- Delivery Method:
- VIA UPS
- Food & Beverages
Recipient NameJeffrey S. Burkhart and Jill L. Burkhart
- Picket Fence Creamery LLC
14583 S Avenue
Woodward, IA 50276
- Issuing Office:
- Division of Human and Animal Food Operations West II
January 14, 2022
Reference CMS #: 618726
Dear Mr. and Ms. Burkhart:
The United States Food and Drug Administration (FDA) inspected your food manufacturing facility located at 14583 S. Avenue, Woodward, Iowa 50276 on September 13-15, 2021. During our inspection of your facility, Investigators found twelve flavors of ice cream and three flavors of cheese curds contained undeclared ingredients and sub-ingredients. This caused the products to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], in that the finished product labels fails to declare ingredients and sub-ingredients, as required by section 403(i)(2) of the Act. Your firm made corrections to these issues but did not fully correct your product labels as noted in this letter. You may find the Act and further information through links in FDA’s home page at http://www.fda.gov
Your Picket Fence Creamery brand Dutch Letter! Ice Cream, Key Lime Pie! Ice Cream, and Taco! White Cheddar Cheese Curd products are 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:
1. Your Picket Fence Creamery brand Dutch Letter! Ice Cream product is manufactured using a baked “Dutch Letter” that includes multiple sub-ingredients such as flour, butter, eggs, and almond paste. Your product label only refers to the ingredient as “Dutch letters” and fails to list the sub-ingredients. Further, the product is labeled to include “almond syrup” which appears to also be a multi-ingredient product; however, your label does not list any sub-ingredients.
2. Your Picket Fence Creamery brand Key Lime Pie! Ice Cream product is manufactured using a graham cracker that has the ingredient, unbleached enriched flour, which is comprised of multiple sub-ingredients, including wheat flour, niacin, reduced iron, and thiamine mononitrate, etc. Your product label fails to list the graham cracker ingredient or it’s sub-ingredients. Your product label also fails to list the sub-ingredients of the key lime pie filling and lime syrup. Finally, you list the colors “FDC blue #1 yellow #5” in the “contains” statement which is not appropriate as they are not major food allergens as defined in section 201(qq) of the Act nor does this placement ensure that it is understood by the consumer as to the relative amount of these colors in the descending order of predominance required by 21 CFR 101.4.
3. Your Picket Fence Creamery brand Taco! White Cheddar Cheese Curd product is manufactured using a premade taco seasoning blend that includes numerous sub-ingredients, including chili pepper, wheat flour, dextrose, etc. Your product label only states “taco seasoning.” Further, your product label, as revised during the inspection, now includes two contains statements, one of which may be accurate but the one listing only milk is not accurate as it doesn’t consider the wheat flour in the taco seasoning.
According to 21 CFR 101.4(b)(2), the requirement to list these component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient [21 CFR 101.4(b)(2)(i)], or by listing the component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
We note that you have listed the allergen sub-ingredients of these ingredients in the product label “contains” statement. While this may satisfy the requirements of section 403(w) of the Act, it does not satisfy the requirements of section 403(i)(2) as noted above.
We also offer the following comments:
• A Nutrition Facts label is required for each of your products under 21 CFR 101.9 unless you meet the requirements for exemption in 21 CFR 101.9(j)(18). Otherwise, the products may be in violation of section 403(q) of the Act.
• The full street address of the firm is not listed on the revised labels. In accordance with 21 CFR 101.5(d), the statement of the place of business must include the street address, City, State, and ZIP code; however, the street address may be omitted if it is shown in a current city directory or telephone directory.
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 CGMPs, labeling regulations, 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.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Your written response should be sent to the following address: U.S. Food and Drug Administration, 8050 Marshall Drive, Suite 205, Lenexa, Kansas 66214, to the attention of Bruce E. Taylor, Compliance Officer. If you need additional information or have any questions, please contact CO Taylor at 913-495-5114 or at the above address or via email at: email@example.com.
LaTonya M. Mitchell, Ph.D.
Program Division Director
Office of Human and Animal Food
West Division II