FDA Issues Warning Letters to Companies Manufacturing ‘Alternative’ Therapies

The Food and Drug Administration (FDA) issued warning letters to five companies that manufacture products listed as homeopathic for violating current good manufacturing practice (CGMP) regulations. The five companies that received letters are Kadesh Inc.; U.S. Continental Marketing, Inc.; Fill It Pack It, Inc.; Bershtel Enterprises LLC, doing business as WePackItAll; and Newton Laboratories.

“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,” said FDA Acting Commissioner Ned Sharpless, MD, in a 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.”

There are currently no products labeled as “homeopathic” that have been approved by the FDA. The FDA defines homeopathy as “an alternative medical practice that was developed in the late 1700s”; homeopathic products can typically be identified because they contain “homeopathic” in the name, or ingredients are listed in terms of dilution (such as 1X or 2C).

“These products are often marketed as natural, safe and effective alternatives to approved prescription and nonprescription products, and are sold online and in major retail stores,” according to the FDA.

Although the products are advertised as heavily diluted, previous FDA investigations have found these products to contain significant levels of active ingredients that could unknowingly cause a patient harm.

The current letters that went to Kadesh Inc.; U.S. Continental Marketing, Inc.; Fill It Pack It, Inc.; and Bershtel Enterprises LLC pertained to their failure to adhere to CGMP requirements regarding improper methods, facilities, or controls for manufacturing, processing, and packing. Multiple samples of Puriton Eye Relief Drops, a homeopathic product the companies jointly manufacture and package, were found to be non-sterile and contain high pH levels. These could result in eye infection, glaucoma, corneal scarring, and loss of vision.

Newton Laboratories was accused of human drug CGMP, misbranding violations, and unapproved new animal drug violations. Some of the company’s products indicated for use in infants and children were found to contain poisonous ingredients—some of which are found in rodent-killing products.

“Producing such a product without proper manufacturing controls may lead to super-potent drugs, which could be a potential poisoning risk for consumers,” according to the FDA.

The manufacturers were given 15 working days to correct the violations outlined by the FDA, or provide a reason as to why the corrections are delayed.