The Food and Drug Administration on May 8 issued a draft guidance to industry that expanded the definition of “major food allergen” while explaining how the agency will weigh petitions and notifications for exempting certain food ingredients derived from major food allergens from allergen labeling requirements.

Industry and other stakeholders may comment on the draft Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications until Sept. 5, 2014.

The F.D.A. explained in the draft guidance that the Food, Allergen, Labeling and Consumer Protection Act of 2004 (FALCPA) amended the Food, Drug & Cosmetics Act by defining the term “major food allergen” and stating that foods regulated under the F.D.&C. Act are misbranded unless they declare the presence of each major food allergen on the product label using the common or usual name of that major food allergen. FALCPA defined a major food allergen as “milk, egg, fish (e.g. bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster or shrimp), tree nuts “e.g., almonds, pecans or walnuts), wheat, peanuts, and soybeans.”

The draft guidance would expand the definition to include “a food ingredient that contains protein derived from these foods.” The expanded definition excluded any highly refined oil derived from a major food allergen and any ingredient derived from such highly refined oil.

The guidance then provided recommendations on what data the F.D.A.’s Center for Food Safety and Applied Nutrition will consider when evaluating petitions and notifications seeking exemptions from the allergen labeling requirements.

The F.D.A. acknowledged that in some cases, the production of an ingredient derived from a major food allergen may alter or eliminate the allergenic proteins in that derived ingredient to such an extent that it does not contain allergenic protein.

“In addition, a major food allergen may be used as an ingredient or as a component of an ingredient such that the level of allergenic protein in finished food products does not cause an allergic response that poses risk to human health,” the F.D.A. said.

Digging into the details

FALCPA provided two mechanisms through which such an ingredient may become exempt from the allergen labeling requirements.

The act stated an ingredient may obtain an exemption through submission and approval of a petition containing scientific evidence that demonstrates that the ingredient “does not cause an allergic response that poses a risk to human health.” The act also stated that “the burden shall be on the petitioner to provide scientific evidence (including the analytical methods used to produce the evidence) that demonstrates that such food ingredient, as derived by the method specified in the petition, does not cause an allergic response that poses a risk to human health.”

The acts further stated an ingredient may become exempt from the labeling requirements through submission of a notification containing scientific evidence showing that the ingredient “does not contain allergenic protein” or that there has been a previous determination through a premarket approval process that the ingredient “does not cause an allergic response that poses a risk to human health.”

The draft guidance indicated the F.D.A. will consider scientific evidence that describes the identity or composition of the ingredient, the methods used to produce the ingredient, the methods used to characterize the ingredient, and the intended use of the ingredient in food. Also, for a petition for exemption, information should be submitted — including the expected level of consumer exposure to the ingredient — that demonstrate, that the ingredient, when manufactured and used as described in the petition, does not cause an allergic reaction that poses a risk to human health.

In the case of notifications, data and information should be provided that demonstrate that the ingredient when manufactured as described does not contain allergenic protein, or documentation of a previous determination that under a premarket approval process that the ingredient does not cause an allergic response that poses a risk to human health.

“We will evaluate this scientific evidence only for the specific ingredient and specific use(s) identified in the submission,” the F.D.A. said in the draft guidance. The guidance then provided extensive recommendations on how the scientific evidence should be gathered and presented in petitions and notifications for exemptions.

Real world implications

David Acheson, founder and chief executive officer of The Acheson Group, said in relation to the expanded definition of major food allergens, “With undeclared allergens already driving the majority of food recalls, this could be a critical difference for some manufacturers, particularly those who don’t have a robust supplier management program by which you require specifications on all ingredients and maintain updated documentation. We also could see it increasing the ‘may contain’ and other precautionary labeling statements, further reducing product options for those with food allergies.”

Mr. Acheson posed the question: What do the additions to the definition of allergens and the lengthy process for exemption requests mean for food manufacturers’ allergen labeling programs?

“To answer this, we took a look at F.D.A.’s ‘Withdrawn: Guidance on the labeling of certain uses of lecithin derived from soy,’” Mr. Acheson said. “The withdrawn guidance and the new draft guidance on Food Allergen Labeling Exemption Petitions and Notifications change the way non-allergenic ingredients derived from allergens will be labeled.

“For example, if lecithin derived from soy was used as a release agent, it was not required to be labeled in the ingredient statement, because it met the definition of an incidental additive (an incidental additive is an ingredient that is present in insignificant amounts and does not have any technical or functional effect in the food).

“In current labeling under FALCPA, however, if the lecithin used as a release agent was derived from soy, it was required to be declared on the label either in the ingredient statement as ‘soy lecithin’ or ‘lecithin (soy)’; or declared in the ingredient statement as ‘lecithin,’ and the contains statement would be required to say ‘contains soy.’

“We expect the new draft guidance to require a similar labeling change for other non-allergenic ingredients derived from allergens. With these changes, a few questions that those who manufacture food should consider are: How will you label your products? When you review a new supplier, or updated documentation from an existing supplier, will you ask them to identify any non-allergenic ingredients derived from allergens? What will you do with this information? For example, if you market your product to a target audience that is sensitive to soy, will you update your supplier questionnaire or specifications to ensure you know if your lecithin is derived from soy or corn, etc.? Will you continue to label lecithin as ‘soy lecithin’ in the ingredient statement?”

Preparing for the future

Mr. Acheson observed one thing missing from the draft guidance was no mention of the evolution of science or a potential increase in methodology sensitivity.

“This would require the submitter to reassess an exemption petition or notification to change the label if it were found that a product did, indeed, have protein derived from an allergen,” he asserted. “With technological advances continually increasing instrument sensitivity and enabling detection to ever lower levels, we have to question how F.D.A. and the industry intend to handle these changes and inform consumers.

“An exempted ingredient may be passed through as allergen-free today, but, in actuality may contain a level that would have been detected with tomorrow’s technology.”

He added, “What responsibility will a company have to update to current technology to detect lower levels to protect these (highly sensitive consumers) — or to withdraw an exemption if levels are found? And, will these lower levels actually mean that a threshold is reached whereby the allergen causes an allergic reaction?  We may be chasing zero here for some time to come.

“Although the draft guidance does require the submitter to address any uncertainties in the data, we were unable to find answers to these questions from the information posted on this recent subject. We can only hope that industry does not simply turn to precautionary labeling to protect itself — and cause allergenic consumers to see ‘may contain’ on every product they pick up.”