Inspections, Compliance, Enforcement, and Criminal Investigations
Med-Diet Laboratories, Inc. 4/10/12
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 10, 2012
RETURN RECEIPT REQUESTED
Refer to MIN 12 -31
Donald L. Tymchuck
3600 Holly Lane North, Suite 80
Plymouth, Minnesota 55447-1286
Dear Mr. Tymchuck:
The Food and Drug Administration (FDA) conducted an inspection of your facility located at 3600 Holly Lane North, Suite 80, Plymouth, Minnesota, on November 8 and 10, 2011. During the inspection, product labels were collected. Our review of your labels reveals that your Med Diet brand (low sodium products) Brown Gravy Mix, Instant Chicken Flavored Broth & Seasoning Mix, and Beef-Like Soup Base Mix-Clear products are misbranded within the meaning of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 343, and the implementing regulations contained within Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You may find the Act and the referenced FDA regulations through links on FDA's internet home page at www.fda.gov.
The significant violations are as follows:
1. Your Brown Gravy Mix and Instant Chicken Flavored Broth & Seasoning Mix products are misbranded within the meaning of section 403(w) of the Act, 21 U.S.C. § 343(w), in that the labels fail to declare all major food allergens present in the product, as required by section 403(w)(1) of 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 certain exceptions, e.g., highly refined oils derived from a major food allergen. A food is misbranded under section 403(w) of the Act 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 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, your Brown Gravy Mix contains whey from cow's milk as an ingredient, and based on the ingredients shown on your website at http://www.med-diet.com/p-846-med-diet-chicken-broth-packet.aspx, your Instant Chicken Flavored Broth & Seasoning Mix contains hydrolyzed soy protein. However, the case label for your Brown Gravy Mix fails to declare the presence of the major food allergen, milk, and your Instant Chicken Flavored Broth & Seasoning Mix case label and individual packet label fail to declare soybean.
2. Your Beef-Like Soup Base Mix-Clear 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 label bears a nutrient content claim but does not meet the requirements to make the claim. Under section 403(r)(1)(A) of the Act, 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 in food labeling without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(1)(A) of the Act. The label of your Beef-Like Soup Base Mix-Clear product bears the claim "low sodium," which meets the definition of a nutrient content claim because it characterizes the product's level of sodium which is a nutrient of the type required to be in nutrition labeling, 21 CFR 101.13(b). Under 21 CFR 101.61(b)(4), foods may only use a "low sodium" claim on their label or in their labeling if they contain 140 milligrams or less sodium per Reference Amount Customarily Consumed (RACC) greater than 30 grams. The RACC for soup is 245 grams, 21 CFR 101.12(b)--Table 2, which is 8.28 fluid ounces. The Nutrition Facts information for this product states that a 6 fluid ounce serving contains 140 milligrams of sodium. Based on this labeling information, an 8.28 fluid ounce serving necessarily contains more than 140 milligrams of sodium. Therefore, the amount of sodium per RACC contained in your product is greater than 140 milligrams and your product does not meet the requirements to bear a "low sodium" claim.
3. Your Beef-Like Soup Base Mix-Clear case label is misbranded within the meaning of section 403(i)(1) of the Act, 21 U.S.C. § 343(i)(1), in that it does not bear an adequate common or usual name of the food. Specifically,
• The term "Beef-Like" is not an appropriately descriptive term as required by 21 CFR 101.3(b)(3).
• In addition, the name of this food does not.meet the requirements in 21 CFR 101.22(i) for declaration of a characterizing flavor. For example, if the food is one that is commonly expected to contain a characterizing food ingredient, e.g., strawberries in "strawberry shortcake," and the food contains natural flavor derived from such ingredient and an amount of characterizing ingredient insufficient to independently characterize the food, or the food contains no such ingredient, the name of the characterizing flavor may be immediately preceded by the word "natural" and shall be immediately followed by the word "flavored" in letters not less than one-half the height of the letters in the name of the characterizing flavor, e.g., "natural strawberry flavored shortcake" or "strawberry flavored shortcake," 21 CFR 101.22(i)(1)(i). In addition, if the food contains any artificial flavor that simulates, resembles, or reinforces the characterizing flavor, the name of the food must be accompanied by the common or usual name of the characterizing flavor, and the name of the characterizing flavor must be accompanied by the word(s) "artificial" or "artificially flavored" (e.g., "artificially flavored beef), 21 CFR 101.22(i)(2). We note that your product does not contain any beef and contains natural and artificial flavor; therefore, the term "beef-like" does not adequately characterize the flavor of your product.
