Food and Drug Administration — Drug, Device & Food Safety

The Food and Drug Administration is the federal agency whose approval decisions determine whether Americans can access new drugs, medical devices, and biological products — and whose oversight failures have historically cost lives on a mass scale. A component of the Department of Health and Human Services (not an independent agency, despite its substantial operational autonomy), the FDA derives its core authority from the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA, 21 U.S.C. § 301 et seq.), enacted after 107 deaths caused by a sulfanilamide elixir dissolved in diethylene glycol. The FDA oversees approximately $2.8 trillion in consumer goods annually — roughly 20 cents of every dollar Americans spend — including prescription and over-the-counter drugs, biological products (vaccines, blood products, gene therapies), medical devices, food (excluding meat and poultry, which USDA/FSIS regulates), dietary supplements, cosmetics, tobacco products, and veterinary products. With approximately 18,000 employees and a budget exceeding $6 billion (partially user-fee funded through PDUFA and MDUFA agreements with industry), the FDA's approval decisions shape pharmaceutical markets worth hundreds of billions of dollars and affect the health of every American.

Legal Authority

• 21 U.S.C. § 301 et seq. — Federal Food, Drug, and Cosmetic Act of 1938 (FDCA): the primary statutory authority for all FDA regulatory activities; prohibits the introduction of adulterated or misbranded food, drugs, devices, or cosmetics into interstate commerce; authorizes FDA to inspect facilities, seize violating products, and seek injunctions
• 21 U.S.C. § 355 — New Drug Approval (NDA): requires that new drugs be shown safe and effective before marketing; authorizes FDA to approve or refuse marketing applications and to withdraw approvals when safety problems arise
• 42 U.S.C. § 262 — Public Health Service Act § 351 (biologics): requires biological products (vaccines, blood products, gene therapies) to be licensed before interstate distribution; grants FDA/CBER authority to inspect biologics manufacturers
• 21 U.S.C. § 360c et seq. — Medical Device Amendments of 1976: establishes the risk-based classification system for medical devices (Class I, II, III); authorizes FDA to require premarket clearance (510k) or approval (PMA) before device marketing
• 21 U.S.C. § 2201 et seq. — Food Safety Modernization Act (FSMA) of 2011: authorizes FDA to require written food safety plans, impose mandatory recall authority, and establish produce safety and supplier verification standards

Key Mechanics

FDA's regulatory authority varies by product type. For drugs, the central mechanism is premarket review: no prescription drug may be marketed without FDA approval of a New Drug Application (NDA) or Biologic License Application (BLA) demonstrating safety and efficacy through clinical trials. For devices, the mechanism depends on classification: Class I devices are subject to general controls (registration, good manufacturing practice) but mostly exempt from premarket review; Class II devices are typically cleared through 510(k) substantial equivalence review; Class III devices require the most rigorous Premarket Approval (PMA). For food, FDA regulates through FSMA's preventive controls framework — requiring written food safety plans but generally not approving food before marketing; the major exception is food additives and color additives (21 U.S.C. § 348), which require FDA approval. About 45% of FDA's budget comes from industry user fees (PDUFA for drugs, MDUFA for devices, GDUFA for generics) paid in exchange for review timeline commitments.

Organization & Structure

The FDA is organized into seven product-specific centers plus the Office of Regulatory Affairs (ORA) which conducts inspections. The Center for Drug Evaluation and Research (CDER) reviews prescription and OTC drugs; the Center for Biologics Evaluation and Research (CBER) reviews vaccines, blood products, and gene therapies; the Center for Devices and Radiological Health (CDRH) reviews medical devices; the Center for Food Safety and Applied Nutrition (CFSAN) regulates food and dietary supplements; the Center for Veterinary Medicine (CVM) regulates animal drugs; and the Center for Tobacco Products (CTP) regulates tobacco. The Commissioner reports to the HHS Secretary; unlike independent commissions (FTC, SEC), the FDA Commissioner is removable at will through the HHS Secretary and ultimately the President, making the FDA's regulatory direction fully subject to executive branch policy.

