FDA issues draft guidance for honey labeling (FDA)

FDA issues draft guidance for honey labeling (FDA)

Published: Wednesday, April 9, 2014

Editor's Note: This draft guidance summarizes FDA's legal authority over honey and honey products and provides a commonly used definition of honey. FDA also provides draft guidance on labeling issues like the floral source of honey, blends of honey and other sweeteners and blends of honey and other ingredients, such as flavors. It also describes some of the measures FDA takes to guard against honey adulterated with cane sugar, corn syrup, or residues of chloramphenicol or fluoroquinolones.

 

Food and Drug Administration
April 8, 2014

Draft Guidance for Industry: Proper Labeling of Honey and Honey Products

Labeling of Honey: Questions and Answers (Q&A)

What is honey?

Reference materials in the public domain define honey as "a thick, sweet, syrupy substance that bees make as food from the nectar of flowers and store in honeycombs." 2,3 FDA has concluded that this definition accurately reflects the common usage of the term "honey."

How shall I name my honey or honey product?

If a food contains only honey, the food must be named "honey," which is its common or usual name. The common or usual name may also include the source of the honey, such as "Clover Honey," on the label. (See Q&A 3 below.) Because honey is a single ingredient food, you do not need to include an ingredient statement on the label. However, you must include all other mandatory information (e.g., net weight).

Do I have to declare the floral source of honey?

No. You do not have to declare the floral source of honey on the label. However, you may label the honey with the name of the plant or blossom, if:

The particular plant or blossom is the chief floral source of the honey, such as "Orange Blossom Honey" or "Clover Honey" and

You, or the honey producer, can show that the plant or blossom designated on the label is the chief floral source of the honey. (See FDA Compliance Policy Guide, section 515.300.)

If a food consists of honey and a sweetener, such as sugar or corn syrup, can I label the food as only "honey"?

No, a product consisting of honey and a sweetener cannot be labeled with the common or usual name "honey." The food is a blend or a mixture of honey and another sweetener. You must sufficiently describe the name of the food on the label to distinguish it from simply "honey" (21 CFR 102.5(a)).

If a food consists of honey and a sweetener, such as sugar or corn syrup, how shall I label the food?

For a food consisting of honey and a sweetener, you must label the food with:

The common or usual name, which must be a name that accurately identifies or describes the basic nature of the food or its characterizing properties or ingredients; for example:

"Blend of honey and sugar," if the food has more honey than sugar (likewise, "Blend of honey and corn syrup," if the food has more honey than corn syrup).

"Blend of sugar and honey," if the food has more sugar than honey (likewise, "Blend of corn syrup and honey," if the food has more corn syrup than honey).

The common or usual name of each ingredient in the ingredient statement. In this case, the label would show "honey" and "sugar," (likewise, "honey" and "corn syrup") in descending order of predominance by weight in the ingredient statement because the food is made from two or more ingredients (see section 403(i) of the FD&C Act, 21 CFR 102.5(a), and 21 CFR 101.4(a)(1)).

All other mandatory labeling information (e.g., net weight).

If a food consists of honey and another ingredient, such as natural raspberry flavor, how shall I label the food?

For a food consisting of honey and another ingredient, such as natural raspberry flavor, you must label the food with:

The common or usual name, which must be a name that accurately describes the food, such as "raspberry flavored honey."

The common or usual name of each ingredient, in this case, "honey," and "natural flavor." (See section 403(i) of the FD&C Act, 21 CFR 102.5(a), and 21 CFR 101.22(h)(1).)

How would consumers know whether the food is honey, a blend of honey and another sweetener (e.g., sugar or corn syrup), or honey that contains flavoring agent (e.g., natural raspberry flavor) or other ingredients?

Consumers would know what the food is and what the food contains by reading the label. A properly labeled package of only honey would show the name of the food as "honey," and it would not need an ingredient statement because it would only contain one ingredient. In comparison, a properly labeled package of a blend of honey and a sweetener would have a name such as "blend of honey and sugar" (likewise, "blend of honey and corn syrup") and an ingredient statement that lists each ingredient, such as "honey" and "sugar" (likewise, "honey" and "corn syrup"). Similarly, a properly labeled package of honey with natural raspberry flavor would have a name such as "raspberry flavored honey" and an ingredient statement that lists each ingredient, such as "honey" and "natural flavor."

How would consumers know if a food product that contains two or more ingredients contains honey?

Consumers would know that a food product contains honey by reading the ingredient statement. A properly labeled food product would list the ingredient by its common or usual name, "honey," in the ingredient statement.

What enforcement authorities does FDA have for food products that are represented as "honey," but contain other ingredients?

FDA's enforcement authorities for food products that are represented as "honey," but contain other ingredients, are described below.

Case A: A product is labeled as "honey," but it contains natural raspberry flavoring. The ingredient statement lists only "honey."

According to section 403(i) of the FD&C Act, a food is misbranded unless the label bears (1) the common or usual name of the food and (2) the common or usual name of each ingredient, if the food is made from two or more ingredients. In this case, the name of the food "honey" does not accurately describe that the food is a raspberry flavored honey, which is a characterizing flavor; this is not an appropriate common or usual name under 21 CFR 102.5(a). Moreover, the ingredient statement lists only one ingredient, "honey," when the food contains "honey" and "natural flavoring." Therefore, FDA can take enforcement action against the food for being misbranded.

Case B: A product is labeled as "honey," but it contains honey and another sweetener, such as sugar or corn syrup. The ingredient statement lists only "honey."

Under section 402(b) of the FD&C Act, a food is adulterated if any valuable constituent has been omitted in whole or in part or if any substance has been added so as to reduce the quality of the food or make it appear to be better or of greater value than it is. In this case, the food is represented as honey when another sweetener (e.g., sugar or corn syrup) has been substituted in part for honey. The food is then labeled as "honey." Honey is considered a more valuable food than a food that contains both honey and sugar (likewise, a food that contains both honey and corn syrup).4 Therefore, we can take enforcement action against the food for being adulterated under section 402(b)(1) of the FD&C Act because a valuable constituent (honey) has been omitted in part, section 402(b)(2) of the FD&C Act because a substance (sugar or corn syrup) has been substituted in part, and/or under section 402(b)(4) of the FD&C Act because a substance (sugar or corn syrup) has been added to the honey so as to increase its bulk or weight or make it appear better or of greater value than it is.

Further, we may take additional enforcement action against the food for being misbranded under section 403 of the FD&C Act due to improper labeling of the food; i.e., the name of the food and the ingredient statement (see Case A and Q&A 5).

Case C: A product, labeled as "honey," contains residues of chloramphenicol and fluoroquinolones.

A food is adulterated if it contains residues of chloramphenicol or fluoroquinolones (see section 402(a)(2)(C) of the FD&C Act). Therefore, we can take enforcement action against honey that bears residues of chloramphenicol or fluoroquinolones for being adulterated.

Some imported packages of honey are adulterated with cane or corn sugars while some are adulterated with residues of chloramphenicol and fluoroquinolones. How does FDA monitor such adulterated honey products?

We have a long-standing import alert for surveillance of honey for adulteration with cane or corn sugars. In addition, we have import alerts recommending that field personnel detain without physical examination imported honey that appears to contain residues of chloramphenicol and fluoroquinolones. Such a product would not be released into U.S. distribution until we determined that the product was not adulterated or misbranded. ...

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