The U.S. Food and Drug Administration ("FDA"), the agency of the United States Department of Health which is responsible for food, food supplements, pharmaceuticals, biological medical products, blood products, medical devices, radiation emitting devices, veterinary devices, and cosmetics, published the Draft Compliance Policy Guide on Major Food Allergen Labeling and Cross-Contact ("Draft") on 16.05.2023. Draft, which contains much more comprehensive regulations on labeling requirements than the draft published in 2005, aims to minimize the possibility of individual FDA personnel following different regulatory approaches by establishing a uniform standard. The parts of the relevant Draft that we consider important shall be evaluated under the following headings.
1- Regulations Regarding Food Allergy
Food allergy is defined as a specific response of the immune system to a substance in food consumed. Adverse allergic reactions can result from even a single consumption of the food allergen and can range in severity from skin rashes to severe anaphylaxis symptoms that can be fatal. There is currently no effective treatment to prevent all allergic reactions caused by exposure to food allergens, so consumers with food allergies need to be able to identify and avoid food allergen hazards to prevent adverse health consequences. As a matter of fact, the Turkish Food Codex Regulation on Food Labeling and Informing Consumers ("Regulation") which was published in the Official Gazette dated January 26, 2017 and numbered 29960 stipulates that certain information regarding food shall be mandatorily notified to the end consumer. In this context, certain substances or products that cause allergies or intolerances shall also be notified to the end consumer.
According to Draft, major food allergens used as ingredients in packaged foods shall be declared in the ingredient list or with the phrase "Contains”, including the name of the food source from which the major food allergen is derived. For major food allergens, if the common or usual name of the ingredient does not include the name of the food source from which the major food allergen is derived, food allergen labeling requirements may be met if the name of the ingredient is followed in parenthesis by the name of the food source, e.g., “whey (milk).” Indeed, according to Regulation, all foods supplied to the end consumer, including non-prepackaged foods and foods served in places of mass consumption, are required to be labeled with the 14 allergens or intolerance-causing substances or products listed in Annex 1 of Regulation. When making an allergy declaration, the names of the substances or products in Annex-1 of Regulation must be clearly stated in the list of ingredients. For the foods that are not required to have an ingredient list, the substance or product causing allergy or intolerance shall be indicated as ".... contains".
2- Concept of Cross-Contact
The concept of "cross-contact" is the most important feature that sets the present Draft apart from the prior draft. Cross-contact, a relatively new concept, is the unintentional inclusion of a food allergen in a food that does not contain that allergen as an ingredient. As a result of this contact, a food may contain traces of other foods. The likelihood of an allergen being present due to cross-contact can be affected by factors such as the characteristics of the food, the distribution of the allergen in the food (homogeneous or particulate), the type of production process, the equipment used, and the cleaning procedures applied. Cross-contact can be caused by improper separation of allergens due to inadequate equipment cleaning, wrong production planning, and other related issues. Draft also endorses the approach of FDA, which states that significant food allergens unintentionally included in a food product shall not be declared in the ingredients list or labeled with the statement “Contains”. Instead of the
obligation to provide this, the view has been taken that companies shall comply with the requirements to prevent allergen cross-contact.
Furthermore, according to Draft, allergen cross-contact occurs due to practices such as insufficient cleaning of shared equipment, improper segregation of allergens, or inappropriate production planning. The likelihood of unwanted allergen presence can be affected by a variety of factors, including the characteristics of the food, the distribution of the allergen in the food, the type of production process, the equipment used, and the cleaning procedures implemented. The food allergen labeling requirements of US law apply only to a major food allergen that is a component of the product. Therefore, major food allergens that are unintentionally incorporated into food should not be declared in the ingredient list or with the phrase "Contains". Instead, companies are required to comply with the requirements to avoid allergen cross-contact.
3- Assessment and Possible Sanctions
If as a result of testing, an allergen is detected in the food, or if FDA suspects the presence of an allergen due to one or more adverse consumer reactions and the source of the allergen in the product is unknown, FDA may monitor the manufacturer on watch to obtain additional information, such as product formulation, ingredient information, and information about other products produced on the same production line or in the same environment. Draft also provides examples of the types of spellings that would be considered labeling violations and examples of incomplete or inconsistent spellings that might cause confusion.
FDA's approach to handling allergen violations shall be determined on a case-by-case basis. A product may be considered adulterated if FDA's examination of the evidence shows that allergen cross-contact could render the product harmful to health. A product may also be considered adulterated if, even if the product carries an allergen advisory, there is evidence that controls to minimize allergen cross-contact are inadequate. In these cases, CFSAN/Compliance Office shall be consulted on the health risk posed by the product to determine whether the product is adulterated. This assessment shall consider factors such as the estimated exposure to the presence of the allergen, the likelihood of the product being consumed by allergic consumers, the type of allergen control problem resulting in cross-contact, the characteristics of allergen residues due to cross-contact and consumer adverse reactions.
A product shall be deemed to be mislabeled if the FDA's examination finds that the product labeling contains incomplete or inconsistent product information on major food allergens. If there is a substantial likelihood of serious health problems or death due to mislabeling or adulteration, FDA shall take immediate action to remove the food from the market; if the company does not initiate a voluntary recall, FDA shall take other enforcement actions, such as a mandatory recall, administrative detention, and/or suspension of facility registration.
FDA, which always accepts comments on guidance documents, requests that comments on Draft be submitted by July 17, 2023. In particular, if Draft enters into force, it may affect domestic regulations in the future, as it contains important evaluations on cross-contact, which is a very new concept.
You can access Draft from this link.