Food, Drug, and Cosmetic Act

Definition/Introduction

The 1938 Federal Food, Drug, and Cosmetic Act (FDCA) is a set of United States (US) laws that authorize the Food and Drug Administration (FDA) to oversee and regulate the production, sale, and distribution of food, drugs, medical devices, and cosmetics. The FDCA intends to protect the general public from adulterated and misbranded products manufactured and sold in the US. Its introduction was largely influenced by a mass poisoning event in which elixir sulfanilamide, an untested antibiotic containing the toxin diethylene glycol, led to over 100 deaths across 15 states.[1] 

Under the drug regulations at the time, drug manufacturers were not required to submit evidence of the safety or efficacy of their drugs before marketing them to the general public. On June 25th, 1938, President Franklin D. Roosevelt signed the FDCA into law, marking a milestone for modern-day consumer protections. The FDCA and its subsequent amendments paved the way for numerous public health reforms from which we derive benefits today.

The FDCA is enforced by the FDA, a regulatory agency within the US Department of Health and Human Services. The FDCA authorizes the FDA with the following tasks, among many others:

• Mandate drug manufacturers to submit evidence of new drugs’ safety and effectiveness before marketing and distribution to the general public.
• Issue and enforce quality standards for food, drugs, medical devices, and cosmetics.
• Inspect facilities where food, drugs, medical devices, cosmetics, and tobacco products are manufactured, processed, packaged, and stored.
• Recall and/or seize products it deems unsafe or not FDCA-compliant.
• Regulate advertising of prescription drugs and medical devices.
• Issue regulations for product labeling and claims, including nutrition information found on food packaging and health claims for foods and dietary supplements.
• Approve new drugs, medical devices, and food and color additives.

Presently, the FDA regulates more than $1 trillion worth of products on an annual basis. The FDCA continues to influence the FDA’s mission to protect the interests of public health by helping to ensure the security, safety, and efficacy of food, drugs, medical devices, and cosmetics. Other FDA-regulated products include tobacco and certain biologic products such as vaccines, blood components, and tissues for transplantation. The FDA also helps to ensure that certain products that emit radiation cause no harm.

Key Amendments

Since the FDCA was signed into law in 1938, it has undergone numerous amendments to meet the ever-changing needs of the general public and ultimately become the FDCA as we know it today. Selected notable amendments are described in chronological order as follows:

1951 Durham-Humphrey Amendment (PL 82-215)

This Amendment explicitly defines two specific medication categories: over-the-counter and prescription. Until this Amendment, there was no requirement that any medication could be available for sale by prescription only. The Amendment defines prescription medications as those unsafe for self-medication. It requires them to be dispensed with a valid prescription by a practitioner who is licensed by law to prescribe them.[2]

1962 Kefauver-Harris Amendment (PL 87-781)

This Amendment was a response to the thousands of children born with congenital disabilities resulting from maternal thalidomide use for morning sickness. It requires drug manufacturers to provide evidence of the effectiveness in addition to the safety of new drugs before approval. In addition, it requires drug advertising to disclose drug side effects and prohibits cheaper generic drugs from being marketed as more expensive drugs under new trade names.[3]

1976 Medical Device Amendments (PL 94-295)

These Amendments were introduced in response to a US Senate report that faulty medical devices had caused approximately 10,000 injuries, including 731 deaths. It requires that all medical devices be classified into one of three classes:

• Class I (General Controls): devices deemed low-risk for human use.
• Class II (Performance Standards): devices considered moderate-risk for human use.
• Class III (Premarket Approval): devices deemed high-risk for human use.

1980 Infant Formula Act (PL 96-359)

This Act establishes minimum nutrient requirements for infant formula; defines adulteration of infant formula; and specifies quality and nutrient control procedures, recall procedures, and inspection requirements. This Act was influenced by the finding that chloride deficiency became more prevalent in infants in the 1970s due to a company removing salt from its infant formula.[4]

1983 Orphan Drug Act (PL 97-414)

This Act incentivizes the development of “orphan drugs” to treat rare diseases such as cystic fibrosis, amyotrophic lateral sclerosis, and Huntington disease. Incentives include tax benefits, expedited regulatory reviews, clinical research subsidies, and extended market exclusivity. Before the Orphan Drug Act passed, only ten orphan drugs were available for patient use. As of 2015, the FDA has approved over 550 orphan drugs to treat 277 rare diseases.[5]

1987 Prescription Drug Marketing Act (PL 100-293)

This Act implements a legal framework for the safe and effective distribution of prescription drugs. It is intended to establish legal safeguards and discourage the sale of adulterated, misbranded, compromised, and expired prescription drugs. The Act’s introduction was influenced by the growth of the “diversion market,” a wholesale submarket for the illegal distribution of prescription drugs.[6]

1990 Nutrition Labeling and Education Act (PL 101-535)

This Act requires FDA-regulated foods to have nutrition labeling and that all nutrient content and health claims meet FDA regulations.[7]

1994 Dietary Supplement Health and Education Act (PL 103-417)

This Act defines and establishes the regulation of dietary supplements, which it reaffirms as a food category. It is intended to prohibit the manufacture and sale of adulterated and misbranded dietary supplements and prohibit dietary supplement manufacturers from making false claims on supplement labels.[8]

1996 Food Quality Protection Act (PL 104-170)

This Act regulates the use of pesticides in food cultivation, including mandating a health-based standard for their use in food and providing special protections for babies and infants. It also incentivizes the creation of safer pesticides and streamlines their approval.[9]

Issues of Concern