- Solomon Snacks and Bakery, LLC
- Issuing Office:
- Minneapolis District Office
| || |
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
January 5, 2016
Via UPS Overnight Delivery
Refer to MIN 16 - 05
Veronica O. Anczarski
Solomon Snacks and Bakery, LLC
833 ThirdStreet SW
New Brighton, Minnesota 55112
Dear Ms. Anczarski:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your food manufacturing facility located at 833 ThirdStreet SW, New Brighton, Minnesota, on July 30-31 and August 4, 2015. We reviewed your product labels and find that your labels cause your products to be 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 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 homepage at www.fda.gov.
1. Your Solomon’s Bread product is misbranded within the meaning of section 403(w) of the Act, 21 U.S.C. § 343(w), in that the finished product label fails to declare major food allergens, wheat and milk, as required by section 403(w)(1) of the Act.
Section 201(qq) of the Act, 21 U.S.C. § 321(qq), defines 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, as “major food allergens.” 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., “Whey (Milk),” 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 Solomon’s Bread product is manufactured using flour that contains wheat. Additionally, your Solomon’s Bread product is manufactured using margarine that contains milk.
2. Your Solomon’s Bread product is misbranded within the meaning of section 403(i)(2) of the Act, 21 U.S.C. § 343(i)(2), in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. For example, your Solomon’s Bread product is manufactured using the ingredients “Margarine” and “Winona flour” which are multi-component ingredients in that they contain two or more ingredients. However, you fail to list all the sub-ingredients on your finished product label. In addition, lemon juice is also not declared.
3. Your Solomon’s Bread product is misbranded within the meaning of section 403(q) of the Act, 21 U.S.C. § 343(q), in that the label does not include the nutrition information as required by 21 CFR 101.9 and the firm has not filed for a Small Business Nutrition Labeling Exemption.
The violations cited in this letter are not intended to be an all-inclusive statement of labeling violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complieswith all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
We also offer the following comments:
- We note that the address does not declare a street address or ZIP code. The street address may only be omitted if it is shown in a current city directory or telephone directory, 21 CFR 101.5(d).
- The net weight is not declared in accordance with 21 CFR 101.105(j)(1) in that it does not declare the net weight in ounces in addition to the pounds. Additionally, it should be followed by the metric equivalent in parenthesis, 15 U.S.C. § 1453(a)(2) of the Fair Packaging and Labeling Act.
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 re-inspection-related costs. 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 re-inspection-related costs.
Within 15 working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. 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.
Your response should be addressed to Compliance Officer Dianna C. Sonnenburg at the address indicated on the letterhead.
Michael Dutcher, DVM