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Cheese Manufacturing Facility - Quesos La Vasco Navarra S.A.

FDA Logo Seal

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service
Food and Drug Administration
College Park, MD 20740

 

May 17, 2012

 

VIA OVERNIGHT DELIVERY

Mr. Ramon Perez de Albéniz
General Manager
Quesos La Vasco Navarra S.A.
Apartado de Correos 45
Alsasua, Navarra
Spain 31800

 

Re: 303919

 

Dear Mr. Perez de Albéniz:

 

The Food and Drug Administration (FDA) conducted an inspection of your facility on November 17 – 18, 2011.  During the inspection, labels of your Albéniz Queso de Oveja, Albéniz Queso Semi Curado, Albéniz Queso Ibérico Viejo, La Vasco Navarra Idiazabal Cheese, and V d Navarra Queso Madurado de Oveja cheese products were collected for review.  Subsequently, on January 13, 2012, you provided FDA with revised labels for your products. FDA has reviewed the revised 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 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.

FDA was not provided with a revised label for your Albéniz Queso Ibérico Viejo product.  The revised labels provided included Albéniz Queso Ibérico Curado instead.  It is unclear whether the Albéniz Queso Ibérico Viejo is the same product as Albéniz Queso Ibérico Curado; however, we have commented on the latter.  You should ensure all of your labels are in compliance with the Act and regulations.

Your Albéniz Queso de Oveja, Albéniz Queso Semi Curado, Albéniz Queso Ibérico Curado, and V de Navarra Queso Madurado de Oveja 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 or 21 CFR 101.22(j) in the case of a chemical preservative ingredient.  For example,

  • The ingredient list for Albéniz Queso de Oveja declares “preservative E1105             b(4) ” however, the common or usual name of the preservative is not declared in accordance with 21 CFR 101.22(j) and 21 CFR 101.4.
  • The ingredient lists for Albéniz Queso de Oveja and V de Navarra Queso Madurado de Oveja include European Union e-numbers.  The use of e-numbers is not provided for in 21 CFR 101.4.
  • The ingredient list for Albéniz Queso Ibérico Curado appears to group the milk ingredients by declaring “Raw cow’s and sheep’s milk.”  The grouping of milk from different animal sources is not provided for in 21 CFR 101.4.  These ingredients must be declared in descending order of predominance.
  • The ingredient list for Albéniz Queso Semi Curado includes the term “lactic ferments.”  It is unclear what this ingredient is.

Your cheese products are 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,

  • The calories, nutrients, and percent Daily Values declared on your Albéniz Queso de Oveja, Albéniz Queso Semi Curado, Albéniz Queso Ibérico Curado, La Vasco Navarra Idiazabal Cheese, and V d Navarra Queso Madurado de Oveja cheese product are not all rounded to the nearest reference increment as required for your products [21 CFR 101.9(c)].
  • The label for your La Vasco Navarra Idiazabal Cheese uses the linear format for the nutrition label.  The linear format for nutrition information may only be used if the product has a total surface area available to bear labeling of less than 12 square inches, or if the product has a total surface area available to bear labeling of 40 or less square inches and the package size or shape cannot accommodate a standard vertical column or tabular display on any label panel according to 21 CFR 101.9(j)(13)(ii).  If the product meets the requirements to use a linear format, it must comply with the format requirements in this section.
  • Your Albéniz Queso de Oveja and Albéniz Queso Semi Curado product labels state that the servings per container are varied; however, if the net weight of your product is, in fact, 3 kg, the servings per container is not varied and should be indicated on your label.  In accordance with 21 CFR 101.9(b)(8)(iii), the use of the term “varied” for the number of servings per container is for random weight products only.
  • The serving sizes on all of your labels are not declared in accordance with 21 CFR 101.9(b)(5)(vi) and 101.12(b) because they do not include a visual unit of measure.
  • The labels for Albéniz Queso de Oveja, Albéniz Queso Semi Curado, La Vasco Navarra Idiazabal Cheese, Albéniz Queso Ibérico Curado, and V de Navarra Queso Madurado de Oveja do not include the full footnote required in 21 CFR 101.9(d)(9).  The use of the abbreviated footnote “Percent Daily Values are based on a 2,000 calorie diet” is provided only for packages that have a total surface area available to bear labeling of 40 or less square inches (21 CFR 101.9(j)(13)(ii)(C)) or for the simplified nutrition label format (21 CFR 101.9(f)(5)).

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 may be exempt from nutrition labeling in accordance with 21 CFR 101.9(j)(2) and 101.9(j)(9).  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.

Your Albéniz Queso Ibérico Curado, La Vasco Navarra Idiazabal Cheese, and V d Navarra Queso Madurado de Oveja 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, your Albéniz Queso de Oveja and Albéniz Queso Semi Curado products fail to declare the terms “Net Weight” as required by 21 CFR 101.105(j)(3).

Your Albéniz Queso de Oveja, Albéniz Queso Semi Curado, Albéniz Queso Ibérico Curado, La Vasco Navarra Idiazabal Cheese, and V d Navarra Queso Madurado de Oveja cheese 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).

It appears that you plan on using the “Spanish” label along with the “English” label.  We do not know how the labels will be displayed on the finished product; however, please note that the “English” label must not cover any of the mandatory information on the “Spanish” label.  Additionally, the labeling information in all languages must meet US labeling requirements.

Your labels are also misbranded under section 403(f) of the Act [21 U.S.C. § 343(f)] because the statement of identity on your La Vasco Navarra Idiazabal Cheese product is not in a size reasonably related to the most prominent printed matter on the PDP in accordance with 21 CFR 101.3(d) and 21 CFR 101.15(a).  Brand names are not considered to be statements of identity and should not be unduly prominent compared to the statement of identity.  For example, “Idiazabal” and “La Vasco Navarra” appear to be brand names, while “Mature sheep’s milk cheese” appears to be the statement of identity; thus, “mature sheep’s milk cheese” 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 Thomas
Director
Division of Enforcement
Office of Compliance
Center for Food Safety
and Applied Nutrition