Author

Anna Benevente

Director of Labeling, Ingredient and Product Review

Keto, Vegan, or Plant-Based Labeling Requirements on Food and Beverages

Jun 7, 2022

U.S. consumers regularly purchase food and drink products to meet the nutritional standards set forth by popular diets. As people seek to follow these guidelines consistently, the demand for additional products provides opportunity for marketplace expansion. Currently, three of the most popular diets in the U.S. are keto, vegan, and plant-based diets.

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Though many food and beverages bear labels indicating that the products meet nutritional guidelines for consumers following keto, vegan, and plant-based diets, what does the U.S. Food and Drug Administration (FDA) have to say about these terms? Keep reading for information on labeling food products marketed for these diets.

Keto Labeling Requirements

The Ketogenic Diet, or keto, is a low-carb, moderate protein, high fat diet. FDA does not regulate the terms “keto” or “ketogenic” on food labels. However, firms marketing these products should be aware of the language surrounding nutrition information on their product’s labels.

One of the hallmarks of the keto diet is low carbohydrate consumption. FDA does not have regulations that specify how a “net carb” or “low carb” claim could be made. Generally speaking, FDA states that companies cannot make “a claim that expressly or implicitly characterizes the level of a nutrient of the type required to be in nutrition labeling” unless the claim adheres to existing claim regulations, which FDA does not have for characterizing a low amount of carbohydrates. FDA will allow for quantitative amounts to be declared as long as the statement does not implicitly characterize the level of the nutrient, such as “2 grams of carbs per serving.” In the absence of specific regulations for “carb” claims, companies may find this to be the safest approach.

Consumers following the keto diet will also be looking for high fat and moderate to high protein levels on labels. “High” can be listed on a food label, “provided that the food contains 20 percent or more of the RDI or the DRV per reference amount customarily consumed.” Meal product labels may also be able to include a modified “high” claim if one of the foods within the meal qualifies. A “good source” claim in relation to a nutrient may also be possible if it is present at 10 to 19 percent of the RDI or DRV.

Many consumers on the keto diet will be calculating their nutrient intake. Placing the level of protein, fats, and carbs prominently on the front label is allowed, provided that the content is also listed in the manner and locations FDA requires on all other parts of the label.

Regardless of the presence of nutrition statements, all food labels must include a compliant “Nutrition Facts” panel that includes the levels of total carbohydrates, protein, total fat, and other required nutrients.

Vegan Labeling Requirements

Vegan products claim to be free of all animal ingredients and animal by-products. The term “vegan” is not regulated by FDA but is understood to have certain meaning in the marketplace. It is possible that a trace amount of an animal product such as dairy could end up in a vegan product. For example, in January 2022, food manufacturer Amy’s Kitchen initiated a voluntary Class I recall of a vegan macaroni and cheese product due to the potential of having trace amounts of milk, which was not declared on the product label. As an animal product, milk would invalidate the common understanding of a “vegan” claim. Further complicating matters was milk’s status as a major food allergen.

FDA states that allergens contained in a food product but not named on the label are a leading cause of FDA requests for food recalls, with undeclared milk being the most common cause. Strictly speaking, the reason that the Amy’s label would have violated regulations is that it contained a potentially undeclared ingredient/allergen, and FDA requires manufacturers to list all ingredients included in a food product on the product’s label. If a dairy ingredient is included in a vegan product and is properly listed according to FDA’s requirements, it would not violate FDA’s regulations, since the agency does not regulate what vegan means

FDA also does not define absence terms such as “dairy free”, except when the term applies to gluten. These claims are allowed on labels, provided that the information is not misleading.

Plant-Based Labeling Requirements

Those who follow a plant-based diet aim to eat mostly food that is minimally processed and derived from plants instead of animals. FDA does not regulate the term “plant-based” on labels, and since there is much debate about what “plant-based” means, there is a lack of consistency among products that include the term on their labels.

In 2021, the House Committee on Appropriations released a report which “encourages the FDA to provide clarity around the labeling of plant-based foods that use traditional meat, dairy, and egg terminology.” The report noted that current labels that bear such terminology may be misleading or confusing to consumers. The report also mentioned that some “plant-based” food products claim to contain seafood, but no actual seafood ingredient is present in the food.

Subsequently, FDA has noted that it currently intends to develop draft guidances for “Labeling of Plant-Based Milk Alternatives” and “Labeling of Plant-Based Alternatives to Animal-Derived Foods”.

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.

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