The FDA sent warning letters to the companies in August and October, posting 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.
Bovina Dairy LLC
In an Aug. 30 warning letter to owner Jared R. Hettinga, the FDA described violations observed during a inspection visits on May 16- 17 at the Bovina Dairy LLC operation in Farewell, TX. Investigators found that the firm holds animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the human food supply.
The FDA’s inspectors discovered the firm sold a culled dairy cow for slaughter as human food.
“On or about Jan. 27, Preferred Beef Group Booker, Texas, slaughtered this animal,” according to the warning letter. During routine testing of tissue samples from the animal the USDA’s Food Safety and Inspection Service (FSIS) found the presence of the antibiotic Sulfamethazine in the liver at 0.123 parts per million (ppm).
The legal limit under federal law is 0.1 ppm for residues of Sulfamethazine in the edible tissues of beef cattle.
The dairy owner also failed to maintain adequate treatment records, according to FDA inspectors. Records on hand did not include the drug administered, dosage given, route of administration, the person that administered medication and documentation of the withdraw dates for the first day of treatment.
“Further, you did not have a system in place to review treatment records prior to offering an animal for slaughter for human food, to assure that drugs have been used only as directed and that appropriate withdrawal times have been observed,” according to the warning letter.
The dairy owner responded to the FDA’s warning letter, but it was “not adequate” in that it did not include “an example process to maintain accurate records for future reference that includes all required information for medication records.” The firm also did not include an example of their updated treatment protocols for sulfamethazine, penicillin G procaine, Ceftiofur and florfenicol.
“You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur,” the FDA advised.
As a producer of animals offered for use as food, firms are responsible for ensuring that their overall operation and the food they distribute is in compliance with the law.
Snyder’s Lance Inc.
In an Oct. 4 warning letter to company president and CEO Brian J. Driscoll, the FDA described violations found through a routine sample collected from a retail showed the firm’s product nutrition labels were not in compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s requirements.
The company produces many well-known snack brands including Snyder’s of Hanover, Archway Lance, Cape Cod, Emerald and Pop Secret.
“FDA analyzed the sample of your Lance Toast Chee Cracker to determine whether the nutrition information on your Nutrition Facts panel accurately reflects the nutrient content of the product,” according to the warning letter.
“The product label states one serving is one package/6 crackers and contains 10 percent of the Daily Value for iron. However, the sample analysis performed by FDA found the product to contain 51.7 percent (in the) original and 57.2 percent (in the) check of the declared amount.”
FDA declared the product to be misbranded because the label is false or misleading.
“Specifically, the iron content is less than 80 percent of the amount declared on the label,” the warning letter states.
The FDA found additional labeling problems:
The information panel labeling does not meet the requirements in 21 CFR 101.2(e) because the bar code is intervening material within the ingredient list.
The product label does not declare the street address of the firm. Under 21 CFR 101.5(d), the street address is required unless it is shown in a current city directory or telephone directory.
The FDA recently finalized new requirements for nutrition labeling on May 27, 2016. The new Nutrition Facts label includes updates to the required nutrient declarations and formatting requirements. More information on the new requirements of the Nutrition Facts Label can be found on the FDA’s website.