The FDA today released a Draft Guidance that offers a definition for “honey” without formally establishing a standard of identity and cites to existing laws and regulations to respond to questions regarding the proper labeling of honey and honey products. The Draft Guidance follows FDA’s 2011 denial of a petition for a standard of identity for honey based on the 2001 Revised Codex Alimentarius Commission’s Standard for honey. According to FDA, a standard of identity for honey is not necessary to promote honesty and fair dealing because honey already has a commonly understood meaning as “a thick, sweet syrupy substance that bees make as food from the nectar of flowers and store in honeycombs.”

In the Draft Guidance, FDA explains that products that contain ingredients other than honey, as defined above, would be misbranded and potentially adulterated under the Federal Food, Drug & Cosmetic Act (FDCA) if they are labeled as “honey” without disclosing the other ingredients. For instance, the Draft Guidance notes that products that contain both honey and a sweetener should employ a common or usual name that clearly discloses both ingredients (e.g., “blend of honey and sugar” or “blend of corn syrup and honey”) consistent with 21 C.F.R. 101.25(a). Products that contain a flavoring ingredient should similarly disclose that ingredient as part of the common or usual name (e.g., “raspberry flavored honey”).

In addition to misbranding violations, the Draft Guidance notes that a product that fails to disclose the presence of a less valuable constituent such as a non-honey sweetener would be considered adulterated under FDCA section 402(b), which prohibits the addition of any substance to “make [the food product] appear better or of greater value than it is.” The Draft Guidance notes that FDA has a longstanding import alert for honey with cane or corn sugars and honey that appears to contain residues of chloramphenicol and fluoroquinolones.

While comments can be submitted on guidance documents at any time, FDA asked for comments within 60 days in order to ensure consideration prior to work on any forthcoming finalized version of the guidance.