How To Contact FDA About Bad Food-Drugs-Cosmetics-Pet Food
Posted Oct 22 2008 4:37pm
With the latest tomato salmonella outbreaks and many other food-drug-pet food recalls this year I wanted to share information on how to contact the FDA.
Tips for Reporting 1. Report what happened as soon as possible after you discover a problem. Be prepared with the following information:
names, addresses, and phone numbers of people affected your name, postal and e-mail address, and phone number name, address, and phone number of doctor or hospital if emergency treatment was provided product codes or identifying marks on the label or container name and address of store where product was bought and date of purchase name and address of company on the product label
2. Do not discard the product packaging and labeling. They provide codes, numbers, and dates that will help FDA trace the product back to the plant.
3. In addition to reporting to FDA, the agency recommends reporting the problem to the manufacturer and to the store where the product was purchased.
4. When in doubt about how to report a problem, call your local FDA Consumer Complaint Coordinator listed at www.fda.gov/opacom/backgrounders/complain.html.
If you have a complaint about a product regulated by the Food and Drug Administration (FDA), the agency wants to hear about it.
FDA offers a number of ways to report a complaint. Two of the main reporting systems available to consumers are the Consumer Complaint Reporting system and MedWatch.
1. Consumer Complaint Reporting FDA's Consumer Complaint Coordinators (CCC's) located in FDA offices throughout the United States and Puerto Rico will listen, document your complaint about an FDA-regulated product, and follow up as necessary. Consumers should report problems to the CCC for their geographic region. (See the accompanying list of CCC's. The list is also on FDA's Web site at www.fda.gov/opacom/backgrounders/complain.html.)
Some examples of complaints that your CCC wants to hear about are food-related illnesses, especially when a specific food is suspected allergic reactions when a person has a known allergy to a food ingredient not identified on the product label problems related to infant formula problems related to baby food swollen or leaking canned goods suspected product tampering adverse events after taking dietary supplements problems related to prescription or over-the-counter medications problems related to pet food and treats
Reporting Problems Can Spur Action If a person reports an illness or injury that appears likely to be caused by an FDA-regulated product, FDA acts immediately. Depending on the seriousness of the problem, an FDA investigator may visit the person who made the complaint, collect product samples, and initiate inspections.
"Just a few complaints can make a difference," says Joan Trankle, FDA's National CCC. For example:
CCC's in different parts of the country received three reports of allergic reactions to a type of soymilk. FDA followed up with an inspection of the soymilk company. The product did not declare the allergenic substance, milk protein, on the label, and the company recalled the product.
CCC's received two complaints in one week about skin burns after use of an adhesive patch that generates heat to relieve muscle and joint pain. "When that second complaint arrived, we sprang into action," says Trankle. "We contacted the firm and, based on our follow-up, the firm recalled the product."
Complaints of a less serious nature, or those that appear to be isolated incidents, are monitored and the information is used during a future inspection of a company to help FDA identify problem areas in a production plant. The complaints are also discussed with company management during these inspections.