Drugs

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

    1. – 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.  

Page Last Updated: 01/27/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English