Views: 222 Author: Loretta Publish Time: 2026-02-09 Origin: Site
Content Menu
● What Is the FDA and Why It Matters
● Origins: Unsafe Products and Public Outrage
● The 1906 Pure Food and Drugs Act: Birth of Federal Regulation
● From Bureau of Chemistry to “Food and Drug Administration”
● Closing Loopholes: The Sherley Amendment and Early Court Battles
● The 1938 Food, Drug, and Cosmetic Act: A New Foundation
● Post War Expansion and Consumer Protection
● Medical Device Regulation and New Technologies
● Modern FDA: Scope, Resources, and Global Reach
● How the FDA Protects Consumers Today
● Packaging, Coding, and Carton Machinery in an FDA Regulated World
● How Hebei Ouye Carton Machinery Supports Compliance and Efficiency
● Practical Takeaways for Businesses and Manufacturers
● Clear Call to Action: Align Your Packaging Line With Regulatory Expectations
● Frequently Asked Questions (FAQ)
>> 1. When was the FDA officially created?
>> 2. What triggered the 1938 Food, Drug, and Cosmetic Act?
>> 3. How did the thalidomide crisis affect FDA regulations?
>> 4. Does the FDA regulate medical devices the same way as drugs?
>> 5. Why is FDA history important for today's manufacturers?
The history of the Food and Drug Administration (FDA) is the story of how the United States went from unregulated “snake oil” cures to one of the most powerful public health regulators in the world. Understanding how the FDA evolved helps explain why food, drugs, medical devices, and packaging systems are regulated the way they are today.
The United States Food and Drug Administration (FDA) is a federal agency responsible for protecting public health by overseeing the safety, effectiveness, and proper labeling of many everyday products. Its authority covers human and animal drugs, most foods, medical devices, vaccines and biologics, cosmetics, and certain radiation emitting products.
The FDA's modern functions trace back to the 1906 Pure Food and Drugs Act, which targeted misbranded and adulterated products. Today, FDA regulated products account for a significant share of the United States economy, reflecting the agency's huge impact on both public health and industry.
For global brands, manufacturers, and packaging equipment suppliers, this history is not just background information. It defines how food and drug products must be labeled, coded, and packaged, and it shapes the technical requirements that modern carton packaging machinery must help clients meet in export markets.
Before the FDA existed, the United States marketplace was flooded with adulterated food and fraudulent “patent medicines.” Manufacturers routinely used fillers, dyes, and unlisted drugs like morphine or alcohol, while labels promised miracle cures without any scientific evidence.
Key developments that set the stage for a federal regulator included:
- 1820: Creation of the United States Pharmacopeia, a standardized compendium of drugs.
- 1848: The Drug Importation Act required inspection of imported drugs to block adulterated products.
- Late 19th century: The Division of Chemistry in the U.S. Department of Agriculture, led by chemist Harvey Washington Wiley, began systematically studying food and drug adulteration.
Wiley's high profile experiments and publications showed the dangers of preservatives and adulterants, helping to build public pressure for national laws and a more coherent food and drug regulatory history.
The turning point came in 1906 with the Pure Food and Drugs Act, often called the “Wiley Act.” This landmark law marked the beginning of the modern history of the Food and Drug Administration and created the first comprehensive federal framework for food and drug safety.
The 1906 Pure Food and Drugs Act:
- Prohibited interstate commerce in misbranded or adulterated foods and drugs.
- Targeted deceptive practices, including the use of unsafe additives, fillers that reduced quality, and misleading labels.
- Laid the groundwork for the federal regulatory program that would evolve into the modern FDA.
On the same day, Congress also passed the Meat Inspection Act, responding to public outrage over filthy meat packing conditions. Together, these laws marked the start of a national commitment to food and drug safety rather than leaving everything to inconsistent state laws.
After 1906, the regulatory work remained within the Bureau of Chemistry, but its identity and mission evolved over several decades.
- 1906–1927: The Bureau of Chemistry enforced the Pure Food and Drugs Act, combining scientific analysis with enforcement.
- 1927: The regulatory functions were reorganized into the Food, Drug, and Insecticide Administration, while non regulatory research moved elsewhere.
- 1930: The name was shortened to the Food and Drug Administration, or FDA, a title it still holds today.
Even in this early period, enforcement challenges and court decisions revealed loopholes in the 1906 law, especially around false therapeutic claims and misleading advertising.
Soon after the Pure Food and Drugs Act took effect, companies and courts exposed its weaknesses.
- In 1911, in the case of United States v. Johnson, the Supreme Court ruled that the 1906 law did not prohibit false therapeutic claims, only misstatements about a drug's ingredients or identity.
- In response, Congress passed the Sherley Amendment in 1912, which prohibited intentional false therapeutic claims on drug labels.
This allowed the government to prosecute notorious products such as “soothing syrups” marketed for infants that contained dangerous ingredients and deceptive claims. However, proving “intent to deceive” remained difficult, showing the need for stronger and clearer legislation.
