Author

Anna Benevente

Director of Labeling, Ingredient and Product Review

Is Coconut an Allergen According to FDA?

Jul 12, 2019

Approximately 33 million Americans suffer from food allergies. In response, Congress passed the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) which requires food labels to list all ingredients that may cause allergic reactions. 

The law identifies nine major food allergens, one of which is tree nuts.

The U.S. Food and Drug Administration (FDA) recognizes coconut as a tree nut, and thus an allergen that must be declared. This can be confusing for some, as coconuts are not typically considered to be nuts and there are few instances of people being allergic to both true tree nuts and coconuts.

Despite this, coconut remains on the list, so food facilities labeling products containing coconut must list it in the ingredients appropriately. 

FALCPA Requirements for Declaring Allergens

FALCPA is applied to nine food groups that were chosen because they account for over 90% of all food allergies in the United States. They are:

  • Milk
  • Eggs
  • Fish
  • Crustacean shellfish
  • Tree nuts
  • Peanuts
  • Wheat
  • Soybeans
  • Sesame

The Act requires food containing one or more of these nine major food allergens to label the product with either a ‘Contains’ statement, which lists the food source from which the allergen is derived, or to list the common or usual name of the food allergen in the standard list of ingredients. This is done to avoid consumer confusion over ingredients that are derived from food allergens (i.e. whey and milk).

The ‘Contains’ statement must be adjacent to the ingredient list and in the same size and font. For food products containing tree nuts, crustacean shellfish, or fish, the specific type of nut, or species of fish or shellfish, must be declared by its common or usual name. 

It’s also important to assure you are taking measures in protecting against allergen cross-contact through both current good manufacturing practices (cGMPs) and Preventive Controls as set forth by the Food Safety Modernization Act (FSMA).

Is Coconut a Tree Nut Allergen?

While coconuts grow on trees and contain the word ‘nut’ in their title, Coconuts are botanically a drupe, a fruit with several hard layers. Despite this, they still fall under FDA’s designation of ‘tree nuts’ for the purpose of FALCPA. This can be confusing for labelers who may have not thought of coconut as being an actual nut or as a major food allergen.

While rare, there are a number of people who are allergic to coconut in the United States. FDA likely included coconut in the tree nut category to cover this known food allergen under the Act. FDA acknowledges that their tree nut- list is broad and may even contain species with no current food use.

In fact, many of the nuts identified as tree nuts under the Act are not botanically tree nuts, but it is FDA’s job to protect as many people as possible from food allergy concerns, not necessarily to determine the correct taxonomy of all food.

Coconut and Allergen Labeling

With all this in mind, if you are a food facility labeling products containing coconut, you must declare the presence of coconut either in the ingredients statement or with an adjacent ‘Contains’ statement. Ingredients that are derived from coconut must use the common name ‘Coconut’ in the ingredients or say “contains coconut”.

Failure to do so could result in FDA considering the product misbranded and could thus result in regulatory action such as warning letters, import alerts, or detentions. Failure to appropriately list allergens is one of the most common food safety violations and is important to consider when creating your product’s label.

Registrar Corp is a private FDA compliance consultant that assists companies in complying with FDA regulation. Registrar Corp offers a Labeling and Ingredient Review service to help ensure your food label is FDA compliant, including that it contains appropriate allergen statements. For more information, contact us at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

 

Author


Anna Benevente

Director of Labeling, Ingredient and Product Review

Highly regarded as a top expert on FDA labeling regulations, Anna Benevente continues to educate companies on existing regulations and updates from U.S. FDA for food and beverage, cosmetic, drug, and medical device products. She has researched thousands of products to determine whether they meet the FDA requirements for compliance. In addition, Ms. Benevente has conducted multiple seminars for trade and customs broker associations.

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