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  5. Minerva Dairy Inc - 10/09/2014
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WARNING LETTER

Minerva Dairy Inc 09/10/2014

Minerva Dairy Inc - 10/09/2014


Recipient:
Minerva Dairy Inc


United States

Issuing Office:
Cincinnati District Office

United States


  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2775

 

Via United Parcel Service
 
October 9, 2014
 
Adam P. Mueller, President
Minerva Dairy, Inc.
430 Radloff Avenue
Minerva, Ohio 44657
 
WARNING LETTER
CIN-15-431214-02
 
Dear Mr. Mueller:
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your cheese and butter manufacturing facility located at 430 Radloff Avenue, Minerva, OH 44657, from February 28, 2014 through March 10, 2014. During the inspection of your facility, we collected product labels for your Greek yogurt butter products. We have reviewed your product labels and find that your labels cause certain 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 101). You may find the Act and FDA’s regulations through links on FDA’s home page at www.fda.gov.
 
Our review identified the following violations:
 
1.    Your All Natural Ilios Greek Yogurt Butter 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 label bears nutrient content claims, but the product does not meet the requirements to make the claims.
 
Under section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)], a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim. Characterizing the level of a nutrient on food labeling without complying with the specific requirements pertaining to the nutrient content claims for that nutrient misbrands the product under section 403(r)(1)(A) of the Act.
 
The label of your All Natural Ilios Greek Yogurt Butter product bears an implied nutrient content claim because it displays statements suggesting that the product may be useful in maintaining healthy dietary practices.  Those statements are made in connection with claims or statements about nutrients. Specifically, the label of your All Natural Ilios Greek Yogurt Butter product bears the claim “A Healthy Butter!” in connection with the following statements under the “Nutritional Facts” on your product label, which compare the fat, calorie, cholesterol, and sodium content of your product to that of butter: “15% less fat” (“When compared to butter”), “15% less cholesterol,” “10% less calories,” and “50% less sodium.”
 
However, this product does not meet the requirements for the use of the nutrient content claim “healthy” that are set forth in 21 CFR 101.65(d)(2).  In accordance with 21 CFR 101.65(d)(2), you may use the term “healthy” as an implied nutrient content claim on the label or labeling of a food provided that the food, among other requirements, is “low saturated fat” as defined in 21 CFR 101.62(c)(2) (i.e., the food has a saturated fat content of 1 g or less per Reference Amount Customarily Consumed (RACC) and no more than 15 percent of calories from saturated fat).  According to the Nutrition Facts panel, your All Natural Ilios Greek Yogurt Butter contains 6 g of saturated fat per 14 g serving of the food. This amount exceeds the maximum of 1 g of saturated fat per RACC and the maximum of 15% of calories from saturated fat in the “low saturated fat” definition.   See 21 CFR 101.62(c)(2). 
 
Furthermore, in accordance with 21 CFR 101.65(d)(2), you may use the term “healthy” as an implied nutrient content claim on the label or labeling of a food provided that the food, among other requirements, contains at least 10 percent of the Reference Daily Intake or the Daily Reference Value per RACC of one or more of the following nutrients: vitamin A, vitamin C, calcium, iron, protein, or fiber. Your All Natural Ilios Greek Yogurt Butter product contains 6% Vitamin A, 0% Vitamin C, 5% Calcium, 0% Iron, 0.5 mg of Protein, and no declared value for fiber and thus does not meet the minimum requirement of at least 10% of the percent Daily value per RACC for one or more of these nutrients. Accordingly, this product does not meet the requirement for use of the implied nutrient content claim “healthy” on a food label [21 CFR 101.65(d)(2)]. We further note that the label includes an additional implied nutrient content claim “good for you,” which is an unauthorized synonym for “healthy.
 
In addition, in accordance with 21 CFR 101.62(b)(4)(i), to bear the nutrient content claim “less fat,” a food such as your All Natural Ilios Greek Yogurt Butter must contain at least 25% less fat per RACC than the reference food. According to the product label, this product contains only “15% less fat (When Compared to Butter).” Accordingly, this product does not meet the requirement for use of the nutrient content claim “less fat” on a food label [21 CFR 101.62(b)(4)(i)].   
 