A major tragedy, the sulfanilamide disaster of 1937, involving a toxic drug formulation that caused many deaths, pushed Congress to overhaul the law. In 1938, President Franklin D. Roosevelt signed the Federal Food, Drug, and Cosmetic Act (FD&C Act), which remains the core legal foundation of FDA authority today.
The 1938 FD&C Act:
- Required pre market safety review for new drugs before they could be sold.
- Expanded FDA oversight to cosmetics and therapeutic devices.
- Authorized factory inspections and stronger enforcement tools.
- Banned false therapeutic claims without requiring proof of fraudulent intent.
- Set new standards for food safety and labeling.
This law transformed the FDA from a limited enforcement body into a proactive safety regulator with broad powers over product entry and marketing.
From the 1940s onward, rapid advances in pharmaceuticals and consumer products pushed the FDA into new territory and shaped the modern FDA regulatory history.
Important milestones included:
- 1951: The Durham Humphrey Amendment clarified which drugs required a prescription, defining the boundary between prescription and over the counter products.
- 1958: The first “generally recognized as safe” (GRAS) list helped structure food additive regulation.
- 1962: In the wake of the thalidomide birth defect crisis abroad, the Kefauver Harris Amendments required that new drugs be proven effective, not just safe, and strengthened clinical trial and informed consent standards.
- 1966: The Fair Packaging and Labeling Act and the Child Protection Act improved labeling clarity and banned hazardous toys.
These changes signaled a shift from simply removing dangerous products to actively shaping how products are tested, labeled, and prescribed.
Until the 1970s, medical devices were less tightly regulated than drugs, which led to several high profile safety crises. One of the most significant was the Dalkon Shield intrauterine device, which caused severe injuries and infections in the early 1970s.
Key developments in device regulation included:
- 1976: The Medical Device Amendments created a comprehensive framework for device classification, pre market review, and post market surveillance.
- 1980s–1990s: Additional laws refined device approval pathways, labeling, and quality system requirements.
During the same period, the FDA's responsibilities grew to include vaccines, blood products, biotechnology derived therapies, and radiation emitting products, reflecting advances in medical science and the ongoing evolution of FDA regulations.
By the late twentieth and early twenty first century, the FDA had become a multibillion dollar agency with thousands of employees, including chemists, pharmacologists, physicians, microbiologists, veterinarians, and lawyers.
Modern characteristics of the FDA include:
- A workforce spread across headquarters and numerous field offices and laboratories.
- Oversight of products that together represent a substantial part of the United States gross domestic product.
- Collaboration with international regulators and reliance on global supply chain oversight, especially for drugs and ingredients imported from abroad.
The agency now evaluates complex new drugs and biologics, high risk medical devices, food additives, animal drugs, and more, while also monitoring manufacturing, importation, and distribution.
To quickly understand FDA milestones, it is useful to see a concise timeline of major events.
| Year | Milestone in FDA History |
|---|---|
| 1906 | Pure Food and Drugs Act establishes federal regulation of misbranded and adulterated foods and drugs. |
| 1912 | Sherley Amendment bans intentional false therapeutic claims on drug labels. |
| 1938 | Federal Food, Drug, and Cosmetic Act mandates pre market safety review and extends FDA authority. |
| 1951 | Durham Humphrey Amendment defines prescription only drugs. |
| 1962 | Kefauver Harris Amendments require proof of drug effectiveness and stronger clinical trial standards. |
| 1976 | Medical Device Amendments create a modern device regulatory framework. |
| 1983 | Orphan Drug Act promotes drugs for rare diseases. |
This FDA milestones timeline shows how major crises and technological advances have repeatedly triggered new laws and expanded regulatory oversight.
The modern role of the FDA involves a mix of pre market review, post market surveillance, facility inspections, and risk communication.
Core functions include:
1. Pre market evaluation
- Reviewing New Drug Applications (NDAs) and Biologics License Applications (BLAs) for safety and effectiveness.
- Assessing medical devices through clearance or approval pathways, such as the 510(k) process or Premarket Approval (PMA).
2. Manufacturing and quality oversight
- Enforcing current Good Manufacturing Practice (cGMP) regulations for drugs, biologics, and certain foods.
- Inspecting domestic and foreign facilities to ensure compliance with FDA standards.
3. Labeling and marketing control
- Ensuring that labels are truthful, not misleading, and carry required warnings.
- Regulating promotional materials for prescription drugs and certain medical products.
4. Post market safety and recalls
- Monitoring adverse event reports and safety signals.
- Coordinating product recalls when risks are identified and ensuring effective communication to the public.
Through these tools, the FDA aims to reduce preventable harm while still allowing innovation in medicine and food technology.
For food, beverage, pharmaceutical, and nutraceutical brands, FDA history directly influences how products must be packaged, coded, and traced across the supply chain. Labeling rules, lot coding expectations, and traceability requirements mean that packaging lines must deliver accurate, consistent information on every carton, case, and pallet.
