Federal health regulators have sent warning letters to the makers of Puriton Eye Relief Drops, indicating that the homeopathic product may place consumers at risk due to non-sterile manufacturing processes.
The FDA issued a press release on May 14, announcing that it has issued warning letters to several companies manufacturing homeopathic products, including U.S. Continental Marketing, Inc., Fill It Pack It Inc., Bershtel Enterprises LLC, doing business as WePackItAll, and Kadesh Inc.
The companies jointly manufacture homeopathic Puriton Eye Relief Drops. FDA investigators say samples tested as not sterile and had a high pH level. Using eye drops that are not sterile could lead to eye infection, glaucoma, corneal scarring, and blindness.
FDA inspectors said the manufacturing processes were in violation of current good manufacturing practice (CGMP) regulations.
“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,” FDA Acting Commissioner Dr. Ned Sharpless said in the press release “When products labeled as homeopathic are contaminated or contain potentially harmful ingredients, we will take action so consumers are not put at risk.”
The FDA announcement also noted another warning letter was also sent to Newton Laboratories, which also makes homeopathic products. The FDA warned the company that it did not have systems in place to ensure monitoring and control of manufacturing processes. The company also violated manufacturing practices for human drug products, as well as misbranding violations, according to the agency.
Some homeopathic products contain toxic ingredients such as strychnine, nux vomica, belladonna, aconitum napellus, and gelsemium sepervirents, which can have toxic effects. For example, strychnine is used to kill rodents and is put in some homeopathic products, but if it isn’t manufactured with strict controls it can lead to serious and sometimes lethal consequences.
Homeopathic products can be made from various ingredients like plants, healthy or diseased animal or human sources, minerals, and chemicals. However, homeopathic products are not approved by the FDA for any use and may not meet modern standards for safety, effectiveness, and quality. For this reason, they are often marketed as safe and natural even when they are not. Yet, if they are manufactured not using strict regulations, they can cause serious harm.
In 2017, the FDA proposed new guidelines for overseeing and regulating homeopathic products, giving the agency more regulatory power. Several recalls were issued in recent years, including a recall of homeopathic teething tablets containing belladonna.
The agency expects the companies to respond to the warning letters and outline plans to correct the manufacturing concerns and quality issues.
The FDA also encouraged consumers and health care professionals to report any adverse effects or quality problems experienced after using any of the products to the FDA MedWatch Adverse Event Reporting program.