We welcome the opportunity to comment on Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Guidance for Industry [Draft Guidance].

As a consumer organization, we prioritize providing clear, helpful label information that consumers can use to make an informed choice. We commend the FDA for their consideration of newer methods of food production and trends in food choices and for promoting the provision of clear information to consumers.

Specifically, we were pleased to see guidance specifying that products packaged in containers or in bulk to be used by food manufacturers that contain a major food allergen must comply with the allergen labeling requirements (B.2, B.3). This is important to help assure proper handling and clear labeling of the finished products. We were also pleased with the guidance for declaration of incidental additives in spice mixes which might be major food allergens (B.4). This guidance will also protect consumers. We also agree that an incidental additive that contains a major food allergen would have to be declared as a food source of the major food allergen (D.10).

Allergic reactions have been associated with the consumption of milk from other ruminants in addition to cows. In order to protect consumers, we are in favor of a revision of the FDA’s interpretation of “milk” for this guidance (C.1). We propose a revised phrase “animal milk” or “animal-derived milk” which would distinguish cow, sheep, goat, buffalo and other ruminant species’ milk from “plant milk” which would include milk derived from plant sources and that does not contain animal products. These revised phrases would be used in educational and informative materials about major food allergens. On food labels, the source of the animal milk should be identified similar to the way in which the specific species of fish or Crustacean shellfish or type of tree nut are identified.

Similarly, due to the potential risk of allergic reaction from various bird species, the definition of “egg” (C.2) should be revised to include eggs from other bird species in addition to chickens. On food labels, the source of the egg should be identified similar to the way in which the specific species of fish or Crustacean shellfish or type of tree nut are identified.

We support the proposed guidance that proteins from major food allergens, produced in other sources through the use of genetic engineering are subject to the food allergen labeling requirements of the FD&C Act (B.14). This type of labeling will help to protect people with food allergies who may be misled by product labels containing statements such as “animal-free” or “vegan.” We propose that food allergen information on these products should be in readable type or a readable background, not only in the ingredient listing but also along with any other declarations on the labels which may be confusing to the consumer related to the presence of the allergen. These could include terms such as “animal-free” or “vegan.” We do not think that these terms (“animal-free” or “vegan”) should be used on labels of foods that were produced through genetic engineering based on the DNA of animals (whether based on actual DNA, cell lines, or virtual DNA), due to concern for consumer confusion

We are concerned with the response to question D.8 that does not clearly state what is needed in order to “ensure that the ingredient does not contain protein.” In order to protect the consumer, products containing lactose or ghee should be required, without exception, to declare milk on the label. The possibility that a product may contain residual protein from milk is of great concern for those with food allergies.

We agree with the statement in response to question D.13 that good manufacturing practices should be used to protect against food allergen cross-contact. We are concerned that sometimes allergen advisory statements to warn consumers about potential allergen cross-contact are confusing to consumers. The allergen advisory statement may list an ingredient that does not appear in the product. It would be helpful to consumers to clarify that shared equipment or other cross-contact is the source of the allergen. Thank you for the opportunity to comment on this issue.