[Federal Register Volume 86, Number 169 (Friday, September 3, 2021)]
[Notices]
[Pages 49548-49549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19096]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-4844]


``Ruby Chocolate'' Deviating From Identity Standard; Temporary 
Permit for Market Testing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
extension of a temporary permit issued to Barry Callebaut U.S.A. LLC 
(the applicant) to market test products (designated as ``ruby 
chocolate'') that deviate from the U.S. standards of identity for cacao 
products. The extension allows the applicant to continue to evaluate 
commercial viability of the product and to collect data on consumer 
acceptance of the product in support of a petition to establish a 
standard of identity for ``ruby chocolate.'' We also invite other 
interested parties to participate in the market test.

DATES: The new expiration date of the permit will be either the 
effective date of a final rule establishing a standard of identity for 
``ruby chocolate'' that may result from the petition or 30 days after 
denial of the petition.

FOR FURTHER INFORMATION CONTACT: Marjan Morravej, Center for Food 
Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740, 240-402-2371; or Carrol 
Bascus, Center for Food Safety and Applied Nutrition, Office of 
Regulations and Policy (HFS-024), Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740, 240-402-2378.

SUPPLEMENTARY INFORMATION: In accordance with Sec.  130.17 (21 CFR 
130.17), we issued a temporary permit to Barry Callebaut U.S.A. LLC, 
600 West Chicago Ave, Suite 860, Chicago, IL 60654, to market test 
products identified as ``ruby chocolate'' that deviate from the 
requirements of the standards of identity for cacao products in part 
163 (21 CFR part 163) (84 FR 64541, November 22, 2019). We issued the 
permit to facilitate market testing of products that deviate from the 
requirements of the standard of identity for cacao products issued 
under section 401 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 341). The permit covers limited interstate marketing tests of 
products identified as ``ruby chocolate.'' These test products deviate 
from the U.S. standards of identity for cacao products (Sec. Sec.  
163.111, 163.123, 163.124, 163.130, 163.135, 163.140, and 163.145).
    For the purpose of this permit, ``ruby chocolate'' is the solid or 
semi-plastic food prepared by mixing and grinding cacao fat with one or 
more of the cacao ingredients (namely, chocolate liquor, breakfast 
cocoa, cocoa, and low-fat cocoa), citric acid, one or more of optional 
nutritive carbohydrate sweeteners. ``Ruby chocolate'' contains not less 
than 1.5 percent nonfat cacao solids, not less than 2.5 percent by 
weight of milk fat, not less than 12 percent by weight of total milk 
solids, not more than 1.5 percent of emulsifying agents, and not more 
than 5 percent of whey or whey products. It may also contain other 
ingredients such as antioxidants approved for food use, spices, natural 
and artificial flavorings, and other seasonings. However, these other 
ingredients cannot imitate the flavor of chocolate, milk, butter, 
berry, or another fruit. Additionally, ``ruby chocolate'' contains no 
added coloring. The test product ``ruby chocolate'' contains the 
principal ingredients used in most of the current standards for cacao 
products under part 163; however, it deviates from the current standard 
of identify for chocolate products in terms of its final composition, 
taste, and color.
    On February 19, 2021, the applicant asked us to extend the 
temporary permit so the applicant could have more time to market test 
the ``ruby chocolate'' and gain additional consumer acceptance in 
support of the petition to establish a standard for ``ruby chocolate.'' 
We find that it is in the interest of consumers to extend the permit 
for continued market testing of ``ruby chocolate'' to gain additional 
information on consumer expectations and acceptance. Therefore, under 
Sec.  130.17(i), we are extending the temporary permit granted to Barry 
Callebaut U.S.A. LLC for temporary marketing of approximately 60 
million pounds (27,215,540 kilograms) of ``ruby chocolate'' to provide 
continued market testing of the specified amount of product for the 
applicant on an annual basis. The test products will bear the name 
``ruby chocolate.'' The new expiration date of the permit will be 
either the effective date of a final rule establishing a standard of 
identity for ``ruby chocolate'' that may result from the petition or 30 
days after denial of the petition. All other conditions and terms of 
this permit remain the same.
    In addition, we invite interested persons to participate in the 
market test under the conditions of the permit, except for the 
designated area of distribution. Any person who wishes to participate 
in the extended market test should notify, in writing, the Branch 
Chief, Product Evaluation Labeling Branch, Division of Food Labeling 
and Standards, Office of Nutrition and Food Labeling, Center for Food 
Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740. The notification must describe 
the amount to be distributed, the area of distribution, and include the 
labeling that will be used for the test product (see Sec.  130.17(i)). 
For information on what to include in the notification to FDA, see 
Sec.  130.17(c). Test products must be labeled in accordance with 21 
CFR part 101.


[[Page 49549]]


    Dated: August 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy
[FR Doc. 2021-19096 Filed 9-2-21; 8:45 am]
BILLING CODE 4164-01-P