As part of the FDA’s new Human Foods Program reorganization, which went into effect Oct. 1, the agency has announced a streamlined approach for processing consumer complaints.
The process includes steps to handle whistleblower complaints in addition to consumer complaints. Whistleblower complaints came to the forefront in 2022 when a complaint regarding problems at an Abbott Laboratories infant formula production plant was mishandled, causing a delay in FDA action amid an outbreak of Cronobacter infections in babies. That outbreak caused a massive recall of infant formula, resulting in nationwide shortages.
The Food and Drug Administration’s updated process is a “streamlined approach for processing complaints, including whistleblower complaints, that will improve the agency’s ability to detect and respond to problems related to FDA-regulated products and better protect public health,” according to an agency announcement.
“A complaint may be about an illness, injury, allergic reaction, or other health-related issue or defects in the quality or safety of an FDA-regulated food, dietary supplement, or cosmetic product. Now, the public can direct complaints about foods and dietary supplements to HFP (Human Foods Program) by using our online reporting forms.”
Consumers can use the Foods and Dietary Supplements complaint forms at the Safety Reporting Portal. The link to these forms and more information about submitting questions or complaints about FDA-regulated products can be found on the Industry and Consumer Assistance from HFP webpage.
There is also a phone option for consumer complaints, which has also been streamlined.
Previously, complaints were directed to dozens of Consumer Complaint Coordinators (CCCs) in the FDA’s Office of Regulatory Affairs (ORA). As of Oct. 1, the phone numbers associated with the CCCs will no longer be in service. Instead, consumers will be able to call 1-888-SAFEFOOD to submit complaints about foods and dietary supplements.
The Human Foods Program will now receive, triage, and evaluate complaints, and the new Office of Inspections and Investigations, formerly ORA, will follow up with firms as needed. This streamlined process is designed to expedite the delivery of inquiries and complaints to the appropriate public health experts at the FDA and allow for more consistent processing and earlier detection of potential public health problems.
The FDA announcement says the change in the complaint process is part of a larger reorganization of the agency. It impacts more than 8,000 employees involved in every facet of FDA-regulated foods.
“Establishment of the Human Foods Program with a new streamlined process for consumer complaints and inquiries will allow the FDA to more effectively interface with consumers to learn new and valuable information about FDA-regulated products. It will also help the FDA deliver on its mission to protect and promote public health through science-based approaches to prevent foodborne illness, reduce diet-related chronic disease, and ensure the safety of chemicals in food,” the agency announcement stated.
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