Hyland's is a brand of homeopathic products sold in the

United States The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 states, a federal district, five major unincorporated territorie ...

and

Canada Canada is a country in North America. Its ten provinces and three territories extend from the Atlantic Ocean to the Pacific Ocean and northward into the Arctic Ocean, covering over , making it the world's second-largest country by tot ...

. 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. Hyland's began selling products in Canada in 1990. In 2013, the

FDA The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food s ...

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) 1 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 Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, as opposed to prescription drugs, which may be supplied only to consumers possessing a valid prescr ...

for diagnoses and treatments that require a physician's consultation.

Safety concerns

In 2004, Hyland's Teething Tablets were the second most popular

teething Teething is the process by which an infant's first teeth (the deciduous teeth, often called "baby teeth" or "milk teeth") appear by emerging through the gums, typically arriving in pairs. The mandibular central incisors are the first primary te ...

product. 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. Hyland's voluntarily recalled its Hyland's Teething Tablets product after the 2010 warning in both the US and Canada. Hyland's began selling a reformulated version of the product with a child proof cap in 2011. In 2016, Hyland's indicated it would stop selling its Hyland's Teething Tablets product in the U.S. after the

claimed it received reports of 10 child deaths and 400 adverse effects associated with the product. Hyland's calls the FDA's claims unsubstantiated. 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. The FDA confirmed in 2017 that inconsistent and sometimes excessive levels of belladonna had been found in the product.

Notes

{{reflist Pseudoscience Homeopathic remedies Privately held companies based in California