Key Functions & Authorities

Drug approval (New Drug Applications) — the FDA's drug approval process requires manufacturers to demonstrate safety and efficacy through clinical trials before a drug can be marketed in the United States (21 U.S.C. § 355). The standard pathway is the New Drug Application (NDA) or Biologic License Application (BLA): Phase I trials (safety in healthy volunteers), Phase II (efficacy signal and dosing in patients), Phase III (large randomized controlled trials vs. placebo or standard of care). The FDA reviews the trial data and can approve, reject, or require additional studies. The Prescription Drug User Fee Act (PDUFA, first enacted 1992, periodically reauthorized) requires drug companies to pay application fees that fund FDA review capacity in exchange for performance commitments (review timelines). Expedited pathways — Breakthrough Therapy Designation, Accelerated Approval, Fast Track, Priority Review — are available for serious conditions with unmet medical needs.

Generics and biosimilars — the Hatch-Waxman Act (1984) created the Abbreviated New Drug Application (ANDA) pathway allowing generic drug makers to prove bioequivalence to reference listed drugs without repeating full clinical trials. The Biologics Price Competition and Innovation Act (BPCIA, 2010, part of the ACA) created a similar "biosimilar" pathway for generic versions of biological products. Generic and biosimilar approvals are the FDA's primary tool for reducing drug prices after patent expiration; CDER approves hundreds of ANDAs annually.

Medical device regulation — the FDA regulates medical devices through a risk-based classification system (21 U.S.C. § 360c–360n). Class I (low risk, e.g., bandages): general controls, most exempt from premarket review. Class II (moderate risk, e.g., surgical gloves, X-ray systems): typically cleared through the 510(k) substantial equivalence pathway (showing the device is substantially equivalent to a legally marketed predicate device). Class III (high risk, life-sustaining, e.g., pacemakers, replacement heart valves): requires Premarket Approval (PMA), the most rigorous pathway requiring clinical data on safety and effectiveness. The 510(k) pathway — used for approximately 90% of devices that receive FDA marketing clearance — has been criticized for allowing devices to market without clinical data by citing equivalence to predicates.

Food safety — CFSAN regulates the food supply for approximately 80% of the U.S. food supply (USDA/FSIS covers meat, poultry, and processed egg products). The Food Safety Modernization Act (FSMA, 2011, 21 U.S.C. § 2201 et seq.) — the most significant food safety legislation since 1938 — shifted FDA's approach from responding to outbreaks to preventing them, requiring food facilities to have written food safety plans, foreign supplier verification programs, and enhanced produce safety standards. CFSAN also regulates dietary supplements under the Dietary Supplement Health and Education Act (DSHEA, 1994), which importantly does not require FDA premarket approval for supplements — a much-criticized gap that allows products to market without safety demonstrations.

Tobacco regulation — the Family Smoking Prevention and Tobacco Control Act of 2009 granted FDA authority to regulate tobacco products through the Center for Tobacco Products (21 U.S.C. § 387a). The FDA can restrict marketing, require nicotine disclosure, review new tobacco products (through Premarket Tobacco Product Applications, PMTAs), and issue product standards. The FDA proposed banning menthol cigarettes and flavored cigars in April 2022 but the Biden administration shelved the final rule in 2024; the regulation of e-cigarettes and nicotine pouches — new product categories with enormous revenue stakes — has generated extensive litigation.

