Food, Drug, and Cosmetic Act (2024)

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-regulatedfoods 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

Significant issues of concern focuson the regulatory authority that the FDCA grants the FDA. In numerous instances, the FDA has been accused of overregulation and/or under-regulation by a multitude of governmental and non-governmental organizations.

Concerns about overregulation primarily focus on the drug approval process and drug prices. Critics argue that FDCA components such as the 1962 Kefauver-Harris Amendment, which requires drug manufacturers to submit evidence of drug efficacy in addition to safety, added considerable costs and delays to the drug approval process, resulting in fewer drugs being brought to market.[3] This issue of drug lag was most apparent in the 1970s when new drugs were approved for sale in European markets versus US markets.[10]

Moreover, critics argue that FDA-mandated clinical trials, estimated to have a median cost of $48 million, exacerbate high drug prices for consumers.[11] This is in addition to FDCA patent protection clauses that enable temporary monopolies that impede cheaper alternatives from being brought to the drug marketplace, further worsening drug prices.[12] It is argued that FDA overregulation may consequently discourage new drugs from being brought to market due to the considerable time and financial investments.

Concerns of under-regulation primarily focus on the approval of unsafe drugs and food additives. Critics argue that the FDA has a track record of overlooking safety and efficacy concerns when approving new drugs, necessitating recalls when deemed necessary during postmarket surveillance. Troglitazone, for example, was an FDA-approved medication for diabetes but was withdrawn due to hepatotoxicity and acute liver failure cases.[13]

More recently, the FDA drug approval process has been scrutinized due to the FDA’s approval of aducanumab, a medication for Alzheimer disease, despite a lack of solid evidence for its efficacy.[14]

Furthermore, the FDA has been criticized for allowing routine antibiotic use in domestic animals, which allegedly contributes to widespread antibiotic resistance.[15] This is in addition to allegations of allowing food additives that may potentially be unsafe and those for whichthere is limited or no available toxicology information.[16]

Clinical Significance

The FDCA and its amendments have had significant public health implications. Before the FDCA, Americans were marketed and sold adulterated and misbranded food and drugs. Food often contained harmful additives, and drugs often contained alcohol and opium, among other substances.[17]

In conjunction with the high prevalence of quack medicine at the time, Americans suffered from a dearth of consumer and public health safeguards. Although the 1906 Pure Food and Drug Act, the FDCA’s predecessor, attempted to rectify these issues, the Act had many shortcomings and was difficult to enforce.[18]

The FDCA and its amendments require drug manufacturers to submit evidence of drug safety and effectiveness, that drugs meet specific strength and purity standards, and that drug labels list active ingredients and contain truthful statements. The FDA also issues regulations for product labeling and can recall and/or seize products it deems unsafe or not FDCA-compliant. The five most common reasons for an FDA drug recall are mislabeling, contamination, adverse reaction, incorrect potency, and defects.[19] All these endeavors have led to public health reforms that we benefit from today.

The FDCA and its amendments have also regulated medicine and pharmacy practices more regulated and evidence-based. This is in stark contrast to the quack medicine that was prevalent in the early 1900s. The Durham-Humphrey Amendment, for example, distinguishes between over-the-counter and prescription drugs, requiring the latter to be dispensed only with a valid prescription from a licensed healthcare professional.[2]

Moreover, new drugs and medical devices are independently evaluated by the FDA’s Center for Drug Evaluation and Research for risks and benefits before being approved for sale. As a result, FDA-approved drugs that healthcare professionals prescribe are thoroughly vetted and have clinical data supporting their safety and efficacy. Furthermore, the Orphan Drug Act incentivized the development of newmedications that healthcare professionals can prescribe to treat a myriad of rare diseases, such as narcolepsy and amyotrophic lateral sclerosis, that had limited treatment options in the past.[5]

Nursing, Allied Health, and Interprofessional Team Interventions

Physicians, pharmacists, nurses, and other healthcare professionals must ensure that their patients receive the most appropriate treatment for their condition(s). It is prudent for the interdisciplinary team to have an understanding of FDA approval and FDA recalls when formulating treatment plans and educating their patients. With myriad treatments to choose from, healthcare professionals should know that FDA-approved drugs and medical devices have undergone an independent review for safety and efficacy.

Healthcare professionals should consider that when counseling their patients on treatment options and discussing topics such as complementary and alternative medicine. Improved communication between healthcare professionals is also essential. With many medications currently being prescribed for off-label uses, it would behoove physicians, pharmacists, and other clinicians to educate one another and maintain an open line of communication to improve patient health outcomes.

Another interprofessional team intervention is the voluntary reporting of adverse events and quality issues about drugs and medical devices to the FDA MedWatch surveillance system. Issues with other FDA-regulated products, including infant formula, cosmetics, and medical foods, can also be reported.

