A Kentucky cattle feed manufacturer, a Vermont cheese processing facility, and a New York supplement facility are all on notice from the Food and Drug Administration for violations of federal food safety rules.
The FDA sent the warning letters to the companies in August and September, and posted them for public view in recent days. Companies are allowed 15 working days to respond to FDA warning letters. Failure to promptly correct violations can result in legal action without further notice, including, without limitation, seizure and injunction.
Burkmann Industries Inc. Danville, KY
In an Aug. 29 warning letter to company Vice President Thomas L. Hastings, the FDA described violations observed during an inspections June 2, 6 and 27, in Danville, KY. Burkmann Industries manufactured and distributed a medicated animal food which contained a superpotent concentration of Monensin in violation of the Food, Drug & Cosmetic Act.
According to the warning letter, the FDA inspected the facility when at least 23 cattle died after consuming the product, 2858 – WCN Balancer R1400 TZI, which contained elevated levels of MonensinMonensin. The event was reported to the FDA on May 30.
The FDA warning letter said evidence collected during the investigation, including facility inspection and samples, showed serious violations.
“Results from a sample obtained by FDA for this lot of cattle food found levels of Monensin at 9,070 grams per ton (10,000 mg/kg or ppm), which was 648 percent of the labeled concentration,” according to the warning letter.
The FDA says that Monensin is approved for use in medicated Type B cattle foods for growing cattle on pasture or in dry lots — stocker and feeder cattle and dairy and beef replacement heifers — for increased rate of weight gain.
The inspection also documented significant deviations from the Current Good Manufacturing Practices (CGMP) regulations for non-licensed medicated animal food manufacturers.
“This deviation from CGMP regulations for non-licensed medicated animal food manufacturers is a repeat deviation, which your firm has been cited for during inspections that occurred November/December 2014 and August/September 2015”, according to the warning letter.
The warning letter noted that the firm had recalled the identified product, promised to discontinue production of the concentrated formulations, addressed personnel issues, and intend to compensate for the loss of cattle.
“However, we do not find your promised corrections sufficient to ensure that your firm’s manufacturing processes and controls conforms to the CGMP requirements … your response does not provide any new or updated operating procedures or control steps in your manufacturing operations, or any information on how you intend to verify manufacturing steps are conducted according to your written procedures to ensure that there is no unsafe drug carryover between production runs,” according to the warning letter.
The firm was reminded that CGMP requirements apply to both medicated and nonmedicated animal food: “Steps such as cutting, drying, defatting, grinding, mixing, extruding, pelleting, and cooling, must be performed in a way that protects against the contamination of animal food.”
Taylor Farm Inc. Londonderry, VT
In an Aug. 30 letter to company owner Jonathan H. Wright, the FDA cited serious violations of the FDA’s Current Good Manufacturing Practices (CGMP) regulations, including conditions suitable for the survival and/or growth of Listeria bacteria. The FDA discovered and documented problems at the Londonderry, VT, cheese processing facility April 18 to 21, when inspectors declared the food products to have been prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health.
The FDA cited several serious CGMP violations noted during the inspection including:
- Failure to maintain equipment in an acceptable condition through appropriate cleaning and sanitizing, specifically “metal storage racks in the drying/brine tank room had apparent rust and were stored in close proximity to exposed cheese wheels. Furthermore, the exposed surface of cheese wheels aging on the metal storage racks was observed covered with rust flakes from the racks above the cheese.”
- Failure to take effective measures to exclude pests from the processing areas. Specifically, “apparent insect webbing in the left corner of the drying/brine tank room and aging room adjacent to the cooler system where exposed cheese wheels were stored,” and “three apparent rodent excreta pellets on a cloth sheet covering the cheese vat in the receiving room.”
- Failure to maintain buildings, fixtures, and other physical facilities in a sanitary condition. Specifically, “investigators observed water pooling on the floor of the drying/brine tank room.”
- Additionally, environmental swab No. 25, collected from this area of water pooling on the floor of the drying/brine tank room, confirmed the presence of Listeria innocua. As the FDA notes, “The presence of non-pathogenic Listeria species, including Listeria innocua, is indicative of conditions that are suitable for survival and/or growth of pathogenic Listeria monocytogenes.”
Nd Labs Inc. Lynbrook, NY
In a Sep. 1 warning letter to co-owner Michael A. Beller, the FDA cited serious violations of the Food, Drug, and Cosmetic Act, and determined that the firm’s misbranded conventional food and misbranded dietary supplement do not comply with FDA requirements.
The firm’s Cherry, Liquid Fiber Flow, and Nana Flakes products were declared misbranded because the products’ labeling is false and misleading in that the products are labeled and marketed as medical foods but do not meet the definition of medical food in the Orphan Drug Act or the criteria set forth in the FDA’s Title 21 of Federal Regulations.
The FDA says that under The Orphan Drug Act “medical food” is defined as “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.”
The FDA specifically stated in the warning letter that, “medical foods are not those simply recommended by a physician as part of an overall diet to manage the symptoms, or reduce the risk of a disease or condition. ”
The FDA also reviewed the firm’s website at nutritionaldesignsinc.com in Aug. 2017 and determined that the company takes orders there for several products that are established as drugs through website claims and on product labels.
According to the warning letter, “because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.”
Below are some of the product label claims:
- “Helps to relieve chronic constipation, bowel irregularity, irritable bowel syndrome, and diverticulitis … Helps lower cholesterol levels and stabilize blood sugars … and prevent diarrhea…”
- “[C]hronic constipation … lower blood cholesterol, and helps control blood sugar …”
- “Helps against Hemorrhoids, Diverticulitis, IBS, and lowers Cholesterol …”
The FDA warned the company that it is in violation because its LPS Cherry, Liquid Fiber Flow, and CVF (Cereal Vegetable Fruit Fiber) products are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner.
“Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, your LPS Cherry, Liquid Fiber Flow, and CVF (Cereal Vegetable Fruit Fiber) products fail to bear adequate directions for their intended uses and, therefore, the products are misbranded,” according to the FDA warning letter.
The products are also considered misbranded conventional food because they do not comply with the proper labeling requirements.
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