This is where modern intelligent carton packaging machinery becomes a strategic asset rather than just a piece of equipment. Automated systems that integrate feeding, printing, die cutting, folding, gluing, and online inspection help manufacturers:
- Apply clear, legible lot codes, dates, and regulatory statements on every box.
- Maintain high speed output while preventing misprints and mixed batches.
- Align with customer and retailer requirements in FDA regulated markets, especially in North America and Europe.
As a smart factory specializing in carton packaging machinery design and manufacturing, Hebei Ouye Carton Machinery Co., LTD. designs OEM solutions that support global brands and converters in meeting these compliance and quality targets on their packaging lines.
Our intelligent carton packaging machinery is engineered with the realities of FDA regulated supply chains in mind. For overseas brand owners, wholesalers, and manufacturers, this means equipment that is built not only for productivity, but also for stability, traceability, and integration with modern coding and inspection systems.
With advanced automated solutions, such as high speed corrugated carton production lines, die cutting and creasing equipment, folding and gluing systems, and downstream packaging automation, we help customers:
- Standardize carton dimensions and structural performance for food and pharmaceutical applications.
- Integrate inkjet or laser coding modules to print dates, batch numbers, and traceability data required by importers and retailers.
- Improve overall equipment effectiveness (OEE) and reduce waste caused by labeling or packaging errors.
Through OEM cooperation, we work closely with local integrators, distributors, and end users to customize machine configurations for specific product categories and regulatory expectations in their target markets.
For companies operating in food, drug, or device supply chains, the history of the FDA is more than an academic topic, because it directly shapes day to day compliance requirements.
Key lessons for regulated businesses include:
- The FDA's authority grew in response to past harms, so regulators are especially attentive to issues that resemble previous crises.
- Documentation, traceability, and robust quality systems are central, not optional, in modern FDA expectations.
- Clear labeling and honest marketing are critical to avoiding misbranding violations rooted in early twentieth century cases.
- Packaging and coding equipment must consistently support readable, accurate information to align with importer, retailer, and audit expectations.
By understanding how laws like the 1906 Act, the 1938 FD&C Act, and later amendments evolved, manufacturers can better anticipate regulatory focus areas and design stronger compliance strategies, including the selection of appropriate carton machinery and automated packaging solutions.
Understanding the history of the FDA is crucial for anyone working with regulated products, advising on compliance, or making decisions about food and health. If you manufacture, label, or distribute products that fall under FDA oversight, now is the time to review your processes in light of more than a century of evolving regulation.
Use this FDA milestones timeline and regulatory history as a framework to audit your labeling, quality systems, and packaging equipment, and identify gaps before they become enforcement issues. If you are ready to upgrade your corrugated carton production, improve coding accuracy, or design an OEM solution tailored to FDA regulated markets, contact Hebei Ouye Carton Machinery Co., LTD. to discuss how our intelligent carton packaging machinery can support your next project and help you deliver compliant, reliable packaging to your global customers.
Contact us to get more information!
The FDA's modern regulatory role began with the 1906 Pure Food and Drugs Act, but the name “Food and Drug Administration” was formally adopted in 1930. The agency's roots, however, reach back to the nineteenth century work of the Bureau of Chemistry.
The 1938 FD&C Act was passed after the sulfanilamide tragedy, in which a toxic drug formulation caused many deaths and exposed serious gaps in federal oversight. The law mandated pre market safety review and expanded the FDA's authority over drugs, foods, and cosmetics.
Although thalidomide never reached widespread use in the United States, the severe birth defects associated with the drug abroad led to the 1962 Kefauver Harris Amendments. These amendments required proof of drug effectiveness, strengthened clinical trial standards, and raised expectations for safety and monitoring.
The FDA does not regulate medical devices exactly the same way as drugs. Medical devices follow a distinct framework, especially after the 1976 Medical Device Amendments, which introduced device classes, different pre market review pathways, and tailored post market surveillance based on risk.
FDA history is important for manufacturers because current regulations are built on lessons learned from past crises and legal reforms. Knowing this background helps companies understand why requirements exist, how regulators evaluate risk, and how to design labeling, quality systems, packaging, and documentation that align with FDA expectations and the needs of international buyers.
1. https://www.fda.gov/about-fda/fda-history
2. https://www.fda.gov/about-fda/fda-history/milestones-us-food-and-drug-law
3. https://en.wikipedia.org/wiki/History_of_the_Food_and_Drug_Administration
4. https://www.emmainternational.com/the-history-of-the-food-and-drug-administration-fda/
5. https://www.fda.gov/medical-devices/overview-device-regulation/history-medical-device-regulation-oversight-united-states
6. https://www.fda.gov/about-fda/fda-history-exhibits/our-story-food-and-drug-administration
7. https://www.freshbyte.com/blog/fda-its-history-and-role
8. https://eh.net/encyclopedia/history-of-food-and-drug-regulation-in-the-united-states/