Of note,pharmacists are most likely to report adverse medication reactions. However, the FDA encourages all interprofessional healthcare team members to report concerns in the interests of public health. The information from these reports is made available to the medical community and the general public. Aiding with postmarket surveillance, MedWatch can alert the FDA to consider product recalls, withdrawals, and changes to labeling to protect the general public. Reporting can be done online, by phone, mail, or fax.[20]

References

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2.

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3.

Zhang P, Winston NR. StatPearls [Internet]. StatPearls Publishing; Treasure Island (FL): Jun 12, 2023. Federal Medication Development Regulation. [PMC free article: PMC574558] [PubMed: 34662072]

4.

Newberry RE. The Infant Formula Act of 1980. J Assoc Off Anal Chem. 1982 Nov;65(6):1472-3. [PubMed: 7174587]

5.

Roberts AD, Wadhwa R. StatPearls [Internet]. StatPearls Publishing; Treasure Island (FL): Jun 5, 2023. Orphan Drug Approval Laws. [PMC free article: PMC572052] [PubMed: 34283418]

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Cullen C, Stephens-Utne R. StatPearls [Internet]. StatPearls Publishing; Treasure Island (FL): Jun 20, 2023. Prescription Drug Marketing Act. [PMC free article: PMC574533] [PubMed: 34662047]

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Marietta AB, Welshimer KJ, Anderson SL. Knowledge, attitudes, and behaviors of college students regarding the 1990 Nutrition Labeling Education Act food labels. J Am Diet Assoc. 1999 Apr;99(4):445-9. [PubMed: 10207397]

8.

Wallace TC. Twenty Years of the Dietary Supplement Health and Education Act--How Should Dietary Supplements Be Regulated? J Nutr. 2015 Aug;145(8):1683-6. [PubMed: 26063064]

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Wagner JM. Food Quality Protection Act: its impact on the pesticide industry. Qual Assur. 1997 Oct-Dec;5(4):279-83. [PubMed: 9670242]

10.

Wileman H, Mishra A. Drug lag and key regulatory barriers in the emerging markets. Perspect Clin Res. 2010 Apr;1(2):51-6. [PMC free article: PMC3148610] [PubMed: 21829782]

11.

Moore TJ, Heyward J, Anderson G, Alexander GC. Variation in the estimated costs of pivotal clinical benefit trials supporting the US approval of new therapeutic agents, 2015-2017: a cross-sectional study. BMJ Open. 2020 Jun 11;10(6):e038863. [PMC free article: PMC7295430] [PubMed: 32532786]

12.

Kesselheim AS, Avorn J, Sarpatwari A. The High Cost of Prescription Drugs in the United States: Origins and Prospects for Reform. JAMA. 2016 Aug 23-30;316(8):858-71. [PubMed: 27552619]

13.

Wagenaar LJ, Kuck EM, Hoekstra JB. Troglitazone. Is it all over? Neth J Med. 1999 Jul;55(1):4-12. [PubMed: 10431549]

14.

Knopman DS, Jones DT, Greicius MD. Failure to demonstrate efficacy of aducanumab: An analysis of the EMERGE and ENGAGE trials as reported by Biogen, December 2019. Alzheimers Dement. 2021 Apr;17(4):696-701. [PubMed: 33135381]

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Price LB, Lackey LG, Vailes R, Silbergeld E. The persistence of fluoroquinolone-resistant Campylobacter in poultry production. Environ Health Perspect. 2007 Jul;115(7):1035-9. [PMC free article: PMC1913601] [PubMed: 17637919]

16.

Trasande L, Shaffer RM, Sathyanarayana S., COUNCIL ON ENVIRONMENTAL HEALTH. Food Additives and Child Health. Pediatrics. 2018 Aug;142(2) [PMC free article: PMC6298598] [PubMed: 30037974]

17.

Wu F, Rodricks JV. Forty Years of Food Safety Risk Assessment: A History and Analysis. Risk Anal. 2020 Nov;40(S1):2218-2230. [PubMed: 33135225]

18.

Barkan ID. Industry invites regulation: the passage of the Pure Food and Drug Act of 1906. Am J Public Health. 1985 Jan;75(1):18-26. [PMC free article: PMC1646146] [PubMed: 3881052]

19.

Hall K, Stewart T, Chang J, Freeman MK. Characteristics of FDA drug recalls: A 30-month analysis. Am J Health Syst Pharm. 2016 Feb 15;73(4):235-40. [PubMed: 26843501]

20.

Getz KA, Stergiopoulos S, Kaitin KI. Evaluating the completeness and accuracy of MedWatch data. Am J Ther. 2014 Nov-Dec;21(6):442-6. [PubMed: 23011177]