Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm518515.htm
Timestamp: 2019-03-19 17:38:26
Document Index: 443728834

Matched Legal Cases: ['§ 343', 'art 101', 'art 101', '§ 343', '§ 343', '§ 343', '§ 343', '§ 343', '§ 1453']

Middlefield Original Cheese Coop 8/29/16
Warning Letter CIN-16-500180-21
Nevin R. Byler, Manager
16942 Kinsman Road
Dear Mr. Byler
The U.S. Food and Drug Administration (FDA) conducted an inspection of your food manufacturing facility located at 16942 Kinsman Road, Middlefield, OH on May 16-19, 2016. During the inspection of your facility, product labels for your cheese products were collected. We have reviewed your product labels and find that your labels cause your products to be misbranded within the meaning of section 403 [21 U.S.C. § 343] of the Federal Food, Drug, and Cosmetic Act (the Act) and the implementing regulations under Title 21, Code of Federal Regulations, Part 101 (21 CFR Part 101). You may find the Act and FDA’s regulations through links on FDA’s homepage at www.fda.gov.
1. Your Northeast Family Goat Farms Goat Sharp White Cheddar product is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the product labeling is false or misleading. Specifically, the product labeling states “No BST Hormones Added.” This product is made with goat milk rather than cow milk, as reflected in the ingredient statement in the product labeling. Recombinant bovine somatotropin (rBST) is only approved for use in lactating dairy cows under 21 CFR 522.2112(c). Because rBST is not approved for use in goats, no goat milk cheeses should contain rBST. The claim in your product labeling is misleading because it fails to reveal that fact and therefore implies that your Northeast Family Goat Farms Goat Sharp White Cheddar product differs from other brands of goat milk cheese in that the latter may be made with milk from goats treated with rBST.
2. Your Middlefield Original Cheese Certified Organic Sharp Cheddar product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product labeling bears a nutrient content claim, but the product does not meet the requirements to bear the claim. Specifically, the product’s label bears the implied nutrient content claim “healthy” in connection with “calcium-rich”; however, it does not meet the requirements to bear the claim under 21 CFR 101.65(d)(2). To bear the implied nutrient content claim "healthy," under 21 CFR 101.65(d)(2), the food, among other things, must be "low saturated fat" as defined in 21 CFR 101.62(c)(2) (i.e., saturated fat content of 1 gram or less per RACC and no more than 15 percent of calories from saturated fat). In this case, the product contains 6 grams of saturated fat per labeled serving (1 oz.). Thus, the product contains approximately 6 grams of saturated fat per RACC (30 grams).
3. Your Middlefield Original Cheese Buffalo Jack Cheese is misbranded within the meaning of 403(g) of the Act [21 U.S.C. § 343(g)]. The product appears to be represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401. The food does not appear to confirm to such definitions and standards in accordance with 21 CFR 133.153 and 21 CFR 133.193. Specifically, the product purports to be a food for which a definition and standard of identity has been prescribed by regulation under 21 CFR 133.153 for Monterey cheese and Monterey jack cheese and 133.193 for spiced, flavored standardized cheese, but the food fails to conform to such definition and standard. Your product does not meet either of these standards because neither standard provides for the addition of buffalo wing sauce. In accordance with 21 CFR 133.193, one or more safe and suitable spices and/or flavorings may be added to a standardized cheese. However, the addition of buffalo wing sauce is not within the scope of 21 CFR 133.193 because buffalo wing sauce is a multicomponent food, not a simple spice or flavor. Therefore, your product cannot be named under 21 CFR 133.193, but may be named as a combination food, e.g. “buffalo sauce-infused ____ cheese.” In addition, if your product meets the standard of identity under 21 CFR 133.153, the food must be named using the terms “Monterey cheese” or “Monterey jack cheese” in accordance with the standard.
