Homeopathy is a pseudoscience that is based on two core principles. The first is that like cures like. So if you get bitten by a venomous snake, this same snake venom will prevent you from dying. In reality, a dangerous snake bite from a venomous snake is treated with, for instance, antivenom that via specific molecular mechanisms prevent the venom from having negative health effects on the body. The second is that the more you dilute something, the stronger it becomes. In particular, homeopathy involves diluting products so much that there is almost always not a single molecule left of the supposed active ingredient.
Based on basic science considerations from physics, chemistry and biology, homeopathy does not work and cannot work. Large-scale and methodologically sound scientific studies have also shown that homeopathy is ineffective as a treatment for real medical conditions. In essence, homeopathy is quackery that does not work above placebo. Homeopaths push these ineffective remedies for a large range of real medical conditions and even some minor issues, like teething (when new teeth push through the gums of a young child).
What are these belladonna-containing teething tablets?
The products in question are teething tablets that are manufactured by the Standard Homeopathic Company. These are supposed to contain no detectable levels of belladonna (since it is all diluted away), but since homeopathy is a pseudoscience, one cannot really assume that they will have good manufacturing practices. Laboratory analyses performed by the U. S. Food and Drug Administration (FDA) showed that Hyland’s homeopathic teething tablets contained too large and inconsistent amounts of belladonna (a plant that contains dangerous secondary metabolites such as atropine, scopolamine and hyoscyamine).
This is a considerable problem since very variable concentrations suggests that something is seriously wrong with the manufacturing process and signals that some tablets may contain belladonna in a concentration that harms children who take it. This was discussed in additional detail in the previous article on homeopathic teething products that contained elevated amounts of belladonna. Very little is know about what doses of belladonna are safe in children, because there are so many factors that can affect the outcome. A total of 10 children deaths have been linked to these products according to FDA spokesperson Lyndsay Meyer.
On January 27th, the FDA released a news item stating that they had discovered these problems and requested that the Standard Homeopathic Company issued a voluntary recall, but they refused. Until now.
The current recall
On April 13, Standard Homeopathic Company issued a press release and a formal recall for Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets due to concerned about elevated and inconsistent amounts of belladonna that did not correspond to the amounts listed on the label. This recall is not restricted by production date and so include all items of the product that retailers has. The company also echoes the recommendation set by the FDA and encourages all customers who have bought their products to discard them. Their press release state that they will contain their distributors and retailers by mail.
Although the Standard Homeopathic Company complied with the request by the FDA, the press release contains several instances of deceptive language where the company attempts to carry out substantial damage control. First, the reason for why they are recalling the product is not stated as due to the FDA finding, but rather to “because it is appropriate to do what our regulating agency has formally requested”. Although it is certainly a good idea for manufacturers of quackery to follow the requests by their regulatory agency, it is clear that the way they phrased this shows that they do not think there is a real issue. They are not recalling their products because they agree with the FDA findings and conclusions, but just because they felt compelled to do so due to regulatory issues. This is a stark reminder that we cannot expect manufacturers of alternative medicine to have a high level of intellectual integrity or even monitor and regulate their own products and activities properly.
Second, the Standard Homeopathic Company does not refer the scientific conclusions of the FDA as based on fact, but rather that the FDA merely “believes” that belladonna is dangerous for the health of children and has unpredictable effects when used on children. By stating that the FDA “believes” it, they are implicitly attacking the scientific credibility of the laboratory analyses carried out the by the FDA on their products and even the basic medical facts about the effects of the secondary metabolites of belladonna.
Third, they highlight the fact that they, as manufacturers, have already stopped producing the product in the fall of 2016 not just once, but twice. This gives the misleading impression that the Standard Homeopathic Company did that because of safety concerns and that this is merely the last step that they are performing in an effort to appear responsible. One cannot help but wonder why it took three months for them to agree to do a voluntary recall after the FDA laboratory findings became publicly available. Do they really care about the health and safety of their customers, or are they more interested in their reputation and financial outcomes? Why did they wait until the FDA made a formal request on April 10?
Fourth, despite having stopped manufacturing these tablets, recalling the remaining retailer stock and urging buyers to throw them away, the Standard homeopathic Company still labels them as “medicines”. Yet there is no credible evidence that homeopathic teething tablets that contain belladonna are a safe and effective medication for anything. Calling them “medicines” is deeply deceptive.
In sum, the Standard Homeopathic Company has issued a national recall for two of their homeopathic teething tablets. Laboratory analyses carried out by the FDA showed that these tablets contain detectable, elevated and inconsistent amounts of belladonna that could pose a considerable health risk to children for which the products was marketed to. After knowing about this problem for close to three months without recalling it, they finally agreed to recall it after receiving a formal request from the FDA. Their press release was carefully engineered to appear compliant with the FDA, but be implicitly dismissive of their findings.