4. Your Instant Chicken Flavored Broth & Seasoning Mix is misbranded within the meaning of section 403(i)(2) of the Act, 21 U.S.C. § 343(i)(2), in that it is fabricated from two or more ingredients. However, both the individual packet and the case label fail to bear the common or usual name of each ingredient in the product as required by 21 CFR 101.4(a)(1).
5. Your Brown Gravy Mix, Beef-Like Soup Base Mix-Clear, and Instant Chicken Flavored Broth & Seasoning Mix are misbranded within the meaning of section 403(q)(1) of the Act, 21 U.S.C. § 343(q)(1), in that their labels fail to bear nutrition labeling as required by 21 CFR 101.9. Specifically,
• Your Instant Chicken Flavored Broth & Seasoning Mix individual packet label and case label do not bear any nutrition information.
• Your Brown Gravy Mix and Beef-Like Soup Base Mix-Clear case labels do not bear adequate nutrition information as required by 21 CFR 101.9(c). The case labels do not provide information about the levels of the following nutrients: Calories from Fat, Saturated Fat, Trans Fat, Cholesterol, Dietary Fiber, Sugars, Vitamin A, Vitamin C, Calcium and Iron.
If your products qualify to use the simplified format for nutrition labeling, the statement "Not a significant source of _" (with the blank filled in as specified in 21 CFR 101.9(f)(4)) must be included at the bottom of the Nutrition Facts panel.
• Your Brown Gravy Mix and Beef-Like Soup Base Mix-Clear case labels do not bear nutrition information in the format required by 21 CFR 101.9(d). For example, your information is not set off in a box; the headings Nutrition Facts, Amount Per Serving, and % Daily Values are missing; % Daily Values are not provided; nutrients are not aligned, bolded or indented as necessary; nutrients are not separated by bars or hairlines as appropriate; footnote is missing; and quantitative information for nutrients is not rounded appropriately.
• The serving size on your case labels for your Brown Gravy Mix and Beef-Like Soup Base Mix-Clear products is not declared as required by 21 CFR 101.9(b). As required by 21 CFR 101.9(b)(2)(iii), the serving size for non-discrete bulk products shall be the amount in household measure that most closely approximates the reference amount for the product category. The RACC for Sauces, Dips, Gravies and Condiments, Minor main entree sauces (e.g., gravy) is % cup and the RACC for Soups, All varieties is 245 grams, 21 CFR 101.12(b)--Table 2. Therefore, the serving size should be the amount of your products in household measure needed to prepare % cup of gravy or 245 grams of soup because, as required by 21 CFR 101.9(b)(9), the declaration of nutrient and food component content shall be on the basis of food as packaged or purchased.
6. Your Instant Chicken Flavored Broth & Seasoning Mix is misbranded within the meaning of section 403(e)(1) of the Act, 21 U.S.C. § 343(e)(1), in that the case label fails to bear the place of business of the manufacturer, packer, or distributor as required by 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. Please take prompt action to correct all of the violations noted in this letter. Failure to promptly correct these violations may result in regulatory action without further notice. Such actions include seizure and/or injunction. It is your responsibility as top management to ensure that your establishment is in compliance with all FDA requirements.
We also note, and request that you address, the following:
A. The label for Beef-Like Soup Base Mix-Clear that was collected during the inspection is missing ingredient information, possibly due to printer and/or label alignment problems.
B. Your ingredient declaration on your Beef-Like Soup Base Mix-Clear case label differs from the ingredients shown on your website www.foodseroiceexpress.com. The website ingredient declaration for your product includes soy protein and partially hydrogenated soybean oil; however, your case label does not include these ingredients. Your labels and labeling must bear an accurate list of ingredients as required by 21 CFR 101.4.
C. Your Instant Chicken Flavored Broth & Seasoning Mix case label only provides a numeric count. As required by 21 CFR 101.105(c), when the declaration of quantity of contents by numerical count does not give adequate information as to the quantity of food in the package, it shall be combined with such statement of weight, measure, or size of the individual units of the foods as will provide such information.
D. Your Brown Gravy Mix and Beef-Like Soup Base Mix-Clear case labels fail to declare metric equivalents in parenthesis following the net weight declarations, 15 U.S.C. § 1453(a)(2) of the Fair Packaging and Labeling Act (FPLA).
Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including costs related to reinspection. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, 21 U.S.C.§ 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any costs related to re-inspection.
We received a post-inspection response dated November 15, 2011, from Jed R. Williams, Director of Operations. The response states that your firm has contacted the manufacturer of the products to initiate a redesign of the labels, but there is no detailed commitment on the scope, timing, or details of the corrections. Thus, the response does not sufficiently address the violations cited in this letter.
You should notify this office in writing within 15 working days of receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Your reply should be directed to Compliance Officer Timothy G. Philips at the address indicated on the letterhead.
Joann M. Givens