Implementing Regulations

• 21 CFR Part 12 — Formal Evidentiary Public Hearing (45 sections, implementing 5 U.S.C. §§ 556–557 and 21 U.S.C. § 148): FDA's rules of practice for formal evidentiary public hearings — the most rigorous adjudicative proceeding in the FDA's procedural toolkit, used when a person has a statutory right to a hearing on a contested question of fact underlying an FDA regulation or order. Part 12 hearings are formal APA proceedings with full trial-type rights; they are the mechanism through which drug sponsors, food manufacturers, or device makers can contest FDA findings (e.g., challenging a drug withdrawal, disputing a food additive safety finding, or contesting a medical device ban) before an Administrative Law Judge:

  • § 12.1 — Scope: Part 12 applies when a person has a statutory right to a formal hearing under the FDCA, the Flammable Fabrics Act, or other statutes the FDA administers; it does not apply to informal public hearings (21 CFR Part 15) or to public advisory committee meetings (Part 14)
  • §§ 12.20–12.22 — Initiation: proceedings begin either on FDA's own initiative (when the Commissioner proposes to issue, amend, or revoke a regulation or order) or on a party's objection; a party who receives an adverse proposed rule or order may file written objections specifying the grounds for dispute and requesting a formal hearing; objections must be specific — vague or general objections are not entitled to a hearing; the Commissioner rules on whether the objections raise genuine issues of material fact warranting a formal hearing
  • § 12.24 — Ruling on objections: the Commissioner reviews all timely objections and determines which (if any) raise genuine issues of material fact; if no objection raises such an issue, the Commissioner may proceed without a formal hearing; the ruling on objections is the critical gatekeeping step — parties who successfully show a material factual dispute earn the right to a Part 12 hearing; parties whose objections are denied must seek review in federal court
  • § 12.120 — Initial decision: after the hearing, the Presiding Officer issues an Initial Decision containing findings of fact, conclusions of law, and a recommended disposition; the Presiding Officer's credibility determinations on witness testimony receive deference on appeal
  • §§ 12.125–12.130 — Appeals: any participant may appeal the Initial Decision to the Commissioner of Food and Drugs within a specified period; the Commissioner's decision on appeal constitutes final agency action; the Commissioner may adopt, modify, or reverse the Initial Decision, but must provide reasons for departing from the Presiding Officer's findings
  • § 12.140 — Judicial review: the Commissioner's final decision is subject to review in the U.S. Court of Appeals under the APA's substantial evidence standard for formal adjudications (5 U.S.C. § 706(2)(E)); parties challenging FDA drug or device decisions typically file in the D.C. Circuit or the circuit where they are headquartered

  Part 12 formal hearings are rare in modern FDA practice — most contested FDA decisions are challenged through informal rulemaking objections (Part 10 petitions) and then federal court, bypassing the formal adjudicatory route. The formal hearing mechanism matters most in contexts where Congress expressly mandated it: drug withdrawal proceedings under 21 U.S.C. § 355(e), color additive listing proceedings, and a few other statutory contexts. Recent rulemakings: Part 12 has not been substantially amended recently; the FDA's practice guidance emphasizes that formal hearings are not routinely available — objectors must affirmatively demonstrate that a genuine material factual dispute exists before a hearing is granted.

• 21 CFR Part 14 — Public Hearing Before a Public Advisory Committee (43 sections — the procedures governing how FDA's scientific advisory committees operate, deliberate, and issue recommendations on drugs, biologics, devices, food ingredients, and other FDA-regulated products; Part 14 implements the Federal Advisory Committee Act (FACA) within the FDA's specific regulatory context; advisory committee votes and recommendations are not binding on FDA but as a practical matter strongly influence approval and regulatory decisions):

