Source: https://www.naturalgrocers.com/products/vendors/sample-fda-warning-letter-to-small-business/
Timestamp: 2018-02-22 07:14:36
Document Index: 9248507

Matched Legal Cases: ['art 101', '§ 343', '§ 343', '§ 321', '§ 343', '§ 343', '§ 343', '§ 343', '§ 343', '§ 343', 'art 101']

Sample FDA Warning Letter to Small Business | Natural Grocers
Sample FDA Warning Letter to Small Business
We love small businesses, and we love new food companies with unique, local products. If you do too, then you may be dreaming up your next innovative and tasty product idea. Please take a moment to read the Warning Letter from the FDA reprinted below. We do not know Muddypaws cheesecake bakery personally, nor are they a vendor of ours. However, you can see that this family start-up did not fully appreciate just how involved the federal government is in food labeling, not to mention food safety, marketing, advertising, etc. No one is too small to fly below the FDA radar.
Please know the federal, state, and local rules governing your products and comply with them to avoid warnings, relabeling, withdrawals, recalls and the like. But don’t give up… you can do it. We are sure that Muddypaws is now well on their way to compliance and we wish them the best with their product line.
We would also like to point out that the letter was written after a full FDA on-site inspection of Muddypaws facility. On site inspections are now more common under the Food Safety Modernization Act. Kudos to the Chef whose clean kitchen met all health and safety measures with nary a mention from the Feds.
Too bad the FDA doesn’t send out “You Are Fabulous” letters, too!
Refer to MIN 11 – 44
Tami J. Cabrera Weimann
Muddypaws Cheesecake Co.
St. Louis Park, Minnesota 55426-3100
Dear Ms. Weimann:
We inspected your processing facility located at 7600 W. 27th Street, St. Louis Park, Minnesota, on May 17-18, 2011. Our inspection found significant deviations from the food labeling regulations, Title 21, Code of Federal Regulations (21 CFR), Part 101. These violations cause the cheesecake 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 FDA’s regulations through links on FDA’s home page at www.fda.gov1.
1. Your cheesecake products are misbranded within the meaning of section 403(w) of the Act, 21 U.S.C. § 343(w), in that the label fails to declare the major food allergens present in the products 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 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, many of your cheesecake products, such as Raspberry Swirl, Caramel Swirl, Chocolate Decadence, and Chocolate Marble are made with cream cheese, eggs, sour cream, butter, and graham cracker crumbs. However, your product label fails to declare the allergens milk, egg, and wheat. Your Caramel Swirl cheesecake also contains soy lecithin, but your label fails to declare soy.
2. Your cheesecake products are misbranded within the meaning of section 403(i)(2) of the Act, 21 U.S.C. § 343(i)(2), because your products are fabricated from two or more ingredients, but fail to bear the common or usual name of each ingredient as specified by 21 CFR 101.4. For example, your cheesecake varieties such as Raspberry Swirl, Caramel Swirl, Chocolate Decadence, and Chocolate Marble contain several ingredients; however, your labels do not contain a declaration of ingredients.
3. Your cheesecake product labels are misbranded within the meaning of section 403(k), 21 U.S.C. § 343(k), in that your cheesecake products bear artificial flavor and chemical preservatives but fail to bear labeling stating that fact. For example,
Your Raspberry Swirl, Caramel Swirl, Chocolate Decadence, and Chocolate Marble cheesecake varieties contain artificial flavor but your label fails to declare this ingredient in accordance with 21 CFR 101.22(h).
Your Caramel Swirl cheesecake contains the chemical preservatives potassium sorbate and sodium benzoate, but your label fails to declare these ingredients in accordance with 21 CFR 101.22(j).
4. Your cheesecake products are misbranded within the meaning of section 403(e)(2) of the Act, 21 U.S.C. § 343(e)(2), in that the label fails to include an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count, in accordance with 21 CFR 101.105(a).
5. Your cheesecake products are misbranded within the meaning of section 403(e)(1), 21 U.S.C. § 343(e)(1), in that the packages do not contain the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5(d). Specifically, your labels fail to include the state and ZIP code of your place of business.
We also have the following comments about your labeling:
We note that your cheesecake product labels fail to bear a statement of identity. In accordance with 21 CFR 101.3(a), the principal display panel of a food in package form shall bear as one of its principal features a statement of the identity of the commodity.
In accordance with 21 CFR 101.13(n), any of your product labels that bear nutrient content claims such as Sugar Free and Reduced Fat are not exempt from nutrition labeling requirements found in 21 CFR 101.9.
We note that you offer a Low Carb Cheesecake. Only nutrient content claims which are defined in the regulations may be made on the label or in the labeling of foods, 21 CFR 101.13(b). There are no nutrient content claims defined in the regulations for carbohydrates.
We note that your cheesecake product labels fail to bear a Nutrition Facts panel as required by 21 CFR 101.9. Your firm may be eligible for certain exemptions from nutrition labeling requirements, such as the Small Business Nutrition Labeling Exemption. We recommend you review the nutrition labeling exemptions in 21 CFR 101.9(j)(18), or see http://www.fda.gov/Food/LabelingNutrition/FoodLabelingGuidanceRegulatorylnformation/2
SmallBusinessNutritionLabelingExemption/default.htm33 for information on filing for an annual exemption. The application may be submitted online at https://www.accessdata.fda.gov/scripts/NLE/client/login.cfm44.
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.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant 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.