FDA WarningLast week, the U.S. Food and Drug Administration (FDA) issued warning letters to a veterinarian, a juice producer, and two seafood facilities – one processor and an importer. FDA wrote to Dr. Rebecca W. Allen, DVM, of Vergennes, VT, about extralabel use of approved veterinary or human drugs in animals that didn’t comply with the Federal Food, Drug, and Cosmetic Act. The vet allegedly prescribed Meloxicam Tablets and Ampicillin without establishing a substantially extended withdrawal period prior to marketing of milk, meat, eggs, or other edible products; instituting procedures to assure that the identity of the treated animal is carefully maintained, or taking appropriate measures to assure that assigned timeframes for withdrawal are met and no illegal drug residues occur in any food-producing animal subjected to extralabel treatment, FDA stated. “As a licensed veterinarian, you are responsible for complying with the requirements of the FD&C Act, including the extralabel use regulations promulgated under the FD&C Act,” the agency wrote. “You should take prompt action to correct the … violations and to establish procedures whereby such violations do not recur.” Nikki’s Ginger Tea of Detroit, MI, was cited for “serious violations” of the Juice Hazard Analysis and Critical Control Point (HACCP) regulation. According to FDA’s letter, the company did not have a HACCP plan for its 100-percent ginger root juice and 100-percent carrot juice ingredients to control the food safety hazards of pathogens. Neither did the company have a standard operating procedure that addresses sanitation conditions and practices before, during, and after processing for these juices. FDA said that the company must also apply a process directly to the juice that will consistently produce a 5-log reduction of microorganisms for the shelf life of the product, but the ginger root and carrot juices were allegedly manufactured without these treatments. According to the warning letter, the company also failed to hold raw materials and ingredients at temperatures that prevent food from becoming adulterated, the investigator observed bottles and caps being stored in open containers that were in direct contact with the floor, and the refrigerator used to store raw materials was soiled with spilled juice residue. Also, based on a review of product labels collected during inspection, FDA determined that Nikki’s Ginger Organic Carrot Apple, Nikki’s Ginger Organic Mint, and Nikki’s Ginger Organic Apple juice products were misbranded because each product contained two or more ingredients not declared on the label by its common or usual name. In addition, the products purport to contain vegetable or fruit juice but fail to include a percentage, the labeled serving sizes were provided in grams and ounces (which FDA stated is not acceptable), and the products bear or contain artificial coloring or chemical preservative but don’t state that on the label. FDA had some more comments on the products labels:

  • Your statement of identity includes “tea;” however, your products are beverages that are made from fruit and vegetable juices and do not contain any actual tea.
  • A website or email address is not an acceptable substitute for the actual name and address of the place of business of the manufacturer, packer, or distributor.
  • The net quantity of contents declarations for the 32 oz. products also declares “473ML,” which is not mathematically consistent. It is also the same milliliter declaration that is declared on the 16 oz products. Additionally, the gram and ounce information provided is not mathematically consistent.

FDA wrote to Two Rivers Smoked Fish, a seafood processing facility in Hailey, ID, about “serious violations” of seafood HACCP regulations. FDA found the company’s Smoked Steelhead, Smoked Trout, and Smoked Salmon products to be adulterated because they were prepared, packed, or held under insanitary conditions “whereby they may have been rendered injurious to health.” The agency received a letter from the owner of the company in February in response to inspector observations. The response was “partially adequate in that he has promised or initiated corrections,” FDA wrote, but “insufficient detailed evidence was provided to support implementation of the corrections.” Some alleged violations were a lack of records for the corrective action taken when the internal temperature for smoked trout deviated from the critical limit for controlling Clostridium botulinum, failure to identify a minimum or maximum temperature value for trout fillets at any stage of cooling post-cooking, failure to specify who will attend training in the application of HACCP principles to fish and fishery product processing, and not addressing who will be responsible for HACCP oversight until an employee has been trained. FDA also wrote to Chang Jiang Seafood CA, a seafood importer in Irwindale, CA, about alleged violations of seafood HACCP regulation. According to the warning letter, the company didn’t have product specifications for Frozen Fish Balls, Farm Raised Frozen Shrimp, and Wild Caught Frozen Baby Octopus that ensure the foods are not injurious to health and have not been processed under insanitary conditions. In each letter, FDA requested that the companies provide written responses detailing steps taken to bring the facilities into compliance with food-safety laws and regulations, to correct violations cited in the letters, and to prevent their recurrence. 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.