What is the FDA and What Does It Do?

Introduction to the FDA

The Food and Drug Administration (FDA) is a pivotal agency of the U.S. federal government that regulates a wide range of consumer products—including foods, pharmaceuticals, cosmetics, biologics, veterinary products, and medical devices. With over 18,000 full-time employees operating across all 50 states and globally, the FDA ensures safety, efficacy, and quality through science-based regulation.

For more than 100 years, the FDA has been advancing and protecting public health, working closely with food industry consultants, pharmaceutical firms, and medical researchers.

What the FDA Regulates

To ensure safety and quality, the FDA oversees:

Human food and beverages
Tobacco products
Dietary supplements
Prescription and OTC drugs
Vaccines and biopharmaceuticals
Blood transfusions
Medical devices
Radiation-emitting products
Cosmetics
Animal feed and veterinary medicines

The FDA primarily enforces the Federal Food, Drug, and Cosmetic Act (FD&C Act), along with the Public Health Service Act, among other federal laws.

Organizational structure

The FDA operates under the U.S. Department of Health and Human Services. The Commissioner of Food and Drugs, appointed by the President with Senate approval, leads the agency. As of February 17, 2022, the Commissioner is Dr. Robert Califf.

History

1906: The Pure Food and Drug Act signed by President Theodore Roosevelt laid the foundation for food and drug safety.
1938: The FD&C Act greatly expanded regulatory authority over drugs.
1962: The Kefauver-Harris Amendment introduced modern FDA approval standards.
1984: The Drug Price Competition and Patent Term Restoration Act helped shape today’s generic drug market.
1987: Phase II of the FDA Action Plan expedited AIDS drug approvals.
1990s–2000s: States attempted to allow unapproved drugs; the FDA enforced federal authority.

These regulatory milestones underscore the FDA's role in ensuring food safety, pharmaceutical integrity, and consumer protection.

Funding

As of 2021, the FDA regulated an estimated $2.7 trillion worth of food, drug, and tobacco products. Its funding is split:

54% from federal government
46% from industry user fees (e.g., pharmaceutical companies pay to expedite drug reviews)

This public-private funding balance helps sustain regulatory functions while accelerating innovation.

Regulatory programs

a. Emergency Use Authorization (EUA)

Enables rapid approval of vaccines, diagnostics, and PPE during emergencies like COVID-19, Ebola, or Zika.

b. Drug & Cosmetic Regulation

Drugs: Complete oversight—from development to marketing.
Cosmetics: Focused on safety and labeling.

c. Medical Countermeasures (MCMs)

Regulates biologics and pharmaceuticals for public safety during chemical, radiological, or biological threats.

d. Innovative Medical Devices

Example: FDA-approved medical maggots for wound therapy—a first of its kind.

e. Global Collaboration

Operation Pangea XI (2018) with Interpol tackled illegal online pharmaceutical sales worldwide.

6. Science and research programs

The FDA conducts research and development across fields like:

Food safety and applied nutrition
Pharmaceuticals
Medical devices
Toxicology
Women’s health
Veterinary science

These programs ensure that food technology consultants and industry regulators stay aligned with modern science and compliance standards.

Criticism

The FDA’s broad regulatory powers also attract scrutiny:

a. Institute of Medicine Report (2006)

A $1.8M investigation highlighted shortcomings in drug safety regulations, urging:

More independence
Greater funding
Expanded regulatory authority

b. COVID-19 Hand Sanitizer Penalties

Small distilleries faced heavy fines for making hand sanitizers during shortages, sparking backlash.

These issues highlight the ongoing debate over the FDA’s reach, responsiveness, and regulatory

Conclusion

The FDA is instrumental in regulating food and health-related products to ensure safety and efficacy. With fast-evolving technologies, the agency must continuously adapt to emerging challenges in public health, food manufacturing, and pharmaceutical development.

For food processing consultants and engineering firms in the food sector, understanding the FDA's structure and influence is crucial for compliance, innovation, and growth in global markets.

Reference

Wikipedia – FDA

FDA.gov – Regulatory Science Plan

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