The U.S. Food and Drug Administration has two roles related to its food jurisdiction: (1) ensure food safety and (2) protect against consumer fraud or deception. Over FDA’s 110-year history, the Agency’s focus has oscillated between these two areas. Since the early 2000s, FDA’s focus has largely been centered on food safety, especially as it applies to preventing and controlling for pathogenic bacteria like Salmonella, Listeria, and E. coli. This created the impression that FDA lost interest in food labeling, which has resulted in some companies paying less attention to label compliance.
However, over the last few years, we have seen FDA stressing the importance of food labeling. While we have not seen a massive seizure of product based on a labeling claim (such as former Commissioner David Kessler’s 1991 attack on “fresh” orange juice), FDA has issued several high-profile Warning Letters focused exclusively on food labeling. Such Warning Letters not only create burdens for companies as they work to resolve the issues with FDA, but also frequently result in consumer protection civil lawsuits from the class action plaintiff’s bar.
For imported food, food labeling errors can result in import refusals, a requirement to relabel products prior to FDA release, and FDA Import Alerts (resulting in automatic FDA detentions of all future imported shipments of the product). For both imported and domestic foods, labeling errors can result in product recalls; allergen labeling errors are not only a matter of label compliance but also of public safety, and can be very expensive to correct.
The easiest violation for FDA to find is a labeling violation. Because the agency is graded based on its enforcement actions, even small labeling violations can bring about some level of FDA interference. For food importers, the simplest, and even silliest labeling violation can result in significant delays, detentions, and increased costs.
It is critical for companies to continue to invest in label reviews to ensure compliance, as we expect FDA will continue to prioritize this matter. FDAImports.com has a team of former FDA-officials, regulatory specialists and attorneys ready to help companies comply with agency regulations. Contact us to find out more.
