Food

Cheese Product Facility - Onetik, SAS

DEPARTMENT OF HEALTH & HUMAN SERVICES

March 29, 2012

VIA OVERNIGHT DELIVERY

Mr. Xavier Maurance
President
Onetik, SAS
RD 252
64240 Macaye
France

Reference No.: 273976

Dear Mr. Maurance:

The Food and Drug Administration (FDA) conducted an inspection of your facility on December 1 – 2, 2011.  During the inspection, labels of your Le Montcayol, Prairiol, Tomme Noire Des Pyrénées, and Saint-Paulin cheese products were collected.  FDA has reviewed the labeling for these products, and based on our review, we have concluded that these products are in violation of the Federal Food, Drug and Cosmetic Act (the Act), and the implementing food labeling regulations in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101).  You may find these regulations through links in FDA’s home page at www.fda.gov.

Ingredient Statements

Your Le Montcayol, Prairiol, Tomme Noire Des Pyrénées, and Saint-Paulin cheese products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they are fabricated from two or more ingredients but the labels fail to list the common or usual name of each ingredient, in accordance with 21 CFR 101.4. Food additives are listed on your labels using E numbers, which are not the common or usual names for the ingredients. For example, “E235” should be declared on the label as Natamycin.

The declared ingredients on the English label for your Saint-Paulin product are not consistent with the French label; “E160b,” “E350,” and “E180” are listed on the English label, while only “E235” is listed on the French label. You should determine the correct ingredients for this product and correct both labels accordingly. Note that “E160b” is listed under 21 CFR 73.30 as Annatto extract, which is not required to be declared on butter, cheese, or ice cream in the U.S. [21 CFR 101.22(k)(3)]. Voluntary declaration of all colorings added to butter, cheese, or ice cream is, however, recommended. If you choose to declare this color additive, you may declare it as “Artificial Color,” “Artificial Color Added,” or “Color Added” (or by an equally informative term), or by its listed name [21 CFR 101.22(k)(2)].

Net quantity

Your Le Montcayol, Prairiol, and Tomme Noire des Pyrénées products are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the product labels fail to bear the net quantity of contents in accordance with 21 CFR 101.105.

Additionally, the net quantity of contents statement on your Saint-Paulin product must be placed as a distinct item in the bottom 30 percent of the principal display panel as required by 21 CFR 101.105(e).

Dual Language Requirement

Your Prairiol, Tomme Noire des Pyrénées, and Saint-Paulin products are misbranded with the meaning of section 403(f) of the Act [21 U.S.C. § 343(f)] because the product labels contain information in two languages but do not repeat all the required label information in both languages. As required by 21 CFR 101.15(c)(1), all information required to appear on the label must appear in English. Your Prairiol product does not repeat the ingredient statement in English, including a declaration in English of the common food allergen “milk”, and your Tomme Noire des Pyrénées product does not contain an ingredient statement or a statement of identity in English. Additionally, as required by 21 CFR 101.15(c)(2), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. Your Saint-Paulin product contains French representation, but does not contain a statement of identity in French.

Nutrition labeling

Your Saint-Paulin product is misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. For example, there is no trans fat declaration as required [21 CFR 101.9(c)(2)(ii)]. The calories, nutrients, and percent Daily Values declared are not all rounded to the nearest reference increment as required [21 CFR 101.9(c)]. The label fails to use hairlines, bars, and bold type in an appropriate format as defined.

It appears that this product is a bulk food intended to be sold for use only in establishments in which food is served for immediate consumption, and not served to the consumer in the package in which it is received. If this is the case, your product would be exempt from nutrition labeling in accordance with 21 CFR 101.9(j)(2). Conversely, if there is a reasonable possibility that the product will be purchased directly by consumers, nutrition information is required. In any case, if you choose to provide nutrition labeling when exemptions apply, you must do so in accordance with 21 CFR 101.9.

The English label of your Saint-Paulin product appears to contain misspellings and errors in required statements. For example, “servings par container” should be changed to “servings per container” and the statement, “Your daily valued may be higher or lower depending on your choice needs,” should be changed to, “Your Daily Values may be higher or lower depending on your calorie needs.”

Color additives

Your Le Montcayol and Prairiol cheese products appear to be adulterated within the meaning of section 402(c) of the Act [21 U.S.C. § 342(c)] because they contain a color additive, identified on your labels as “E153,” which is unsafe within the meaning of section 721(a) of the Act [21 USC § 379e(a)]. “E153” is Vegetable Carbon, which is not permitted for use in coloring food that is marketed in the U.S.

Your Saint-Paulin cheese product also appears to be adulterated within the meaning of section 402(c) of the Act [21 U.S.C. § 342(c)] because it appears to contain a color additive, identified on your label as “E180,” which is unsafe within the meaning of section 721(a) of the Act [21 USC § 379e(a)]. “E180” is Lithol Rubine BK, which is the E.U. equivalent of the pigment certifiable as D&C Red No. 7 for use in coloring drugs and cosmetics. D&C Red No. 7 is not permitted for use in coloring food that is marketed in the U.S. Although you stated during the inspection that these colorants are used in the polyvinyl acetate spray packaging and do not migrate into the finished product, the colors may, in fact, come into contact with the food during the act of spraying. Furthermore, polyvinyl acetate spray packaging is not an adequate barrier to migration and thus, these non-permitted colors may migrate into the finished product.

Statement of Identity

The statements of identity on several of your products are not presented in bold type on the principal display panel (PDP) and are not in a size reasonably related to the most prominent printed matter on the PDP in accordance with 21 CFR 101.3(b) and (d). Brand names are not considered to be statements of identity and should not be unduly prominent compared to the statement of identity. For example, “Le Montcayol” and “Prairiol” appear to be brand names, while “cheese with green pepper” appears to be the statement of identity; thus, “cheese with green pepper” should be larger in prominence on the PDP.

The above violations are not meant to be an all-inclusive list of violations that exist in connection with your products and labeling.  It is your responsibility to ensure that the products you market are in compliance with the Act and regulations.

Please notify this office, in writing, within thirty (30) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur.  Include any documentation necessary to show that correction has been achieved.  If corrective actions cannot be completed within thirty working days, state the reason for the delay and the time within which the corrections will be completed.

Your response should be directed to Carrie Lawlor, U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Compliance, Division of Enforcement, 5100 Paint Branch Parkway (HFS-608), College Park, Maryland 20740. If you have any questions regarding any issues in this letter, please contact Ms. Lawlor at (240) 402-0315 or via e-mail at carrie.lawlor@fda.hhs.gov.

Sincerely,

/S/

Jennifer A. Thomas
Director
Division of Enforcement
Office of Compliance
Center for Food Safety
and Applied Nutrition

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