Cedar’s Cited for Misbranding

From October 25th,2021 Cedars Mediterranean Foods Inc. a ready-to-eat (RTE) food manufacturing facility was notified by a consignee of a misbranded product. The item in question, Cedar’s Organic Mediterranean Hommus, was labeled with the ingredient declaration for Organic Everything Hommus and a voluntary recall was initiated.  The FDA determined that the recalled product was 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–tree nuts (i.e., Pine Nut).

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

  1. After notification of the issue to the public through the recall system a press release stated that the product indeed “may have an incorrect back label and an undeclared allergen.”  A response to the recall coordinator explained the findings of the internal investigation which pointed to a failure to follow label changeover procedures.  This led to retraining and disciplinary action of the employee.  Cedar’s also noted that they had since implemented a label reconciliation program, which the FDA stated they would address and verify next audit.
  2. Based on the above, the FDA stated the letter that it had determined that Cedar’s had significant gaps in their labeling program. It is required that products are labeled with the Major Allergens by either a “Contains” statement or listed in the ingredient statement following the raw material which contains the allergen ( Whey (Milk)).  Failure to do so will result in a recall and regulatory action from the FDA.
  3. The FDA also stated that there was clear evidence that the company was not compliant with good manufacturing practices (21 CFR Part 117). These regulations require a company to identify and implement preventive controls to provide assurances that any hazard requiring a preventive control (e.g., undeclared allergens) will be significantly minimized or prevented and the food manufactured, processed, packed, or held by facilities will not be adulterated.

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.