As a result of the food shortages during the COVID-19 pandemic, the U.S. Food and Drug Administration released new guidance regarding how manufacturers can label their food. The new guidance allows food producers flexibility by letting them make “minor formulation changes” to the labels on foods. The FDA made this decision in an effort to relieve the stress of supply chain distributions during the pandemic.

What is the FDA’s Announcement?

The new guidance that was issued by the FDA says that an ingredient in a food can be changed without updating the ingredient list on the food’s label. However, this can only be done as long as it “does not cause any adverse health effect.” Examples can include food allergens, gluten, sulfites, or other foods that are known to cause sensitivities in some people. The FDA rules require the following:

• The ingredient that is omitted or substituted cannot be a major ingredient and must only make up 2% of the food 
• Characterizing ingredients also cannot be changed 
• The ingredient that is omitted or substituted cannot have an impact on the product’s nutrition.

Examples of ingredients that the FDA provides include the following:

• Green peppers may be left out of a pre-packaged vegetable quiche
• Substituting canola oil for sunflower oil is allowed since they contain similar fats and neither is a common allergen
• Unbleached flour can be substituted for bleached flour as long as the bleaching agent is in short supply

How Can This Result in Product Liability?

Manufacturers have a responsibility to the public when they produce products, such as food. They can be held liable through product liability law if someone becomes harmed due to their neglect. This can be possible in the event of failure to warn. This happens if a manufacturer does not provide a warning label on a product that can harm someone if it is used improperly. In the example of food, this is what an ingredient label is for. If the label does not designate an ingredient that someone can have an allergic reaction to, a lawsuit may be possible. 

In response to the FDA’s guidance, consumer advocacy groups are issuing warnings about how dangerous this can be to those with food allergies. Speaking on the matter, SnackSafely.com CEO Dave Bloom said, “If you have a food allergy, the substitution of ingredients can be extremely dangerous and can cause anaphylaxis. The fact that they (the FDA) say 2% or less of an ingredient is changed means nothing because even a little trace of an allergen can cause a reaction and send someone to the hospital.” He continued, “There are 32 million Americans that have a food allergy – that’s one in 10 of us that are put at risk by this.”

The FDA did not state how long these guidelines will be in effect. If you or someone you know was harmed as a result of negligence and wishes to pursue a product liability lawsuit, contact an experienced New York personal injury attorney for assistance.

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