The U.S. Food and Drug Administration (FDA) issued six warning letters between April 16-22, 2014, for food safety-related violations inspectors indicated they had observed at various establishments. Hahn’s Old Fashioned Cake Company Inc. of Farmingdale, NY, was cited April 17, 2014, for “serious violations of FDA’s Current Good Manufacturing Practice requirements.” In addition to alleged “[f]ailure to maintain equipment, utensils, and finished food containers in an acceptable condition through appropriate cleaning and sanitizing,” Hahn’s was also cited for evidence of birds and mice in the manufacturing facility, for “lubricants from the cake slicer … observed dripping into a finished crumb cake,” and for workers with “open cuts on their hands” handling product without wearing gloves. Biondillo’s Bakery LLC of Chicago, IL, was sent a warning letter dated April 17, 2014, for several violations of Current Good Manufacturing Process, inadequate cleaning and sanitizing, and for misbranding. Specifically, FDA inspectors stated that an open bag of lard was stored in a dirty basement area and uncovered dough was stored in a walk-in refrigerator. The misbranding violations related to incomplete ingredients and lack of nutritional information, as well as lack of information on product origin, FDA stated. Pancrazio S.P.A. of Cava Dei Tirreni, Italy, was cited April 18, 2014, for “serious violations” regarding the “thermal processing of low-acid foods” (specifically canned “Chick Beans in Water & Salt”) and for inadequate record-checking involving “autoclave sterilization control, fill weight, temperature data tables, production control records and container closure records” before products were shipped. In a letter dated April 18, 2014, to Iowa Select Herbs LLC of Cedar Rapids, IA, FDA stated that inspectors had “found serious violations of the Federal Food, Drug, and Cosmetic Act.” Specifically, FDA’s letter continued, the company’s “Flax Seed, Holy Basil, Papaya Leaf Extract, and Ginkgo Leaf Extract products are promoted for conditions that cause them to be drugs” and for which “therapeutic claims” were allegedly being made on the company’s website.

FDA cited River Hills Harvest (dba, Elderberrylife) of Hartsburg, MO, in a letter dated April 22, 2014, for misbranding of the firm’s “100% Pure Premium Elderberry Juice” and, in effect, using language which “promotes the product for conditions that cause the product to be a drug.” Further, the product’s juice percentage and nutritional information were not provided and/or were inadequate, FDA stated.

Misbranding violations were also cited in an April 22, 2014, warning letter from FDA to Charlemagne’s Tree Farm Ltd. (dba, Hudson Valley Homestead) of Craryville, NY. Agency officials stated that the company’s “Bushwhacker’s Hot & Spicy Savory Sauce” and “Bushwhacker’s Mild Sauce” contained allergens (specifically fish) and were misbranded because not all ingredients were listed on the labels, including trans-fat. Recipients of these warning letters have 15 working days from receipt to outline specific steps they have taken to come into compliance with the law.