Laboratory Analysis of Homeopathic Teething Tablets

FDA has completed testing of homeopathic teething tablets labeled as containing belladonna and other ingredients and marketed by CVS and Hyland’s Inc. Our testing found that the belladonna alkaloids (atropine and scopolamine) content and coffea cruda (caffeine) content is not uniform among the manufactured tablets. FDA analysis found the levels of atropine and scopolamine in some of the CVS tablets and the levels of scopolamine in some of the Hyland’s  tablets  far exceeded the amount stated on the products’ labels.

Inconsistency in levels of belladonna, a toxic substance, signals a poorly controlled manufacturing process and poses an unnecessary risk to infants and children under two years of age.

Certain homeopathic teething products are manufactured to contain a very small amount of belladonna and other ingredients. Ordinarily, such low levels  would not be readily detected by even highly sensitive testing methods, including those used by FDA at its laboratories.

Therefore, FDA’s analysis should not have found any detectable belladonna in these products. 

The following tables highlight FDA’s laboratory data:

Table 1: Homeopathic teething tablets manufactured by Raritan Pharmaceuticals

FDA Sample Number	Product Name	Lot Number	Product Description	Label Declarations
816291	CVS Health Homeopathic Infants’ Teething Tablets	43436	1 bottle of 135 Tablets	Belladonna 12X HPUS*
910933	CVS Health Homeopathic Infants’ Teething Tablets	41116	1 bottle of 135 Tablets	Belladonna 12X HPUS

* Homeopathic Pharmacopoeia of the United States

Table 2: Liquid Chromatography/Mass Spectrometry results for teething tablets manufactured by Raritan Pharmaceuticals

An ion mobility spectrometer was used to screen 1088 CVS branded teething tablets for the presence of belladonna alkaloids. Teething tablets testing positive for belladonna alkaloids by ion mobility were further analyzed using liquid chromatography/mass spectrometry.

FDA Sample Number	Number of Tablets Analyzed	Identified	Belladonna alkaloid – Scopolamine	Belladonna alkaloid – Atropine
			Levels/Range (nanograms)	Levels/Range (nanograms)
816291	34 tablets	1 tablet	357	Below Limit of Quantification
		1 tablet	Below Limit of Quantification	Below Limit of Quantification
910933	8 tablets	1 tablet	64	Below Limit of Quantification
		1 tablet	Below Limit of Quantification	Below Limit of Quantification
		1 tablet	Below Limit of Quantification	1100
		1 tablet	Below Limit of Quantification	53
		1 tablet	Below Limit of Quantification	380
		1 tablet	390	Below Limit of Quantification
		1 tablet	Below Limit of Quantification	77
		1 tablet	Below Limit of Quantification	75

Table 3: Homeopathic teething tablets manufactured by Standard Homeopathic Company

FDA Sample Number	Product Name	Lot Number	Product Description	Label Declarations
969837	Hyland’s Baby Natural Relief Nighttime Teething Tablets	A67116	1 bottle of 135 Tablets	Belladonna 12X HPUS Coffea Cruda 6X HPUS
969838	Hyland’s Baby Natural Relief Nighttime Teething Tablets	A31316	1 bottle of 135 Tablets	Belladonna 12X HPUS Coffea Cruda 6X HPUS
969839	Hyland’s Baby Natural Relief Nighttime Teething Tablets	B66915	1 bottle of 135 Tablets	Belladonna 12X HPUS Coffea Cruda 6X HPUS
969840	Hyland’s Baby Natural Relief Teething Tablets	B96615	1 bottle of 135 Tablets	Belladonna 12X HPUS Coffea Cruda 6X HPUS
969841	Hyland’s Baby Natural Relief Teething Tablets	B73615	1 bottle of 135 Tablets	Belladonna 12X HPUS Coffea Cruda 6X HPUS
969842	Hyland’s Baby Natural Relief Teething Tablets	A29916	1 bottle of 135 Tablets	Belladonna 12X HPUS Coffea Cruda 6X HPUS

Table 4: Liquid Chromatography/Mass Spectrometry results for teething tablets manufactured by Standard Homeopathic Company

FDA Sample Number	Number of Tablets Analyzed	Belladonna alkaloid – Scopolamine		Coffea Cruda – Caffeine
		Identified	Levels/Range (nanograms)	Identified	Levels/Range (nanograms)
969837	137 tablets*	1 tablet	Below Limit of Quantification	1 tablet	5.7
				136 tablets	1 – 2.1
969838	20 tablets	Not Detected	-	20 tablets	1.3 – 2
969839	138 tablets	66 tablets	0.1 – 7.2	138 tablets	0.96 – 2.8
		25 tablets	Below Limit of Quantification
969840	139 tablets	1 tablet	11.6	139 tablets	– 4.3
		1 tablet	13.1
		1 tablet	12.2
		1 tablet	25.1
		1 tablet	53.4
		1 tablet	14.5
		57 tablets	0.1 – 6.7
		19 tablets	Below Limit of Quantification
969841	20 tablets	Not Detected	-	20 tablets	1.2 – 1.9
969842	20 tablets	Not Detected	-	20 tablets	1.2 – 2

*Some bottles contained more tablets than labeled.  

Additional Information

• FDA confirms elevated levels of belladonna in certain homeopathic teething products