  • § 14.1 — Scope: Part 14 applies when the FDA Commissioner decides to refer a matter to an advisory committee, when a statute requires advisory committee review, or when any interested person requests committee review of a specific matter; for human prescription drugs, the process under §§ 14.171–14.174 allows manufacturers and patients to request that FDA convene the relevant drug advisory committee before making a final approval, withdrawal, or labeling decision
  • § 14.20 — Notice of hearing: the Commissioner must publish a Federal Register notice at least 15 days before each advisory committee meeting; the notice must identify the committee, describe the product or issue under review, indicate whether the meeting or any portion is open to the public, and explain how to submit written comments; the 15-day minimum provides the public with formal advance notice of significant regulatory deliberations
  • § 14.22 — Committee meetings: meetings may be conducted only with the Commissioner's advance approval; meetings must comply with FACA's open meeting requirements unless the Commissioner determines that some portion must be closed (typically to discuss confidential commercial or trade secret information submitted by the sponsor); closed session determinations must be announced in the Federal Register notice along with the basis for closure
  • § 14.100 — List of standing advisory committees: FDA's standing committees include separate panels for each major therapeutic area (Cardiovascular and Renal Drugs, Oncologic Drugs, Anesthetic and Analgesic Drug Products, Peripheral and Central Nervous System Drugs, Anti-Infective Drugs, Dermatologic and Ophthalmic Drugs, Reproductive Health Drugs, and others); each committee has its own roster of outside experts who serve as special government employees; the list is published and updated in the Federal Register
  • §§ 14.140–14.155 — Color additive advisory committees: a specialized committee type established by statute (21 U.S.C. § 379e) that reviews the safety and appropriateness of color additives proposed for use in food, drugs, or cosmetics; petitioners requesting color additive listing may pay a fee that partially offsets committee review costs; the committee's report becomes part of the rulemaking record for the color additive regulation
  • §§ 14.160–14.174 — Standing drug advisory committees: for human prescription drugs, FDA has established therapeutic-area-specific advisory panels; when an NDA, BLA, or supplemental application raises significant safety or efficacy questions, FDA may convene the relevant panel to review the clinical data and vote on questions the Commissioner poses (e.g., "Does the clinical trial data demonstrate substantial evidence of effectiveness for this indication?"); advisory committee votes are highly publicized and directly influence FDA's final action — a negative committee vote does not automatically require rejection, but overriding a negative vote requires FDA to document its reasoning; manufacturers routinely strategize about whether requesting a committee meeting will help or hurt their application
  • § 14.171 — FDA-initiated committee referral: FDA may refer any matter to an advisory committee on its own initiative; for controversial approvals, novel mechanisms of action, or situations where the clinical evidence is ambiguous, FDA increasingly uses advisory committees as a risk-management tool — the committee's public deliberation provides a check on FDA's internal review and builds public confidence in the agency's scientific judgment
  • § 14.172 — Industry and public requests: any interested person may formally request that FDA convene an advisory committee on a specific drug, device, or regulatory issue; the Commissioner has broad discretion to grant or deny such requests; successful requests typically demonstrate a genuine scientific controversy or an issue of significant public health importance that would benefit from independent expert review

  FDA operates approximately 50 standing advisory committees across its centers (CDER, CBER, CDRH, CFSAN, CVM). Committee members — typically academic physicians, biostatisticians, pharmacologists, and patient/consumer representatives — are screened for conflicts of interest; industry representatives may participate as non-voting members or during specific sessions. The transparency these meetings provide is significant: clinical trial data, safety signals, and internal FDA review memos are made public in advisory committee briefing documents posted days before the meeting, giving patients, investors, and competitors unprecedented access to regulatory deliberations before a final decision. Recent rulemakings: 78 FR 17087 (March 2013) — updated conflict-of-interest waiver procedures for advisory committee members; the FDA has not substantially amended Part 14's core procedures but has issued extensive guidance on meeting management and virtual participation formats following the COVID-19 pandemic.

• 21 CFR Part 17 — Civil Money Penalties Hearings (34 sections): FDA's rules of practice for proceedings in which the agency seeks civil monetary penalties against individuals and entities for violations of statutes the FDA administers — including the FDCA, Fair Packaging and Labeling Act, and Flammable Fabrics Act. Part 17 hearings are conducted before an Administrative Law Judge rather than a federal court; they allow respondents to contest penalty amounts and underlying violations. Key procedural features: the FDA complaints must specify the statutory basis and factual allegations (§ 17.5); respondents may file answers and assert affirmative defenses (§ 17.9); hearings follow APA-consistent procedures with the right to present witnesses and documentary evidence; ALJ decisions are subject to appeal to the Commissioner and then to federal court under the substantial evidence standard. Part 17 is the primary enforcement mechanism for FDA civil penalties — its procedures are distinct from the formal evidentiary hearings under Part 12 (which address regulatory disputes) and from criminal referrals to DOJ.

