For Immediate Release
Contact: Mary Borneman
Hyland's response to FDA advisory regarding homeopathic teething tablets and gels
As you may have seen, on September 30, 2016, the Food and Drug Administration issued a surprise statement recommending that consumers discontinue use of homeopathic teething tablets and gels because they may pose a risk.
We want you to know that we are confident that Hyland’s Baby Teething Tablets remain safe. Of course, parents who may have concerns should consult with their physicians before using any medicines, read labels carefully and follow all instructions.
Homeopathic medicines are regulated as drugs by FDA. We are fully cooperating with FDA’s inquiry and we’re providing them with all the data we have. We also hope to learn from FDA what facts, if any, the Agency has based its action on.
Our Baby Teething Tablets, like all Hyland’s branded homeopathic medicines, are made in facilities that follow current Good Manufacturing Practices and are inspected by the FDA in the same way as other OTC drugs are. You may use them with confidence. We test our products for their belladonna content as well as other tests including microbial contamination. We also have a program to monitor, investigate, and trend all safety reports on any of our products.
We have seen rumors that circulate regarding the safety of belladonna – an active ingredient in Hyland’s Baby Teething Tablets – and we know that these warnings can cause fear and worry. This new FDA statement increases the confusion. The safety and effectiveness of Hyland’s natural homeopathic medicines is our top priority. That’s why we work with regulators to ensure that our products meet the highest standards. If we ever had reason to be concerned of that safety, we would act immediately.
We think it’s important that you have the facts around homeopathically-prepared belladonna:
• The amount of Belladonna used in Hyland’s Baby Teething Tablets is miniscule. There’s two trillionths of a milligram in a tablet.
• A child would have to eat multiple bottles at once to experience the first side effect of belladonna, which is typically dry mouth.
• To better understand homeopathically-prepared belladonna, please see this video:
Thank you for your continued confidence in our company and in our trusted brand of homeopathic medicines.