I wanted to take a moment this month to address this topic and the CNN headlines some of you may have seen and others have asked me about.
Yes, the FDA in a September 30, 2016 news release stated that “The U.S. Food and Drug Administration is warning consumers that homeopathic teething tablets and gels may pose a risk to infants and children.” They also state in that article that they “are analyzing adverse events reported to the agency regarding homeopathic teething tablets and gels. The FDA previously issued a 2010 safety alert about homeopathic teething tablets. The article goes on to say “The FDA is currently investigating this issue, including testing product samples. The agency will continue to communicate with the public as more information is available.”
(Full Article: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm523468.htm)
I think it is important to note that in six years of investigation the FDA has not issued a ban or required a recall of any homeopathic products. In response to the FDA warning in 2010 Hyland’s voluntarily recalled their teething products. The concern in 2010 revolved around manufacturing processes. The FDA found some companies did not have adequate manufacturing and/or testing controls in place to ensure consistency in the amount of Belladonna and other homeopathic remedies from tablet to tablet.
(Full Article; http://www.Hylands.com/news/teethinginfo.php)
On October 1st 2016 in response to the current FDA warning Hyland’s responded by stating “There is no current recall of Hyland’s Baby Teething Tablets. Hyland’s Baby Teething Tablets were re-introduced with a new formula in July 2011. Parents continue to safely use our quick-dissolving homeopathic tablets with young children to soothe pain, and ease irritability associated with teething.”
(Full article: http://www.Hylands.com/news/Hylands-teething-recall.php).
They restated “Over the course of the last six years, Hyland’s has developed and now employs state-of-the-art safety and testing procedures to ensure all its baby products are safe for our youngest users. Data from that program continues to indicate our products are safe. We look forward to working in partnership with the FDA to continue providing safe and effective medicines to families around the world. We regret that such unsubstantiated information is being shared and creating concerns among consumers.”
(Full Article: http://www.Hylands.com/media/press-release/Hylands-affirms-safety-its-products-still-awaiting-data-behind-fda-warning)
Another concern is the use of Belladonna in the product. Hyland’s addresses this concern in this way “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.”
(Full Article: http://www.hylands.com/media/press-release/hylands-response-fda-advisory-regarding-homeopathic-teething-tablets-and-gels)
They go on to say “Hyland’s Baby Teething Tablets have safely treated the pain associated with teething for more than 85 years. There is NO scientific link between homeopathically-prepared belladonna, or Hyland’s Baby Teething Tablets, and seizures.”
On October 12th 2016 Hyland’s made the decision to discontinue distribution of their homeopathic teething products to the United States, while continuing to wait for data from the FDA. “The fact is that we have not been made aware of any medical or statistical evidence to support a causal link between homeopathic teething tablets and adverse outcomes at this point. We continue to request any available information and statistics from the FDA” “ We look forward to working in partnership with the FDA to continue providing safe and effective medicines to families around the world.”
(Full Article: http://www.hylands.com/media/press-release/hylands-affirms-safety-its-products-still-awaiting-data-behind-fda-warning)
The National Center for Homeopathy has issued the following: ACTION ALERT: Help Us Correct Misconceptions about Homeopathic Teething Tablets; citing “Homeopathy has a laudable and extensively documented clinical record and there are hundreds of high quality, peer-reviewed basic science, pre-clinical, and clinical studies showing its efficacy and safety. There are no studies linking homeopathically-prepared medicines and serious adverse events.”
(Full Article: http://www.homeopathycenter.org/news/FDATeething)
In my opinion, homeopathically prepared Belladonna, as well as all homeopathic remedies, are safe and should be used as prescribed. I encourage you to do your own homework and read beyond the headlines. I support the FDAs mission of protecting the public. However, it saddens me, given the growing recognition and acceptance of Homeopathic Remedies in the US and Worldwide, that Hyland’s, CVS, other companies manufacturing homeopathic remedies and consumers have been put in this situation. We now have to wait for this issue to be resolved so Hyland’s will open distribution to the United States again. It’s unfortunate for those people who want to use homeopathy to address their children’s teething needs. I support Hyland’s decision to stand behind their product. I hope the FDA will work to resolve this issue quickly. For parents looking for homeopathic alternatives for their teething babies look to individual remedies to address those symptoms.