack and store covered products
- Regulating advertising for prescription drugs and some medical devices
- Regulating labelling and product claims
- Issuing recalls for unsafe or non-compliant products
Food, Drug, and Cosmetic Act History: The Full Timeline
Before the FD&C Act was passed, federal food and drug regulation was covered by the 1906 Pure Food and Drug Act, signed into law by President Theodore Roosevelt. The Pure Food and Drug Act provided for federal agencies to involve themselves in "preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors." However, it placed the burden of proof on federal regulators who had to prove that a manufacturer intended to defraud consumers before they could take action.
Many products slipped by the 1906 law and, in the early 1930s, national attention began to focus on a number of dangerous and even lethal consumer products. The FDA itself began to warn the public about the worst foods, drugs, and cosmetics that it could not legally remove from the market.
A bill to replace the 1906 bill had been languishing in Congress for five years in 1937 when people began to die from a new antibiotic. A newly formulated liquid version of a well-known product, Elixir Sulfanilamide was tested for flavor, appearance, and fragrance but not for safety. Without enforceable safety regulations, the new formulation — which contained a toxic chemical analogue of antifreeze — killed more than 100 adults and children in a few months and swiftly led to enhancement and passage of the new Food, Drug, and Cosmetic Act.
Since the Act’s passage, several amendments have been made to expand its range, including setting requirements and approval processes for pharmaceutical companies to present proof not only of the safety of their drugs but also of their effectiveness.
Important Sections of the FD&C Act to Know
The Act has ten chapters dealing with definitions, health and economic safeguards, and enforcement. Here are summaries of some important sections.
Section 201 of the federal food drug and cosmetic act
Section 201 is the definition section of the FD&C Act. It includes definitions of a food, a drug, a medical device, a food additive, and a dietary supplement.
Although definitions may not, on the surface, seem like one of the most important sections of an Act, many of the debates between companies and the FDA have centered on how products are defined and classified. Whether a product is a food, food additive or color additive, or whether it is a drug, homeopathic preparation or dietary supplement, can make all the difference in how it is regulated.
Section 401 sets out the FDA’s authority in regard to the food industry. “Whenever in the judgment of the Secretary such action will promote honesty and fair dealing in the interest of consumers, he shall promulgate regulations fixing and establishing for any food, under its common or usual name so far as practicable, a reasonable definition and standard of identity, a reasonable standard of quality, or reasonable standards of fill of container.”
Section 4 goes on to define specific health and economic safeguards mandated by the Act and enforceable by the FDA. These pertain to raw agricultural products, foods, food additives, coloring additives, packaging, containers, and labels.
The Act sets particularly strict rules for pharmaceutical companies and drug wholesalers, regulating how they manufacture, test, label, and distribute their products. Section 505 outlines the rigorous approval process for new drugs.
How the FD&C Affects Covered Industries
The regulations set in place by the FD&C Act have critically altered the way industries covered by this law do business and greatly enhanced public safety and health. Some of the rigorous testing required by the act may mean a slower route to market for some products, but it also means we can rely more securely on the safety of the products in our daily lives.
One of the products the FDA began warning people about before the FD&C Act was passed was an eyelash dye known as Lash-Lure. A number of women who used it to darken their eyelashes suffered injuries to their eyes, including one confirmed case of permanent blindness.
Today, the FD&C Act aims to prevent injury to cosmetics users by prohibiting “adulterated” cosmetics in interstate commerce. Unlike drugs, cosmetic products and ingredients do not need FDA premarket approval, with the exception of color additives. However, the FDA can take legal action to remove cosmetics from the market that are deceptively labeled or that:
- Contain poisonous or deleterious ingredients
- Contain “filthy, putrid or decomposed substance”
- Have been prepared in unsanitary conditions
- Are packaged in a container that contains poisonous or dangerous substances
- Contain prohibited color additives
Food and Beverage
Pre-1938 many problems with foods revolved around deceptive packaging and labeling. Consumers could not be sure that they were getting what they had paid for. To ensure “honest and fair dealing in the interest of consumers,” the Act corrected these abuses in food packaging and set enforceable food quality standards. Today, for example, if you purchase a steak marked “filet mignon” or “top sirloin,” the seller is obliged to provide you with beef that fits that description. Bonito cannot be labeled and sold as “tuna.” Also, sellers cannot try to conceal any damage or inferior quality.
The Act prohibits food that:
- Contains poisonous or dangerous ingredients, whether they are added or naturally occurring
- Was prepared in unsanitary conditions
- Is filthy, putrid, or decomposed
- Is the product of a diseased animal
- Contains residues of unauthorized pesticides
The Act also mandates that food additives must be approved by the FDA prior to their use in foods and after approval, must follow specific usage regulations.
The Act sets particularly strict rules for the drug industry. Pre-Act, some legally sold products included a medicine that falsely claimed to cure tuberculosis (the Wilhide Exhaler) and a radium-containing tonic that slowly killed its users (Radithor). The FDA could not even legally ban the antibiotic that killed hundreds of people and motivated passage of the FD&C Act...until after the Act was passed.
The FD&C Act gave the government authority to oversee the manufacture, distribution, and marketing of both over-the-counter and prescription drugs. Every step of the process is rigorously regulated to promote and safeguard quality. Amendments in 1962 required drug manufacturers to provide proof not only of a medicine’s safety but also of its effectiveness, before it goes to market. This led to the approval process we recently saw at work on COVID-19 vaccines. This amendment is also the law that requires drug manufacturers today to provide information about potential side effects in their advertising.
The Quality Landscape Today — Get Help From Veeva Cloud Applications
No one wants to go back to the old days when consumers could not depend on the safety and efficacy of the products they were buying, and navigating today’s rigorous and evolving regulatory landscape is a task in which every business in these vital industries participates. Without the right supporting tools, however, keeping up with all the required processes and documentation can mire down your staff and negatively impact your bottom line.
Veeva provides modern, easy-to-use, unified cloud solutions for quality, regulatory, and advertising claims management to help our customers establish transparency and trust throughout the product journey — from raw material suppliers through manufacturing and ultimately to the consumer.