In accordance with 21 CFR 101.62(d)(4), to bear the nutrient content claim “less cholesterol,” a food such as your All Natural Ilios Greek Yogurt Butter must contain at least 25% less cholesterol per RACC than the reference food, and it must contain less than 2 g of saturated fat per RACC. According to the product label, this product contains only “15% less cholesterol (When Compared to Butter)” and 6 g of saturated fat. Accordingly, this product does not meet the requirement for use of the nutrient content claim “less cholesterol” on a food label [21 CFR 101.62(d)(4)].
 
In accordance with 21 CFR 101.60(a), a claim about the calorie content of a food may only be made on the label or labeling of a food if, among other requirements, the claim uses one of the terms defined in 21 CFR 101.60 in accordance with the definition for that term. 21 CFR 101.60(b)(4) authorizes the use of the terms “reduced calorie,” “reduced in calories,” “calorie reduced,” “fewer calories,” “lower calorie,” and “lower in calories” for foods that contain at least 25% fewer calories per RACC than the reference food.  Even if “less calories” were authorized under 21 CFR 101.60(b)(4), your All Natural Ilios Greek Yogurt Butter does not contain at least 25% fewer calories than the reference food. According to the product label, this product contains “10% less calories (When Compared to Butter).” Accordingly, the claim “less calories” is not authorized.
 
In accordance with 21 CFR 101.61(b)(6)(ii)(B), to bear the nutrient content claim “less sodium,” a food such as this yogurt butter product must, in part, declare the quantitative information comparing the level of sodium in the product per labeled serving with that of the reference food, and it must be declared adjacent to the “less sodium” claim. However, the product label for this All Natural Ilios Greek Yogurt Butter product does not include this information; accordingly, the product does not meet the requirement for use of the nutrient content claim “less sodium” on a food label [21 CFR 101.61(b)(6)(ii)(B)].
 
2.     Your All Natural Ilios Greek Yogurt Butter and (b)(4) products are misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] because the labels fail to bear the common or usual name of the food in accordance with 21 CFR 101.3(b). Specifically, the labels declare “Greek Yogurt Butter” as the statement of identity; however, butter is not an appropriately descriptive term or phrase that adequately describes the basic nature of the product. The Act of March 4, 1923 (21 U.S.C. 321a), defines butter as “the food product usually known as butter, and which is made exclusively from milk or cream, or both, with or without common salt, and with or without additional coloring matter, and containing not less than 80 per centum by weight of milk fat, all tolerances having been allowed for.” This definition does not include the addition of other ingredients. According to the product formulation sheets, yogurt powder is added to the butter during the last stage of the churning process. 
 
3.    Your All Natural Ilios Greek Yogurt Butter and (b)(4) 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 label fails to bear the common or usual name of each ingredient, as required by 21 CFR 101.4(b)(2)(ii). For example, your products are manufactured using lactic acid; however, you fail to declare lactic acid in the ingredient statements.
 
4.    Your All Natural Ilios Greek Yogurt Butter 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. For example:
  • The label fails to declare dietary fiber as required by 21 CFR 101.9(c)(6)(i).
  • The label fails to declare sugars as required by 21 CFR 101.9(c)(6)(ii).  
 
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 regulatory action without further notice, including, without limitation, seizure and injunction.
 
COMMENTS:
 
  • The Illios product label includes the phrase “pure rBST free cream”; however, the required accompanying statement, “not significant difference has been shown between milk derived from rbST-treated and non-rbST treated cow” is not included (Interim Guidance on the Voluntary Labeling of Milk and Milk Products From Cows That Have Not Been Treated With Recombinant Bovine Somatotropin, 59 FR 6279).
  • The firm name and address on the Illios product and Dutch Farm product labels does not include a street address as required by 21 CFR 101.5(d).
 
Please respond to this letter within 15 days from receipt with the actions you plan to take in response to this letter, including an explanation of each step being taken to correct the current violations and prevent similar violations. Include any documentation necessary to show that correction has been achieved. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections.
 
Please send your reply to the Food and Drug Administration, Attention: Allison C. Hunter, Compliance Officer, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have questions regarding any issues in this letter, please contact Allison C. Hunter, Compliance Officerat (513) 679-2700 extension 2134.
  
 
Sincerely,
/S/ 
Paul J. Teitell
District Director
Cincinnati District

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