Today I received a brief notice that FDA is recalling Hyland's Homeopathic Teething Tablets.
Hyland's is a company that produces a wide range of homeopathic products. According to their web site, their teething tablets are indicated to relieve the "restlessness, peevish whining and irritability" associated with infant teething. The tablets are quite small and dissolve on the tongue. As one might expect, their site carries a plethora of testimonials about how great the tablets are, yet nary a link to any scientific evaluation of the safety and efficacy of the product can be found.
So, with such favorable parent stories, why on earth would FDA recall Hyland's Homeopathic Teething Tablets?
Apparently, the tablets do not contain consistent amounts of belladonna, leading to potential overdose and poisoning. The product labeling for the tablets indicates that each tablet contains a 3X (or 1:1,000) dilution of belladonna. As far as homeopathic products go, that's not very dilute and is very likely to contain biologically active amounts of belladonna, much like recalled Zicam nasal products contained active amounts of zinc (2X dilutions). Further exacerbating the issue is the fact that the bottles do not use child-resistant caps.
Already knowing a bit about drug regulations, I decided to take a look at Hyland's site a bit further. In particular, I looked at their FAQ on whether or not homeopathic "remedies" are regulated. Hyland's is correct that homeopathic products are regulated as drugs under the Food, Drug and Cosmetic Act. What they fail to mention, however, is that such products are exempt from certain regulations that apply to other drugs, namely:
1. Section 211.137 (Expiration dating) specifically exempts homeopathic drug products from expiration dating requirements.
2. Section 211.165 (Testing and release for distribution): In the Federal Register of April 1, 1983 (48 FR 14003), the Agency proposed to amend 21 CFR 211.165 to exempt homeopathic drug products from the requirement for laboratory determination of identity and strength of each active ingredient prior to release for distribution.
That second point is important in this case. Because homeopathic products are generally so dilute as to contain little or no active ingredient, lab testing for the presence and strength of active ingredients (such as Hyland's belladonna) does not make a whole lot of sense. However, simply using an active ingredient that is in the Homeopathic Pharmacopeia of the United States, labeling your product as homeopathic and listing ingredients using homeopathic amounts (e.g., 3X instead of 1mg/mL) is enough to get around the regulations that normally apply to drugs: i.e., making sure that the product you are selling is actually safe and that each dose has a consistent amount of the active ingredients.
What this boils down to is that conventional drugs are required to undergo rather significant testing for safety and efficacy before they are marketed. Homeopathic products, on the other hand, do not. At best, they must follow Good Manufacturing Practice regulations, but they do not need to apply for marketing approval. Because of this, FDA cannot take any action on a homeopathic remedy until after it is already on the market.
This state of affairs leads to potentially unsafe and ineffective products hitting the market, like Zicam or, as we see here, Hyland's Homeopathic Teething Tablets.
With Zicam, consumers ran the risk of loss of smell, potentially permanently. All in all, while not pleasant, that's not as bad as the potential for harm from products like these teething tablets. Belladonna poisoning can be quite serious, even resulting in death.
This episode illustrates, yet again, the flaws in how "alternative" health products are regulated. Manufacturers have a responsibility to ensure that their products are safe and effective. Thanks to the kind of regulations we see for real drugs, the majority of harmful products never even make it to market, and of those drugs that are approved, quite a bit is known about not only the benefits, but also the risks posed. There are, of course, drugs that make it to market that shouldn't have, but such products are relatively rare.
The same cannot be said of homeopathic products.
A decent essay on this issue can be found here (PDF).
Update: FDA has a Q&A about this recall. Standard Homeopathic, the manufacturer, has also issued a press release indicating that they are voluntarily complying with the recall.