Hyland's
 | |
| Industry | Homeopathy |
|---|---|
| Founded | 1903 |
| Headquarters | , |
Number of employees | 51-200 (2017[citation needed]) |
| Website | www |
Hyland's is a brand of homeopathic products sold in the United States and Canada. Hyland's operates in the United States as Hyland's Inc and in Canada as Hyland's Homeopathic Canada Inc and is a division of Standard Homeopathic Co..
History
The company was founded in 1903 in Los Angeles as Standard Homeopathic Pharmacy. It was purchased by George H. Hyland in 1910 and the name was changed to Standard Homeopathic Company.[1] Hyland's began selling products in Canada in 1990.[2]
In 2013, the FDA conducted a review of Hyland's labeling and marketing information which revealed numerous products misbranded in violation of sections 503 and 301 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 353 and 331]. This review included the products for "Infant Earache Drops," "Restful Legs," "Teething Tablets," and other products. The products are marketed as over-the-counter for diagnoses and treatments that require a physician's consultation.[3]
Safety concerns
In 2004, Hyland's Teething Tablets were the second most popular teething product.[4]
The FDA warned consumers about Hyland's teething products in 2010, citing concern over the toxicity of its belladonna ingredient and lack of child proof caps.[5] Hyland's voluntarily recalled its Hyland's Teething Tablets product after the 2010 warning in both the US and Canada.[6][7] Hyland's began selling a reformulated version of the product with a child proof cap in 2011.[8]
In 2016, Hyland's indicated it would stop selling its Hyland's Teething Tablets product in the U.S.[9] after the FDA claimed it received reports of 10 child deaths and 400 adverse effects associated with the product.[10][11] Hyland's calls the FDA's claims unsubstantiated.[12] Hyland's suggests other possible causes, noting possible allergies and citing articles listing possible causes of seizures in children unrelated to the formulation of its product.[13] The FDA confirmed in 2017 that inconsistent and sometimes excessive levels of belladonna had been found in the product.[14]
Notes
- ^ "History". Hyland's Inc. Retrieved 15 October 2016.
- ^ "History". Hyland's Homeopathic Canada Inc. Retrieved 15 October 2016.
- ^ "2013 - Standard Homeopathic Company, Inc. 9/25/13". www.fda.gov. Retrieved 2017-02-03.
- ^ "Homeopathic Remedies Thrive in Mainstream". Los Angeles Times. 20 March 2004. Retrieved 15 October 2016.
- ^ "Hyland's Teething Tablets may pose a risk to children". U.S. Food & Drug Administration. Retrieved 15 October 2016.
- ^ "Working with FDA, Standard Homeopathic Company Voluntarily Recalls Hyland's Teething Tablets to Address Manufacturing Process". Hyland's Inc. Retrieved 15 October 2016.
- ^ "Important Information Regarding the Voluntary Recall of the Children's Product Hyland's Teething Tablets". Healthy Canadians. Retrieved 15 October 2016.
- ^ "Good news, moms: Hyland's Teething Tablets will be back... but not until 2011". New Hope. 2 November 2010. Retrieved 15 October 2016.
- ^ "A Letter from Hyland's". Hyland's Inc. Retrieved 15 October 2016.
- ^ "Teething tablets may be linked to 10 children's deaths, FDA says". CNN. 12 October 2016. Retrieved 15 October 2016.
- ^ "Tragic FDA reports of sick babies reveal toll of homeopathic products". Ars Technica. 21 February 2017. Retrieved 22 February 2017.
- ^ "Hyland's Affirms Safety of Its Products; Still Awaiting Data Behind FDA Warning". Hyland's Inc. Retrieved 15 October 2016.
- ^ "Hyland's Baby Teething Tablets Safety Information". Hylands, Inc. Retrieved 15 October 2016.
- ^ Mole, Beth (30 January 2017). "FDA confirms toxicity of homeopathic baby products; Maker refuses to recall". Ars Technica. Retrieved 30 January 2017.