In recent days the Food and Drug Administration made public warning letters sent to owners of dairy and a feedlot, and producers of salsa and coconut products for violating federal food safety laws.

Companies receiving warning letters have 15 days to respond in writing to FDA. If companies fail to correct problems, their products can be seized and their owners can be court ordered to stop operations.   

Response must include each step taken or planned to be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, owners are required to state the reason for the delay and the time frame within which the corrections will be completed.

To protect “confidential corporate information,” the FDA routinely redacts information in warning letters, using (b)(4) to indicate where information has been blacked out.

Lakeview Dairy LLC — Beaver Dam, WI
Inspectors from the FDA checked operations at the Fox Lake, WI, location of Lakeview Dairy LLC from June 7-28. They found the company had illegally sold a cow for slaughter that was intended for use as human and was contaminated with excessive levels of a drug, according to a warning letter sent to co-owners Michael D. Roecker and Bruce G. Walker.

The warning letter states the cow was sold for slaughter on Feb. 2. Analysis of tissue samples from the animal conducted by the USDA’s Food Safety and Inspection Service showed the presence of desfuroylceftiofur, a marker residue for ceftiofur, at 1.508 parts per million (ppm) in the kidney tissue. FDA has established a tolerance of 0.4 ppm for residues of ceftiofur in the uncooked edible tissue of cattle.

Investigators also found the dairy operators “failed to maintain complete treatment records. Your records did not include the amount of drug administered, the site of administration, milk/meat withhold times, and the name of the person who administered the drug.”

The dairy operators also used the drug illegally because they did not follow label directions and did not have a veterinarian’s prescription for that use.

“You admitted to administering (b)(4) for a duration of nine days rather than the five-day period directed in the approved labeling. Your treatment records indicate that you routinely administer (b)(4) for longer than the five-day period directed in the approved labeling.

“You also admitted to administering a final dose of (b)(4) on Jan. 30, 2018, and shipping this animal on Feb. 1, 2018, sooner than the end of the four-day meat withhold period directed in the approved labeling. Your extralabel use of (b)(4) was not under the supervision of a licensed veterinarian and your extralabel use of this drug resulted in an illegal drug residue.

As of the sending of the warning letter on Oct. 19, the dairy owners had not responded to a Form FDA-483 inspection report issued on June 28.

Circle G Farms & Feed Lots Inc. Oregon, IL
In an Oct. 16 warning letter, FDA officials told the president and vice president of Circle G Farms & Feed Lots Inc. that they had illegally sold a culled steer for slaughter that was intended for use as human and was contaminated with excessive levels of a drug.

Inspectors also found that Robert E. Groenhagen, president, and Gary R. Groenhagen, vice president, allowed animals to be held “under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply.” 

“Specifically, our investigation revealed that on or about Dec. 20, 2017, you sold a culled steer for slaughter as food,” according to the warning letter, which states the steer was slaughtered the same day it was sold.

 “The United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 4.785 parts per million (ppm) of sulfamethazine in the liver tissue. FDA has established a tolerance of 0.1 ppm for residues of sulfamethazine in uncooked edible tissues of cattle.”

FDA investigators also found the owners of the cattle operation did not maintain any treatment records, as required by federal food safety laws. They also failed to adequately identify treated animals, according to the warning letter.

“Our investigation found that you administered (b)(4) orally for gut issues to a steer without following the route of administration and approved conditions as stated in the approved labeling. According to its labeling, (b)(4) is only to be given to treat (b)(4) and to be given by subcutaneous injection,” the FDA warning letter states.

Casa Pablo’s Salsa LLC Missoula, MT
Failure to properly address the food safety hazard of Clostridium botulinum, which causes botulism poisoning, is just one of the serious violations cited in an Oct. 16 warning letter sent to Dominic Alonzo and Robert Powell, managing members of Casa Pablo’s Salsa LLC.

Inspectors reviewed the operations of the salsa production operation for almost a month, May 29 through June 20. At the conclusion of the inspection, an FDA investigator issued the company a Form FDA-483 Inspectional Observations report that lists the serious violations found at your facility. As of the Oct. 16 warning letter, the company had not responded to FDA regarding the violations.

The salsa company operators did not have required distribution information that is required for traceback and during the inspection an employee told FDA officers the company does not maintain distribution records for specific food lots. Also, according to the warning letter, the salsa company operators do not have a recall plan in case they need to pull back products because of food safety concerns. 

“… during the inspection, your employee stated you do not have a written recall plan and have not implemented recall procedures or programs for your acidified food products.”

