FDA Looks To Issue Guidance On Non-Listed Food Allergens

The Food and Drug Administration announced this week it is soliciting public comments to evaluate the importance of issuing guidance on food allergens not named in the Federal Food, Drug, and Cosmetic Act (FD&C Act). The final guidance aims to identify and rank allergens capable of inducing anaphylaxis (also known as immunoglobulin E antibody (IgE)-mediated food allergies). The notice states there are 160 foods known to cause this form of an allergic reaction.

What does this mean?

The current non-binding recommendations will be formalized following the close of the public commentary period, which is open from now until August 17, meaning that the notice is subject to change in accordance with feedback the agency receives from the public, staff and industry stakeholders. The purpose of this period is to evaluate reactions to other food allergens beyond milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame, to continue gathering evidence and information to inform “potential future actions.”

“Constant food vigilance and fear of accidental life-threatening reactions with every meal are daily, patient-centered challenges that can accompany management of IgE-mediated food allergy,” the draft notice states.

When The Food Allergen Labeling and Consumer Protection Act (FALCPA) was amended in 2004 to name the top eight allergens, 90% of anaphylaxis cases were caused from those listed foods and food groups. The agency notes that reactions to non-listed allergens are less common; however, the act was formally amended again last April with the passage of the FASTER ACT by Congress, which named sesame as the ninth top allergen.

Of the 160 known food allergens, prevalence of reactions can be so low that in some cases they may only impact a single individual, according to the agency. Because of this, the FDA said that prevalence, severity and allergenic potency will be the main factors taken into account as it works to determine if guidance on non-listed allergens is necessary.

“The nine major food allergens don’t currently represent all foods nationwide that people are allergic to or that cause food hypersensitivities,” said Susan Mayne, Director of the Center for Food Safety and Applied Nutrition, in a press release. “This draft guidance is part of the FDA’s efforts to evaluate emerging evidence about other non-listed food allergens that can cause serious reactions in a consistent and transparent manner, which can inform potential future actions to better help protect the health of consumers.”

What foods could this include?

Although the draft notice does not explicitly name foods under evaluation, it highlights previous citizen petitions to amend the FALCPA including comments surrounding barley, rye, sesame and garlic. The request for amendments regarding the former two foods has since been denied as the FDA said there is not sufficient evidence to establish specific guidance. However the petition for sesame was partially responsible for initiating last year’s amendment.

Ingredients under consideration include colorings like yellow 5 and carmine (natural red 4), and preservatives like sulfites. Foods like mango, celery and buckwheat are also among the potential common allergens and while poultry and red meat have been found to rarely cause anaphylaxis and will likely not be considered under the guidance due to their low prevalence.

Non-immune mediated reactions, like lactose intolerance, and immune but non IgE-mediated responses, such as celiacs disease, will not be considered in this forum.

What impact will this have?

Following the public commentary period, the FDA will begin to draft final guidance to inform consumers and industry stakeholders on the agency’s “current thinking” on the topic. Guidance documents aren’t binding, meaning that they are simply recommendations.

In response to the draft notice, The Center for Science in the Public Interest (CSPI) published commentary criticizing the agency for falling short again on allergen labeling regulations, stating that the guidance doesn’t offer consumers sufficient protections. Published by Peter Lurie, President and Executive Director of CSPI, the article cites how Congress, not the FDA, finally took action on sesame labeling following the agency’s six-year-long deliberations on the topic.

“Yet while it offers a potentially useful framework for assessing the scientific evidence to decide if a particular food allergen is important for public health, it conspicuously fails to indicate when the agency would actually act on that information to require labeling or other consumer protections, should an allergen be deemed a priority,” said Lurie in the post.

Ingredients that are relatively new to the market or not extremely well-recognized also pose additional challenges as the agency works to establish final guidance, the FDA said in the draft notice. Since guidance is derived from scientific evidence, the rapid development of alternative products like proteins and dairy bring new ingredients into the fold that may not garner enough evidence themselves to even be considered.