The maker of wide-ranging “water-based homeopathic medicines” has recalled 32 products marketed to children and infants due to microbial contamination, according to an announcement posted on the Food and Drug Administration’s website this week.
The announcement does not provide any specifics about the contamination or potential risks. However, the North Carolina-based manufacturer behind the recall, King Bio, issued a similar announcement back in July. At that time, the company recalled three other products after an FDA inspection found batches contaminated with the bacteria Pseudomonas brenneri, Pseudomonas fluorescens, and Burkholderia multivorans.
Pseudomonas brenneri is a bacterium recently found in natural mineral waters, and its clinical significance is murky. However, Pseudomonas fluorescens is known to be an opportunistic pathogen, causing blood infections, and Burkholderia multivorans can cause infections in people with compromised immune systems and cystic fibrosis. It was also recently found to be a rare but emerging cause of meningitis.
King Bio did not respond to Ars’ request for comment on the contamination, its potential source, or the company’s actions to prevent further contamination. Ars did not initially find any information about the recall on King Bio’s website, but the site has since been updated (see update below).
The site does, however, boast of the company’s safety and cleanliness, saying that the company uses “an extensive water purification process to ensure our customers receive clean and healthy medicines” and that it has gone further than FDA guidelines to “ensure the highest quality standards” in its manufacturing.
It is so far unclear what went wrong with those assurances. The company’s recall notice published by the FDA only says that:
The notice then provides a long list of products and their health claims—which are rather extraordinary.
Homeopathic products, as Ars readers are likely familiar, are those based on a pseudoscientific belief that substances generating similar symptoms to an ailment can cure that ailment, aka the “law of similars.” The potentially dangerous substances are generally safe to consume because homeopaths believe that “vigorous shaking” and excessive dilution—often to the point where no atoms of the original substance remain—make them more effective. As King Bio puts it, this preparation “potentizes” the substances.
While that explanation defies basic scientific principles, homeopaths usually generate innocuous placebos, marketed as “natural” remedies, with unfounded, if not remarkable, health claims. That is certainly the case for King Bio.
King Bio’s product called “Kids Candida,” for instance, is said to be for “symptomatic relief of Candida yeast overgrowth.” However, this one product also claims to relieve: “lack of assertiveness, forgetfulness, spacey, poor concentration, irritable, moody, weak muscles, itchy skin and head, overexcitement and fearfulness[sic].”
Similarly, a product called “Children’s Growth & Development” is claimed to be “a natural aid for: impaired growth weak, muscular growth” and also “loss of confidence.” The company’s “DK Attention & Learning Enh” product claims to be “a natural aid for: slow or difficult comprehension, overexcitement, writing wrong words or syllables, oversensitivity, forgetfulness, lack of assertiveness, shyness, apprehension.”
A tonic for newborns is said to relieve “restlessness,” and the company’s infant teething product claims to treat a baby’s “desire to be held constantly.” The company’s “Children’s Fever Reliever” also somehow reduces “fears” and “oversensitivity.”
In 2016, the Federal Trade Commission announced it would begin cracking down on homeopathic product labeling. Labeling would have to clearly indicate that the products do not have any scientific evidence of efficacy and that homeopathic notions are not accepted by the modern medical community.
Likewise, the FDA announced last December that it would boost enforcement of manufacturing and safety regulations for homeopathic products. The announcement followed several other homeopathic recalls in which products marketed to children were found to be contaminated. In the most high-profile case, homeopathic teething products were found to contain toxic belladonna, aka deadly nightshade. Those products were linked to illnesses in 400 children and the deaths of 10 babies.
UPDATE 8/24/2018: King Bio updated its website to include a note about the recall. The company wrote that: “Within the past two weeks, microbial contamination was discovered in two children’s products, but as an added measure of caution, we chose to recall all the children’s products manufactured from August 2015 to August 2018.” It added that no injuries or illnesses have been reported to date.