Inspections, Compliance, Enforcement, and Criminal Investigations
BindMax Protein, LLC 4/11/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Minneapolis District Office|
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142
April 11, 2012
RETURN RECEIPT REQUESTED
Refer to MIN 12 -32
Christopher M. Rebholz
BindMax Protein, LLC
16595 West Stratton Drive
New Berlin, Wisconsin 53151-7301
Dear Mr. Rebholz:
The Food and Drug Administration (FDA) inspected your processing facility located at 16595 West Stratton Drive, New Berlin, Wisconsin, on December 2 and 6,2011. Our inspection found significant deviations from the food labeling regulations, Title 21, Code of Federal Regulations (21 CFR), Part 101. These violations cause your BindMax SS, BindMax Pork Flavor, and MPH20 products, distributed by your firm, to be misbranded within the meaning of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 343, in that they are not labeled with the mandatory information required by the Act. You may find the Act and the referenced CFR regulations through links on FDA's home page at www.fda.gov.
The significant violations are as follows:
1. Your BindMax MPH20 product is misbranded within the meaning of section 403(w) of the Act, 21 U.S.C. § 343(w), in that the label for this product fails to declare the known major food allergen, milk, as specified by the Act.
Section 201(qq) of the Act, 21 U.S.C. § 321(qq), defines as "major food allergens" milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils. A food is misbranded if it is not a raw agricultural commodity and it is, or it contains an ingredient that bears or contains, a major food allergen, unless either:
• the word "Contains," followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients, section 403 (w)(1)(A) of the Act, 21 U.S.C. § 343(w)(1)(A); or
• the common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g. "flour (wheat)"), except that the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the Act, 21 U.S.C. § 343(w)(1)(B).
Specifically, the product label for BindMax MPH20 is a city blend containing sweet dairy whey and partially hydrolyzed caseinate. Both ingredients are declared on the product label but the common or usual name of the major food allergen, milk, is not listed in the ingredient statement or as part of a separate "Contains" statement.
Further guidance and information on food allergens can be accessed on FDA's website at http://www.fda.gov/Food/FoodSafety/FoodAllergens/default.htm.
2. Your BindMax SS, BindMax Pork Flavor, and BindMax MPH20 products are misbranded within the meaning of section 403(i)(2) of the Act, 21 U.S.C. § 343(i)(2), in that you fail to list all the ingredients required to be declared on the label or you fail to declare the ingredients by their common or usual name, as required by 21 CFR 101.4(a)(1). For example:
• The product formulation for your BindMax SS, BindMax Pork Flavor, and MPH20 all contain the ingredient "(b)(4)," a silicon dioxide anti-caking agent; however, the ingredient is not declared on your finished product labels;
• The product label for BindMax Pork Flavor lists the ingredient "pork flavor" with the two sub-ingredients in parentheses, but according to the production blend sheets the product contains (b)(4) Spray-Dried "pork stock" as its primary ingredient. Hence, the specific pork stock ingredient must be declared on the label instead of stating the term "pork flavor";
• The product label for BindMax Pork Flavor lists "hydrolyzed soy protein" as an ingredient, but according to the production blend sheets, (b)(4) soy protein concentrate is used in these formulations, not hydrolyzed soy protein. Similarly, the product label for BindMax MPH20 lists "hydrolyzed whey and casein" in the ingredient statement; however, (b)(4) Grade A sweet dairy whey (not hydrolyzed) (b)(4) and partially hydrolyzed sodium caseinate are used in the BindMax MPH20 product according to (b)(4) who identified the ingredients in the warehouse at the time of inspection.
For additional information on General Food Labeling requirements go to http://www.fda.gov/Food/GuidanceComplianceRegulatorylnformation/GuidanceDocuments/FoodLabelingNutrition/FoodLabelingGuide/default.htm.
3. Your BindMax SS and BindMax MPH20 products are misbranded within the meaning of section 403(e)(1), 21 U.S.C. § 343(e)(1), because the product label fails to accurately declare the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5(a). Specifically, the labels in use at the time of the inspection list the mailing location of the business as "PO Box 510339" and your firm's street address is not listed in a current city or telephone directory. The statement of the place of business must include the street address; however, the street address may be omitted if it is shown in a current city directory or telephone directory, 21 CFR 101.5(d).
This letter is not meant to be an all-inclusive list of deficiencies that may exist in any of your product labeling. You are responsible for ensuring that your facility operates in compliance with the Act and the Food Labeling regulations (21 CFR Part 101). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations. You should take prompt action to correct all of the violations noted in this letter. Failure to promptly correct these deviations may result in regulatory action without further notice. Such actions include seizure and/or injunction.
We also have the following comments:
• Your BindMax SS and MPH20 products fail to bear the common or usual name of the food or an appropriately descriptive statement of identity of the product in accordance with 21 CFR 101.3(a); and
• Your firm distributes a variety of own-label dry blended seasonings and flavorings. Several of the products may be subject to U.S. Department of Agriculture, Food Safety and Inspection Service (FSIS) regulation. To the extent that many of your products may be regulated by FSIS, we defer review of those labels to that agency. Your BindMax SS, BindMax Pork Flavor, and MPH20 products are regulated by FDA, although the violations noted herein may also be applicable to FSIS products.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation, such as verification records and revised labeling, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Your reply should be directed to Compliance Officer Tyra S. Wisecup at the address indicated on the letterhead.
Joann M. Givens