The FDA Has Relaxed Labeling Requirements Under COVID-19. What it Means for the Food Allergy Community

The Food and Drug Administration (FDA) dropped a bombshell on Friday, announcing new guidance relaxing food labeling requirements. Because they chose to do this at the start of the Memorial Day weekend with no prior warning or opportunity for public comment, we presume the administration had no desire to hear from parties who may be affected or harmed by the relaxation of regulations.

As the FDA states in their document, the goal of this guidance is “to provide regulatory flexibility, where appropriate, to help minimize the impact of supply chain disruptions on product availability associated with the current COVID-19 pandemic.” in other words, they have relaxed labeling requirements to allow manufacturers to make ingredient changes without changing the label.

Unless superseded, the new guidance will remain in effect until sometime after the coronavirus pandemic has ended.

Among other requirements, the FDA states that a manufacturer may make formulation changes provided that:

…the ingredient being substituted for the labeled ingredient does not cause any adverse health effect (including food allergens, gluten, sulfites, or other ingredients known to cause sensitivities (see section C.2.a) in some people, for example, glutamates);

Unfortunately, the devil is in the details, and the guidance goes on to introduce numerous loopholes that are of concern to members of the food allergy community.

Note: Our analysis below is not a substitute for reading the guidance yourself.

Concerns for the Top 8 Allergens

For those concerned with the FDA’s “Top 8” allergens — i.e. peanuts, tree nuts, milk, eggs, soy, wheat, fish and crustacean shellfish — the guidance does not change the disclosure requirements: manufacturers must continue to disclose the presence Top 8 ingredients in the ingredient list or in a “Contains:” statement following the ingredient list. (Click here for the exact requirements.)

If there is a possibility that Top 8 allergens may be inadvertently introduced via cross-contact — say when allergens are processed on shared machinery or in the same facility — there is no requirement that an advisory statement such as “made in a facility that also processes peanuts” be included on the packaging. These were voluntary in the past and remain so under the new guidance.

The FDA’s guidance introduces new concerns, such as when a Top 8 allergen is substituted for another ingredient behind the scenes. Take the example of a milk chocolate bar that carries the advisory statement: “Made on equipment that also processes almonds.” If the manufacturer decides to substitute peanut flour for almond flour in another product in the same line, that advisory statement may be rendered incorrect or incomplete.

We also take issue with highly refined derivatives of the Top 8 allergens, such as peanut oil and soy lecithin, which were exempted as allergens by the FDA and never required to be labeled as allergens.

The FDA document states that substitutions for highly refined oils may be made when “the oils are highly refined, [and] the substitutions do not pose an allergenic risk”, but according to the FDA’s own regulations, these ingredients were never considered allergenic to begin with.

Many families avoid such highly refined derivatives because they do react after ingesting them or avoid them out of an abundance of caution. Some have spent countless hours researching manufacturers to ensure the products they buy are not made on equipment or in facilities where such ingredients are processed.

The new guidance compounds that problem. For example, it is conceivable that a manufacturer finding it difficult to source corn oil could substitute highly refined peanut oil or soybean oil without making changes to the label.

The only way for a consumer to discover that such a change has occurred is to contact the manufacturer before they purchase the item, an especially difficult prospect now that many rely on online shopping services where substitutions may be made on their behalf.

Concerns for Other Allergens

Those that suffer from allergies to foods outside of the Top 8 were never adequately protected by the FDA’s labeling requirements in the first place. An allergen of concern can be hidden behind terms such as “spices” or “natural flavor”. Under the FDA’s new guidance, that problem is exacerbated.

In a section of the document entitled “Avoidance Considerations”, the FDA states:

In addition to the eight major food allergens defined at section 201(qq) of the FD&C Act, several other foods (such as sesame, celery, lupin, buckwheat, molluscan shellfish, and mustard) are recognized as priority allergens in other parts of the world, including Canada, European countries, and Japan. There are also other ingredients (such as glutamates and sulfites) that can cause adverse reactions. Manufacturers should avoid substitutions that could result in a safety concern without making a conforming label change or providing other means to inform consumers of the change.

The term “should avoid” is dangerously vague, implying a suggestion, not a requirement. Adding to the uncertainty, the FDA does not provide a definitive list of ingredients “recognized as priority allergens in other parts of the world”, leaving manufacturers and consumers to sort it out for themselves (or not.)

This allows a manufacturer with difficulty sourcing one type of ingredient to switch to another without changing the label. An example might include the substitution of one type of seed or seasoning for another without notifying the consumer.

Lack of Disclosure Requirements

Adding insult to injury, the FDA’s new guidance does not require manufacturers to disclose ingredient substitutions anywhere, such as a central FDA database or even the manufacturer’s own website. The omission makes it virtually impossible for consumers to determine that any such substitution has taken place without calling the manufacturer each time before they purchase a product.

Conclusion

The FDA’s rash action introduces new risks and may cause disruptions to the lives of individuals coping with food allergies at a time when they are already stressed trying to find safe products as they shelter-in-place.

While US labeling regulations were lax to begin with, the FDA managed to take a giant leap backward by issuing this guidance. The food allergy community — comprising some 32 million Americans — now has reason to trust the label even less than they did before.

We urge the FDA to rescind their guidance until these issues have been resolved which can only be done with input from the food allergy community.

Barring that, we urge our readers to exercise additional caution when purchasing food products for an allergic individual. Stick to brands you already know and trust, and reach out to manufacturers to ensure their product labels accurately represent the ingredients they contain.

As always, be sure to protect yourself should the unthinkable happen: remember to Take 2 epinephrine auto-injectors along everywhere, every time.

Video: How the FDA’s New Guidance Will Affect the Food Allergy Community