How would you report a violation of your rights to the FDA?
Call FDA at 1-800-FDA-1088 to report by telephone. Reporting Form FDA 3500 commonly used by health professionals.
How do I contact FDA for recalls?
By phone:
- Call 1-888-INFO-FDA (1-888-463-6332 ).
- Call the FDA Consumer Complaint Coordinator for your state or region.
How do I report a company to the FDA?
Report a problem with FDA-regulated products
- Call 1-888-INFO-FDA (1-888-463-6332).
- Call the FDA Consumer Complaint Coordinator for your state or region.
What does the FDA do for consumers?
The FDA: Protecting Consumers and Patients The FDA is there to protect consumers and patients and ensure their safety by regulating and approving products, issuing recalls and safety notices, and alerting us to health scams and other health threats.
Why would you contact the FDA?
Consumers can play an important public health role by reporting to FDA any adverse reactions or other problems with products the agency regulates. FDA is responsible for ensuring that foods are safe, wholesome, and correctly labeled.
What counts as an adverse event?
• An adverse event (also referred to as an adverse. experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporarily associated with the use of a drug, without any judgment about causality or relationship to the drug.
Can I write to the FDA?
By law, anyone can participate in the rule-making process by commenting in writing. FDA routinely allows plenty of time for public input (typically 60 days) and carefully considers these comments when it draws up a final rule.
How do you petition the FDA?
Petitions can be sent electronicially to FDA via www.regulations.gov at http://www.regulations.gov/#!documentDetail;D=FDA-2013-S-0610-0001 or must be mailed or delivered to the Division of Dockets Management, Food and Drug Administration, Room 1061, 5630 Fishers Lane, Rockville, MD 20852.
Which of your consumer rights does the FDA protect?
The FDA protects the public from unsafe foods to drugs and from medical devices to cosmetics. It also protects the rights and safety of patients in clinical trials of new medical products and monitors the promotional activities of drug and device manufacturers.
What are some examples of consumer drug laws?
Laws passed Wheeler-Lea Act ensures that drugs are fairly advertised. Other Acts that protect consumers include the Fair Packaging and Labeling Act, the Anti-Tampering Act, and the Prescription Drug Marketing Act.
How do I send an email to the FDA?
During Normal Business Hours (8 a.m. – 4:30 p.m. ET, weekdays) For general questions, or if you are unsure of who to contact, contact the Patient Affairs Staff at 301-796-8460 or [email protected].
How do I make suggestions to the FDA?
The public can submit comments about the proposed regulation directly to the agency (through the mail or online at www.regulations.gov). On regulations.gov you can find, read, and comment on FDA draft guidances and other FDA related documents.
Who should pay for product recalls?
Consumer protection laws require manufacturers and suppliers to bear the costs of all product recalls and any associated costs. 7 Though insurance may cover a minimal amount to replace defective products, many product recalls result in lawsuits.
How do I contact the FDA in an emergency?
If you are experiencing a life-threatening medical emergency, call 9-1-1. To report an emergency involving food, drugs, medical devices, dietary supplements, or cosmetics, call 1-866-300-4374 or 1-301-796-8240. Call 1-888-INFO-FDA (1-888-463-6332).
How do I file a complaint with the FDA?
Call 1-888-INFO-FDA (1-888-463-6332). Call the FDA Consumer Complaint Coordinator for your state or region. MedWatch: Use the MedWatch Online Reporting Form to report adverse events with human food and medical products.
How do I contact the FDA public affairs department?
Contact FDA’s Office of Media Affairs. Call 301-796-3900. Search the HHS employee directory (includes FDA employees). Contact an FDA Public Affairs Specialist (FDA’s community-based educators in your region or state). View FDA’s proposed regulations and submit comments online (on Regulations.gov).
How do I submit a comment to the FDA?
Contact an FDA Public Affairs Specialist (FDA’s community-based educators in your region or state). View FDA’s proposed regulations and submit comments online (on Regulations.gov). How to comment on proposed regulations or submit petitions.