- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Food & Beverages
Recipient NameMr. Gregory M. Knowles
- Dianne's Fine Desserts
4 Graf Road
Newburyport, MA 01950
- Issuing Office:
- Office of Human and Animal Food Operations East Division 1
CMS # 600026
March 2, 2020
Dear Mr. Knowles:
The United States Food and Drug Administration (FDA) has determined that your recalled peanut butter brownies labeled in chocolate turtle brownie packaging are misbranded within the meaning of section 403(w) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343(w)], in that the finished product labels did not declare a major food allergen (peanuts). Furthermore, we have determined that you did not follow the requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule) (21 CFR Part 117). The failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301 (uu) of the Act (21 U.S.C. § 331(uu)). You may find the Act and further information about the CGMP & PC rule through links in FDA's home page at http://www.fda.gov.
On December 31, 2019, after being notified by your consignee of the mispackaged product, your firm recalled peanut butter brownies that were packaged in turtle brownie labeling. You indicated in your press release that the problem “was caused by a temporary breakdown in your production and packaging processes.” In your January 13, 2020 email to the Office of Human and Animal Food Operations East Division 1 Recall Coordinator, you further stated that there had been “opportunity during product changeover to introduce pre-printed packaging material to the line before changeover is completed.” The email also stated that you have implemented corrective actions to your line clearance procedures and provided a summary of the changes, including controlling packaging on and in the area of production lines, checking and documenting that the correct packaging is on the line, utilizing photo standards of labeling, and training employees. We will verify implementation of any corrective actions during FDA’s next inspection of your facility.
You did not identify and implement preventive controls to provide assurances that any hazard requiring a preventive control (i.e., undeclared allergens) will be significantly minimized or prevented and the food manufactured, processed, packed or held by your facility will not be adulterated under section 402 or misbranded under section 403(w) of the Act, as required by 21 CFR 117.135(a)(1) and (c)(2). Specifically, your food allergen controls are not adequate at the packaging step to ensure that your finished food is not misbranded under section 403(w) of the Act as evidenced by your firm’s packaging of peanut butter brownies into containers labeled for turtle brownies. This incorrect labeling caused your product to contain an undeclared major food allergen.
Under section 201(qq) of the Act [21 U.S.C. § 321(qq)], peanuts are considered 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., “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)].
Your peanut butter brownies in chocolate turtle brownie packaging products are 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 a major food allergen (peanuts).
This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring that your facility operates in compliance with the Act, the CGMP & PC rule, and other applicable laws. You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by the FDA without further notice, including, without limitation, seizure and injunction.
We will verify implementation of any corrective actions during FDA’s next inspection of your facility. If you would like to provide further details pertaining to the corrective actions taken by your firm and provide documentation, including revised procedures and completed monitoring records that would assist us in evaluating your corrections, please notify this office in writing within fifteen (15) working days of the receipt of this letter.
If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.
Your written response should be directed to the Food and Drug Administration, attention to: W. Martin Rennells, One Winners Circle, Suite 110, Albany, NY 12205 or email at firstname.lastname@example.org. If you have questions regarding this letter, please contact W. Martin Rennells at 518-453-2314 x1038.
Program Division Director
Office of Human and Animal Food Operations
East Division 1