4. Your Middlefield Original Cheese Smoked Cheddar product is misbranded within the meaning of 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] because the labels fail to declare the common or usual name of the food. Specifically, “Smoked Cheddar Cheese” is not an appropriate common or usual name for a product that is not smoked, but rather contains smoke flavor in accordance with 21 CFR 101.3(b). The accurate declarations for the characterizing flavoring of foods is provided for in 21 CRF 101.22(i).
5. Your Middlefield Original Yogurt Cheese, Middlefield Original Smoked Cheddar, Middlefield Original Certified Organic Sharp Cheddar, Middlefield Original Cheese Buffalo Jack Cheese, and Northeast Family Goat Farms Goat Sharp White Cheddar products are misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. Specifically:
a. Your Middlefield Original Cheese Yogurt Cheese, Middlefield Original Smoked Cheddar, Middlefield Original Certified Organic Sharp Cheddar, Middlefield Original Cheese Buffalo Jack Cheese, and Northeast Family Goat Farms Goat Sharp White Cheddar products are manufactured with calcium; however, this ingredient is not declared within the list of ingredients.
b. Your Middlefield Original Smoked Cheddar product fails to declare the smoke flavor used within the list of ingredients.
c. Your Buffalo Jack Cheese states buffalo wing sauce within the product’s ingredient list. Buffalo wing sauce is a multicomponent food, but the label fails to declare the sub-ingredients of the sauce in accordance with 21 CFR 101.4(b)(2).
The above violations are not meant to be an all-inclusive list of violations that may exist in connection with your products or their labeling. It is your responsibility to ensure that your products comply with the Act and its implementing regulations.
You should take prompt action to correct the violations. Failure to promptly correct the violations may result in enforcement action without further notice, including seizure and/or injunction.
We also offer the following additional comments:
Regarding your Yogurt Cheese product, the term “yogurt” may not be used in the statement of identity for the product if the product is not made with an ingredient that conforms to the standard of identity for yogurt in 21 CFR 131.200.
Regarding your Middlefield Original Cheese Buffalo Jack Cheese product, it is unclear if the term “buffalo” in the product’s statement of identity refers to the sauce or the animal source of the milk.
The statement of identity required on the PDP of your Middlefield Original Yogurt Cheese, Middlefield Original Smoked Cheddar, Middlefield Original Certified Organic Sharp Cheddar, Middlefield Original Cheese Buffalo Jack Cheese, and Northeast Family Goat Farms Goat Sharp White Cheddar products under 21 CFR 101.3 must include the full name required by the applicable standard of identity – which appears to be “cheddar cheese.”
The serving size declaration on your Middlefield Original Yogurt Cheese, Middlefield Original Smoked Cheddar, Middlefield Original Certified Organic Sharp Cheddar, Middlefield Original Cheese Buffalo Jack Cheese, and Northeast Family Goat Farms Goat Sharp White Cheddar products is not in accordance with 21 CFR 101.9(b)(5)(iii) and (7), because ounces are used without an appropriate visual unit of measure such as a dimension of a piece, e.g., 1 oz (28 g/visual unit of measure) and the common household unit is not followed by the equivalent metric quantity in parenthesis.
The net quantity of contents declaration on your Middlefield Original Yogurt Cheese, Middlefield Original Smoked Cheddar, Middlefield Original Certified Organic Sharp Cheddar, Middlefield Original Cheese Buffalo Jack Cheese, and Northeast Family Goat Farms Goat Sharp White Cheddar products does not appear on the PDP, as required by 21 CFR 101.105(a). Product weight in ounces should be followed by the metric equivalent in parenthesis [15 U.S.C. § 1453(a)(2) of the Fair Packaging and Labeling Act (FPLA)].
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations. You should include in your response any documentation necessary to show that correction has been achieved. If you cannot complete all corrections within 15 working days, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to the Food and Drug Administration, Attention: Stephen J. Rabe, Compliance Officer, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have questions regarding any issues in this letter, please contact Mr. Rabe at (513) 679-2700 extension 2163.