The FDA cited Juicer Connections, Inc. after a facility inspection in late 2022. This warning letter highlights the labeling violations and the implications of those violations. The company was cited for HACCP monitoring, implementation, verification, and recordkeeping violations, but namely the misbranding label violations stood above all else. So, let’s dive into the warning letter!
Not often do we see a warning letter that really addresses labeling errors on almost the entire label front to back.
- On the package there were vignettes/imagery that depicted many fruits and vegetables, most of which were not actual ingredients in the product, nor present as flavors. We always tell clients, the images you choose are considered claims, so think before you place.
- The product also stated that it was “pasteurized for safety” however, that was not a truthful statement, as the juice was instead subject to high pressure processing (HPP) and the statement is misleading.
- Several of the products in their line did not declare ingredients by their common/usual name. This is a requirement of the FDA. Names such as “carrot (con)” were used in place of “carrot juice concentrate” in the ingredient statement.
- A juice/beverage product that appears to potentially contain juice is required to declare “contains___% juice” on the label, which is required. Remember, even “juicy imagery” can trigger this type of warning requirement.
- Upon inspection the FDA discovered that there were ingredients used in formulation that were not declared in the ingredient statement.
- The serving size was incorrect. The reference amount customarily consumed (RACC) for a juice is 240ml. The product was labeled at 16oz (476ml), which for products which are individually packaged, is between 67-200% the RACC, thus requires the entire bottle to be labeled as 1 serving, it was labeled inaccurately and thus the nutrition information provided was not based on an accurate single serving. RACC seems like a small risk that many companies take, but we see this type of infraction time and time again in warning letters.
- On the NFPs, there were several issues.
- Dietary Fiber and Total sugars were incorrectly labeled at 0, even though total carbohydrates were 22g.
- Rounding rules for the micro and macronutrients were incorrect. Namely, quantitative amounts of potassium, calcium, and iron must use certain UoM and levels of significance.
- The products failed to disclose that they were “from concentrate” on the label.
- The statement of identity (SOI) was missing from the products. All products are required to have an appropriately descriptive statement on the PDP which identifies the product. As this was a juice a statement such as “juice or juice beverage” needed to be directly declared.
- The labels also failed to include a proper declaration of place of manufacture, packer, or distributor, which includes the name of business, street address (unless can be found in local directory), city, state, and zip code.
- The net quantity of contents statement was also incorrect and was not written in terms of fluid measure as the products were liquid.
- Lastly, ingredients such as citric acid and ascorbic acid were added to the product as a preservative. The ingredient statements failed to declare these ingredients not only by common name but also failed to include a separate descriptor of function e.g. “as a preservative” or something similar.
This warning letter can be used as a reminder that what may start as one infraction can quickly steamroll into many. The last thing companies want is an FDA warning letter, which can be costly.
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.