E9-24132. Draft Guidance for Industry: Ingredients Declared as Evaporated Cane Juice; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Guidance for Industry: Ingredients Declared as Evaporated Cane Juice.” The intent of this draft guidance is to advise industry of FDA's view that the common or usual name for the solid or dried form of sugar cane syrup is “dried cane syrup,” and that sweeteners derived from sugar cane syrup should not be declared on food labels as “evaporated cane juice” because that term falsely suggests that the sweeteners are juice.

DATES:

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on the draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by December 7, 2009.

ADDRESSES:

Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written requests for single copies of the draft guidance to Office of Nutrition, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT:

Geraldine June, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1802.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of the draft guidance entitled “Guidance for Industry: Ingredients Declared as Evaporated Cane Juice.” The intent of this draft guidance is to advise the regulated industry of FDA's view that the term “evaporated cane juice” is not the common or usual name of any type of sweetener, including dried cane syrup. Because cane syrup has a standard of identity defined by regulation in 21 CFR 168.130, the common or usual name for the solid or dried form of cane syrup is “dried cane syrup.” This guidance is being issued because the term “evaporated cane juice” has appeared on a number of food labels in recent years. FDA's current policy is that sweeteners derived from sugar cane syrup should not be declared as “evaporated cane juice” because that term falsely suggests that the sweeteners are juice as defined in 21 CFR 120.1(a).

FDA is issuing this draft guidance as a level 1 draft guidance consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on the use of the terms “dried cane syrup” and “evaporated cane juice” in food labeling. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternate approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

II. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding the draft guidance. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet may obtain the draft guidance at http://www.fda.gov/​FoodGuidances or http://www.regulations.gov.

Dated: September 29, 2009.

David Horowitz,

Assistant Commissioner for Policy.