The FDA inspectors also found multiple violations at the production facility, including:

• failure to maintain equipment, including utensils and food containers, in an adequate condition through appropriate cleaning and sanitizing as necessary:
• visible food debris on the dicing blade, chopping blade, and chute for the (b)(4) machine. At the time of this observation, this piece of equipment was identified as clean and ready for use, and subsequently was observed used in the production of salsa products;
• red residue was observed in the well at the bottom of the (b)(4) where the outlet pipe is located. This piece of food manufacturing equipment was identified as clean, sanitized, and ready for use;
• cleaned and sanitized utensils were set to dry in pooled water adjacent to the third compartment of the dishwashing sink;
• buildings, fixtures, and other physical facilities were not maintained in a clean and sanitary condition, and the investigator observed exposed insulation in the ceiling of the warehouse where finished product packaging is stored. This insulation was observed hanging from the ceiling over exposed finished product packaging.
• failure to ensure that all persons working in direct contact with food, food-contact surfaces, and food packaging material conform to hygienic practices while on duty to the extent necessary to protect against contamination of food. Specifically, the investigator observed an employee handling clean produce with gloved hands after touching non-food contact surfaces such as a soiled refrigerator door handle and boxes with the same gloved hands.

Original Living Coconut LLC Stockton, MO
Claims that its coconut products can kill viruses including HIV and measles, as well as repel tapeworms and lice and relieve pain from hemorrhoids, earned Original Living Coconut LLC a warning letter for marketing an illegal drug.

“Your Coconut Cream Dessert, Raw Coconut Cream, and Virgin Cold-pressed Coconut Oil 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 use for a layperson to use your firm’s products safely for their intended purposes,” according to the warning letter.

The Oct. 10 letter to company representative Renee E. Ainlay, the FDA references inspections on Jan. 2 and 4 and Feb. 8. During those inspections, FDA investigators collected product labels for the company’s Coconut Cream Dessert flavors including Vanilla Bean, Chocolate, Sugar Free Vanilla Bean, Salted Caramel, Lemon Crème, Cinnamon Roll, Caramel Mocha Latte, Sugar Free Chocolate; Raw Coconut Cream flavors including Lime and Honey, Chocolate; and Virgin Cold-pressed Coconut Oil.   

“We also printed screenshots from your website at the Internet address http://www.originallivingcoconut.com/ and discussed concerns about potential disease claims on your website. Your website was again reviewed on or about Aug. 14, 2018, and it was determined that you take orders there for your products,” according to the FDA warning letter. 

“The claims on your product labeling, including your website, establish that your firm’s products are drugs … because they are intended for use in the cure, mitigation, treatment, or prevention of disease.”

The warning letter references an alleged testimonial on the company website from a woman whose 14 years of “kidney disease that produced stones, diabetes, high blood pressure, spinal meningitis and more” was resolved by consumption of raw coconut cream. FDA investigators also reported the Original Living Coconut website claims coconut is used worldwide to treat abscesses, asthma, baldness, bronchitis, bruises, burns, colds, constipation, cough, dropsy, dysentery, earache, fever, flu, gingivitis, gonorrhea, … (sic) jaundice, kidney stones, lice, … (sic) rash, scabies, scurvy, skin infections, sore throat, swelling, syphilis, toothache, tuberculosis, tumors, typhoid, ulcers, upset stomach, … (sic) and wounds.” 

The company also claims: “Published studies in medical journals show that coconut, in one form or another, may provide a wide range of health benefits. Some, as quoted by FDA inspectors after reviewing lables and website information from the company, are:

• “Kills viruses that cause influenza, herpes, measles, hepatitis C, SARS, AIDS, and other illness.
• “Kills bacteria that cause ulcers, throat infections, urinary tract infections, gum disease and cavities, pneumonia, and gonorrhea, and other diseases.
• “Kills fungi and yeasts that cause candidiasis, ringworm, athlete’s foot, thrush, diaper rash, and other infections.
• “Expels or kills tapeworms, lice, giardia, and other parasites.
• “Reduces symptoms associated with pancreatitis.
• “Helps relieve symptoms and reduce health risks associated with diabetes.
• “Reduces problems associated with malabsorption syndrome and cystic fibrosis.
• “Helps protect against osteoporosis.
• “Helps relieve symptoms associated with gallbladder disease.
• “Relives symptoms associated with Crohn’s disease, ulcerative colitis, and stomach ulcers.
• “Relieves pain and irritation caused by hemorrhoids.
• “Reduces inflammation.
• “Supports tissue healing and repair.
• “Helps protect the body from breast, colon, and other cancers.
• “… improves cholesterol ratio reducing risk of heart disease;
• “Protects arteries from injury that causes atherosclerosis and thus protects against heart disease.
• “Helps prevent periodontal disease and tooth decay.
• “Helps to protect the body from harmful free radicals that promote…degenerative disease.
• “Helps relieve symptoms associated with chronic fatigue syndrome.
• “Relieves symptoms associated with benign prostatic hyperplasia — prostate enlargement.
• “Reduces epileptic seizures.
• “Helps protect against kidney disease and bladder infections.
• “Dissolves kidney stones.
• “Helps prevent liver disease.
• “Helps prevent obesity and overweight problems.
• “Applied topically helps to form a chemical barrier on the skin to ward of [sic] infection.
• “Reduces symptoms associated the [sic] psoriasis, eczema, and dermatitis.
• “Provides protection from damaging effects of ultraviolet radiation form [sic] the sun.
• “Helps control dandruff.”

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