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COMPLIANCE POLICY GUIDE (CPG)

CPG Sec 525.800 Tomato Sauce or Tomato Hot Sauce Labeling November 2005

Final
Issued by:
Guidance Issuing Office
Office of Inspections and Investigations
Human Foods Program

BACKGROUND:

No standard of identity has been established for tomato sauce or tomato hot sauce.

However, in the case of U.S. v. 254 cases, et al, "Baby Brand Tomato Sauce," Uddo and Taormina Company, Claimant, the Court recognized that "There seems to be no question but that dealers in, and consumers of, tomato products generally throughout the United States consider tomato sauce to be a spiced product containing not less than 8.37% of salt-free tomato solids" (63 F. Supp. 916).

In the same case, a finding was made that "Spanish Style" tomato sauce usually is made with added spice and pepper (sweet peppers or hot peppers) and that such tomato sauce can be made by adding cayenne pepper to tomato puree. In TC-309, dated August 20, 1940, we commented on the proposed labeling of "tomato hot sauce" which we assumed was "The usual product prepared from tomato puree, peppers, and possibly spices and other seasonings."

In TC-309 we explained that, since no standard of identity had been established for "tomato hot sauce" it would be necessary to declare the presence of all ingredients in accordance with section 403(i)(2) of the Federal Food, Drug, and Cosmetic Act.

We explained further in TC-309 that tomato puree might be declared as "tomato puree" unless the puree is made in whole or in part from residual tomato material from canning, and/or residual tomato material from partial extraction of juice, in which case the label of the tomato sauce should bear the additional declaration required by the standard for labeling of tomato puree which includes either or both of these optional ingredients.

POLICY:

Although no standard of identity has been established for tomato sauce, it should consist of a spiced tomato product concentrated to contain not less than 8.37 percent of salt-free tomato solids. It may be made by adding spices to tomato puree.

" Spanish Style" or "tomato hot sauce" contains added pepper(s). It, too, should contain a minimum of 8.37 percent of salt-free tomato solids.

Labels for tomato sauce *and tomato hot sauce must list each ingredient by common or usual name in descending order of predominance by weight in accordance with 21 CFR 101.4(a)(1)*.

If puree used to make tomato sauce has been made in whole or in part from either residual material for canning or residual material after partial extraction of juice, its label declaration as an ingredient in the tomato sauce should be accompanied by the statements required by 21 CFR *155.191(a)(3)*.

*Material between asterisks is new or revised.*

Issued: 12/3/73

Reissued: 10/1/80, revised 5/05

Updated: 11/29/05

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

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All comments should be identified with the title of the guidance.

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