Sep
10
2018

Stay away from water-based King Bio brands.

That’s the warning the US Food and Drug Administration (FDA) gave to veterinarians, pet owners, and parents last week.

“These products may pose a safety risk to people (especially infants, children, pregnant women, and those with compromised immune systems), as well as to pets due to high levels of [waterborne] microbial contamination identified at the manufacturing site,” the agency said in a statement.

The FDA issued the warning as the company expanded an initial recall of these products, made by King Bio Incorporated of Asheville, North Carolina, under the brand name Dr. King’s. King Bio manufactures a range of products for pets as well as for children and adults. The affected pet products are intended for pets that have urinary incontinence, anxiety, allergies, muscle and joint pain, arthritis, and digestion problems.

The full list of recalled products can be found here.

The recalls began in July, when King Bio voluntarily recalled three homeopathic products intended for people because of confirmed microbial contamination. On August 22, the company expanded the recall to include 32 products. On August 23, the FDA recommended that the company expand the recall again to include all products that use water as an ingredient.

King Bio complied late last week, at which point the water-based pet products were added to the list. The FDA also recommended that pet owners and veterinary professionals stop using these products and dispose of them immediately.

Several microbial contaminants were found in the recalled products, including Burkholderia multivorans, which is a strain of bacteria called Burkholderia cepacia complex that can cause illness in people with compromised immune systems.

Veterinary professionals and pet owners should report adverse events or quality problems associated with the use of King Bio products here.

A message from King Bio founder Franklin King posted on the company website says, “While there have been no reports of illness or injury due to any of our products, we chose to issue the recall out of an abundance of caution.”

All of the products on the recall list are homeopathic remedies, which means they’re not regulated by the FDA and do not have to follow standards to ensure that they’re safe and effective.

The FDA may not have any bite when it comes to homeopathic remedies, but they have plenty of bark. In their statement, the agency said, “These unapproved drugs may cause significant and even irreparable harm if they are poorly manufactured, which can lead to contamination, or contain active ingredients that aren’t adequately tested or disclosed to patients.”

The agency goes on to point out that products labeled as homeopathic can contain a wide range of substances—including those derived from diseased animal or human sources—that the FDA has no legal standing to inspect or monitor. In the absence of any official oversight, these homeopathic products are often marketed as “natural, safe, and effective” alternatives to FDA-approved prescription and nonprescription products.

They can be sold online and in major retail stores without fear of censure.

It’s not the first time King Bio has been caught in the FDA’s crosshairs; earlier this year, the agency says, the FDA joined with the Federal Trade Commission in sending the company a warning letter for illegally marketing products to “prevent, cure, or treat opioid addiction.”

The products in question, while perhaps homeopathic and maybe even natural, were not approved for that use.

Photo credit: © iStock/humonia

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