FDA Finds Inconsistent Belladonna Levels in Teething Products

Having a child brings out the natural instinct to protect them. You want to do everything perfectly and not harm your child in any way, including give them a potentially dangerous chemical.


Teething is a time of discomfort and sleepless nights, fussy babies, and tired parents. We want to soothe their pain and make them comfortable, while also being able to get some sleep at night. My grandparents generation would have said to rub some alcohol on their gums to help. However, giving any amount of alcohol to a child has largely gone out of practice. Now, we reach for teething rings, pacifiers, or frozen packs to help ease the pain. There are also companies that have marketed homeopathic teething tablets, gels, and solutions for a “natural” way to comfort your baby.


Belladonna in Natural Baby Products

Standard Homeopathic Co produces Hyland teething tablets and Raritan Pharmaceuticals produces teething tablets along with two liquids for ear discomfort.

  • Belladonna is a listed ingredient, but at safe levels. The Hyland’s website has a very lengthy description on the use of belladonna, its benefits, and its adverse effects.
  • The website also discusses the amount they put in each tablet as being far less than any amount that would result in toxicity. In fact, they state that a 10 lb baby would have to injest more than a dozen bottles of 135 count tablets in order to consume the amount of belladonna associated with toxicity.
  • The safety is based on the presumption that the levels are so low that toxicity is near impossible.
  • The FDA however, has found that each dose contains an inconsistent amount of belladonna. Without a consistent dose, it is hard to say the product is completely safe as the true amount each child gets is largely unknown.


Is Belladonna Safe?

As an expecting mom, this is a product I might have been using. I prefer “natural” remedies and look for a balance between Western and alternative medicine. There are several non-homeopathic medications and vaccines that contain toxic substances in amounts much smaller then what could cause toxicity. I use these products as well. To be clear, the FDA warning is not about the use of belladonna, it is about inconsistent levels in each tablet. Learn more about belladonna here.


The Companies Response

Given the warning issued by the FDA, Raritan Pharmaceuticals has recalled three products. But Hyland’s has chosen not to recall the product, only to stop selling it in the US. They also posted a very interesting letter to consumers on their website discussing the warning.

  • It starts by stating that the FDA warning has caused confusion with mothers and limited access to medicines.
  • Followed by we don’t want to put you in the “position of having to choose who to trust in the face of contradictory information” and “we are confident that any available Hyland’s teething products, including those you already have, are safe for use”.
  • The letter ends with “our team has used Hyland’s teething products on our own children, grandchildren, godchildren, nieces and nephews.”

The letter is not a statement in favor of removing the product for safety precautions. In fact it is quite the opposite with complete denial of any issue and a questioning of the FDA results.

Always speak with your pediatrician for natural remedies and medications for your baby.

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