How It Affects You

If you are a citizen or voter: Every prescription drug, vaccine, medical device, and packaged food you use has passed through FDA review or is subject to FDA oversight. FDA approval decisions determine drug access and pricing timelines; accelerated approvals for cancer drugs have given patients earlier access to treatments that later proved less effective than hoped. Food recalls, drug safety warnings, and device malfunctions are all communicated through FDA's MedWatch and recall systems.

If you are a business or regulated entity: Pharmaceutical companies navigating FDA approval face a 10–15 year, $2+ billion average drug development timeline (including failures) before a drug can reach market. The PDUFA user fee agreements set performance timelines that FDA must meet; missing them creates liability and congressional attention. Medical device companies must navigate 510(k) vs. PMA decisions that determine time to market by years. Food manufacturers must comply with FSMA's preventive controls requirements, foreign supplier verification, and labeling regulations that CFSAN enforces through ORA inspections.

If you work at a federal agency: FDA coordinates closely with NIH (which funds pre-clinical and clinical research that FDA later reviews); with CDC (which tracks safety signals for vaccines and drugs post-approval through VAERS and other systems); with USDA/FSIS (split food safety jurisdiction — FDA/FSIS coordination on combination products); with FTC (on health claims advertising); and with CMS (on Medicare/Medicaid coverage decisions for newly approved drugs and devices).

If you are a journalist, researcher, or policy analyst: FDA's Drugs@FDA database provides the complete approval history for all FDA-approved drugs, including clinical review documents and labeling. The FDA's MAUDE database tracks medical device adverse events. FDA warning letters, import alerts, and enforcement actions are published on the FDA website. Clinical trial data submitted to FDA is partially accessible through the FDA's Drug Trial Snapshots. The FDA Adverse Event Reporting System (FAERS) tracks post-market drug safety signals.

Recent Developments

• 2025 — HHS Secretary Robert F. Kennedy Jr. and DOGE-aligned officials undertook significant FDA restructuring: reducing CDER staffing, placing senior reviewers on administrative leave, questioning the FDA's GRAS (generally recognized as safe) determination process for food additives, and initiating reviews of FSMA implementation; food industry, pharmaceutical companies, and public health groups raised concerns about reduced review capacity and approval timelines.
• 2024 — The FDA's Accelerated Approval pathway faced congressional scrutiny after studies showed that several oncology drugs approved through Accelerated Approval (based on surrogate endpoints) showed no survival benefit in confirmatory trials; Congress enacted reforms in the Omnibus requiring faster completion of confirmatory trials and clearer withdrawal timelines for drugs that fail confirmation.
• 2023 — The FDA approved Leqembi (lecanemab) and Kisunla (donanemab) for Alzheimer's disease under traditional approval (following Accelerated Approval), the first treatments showing modest slowing of disease progression; CMS's coverage decision (initially restricting coverage to clinical trial participants) generated significant controversy about the FDA/CMS interplay in drug access.
• 2022 — The FDA proposed rules banning menthol cigarettes and flavored cigars under the Tobacco Control Act; the Biden administration delayed and ultimately shelved the final rules in 2024 amid political concerns about enforcement and electoral impact; the proposed rules were not finalized before the change in administrations and the Trump FDA is unlikely to revive them.
• 2011 — The Food Safety Modernization Act (FSMA) was enacted after a series of high-profile foodborne illness outbreaks (Salmonella in peanuts, E. coli in spinach); FSMA shifted FDA from reactive to preventive food safety, added mandatory recall authority, and required foreign food facilities exporting to the U.S. to meet U.S. safety standards.