Author

Anna Benevente

Director of Labeling, Ingredient and Product Review

FDA Labeling & Incidental Additives

May 4, 2022

The U.S. Food and Drug Administration’s (FDA’s) labeling regulations generally require that firms list all ingredients present in a food product on the product’s label. However, certain circumstances can allow an exemption from this regulation. An example of a substance that may be exempt from labeling requirements is an incidental additive.

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Registrar Corp’s Regulatory Specialists can help review your product’s label for FDA compliance.

For more information, call us at +1-757-224-0177, email us at info@registrarcorp.com, or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/contact.

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How do you know if a substance may be exempt from FDA’s labeling regulations? Read on for definitions and examples of incidental additives.

What are Incidental Additives?

Incidental additives are substances that are present in a food at insignificant levels and do not
have a functional or technical effect on the food. These substances are essential to the processing, manufacturing, or packing of the food and may come into contact with the food or be found in trace amounts in the finished product.

Incidental additives differ from intentional additives in that incidental additives are not deliberately added to a food, but intentional additives are. For example, the processing of a can of apples may include the intentional additive of calcium chloride, deliberately added to maintain the texture of the apples. The canned apples may also contain the incidental additive of canola oil used as a lubricant on the production line that transports the apples.

How Incidental Additives Appear

FDA provides examples of how an incidental additive may appear in a food product. Incidental additives may emerge in the following instances:

  • As a result of the incidental additive’s presence in an ingredient that was incorporated into the final food product
  • As a processing aid. Processing aids can be added to a food during the processing stage, but removed before packaging or converted into constituents the food normally contains, without significantly increasing the constituents. Processing aids can also be added during processing to achieve a technical or functional purpose, but are not found in significant amounts in the finished food, nor do they have a technical or functional effect in the food. An example of a processing aid is liquid nitrogen used in the manufacturing of BBQ sauce to stabilize the bottle
  • As a substance that has transferred from equipment or packaging to the food but does not meet the definition of a food additive. If the substance meets the definition of a food additive, it needs to be used in conformity with regulations established by section 409 of the Federal Food, Drug, & Cosmetics Act to obtain exemption from labeling requirements

Firms should be certain that a substance meets FDA’s requirements for labeling exemption if they believe the substance to be an incidental additive. If the substance does not meet the requirements, it is subject to all applicable FDA labeling regulations.

Get assistance with FDA compliance.

Registrar Corp’s Regulatory Specialists can help review your product’s label for FDA compliance.

For more information, call us at +1-757-224-0177, email us at info@registrarcorp.com, or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/contact.

Get Assistance

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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