[Added April 2006] Does the FDA intend to issue additional guidance to retail and foodservice establishments on the proper management of food allergens? If you or a family member has had an allergic reaction after eating an FDA-regulated food or a food product with unclear labeling or a possible allergen, discuss it with your doctor. Keep all food packaging as it may contain important information. You can contact the manufacturer. The Food Allergen Labelling and Consumer Protection Act 2004 (FALCPA) (Public Law 108-282) was enacted in August 2004 and deals, inter alia, with the labelling of foods containing certain food allergens. FDA guidelines, including this document, do not establish legally enforceable liabilities. Rather, guidance documents describe the Agency`s current thinking on a topic and should only be considered as recommendations, unless specific regulatory or legal requirements are identified. The use of this word in agency guidelines should mean that something is proposed or recommended, but not necessary. Yes. A food product containing an undeclared allergen may be subject to a recall. In addition, a food that is not properly labelled may be mislabelled and seized and withdrawn from the market.
Indeed, a federal law, the Food Allergen Labeling and Consumer Protection Act of 2004, requires that the labels of most packaged foods marketed in the United States disclose – in easy-to-understand terms – whether they are made with a “significant food allergen.” The first option for food manufacturers is to include the name of the food source in parentheses after the common or common name of the main food allergen in the list of ingredients, if the name of the food source of the main allergen does not appear elsewhere in the ingredient claim. For example: FALCPA requirements only apply to foods regulated by the Food and Drug Administration under the FFD&C Act. We recommend that manufacturers of USDA-regulated meat products, poultry products, and egg products contact the appropriate USDA agency regarding the labeling of these products. All packaged foods regulated under the Federal Food, Drug and Cosmetic Act (FFD&C Act) and labelled on or after January 1, 2006 must comply with FALCPA food allergen labelling requirements. [October 2006 added] Section 403(w)(1) requires that a major food allergen be declared using the name of the food source from which the primary food allergen originates. Section 403(w)(2) provides that, in the case of fish or crustaceans, the term “name of the food source from which the main food allergen originates” means the “species” of fish or crustaceans. What are fish or crustacean “species” as defined in Article 403(w)(2)? If the application or notice is approved by the Secretary, the ingredient in question is not considered a “major food allergen” and is not subject to labelling requirements. Food allergies are a complex public health problem that affects millions of Americans and their families. To protect consumers with food allergies, the U.S.
Food and Drug Administration (FDA) enforces a law requiring the list of ingredients used in packaged food products so that consumers can find ingredients in a food to which they are allergic or sensitive. In addition, foods or ingredients from important food allergens must be clearly listed according to their origin on the label of packaged foods – for example, “flour (wheat)”. The FDA`s current Good Manufacturing Practices, Risk Analysis, and Preventive Controls Based on Human Food Risks (CGMP & PC Rule, 21 CFR part 117) establish requirements that apply to facilities that produce, process, package, or hold human food. The CGMP and PC rules include requirements for allergen prevention controls to prevent cross-contact with allergens during manufacturing and packaging and to prevent undeclared allergens. For example, the FDA requires establishments to establish written procedures to control the cross-contact of allergens between products that contain allergens and those that are not intended to contain allergens, and to ensure that products are accurately labeled for allergens. The FDA audits food manufacturers against the applicable requirements of Part 117 of 21 CFR to determine whether cross-contact with allergens has been minimized or avoided and whether a food facility has appropriate controls in place for allergen labeling. Q: “Information as power” around food allergens seems to be a motivating force for you. Can you tell us what attracted you to this scientific field? To help U.S. consumers avoid the health risks posed by food allergens, the FDA administers the Food Allergen Labeling and Consumer Protection Act of 2004 (the Act). The law applies to the labeling of foods regulated by the FDA, including all foods except poultry, catfish, most meats, certain egg products, and most alcoholic beverages regulated by other federal agencies. The law requires food labels to uniquely identify the food source names of all ingredients that are one of the major food allergens or that contain proteins derived from a major food allergen.
The FDA conducts regular investigations and sampling to gather information on certain foods. For example, the FDA conducted a survey in 2013 and 2014 to estimate the prevalence of undeclared milk allergens in dark chocolate products. A second survey of samples taken in 2018 and 2019 was conducted to understand the extent to which dark chocolate bars and dark chocolate chips labeled as “dairy-free” contained potentially dangerous amounts of milk for consumers with milk allergies. In 2015 and 2016, the FDA collected samples from a variety of foods to determine compliance with “gluten-free” labeling requirements. FALCPA requirements apply to all packaged foods sold in the United States and regulated under the Federal Food, Drug, & Cosmetic Act, including domestically produced and imported foods. The FDA regulates all foods except meat products, poultry products, and egg products. “(qq) The term `major food allergen` refers to one of the following: As stated in the FLCPA, the FDA is constantly working with the Food Safety Conference to develop guidelines for retail and foodservice establishments to properly handle and label food allergens. So far, the FDA has not established thresholds for major food allergens. However, this does not mean that we do not take into account information on allergen thresholds in our regulatory work.
For example, the FDA may consider allergen threshold data when assessing the safety of ingredients exempt from FALCPA allergen labeling requirements. We continue to monitor and evaluate the new scientific evidence that has emerged over the past decade about the dose-response threshold of the population to a variety of food allergens. The FDA can take a number of regulatory actions if a food`s label does not contain the required allergen information for a food ingredient, if a food product inadvertently contains a food allergen due to cross-contact, or if a food product cannot be labeled as “gluten-free.” The FDA considers these products to be mislabeled or falsified depending on the circumstances and are subject to enforcement actions such as recalls, refusal to import, and seizure. The Agency may also send warning letters to establishments producing such food or alert food imported from other countries for such violations. If there is a problem that warrants a recall, companies usually voluntarily recall these food products from the market. Consumers can find out which products have recently been recalled on the FDA`s website or by signing up to receive emails about recalls, market withdrawals, and safety alerts. Yes. The FALCPA provides mechanisms for a manufacturer to request that a food ingredient covered by the FALCPA be exempted from the labelling requirements of the FALCPA. An ingredient may be exempted if it does not cause an allergic reaction that poses a risk to human health or if it does not contain an allergenic protein. What types of foods are covered by FALCPA labelling requirements? Any product where an undeclared allergen is detected will be examined on a case-by-case basis.
A major food allergen is considered a potential serious danger to the public. Therefore, a product containing an undeclared major food allergen is likely to be recalled.