In 1906 the Pure Food and Drug Act (Dr. Wiley’s Law) was passed by the Congress and signed by President Theodore Roosevelt, bringing the governing body of the Food and Drug Administration (FDA) into existence. The first commissioner of the FDA was Dr. Harvey Washington Wiley, who previously was the chief chemist of the USDA Bureau of Chemistry [1]. Previously to the FDA, the Bureau of Chemistry regulated food safety. The implementation of the FDA was the first comprehensive consumer protection agency in the federal government [1]. The first glimpse into what would eventually become the FDA, was the U.S Pharmacopeia which was started back in 1820 and sought to standardize drugs [2].
Throughout the years since its initiation, the FDA has had its hands in some very important amendments and laws that, to this day, are still intact. In 1912, the Congress prohibited the mislabeling of medicines that claimed false therapeutic effects [2]. In 1938, The Federal Food, Drug, and Cosmetics Act passed to extend the reach of regulation on cosmetic and therapeutic devices [2]. In 1966, the Child Protection Act and Fair Packaging and Labeling Act were passed banning hazardous toys and making sure that all products are informatively labeled [2].
The FDA is currently the regulatory body for foods, drugs, biologics, medical devices, cosmetics, veterinary products, tobacco products, and electronic products that give off radiation [3]. Any type of product that falls under any of these categories requires FDA approval for it to be marketed and sold. There are many regulations that are required for compliance with FDA standards to market a product.
If you need help determining the proper classification of your product, or just simply want to meet FDA compliance, the team of experts at EMMA International can help! Contact us today at info@emmainternational.com or by calling 248-987-4497.
[1] FDA. (2018, June 29). FDA History. U.S. Food and Drug Administration. https://www.fda.gov/about-fda/fda-history
[2] FDA. (2023, January 30). Milestones in U.S. Food and Drug Law. U.S. Food and Drug Administration. https://www.fda.gov/about-fda/fda-history/milestones-us-food-and-drug-law
[3] FDA. (2022, January 18). What does FDA regulate? U.S. Food and Drug Administration. https://www.fda.gov/about-fda/fda-basics/what-does-fda-regulate
