Author

Anna Benevente

Director of Labeling, Ingredient and Product Review

FDA Food Labeling Requirements for Additives

Jul 1, 2022

Food additives are a common inclusion in foods distributed in the United States. Food manufacturers often depend on additives to enhance their food products in various ways. These additives can be used to achieve aesthetic purposes or can be functional, preserving the quality of the product or making it safer to consume. The U.S. Food and Drug Administration (FDA) regulates additives in food according to the identity of the additive and its intended use, including establishing and enforcing labeling requirements.

Generally, FDA requires all ingredients in a food product to be listed on the product’s label in order from the greatest amount to the least amount. Along with this stipulation, some additives are subject to other labeling requirements, while others remain exempt.

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/livechat.

Get Assistance

Read more to learn which labeling requirements apply to different additives.

Direct Additives

When a food facility incorporates an additive in a food product to achieve a certain purpose, the substance is a direct additive. For example, carrageenan is often used in products such as almond milk, cottage cheese, ice cream, coffee creamers, and vegan cheese for varying purposes.

Sometimes a direct additive can serve as a preservative to maintain or improve safety and freshness. As a product could rapidly spoil due to mold, air, bacteria, fungi, or yeast, preservatives slow spoilage and help control contamination that can cause foodborne illness. A food facility that manufactures dairy products might add carrageenan to their products as a preservative.

Direct additives also are added to improve the taste, texture, and appearance of food. Carrageenan is not only useful as a preservative but can also be added as a thickener to products such as coffee creamer and ice cream to help achieve a creamier texture. Other examples of direct additives are natural and artificial flavors, spices, and sweeteners incorporated for improved taste.

A direct additive can also be used to improve or maintain nutritional value. A food may contain added vitamins and minerals to enhance the consumer’s nutrient consumption, to offset those substances occurring naturally but lost in processing, or to create a more nutritionally dense product.

All direct additives must be appropriately identified on the label according to FDA’s general labeling requirements for food ingredients.

Chemical preservatives

FDA defines chemical preservatives as, “any chemical that, when added to food tends to prevent or retard deterioration thereof, but does not include common salt, sugars, vinegars, spices or oils extracted from spices, substances added to food by direct exposure thereof to wood smoke, or chemicals applied for their insecticidal or herbicidal properties (21CFR 101.22(a)(5))”.

When a chemical preservative is included on a label, the listing must indicate the common or usual name of the chemical and that it is a preservative with a description such as: “(preservative)” or a statement that also indicates function, such as  ” _________ to promote color retention”.

Incidental Additives

Incidental additives are those that have no technical or functional effect on a finished food and are present in insignificant levels. They are usually present due to them having been a component of one of the ingredients used in the food (where they did have a technical or functional effect) or due to their use as a processing aid.

Processing aids are defined as 1) substances that are added to a food during the processing of such food but are removed in some manner from the food before it is packaged in its finished form; 2) Substances that are added to a food during processing, are converted into constituents normally present in the food, and do not significantly increase the amount of the constitutents naturally found in the food; or 3) substances that are added to a food for their technical or functional effect in the processing but are present in the finished food at insignificant levels and do not have any technical or functional effect in that food (21 CFR 101.100(a)(3).

Any substances conforming to these definitions may be exempt from declaration in the ingredients list on a product label.

Color Additives

A color additive is “any dye, pigment or substance which when added or applied to a food, drug or cosmetic, or to the human body, is capable (alone or through reactions with other substances) of imparting color.”

Color additives can be used in food products to offset color loss, correct natural variations in color, enhance naturally occurring colors, or provide color to colorless foods.

“Certified” color additives are synthetic colorings that are required to undergo batch certification every time a new batch is manufactured. “Exempt” color additives include pigments from natural sources such as vegetables, minerals, or animals. Exempt colors are not subject to batch certification requirements.

Some color additives exempt from certification can be listed collectively as “artificial colors,” “artificial color added,” “color added,” “spices,” or an equivalent description, without naming each one. They may also be declared by name, with a statement such as “colored with ___” or “_____ color.”  However, certain allergenic color additives such as carmine/cochineal extract must be identified by name on food labels. Colors that have been batch certified must be declared by name using the “FD&C” prefix assigned to the certified version of that particular color, such as FD&C Red No. 40.

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/livechat.

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.

Related Article


Subscribe To Our News Feed

To top
This site is registered on wpml.org as a development site. Switch to a production site key to remove this banner.