There was a time in history when food and drugs were not regulated, resulting in products that were produced in unsanitary conditions and were unsafe for people to consume. That all changed with the passage of the Pure Food and Drugs Act in 1906, which provided regulation of consumer products. It also led to the creation of a federal consumer protection agency, currently known as the U.S. Food and Drug Administration. The FDA is primarily responsible for consumer food and drug safety. It ensures most foods are safe for consumption, produced in sanitary conditions and properly labeled. It also ensures that drugs, vaccines and other medical devices are safe and effective. Between passage of the Pure Food and Drugs Act in 1906 and present day, the role and responsibilities of the FDA have significantly expanded, creating more and stronger consumer protections.
TL;DR (Too Long; Didn't Read)
The U.S. Food and Drug Administration regulates most foods, pharmaceuticals, cosmetics, dietary supplements and tobacco products.
Significance of the Pure Food and Drugs Act
The Pure Food and Drugs Act was enacted in 1906 by President Theodore Roosevelt after decades of bills to regulate food and drugs were unsuccessfully introduced in Congress. It was the first federal law to regulate food and drugs in interstate commerce, paving the way for stricter regulation and more transparency in the food and drug industry. The law standardized how foods and drugs are produced, marketed and labeled to increase safety for consumers.
What Can the FDA Do?
In addition to regulating food and drugs, the FDA is tasked with regulating cosmetics, dietary supplements and tobacco products. It also works to protect consumers from radiation given off by electronic products.
The FDA regulates such products as:
- bottled water
- infant formula
- prescription and over-the-counter drugs
- blood and blood products
- surgical implants
- dental devices
- electronic products that give off radiation, such as microwaves and X-rays
- cosmetics, including nail polish and perfume
- veterinary products, including pet food and veterinary devices
- tobacco products, including cigarette and smokeless tobacco
Although the FDA is concerned with food safety, the U.S. Department of Agriculture regulates meat from livestock, poultry and some eggs products.
The FDA’s Legal Authority
The FDA has legal authority to assure compliance with the Federal Food, Drug and Cosmetic Act of 1938, which replaced the Pure Food and Drugs Act. FDA field offices regularly perform inspections, conduct investigations and collect samples to ensure that products and companies are compliant with the laws.
The FDA enforces compliance through warning letters to correct and prevent violations and seizes goods that violate the law. It has the power to criminally punish offenders with fines and jail time. Initial violations result in a misdemeanor with fines ranging from up to $100,000 for a misdemeanor by a single person that doesn’t result in death to up to $500,000 for a misdemeanor by a corporation that results in death. Jail time for each violation is a maximum of one year. For multiple violations of the Federal Food, Drug and Cosmetic Act or violations with intent to defraud or mislead, offenders can be convicted of a felony. A felony conviction means jail time of up to three years and fines of up to $500,000.
FDA and Consumer Reporting
The FDA directly helps consumers by ensuring that the products they use are safe. The agency maintains an ongoing list of recalls, market withdrawals and safety alerts that help keep consumers up to date on products that are not currently recommended for use. If a consumer has a bad reaction to or interaction with a product regulated by the FDA, she can report it directly to the agency. Depending on the product, a nonemergency can be reported online to the FDA or by phone. A consumer experiencing a non-life threatening adverse reaction to a product regulated by the FDA can call an emergency number that is staffed 24 hours a day.
- U.S. Food & Drug Administration: When and Why was the FDA Formed?
- U.S. Food & Drug Administration: What Does FDA Regulate?
- U.S. Food & Drug Administration: What Does FDA Do?
- U.S. Food & Drug Administration: Types of FDA Enforcement Actions
- U.S. House of Representatives History, Art & Archives: The Pure Food and Drug Act
- U.S. Food & Drug Administration: Report a Problem to the FDA