We reported that the FDA has recalled Hyland's Teething Tablets, first claiming that they needed to be in child-proof bottles, then saying that they were toxic due to an herb called Belladonna, then saying that they just need to be consistent in their amounts.
The child-proof cap thing, I get. Consistency, fine.
But it's the fear-mongering about the Belladonna and tablet ingredients that a lot of people are spitting angry about -- that yet again the FDA stomps on homeopathic remedies, when their proof doesn't seem to be scientifically supported, even by their own science.
First, let's look at exactly what the FDA said:
In addition, the FDA has received reports of serious adverse events in children taking this product that are consistent with belladonna toxicity.
Read that carefully. They do not have a single case that was actually proven that the tablets were responsible. They just have reports where the symptoms could potentially match up with the potential side effects of a Belladonna overdose. Maybe, possibly, I guess through coincidence, kids took these then got nauseated? But they can't prove it and don't show their evidence actually linking Hyland's tablets to anything. They said themselves that a conclusive link has not been determined. They don't give parents anything to go off of, other than "Hey, there's something in here that we don't control, and because we don't, we're going to tell you it's potentially, maybe, really dangerous ... but we won't tell you in what amount. But be scared. Be VERY scared."
Let's look at the tablets in question ... the amount of Belladonna in each tablet is approximately 0.0002 milligrams. It's referred to as 3X HPUS (0.0003%) Belladonna alkaloids -- what this means is the Belladonna is prepared homeopathic preparations in the 3X (US scale) homeopathic potency. That means they have been diluted so that there is less than 1 molecule of each substance per thousand molecules of the solvent -- and they're even less concentrated in the final product.
But it's because this results in minuscule variations in amounts that the FDA says:
It is important that the amount of belladonna be carefully controlled. FDA laboratory analysis, however, has found that Hyland’s Teething Tablets contain inconsistent amounts of belladonna.
So, uh, yeah. It may be 0.00021 or 0.00025 milligrams? Normally, the FDA refers to these homeopathic amounts as insubstantial, to the point of being ineffective and in other products, they ignore this amount. In your food, they ignore toxins in this amount and tell you there's no substantial difference. For example, finding 10 parts per billion, or 0.001 milligrams of bovine growth hormone in your milk, is so little that the FDA requires people who don't use the drug to still write on their product that "the FDA found that there was no significant difference between milk from treated and untreated cows." So, when it's hormones in cow's milk it's no significant amount ... but when it's two-tenths of a part per billion of Belladonna in a teething tablet (way less than the hormone in cow's milk), it's potentially deadly enough to destroy a company reputation? I'm sorry, but people aren't buying it.
It's also worth mentioning that the adult dose of Belladonna is 0.4-0.8 milligrams -- that's 2,000-4,000 times stronger than the amount in the teething tablets.
Hyland's Director of Scientific Affairs says:
To put homeopathic dosages in perspective, typically a 10-pound child would need to ingest 1,000 Hyland’s Teething Tablets (at least 6 bottles of 125 tablets [750 tablets]) to exhibit even the first possible side effect of Belladonna.
I called Poison Control and asked about it -- while he and I agree that the tablets shouldn't be used until they can guarantee uniformity because if it is a large deviation, it can be dangerous ... historically speaking, there have never been issues.
The conclusion is that the FDA just needs to come out and say that Belladonna in large doses can be toxic, but there is so little in Hyland's tablets that by their own standards, it might as well not even exist. Its effectiveness is certainly questionable. The REAL thing they're going after is just having Hyland's alter their manufacturing procedures to create a little more uniformity, which Hyland's willingly agreed to do (they don't really have a choice). The scare tactics about the product were completely unnecessary and frankly, pretty darn ridiculous. Hyland's says in the meantime, you can use their teething gel (which has twice as much Belladonna), and the tablets will be back on shelves in early 2011.
What do you think? Are you concerned about Belladonna in teething tablets?
Note: This is general mom advice, speak to a medical professional on any questions regarding Belladonna.
Image via AnneTanne