May 22, 2019

FDA Warns Homeopathic Product Manufacturers

The Food and Drug Administration (FDA) is warning five homeopathic product manufacturers for significant violations of current good manufacturing practice regulations (CGMP). Warning letters were sent to those companies.

FDA Warns Homeopathic Product Manufacturers

Four of the letters target companies who jointly produced a product labeled as homeopathic that was not sterile. The fifth outlines a company’s failure to have a system in place that makes sure there is proper design, monitoring, and control of the manufacturing process.

FDA Acting Commissioner Dr. Ned Sharpless said in a statement, “It’s our public health obligation to protect consumers from unsafe products. Our manufacturing requirements are designed to ensure the quality and safety of drugs distributed to American consumers, and the FDA expects companies to manufacture and label their products appropriately. When products labeled as homeopathic are contaminated or contain potentially harmful ingredients, we will take action so consumers are not put at risk.”

Products that are labeled homeopathic have not been approved by the FDA for any use. They may not meet standards for safety, effectiveness, and quality. These products may be made from many different substances, including “healthy or diseased animal or human sources; minerals and chemicals.”

In addition, homeopathic products are often marketed as safe, natural, and effective alternatives to approved prescription products. If these products are poorly manufactured, or contain active ingredients that aren’t adequately tested or listed on the label, they can cause “significant and even irreparable harm,” according to the FDA notice.

One of the warning letters was sent to four companies that jointly manufacture and package Puriton Eye Relief Drops. The FDA tested multiple samples and found they were non-sterile, which could lead to eye infections, and they had a high pH level, which could damage the eyes with corneal scarring, leading to vision loss. Those companies are Kadesh Inc., U.S. Continental Marketing, Inc., Fill It Pack It, Inc., and Bershtel Enterprises LLC, doing business as WePackitAll.

The fifth warning letter was sent to Newton Laboratories for human drug CGMP and misbranding violations, as well as unapproved new animal drug violations. Some of that company’s products labeled homeopathic are marketed for treating conditions in infants and children. The products contain nux vomica, belladonna, aconite napellus, and gelsemium sempervirents that are potentially toxic. For example, nux vomica contains strychnine, a toxic poison used to kill rodents.

The FDA proposed a risk-based enforcement approach to some homeopathic products in December 2017. The products the government focuses on are those that are potentially ineffective and harmful.

If you have used a homeopathic product and have experienced adverse effects, you can tell the FDA about it. Use their MedWatch Averse Event Reporting Program.

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