The FDA takes several measures to make sure that consumers are protected from ingredients and foods they may be allergic to. These include establishing regulatory requirements, providing industry guidance, conducting surveillance, and taking regulatory actions when appropriate.
Guidance Documents and FDA Regulations
The FDA issues guidance documents to provide industry with its current thinking about various issues. Many FDA guidance documents contain information about allergens. Certain food safety regulations also contain provisions related to allergens and other ingredients that may cause sensitivities.
Inspections
The FDA’s “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” rule (CGMP & PC rule, 21 CFR part 117) establishes requirements applicable to establishments that manufacture, process, pack, or hold human food. The CGMP & PC rule includes requirements for allergen preventive controls to prevent allergen cross-contact in manufacturing and packaging and to prevent undeclared allergens. For example, the FDA requires facilities to put written procedures in place to control allergen cross-contact between products that contain allergens and those that are not supposed to contain them and to ensure that the products are accurately labeled with respect to allergens. The FDA inspects food manufacturers according to the applicable requirements of 21 CFR part 117 to determine whether allergen cross-contact has been minimized or prevented and whether a food facility has appropriate controls for allergen labeling.
Monitoring
The FDA monitors reports of food allergic reactions and reports related to ingredients and food hypersensitivities (including gluten) that come into the FDA Consumer Complaint System. The FDA looks at every complaint to determine the appropriate course of action. Based on an evaluation of the potential safety concern, the FDA may take regulatory action(s) to improve product safety and protect the public health, communicate new safety information to the public, or, in certain cases, remove a product from the market.
The FDA also receives reports from industry regarding undeclared allergens through the Reportable Food Registry (RFR). For example, from September 2009 to September 2014, about one-third of foods reported to the FDA through the RFR as serious health risks involved undeclared allergens. Of the major food allergens, milk represents the most common cause of recalls due to undeclared allergens. The five food types most often involved in food allergen recalls were bakery products, snack foods, candy, dairy products, and dressings (such as salad dressings, sauces, and gravies). Within the candy category, the FDA has received many reports of undeclared milk in dark chocolate products, highlighting this food type as a higher risk product for consumers allergic to milk.
Testing
The FDA conducts periodic surveys and sampling assignments to gather information about specific foods. For example, in 2013 and 2014, the FDA conducted a survey to estimate the prevalence of undeclared milk allergen in dark chocolate products. A second survey of samples collected in 2018 and 2019 was conducted to understand the extent to which dark chocolate bars and dark chocolate chips labeled as “dairy free” contained levels of milk that would be potentially hazardous to consumers with milk allergies. In 2015 and 2016, the FDA conducted sampling of a variety of foods to determine compliance with “gluten-free” labeling requirements.
To test for allergens in foods, the FDA uses enzyme-linked immunosorbent assay (ELISA) testing, through which antibodies attach to various allergens. The FDA tests food samples using two different types of ELISA kits before confirming the results. Other allergen testing methodologies include the DNA-based polymerase chain reaction and mass spectrometry. The FDA has developed the xMAP food allergen detection assay that can simultaneously detect 16 allergens, including sesame, in a single analysis, with a design that allows for expansion to target additional food allergens. These advances will enhance FDA’s ability to monitor the food supply for undeclared allergens and take action when they are found.
Regulatory Action
The FDA can carry out a number of regulatory actions if a food label lacks required allergen information for a food ingredient, if a food product is found to inadvertently contain a food allergen due to cross-contact, or if a food product does not qualify to be labeled as “gluten-free.” The FDA considers such products misbranded or adulterated, depending on the circ*mstances, and subject to enforcement actions such as recalls, import refusal, and seizure. The agency may also issue warning letters to facilities making such foods, or may place foods imported from other countries on import alert for these violations. When there is a problem that justifies a recall, firms generally recall such food products from the marketplace voluntarily. Consumers can learn what products have been recalled recently on the FDA's website, or by signing up to receive Recalls, Market Withdrawals and Safety Alerts emails.
