FDA Warns Five Homeopathic Product Manufacturers for GMP Violations

Regulatory NewsRegulatory News | 14 May 2019 |  By 

The US Food and Drug Administration (FDA) on Tuesday released warning letters sent to five homeopathic product manufacturers because of significant good manufacturing practice (GMP) violations.

For instance, four of the companies jointly manufacture and package Puriton Eye Relief Drops, which are labeled as homeopathic. But FDA said it tested multiple samples and found the eye drops were non-sterile, which could lead to an eye infection, and had a high pH level, which could lead to eye injury such as glaucoma, corneal scarring and loss of vision. One of the companies issued a voluntary recall in November 2018 due to non-sterile production conditions at the manufacturing facility.

“These unapproved drugs may cause significant and even irreparable harm if they are poorly manufactured, which can lead to contamination, or may contain active ingredients that are not adequately tested or disclosed to patients,” FDA said.

The fifth company, known as Newton Laboratories, manufactures products labeled as homeopathic and indicated for treating conditions in infants and children. But they are manufactured from ingredients such as nux vomica, belladonna, aconitum napellus, and gelsemium sempervirents, which pose potentially toxic effects, the agency said.

“For example, nux vomica contains strychnine, which is a highly toxic, well-studied poison that is used to kill rodents. Producing such a product without proper manufacturing controls may lead to super-potent drugs, which could be a potential poisoning risk for consumers,” FDA said.

The agency action follows last month’s four warning letters for manufacturers of homeopathic medicines in Florida, North Carolina, Oregon and India. Another manufacturer of an unapproved product labeled as homeopathic also received a warning letter in March.

And back in December 2017, FDA released draft guidance plotting out how to take enforcement actions against manufacturers of homeopathic products with reported safety concerns.



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