Dutch Letter Warning Letter

From September 13-15th, 2021 the FDA inspected a ready-to-eat (RTE) food manufacturing facility located in Iowa, called Picket Fence Creamery. The inspection resulted in the FDA issuing of a Warning Letter to the company.  During inspection FDA investigators found that twelve ice creams and three cheese curds were misbranded by having undeclared ingredients, sub-ingredients, allergens, as well as many packaging errors.

So now let’s dive into the violations listed in the Warning Letter released.

  1. The FDA cited two main ice creams and one cheese curd to highlight the infractions. It discussed specifically the failure to display the ingredient statement correctly.  It is required under section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] that when ingredients are comprised of two or more sub-ingredients, they must be listed on the ingredient statement.  In the Act it is also required that common and usual names are utilized when they have been defined to avoid misbranding. For example, Picket Fence listed “Dutch Letter” on the ingredient statement, which is made up of flour, butter, almond paste, etc. none of the sub-ingredients were listed, which is in violation of the Act.  
  2. Another flavor of ice cream (Key Lime Pie Flavor) utilizes graham crackers. Neither the graham cracker nor its sub-ingredients are listed on the ingredient statement. The FDA also noted that other sub-ingredients in ingredients such as Key Lime Pie filling and syrup was missing from the ingredient statement listing.
  3. Another violation noted by the FDA was listing colors (namely FD&C Blue #1 and Yellow #5) in the contains statement, which is used to disclose allergens.  In the USA the contains statement, if utilizing, must only include the major allergens stated in the Act. Colors are not to be listed under that statement as they do not contain any of the major allergens as well as it hinders the consumers ability to see the ingredient statement in proper descending order which is required for compliance. 
  4. Other issues noted by the FDA include comments on the requirement that each product in market MUST contain a properly formatted and appropriate nutrition facts panel (NFP) unless the firm meets the exemption requirement.
  5. Lastly, as part of a compliant information panel (IP) a complete street address and place of contact for the firm is required to be listed. 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.

To read the letter in full, click HERE

If anything in the letter sounds familiar from your facility, or you would just like to be better prepared for your own FDA inspection when the time comes, let us know. In addition to label compliance reviews, we do facility audits and consulting on following cGMPs. Contact us today to discuss your needs and get a free quote.