Contact

Reaching the appropriate FDA office or program area requires knowing which regulatory function handles a specific inquiry — whether that involves drug approvals, food safety enforcement, medical device submissions, or adverse event reporting. This page outlines how to direct inquiries to the U.S. Food and Drug Administration, what information to prepare before reaching out, and which channels serve different types of requests. Matching the inquiry to the correct FDA center or office reduces response time and avoids misdirection across the agency's 9 primary centers and offices.

Additional contact options

The FDA operates multiple parallel contact channels depending on the nature and urgency of the inquiry. The primary public-facing resource is the FDA main information line, which routes callers based on product category and inquiry type. For written correspondence, the agency maintains formal dockets through the Federal Dockets Management System (FDMS), accessible at regulations.gov, where public comments on proposed rules and guidance documents are submitted.

For product-specific regulatory questions, the FDA's center-level contact points include:

1. Center for Drug Evaluation and Research (CDER) — drug approvals, labeling, compounding, and shortage inquiries
2. Center for Biologics Evaluation and Research (CBER) — vaccines, blood products, and biologics licensing
3. Center for Devices and Radiological Health (CDRH) — 510(k) clearance, premarket approval, and device recalls
4. Center for Food Safety and Applied Nutrition (CFSAN) — food labeling, dietary supplements, and GRAS determinations
5. Center for Veterinary Medicine (CVM) — animal drug approvals and veterinary device oversight
6. Center for Tobacco Products (CTP) — tobacco product regulation and enforcement

MedWatch, the FDA's safety reporting portal at fda.gov/safety/medwatch, handles adverse event submissions from both healthcare professionals and consumers. Import-related detentions and admissibility questions route to the Office of Regulatory Affairs (ORA), which oversees the agency's field operations across 5 regional offices and 13 district offices nationwide.

How to reach this office

FDA Main Line: 1-888-INFO-FDA (1-888-463-6332), available Monday through Friday during standard business hours Eastern Time.

Mailing address for general correspondence:
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

Online inquiries can be submitted through the FDA's contact portal at fda.gov/contact-fda, which routes messages by product type and subject category. Regulatory submissions — including Investigational New Drug applications, New Drug Applications, and 510(k) premarket notifications — are not submitted through general contact channels; those follow formal submission pathways detailed in the FDA Drug Approval Process, FDA New Drug Application, and FDA 510(k) Clearance Process pages.

Media inquiries are handled by the FDA Office of Media Affairs, reachable at 301-796-4540. Congressional correspondence routes through the Office of Legislation.

Service area covered

The FDA holds regulatory jurisdiction over products that account for approximately 20 cents of every dollar spent by U.S. consumers (FDA, "What We Do"), spanning human drugs, biologics, medical devices, food and dietary supplements, cosmetics, tobacco products, and veterinary medicines sold or distributed within the United States.

Geographically, FDA authority extends to:

• Domestic manufacturers and distributors operating in all 50 states, the District of Columbia, and U.S. territories
• Foreign manufacturers who export FDA-regulated products into the United States, subject to import admissibility review under 21 CFR Part 1
• Clinical trial sites conducting studies under an Investigational New Drug (IND) application, regardless of country of operation

The distinction between FDA jurisdiction and state-level authority matters for certain product categories. Compounding pharmacies, for instance, face overlapping oversight from both FDA and state boards of pharmacy — a division addressed in depth on the FDA Compounding Pharmacy Oversight page. Similarly, pesticide residues on food fall under a shared framework between FDA and the U.S. Environmental Protection Agency.

What to include in your message

Providing complete information at first contact reduces the number of follow-up exchanges required and ensures the inquiry reaches the correct regulatory unit without rerouting delays.

For product safety concerns or adverse event reports, include:

1. The product's name, lot number, and manufacturer as printed on the label
2. A description of the adverse event or safety concern, including date of occurrence
3. The patient's age and sex (no full name required for consumer reports)
4. The reporter's name and contact information (kept confidential under 21 U.S.C. § 399d)
5. Any relevant medical records or laboratory results, if available

For regulatory or compliance inquiries, include:

1. The product category and applicable regulatory pathway (e.g., 510(k), NDA, FSVP)
2. The specific regulation, guidance document, or CFR citation at issue
3. Company name, registration number if applicable, and facility location
4. A concise statement of the question or the regulatory determination being sought

For FOIA requests, submissions must identify the records sought with reasonable specificity and be directed to the FDA's FOIA office at foia.fda.gov. The FDA processed 9,665 FOIA requests in fiscal year 2022 (FDA FOIA Annual Report, FY2022), and specificity in the request description directly affects processing time.

General public inquiries that do not involve an active safety concern, a pending submission, or a FOIA request are typically addressed through FDA's consumer information resources, including the FDA Frequently Asked Questions page, before a direct agency contact is required.

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