Four homeopathic injectable producers warned by FDA

Regulatory NewsRegulatory News
| 16 June 2020 | By Kari Oakes 

The US Food and Drug Administration (FDA) issued warning letters to four companies marketing unapproved homeopathic injectable drugs on Tuesday, noting specific concerns about the potential for public harm from their products.
“The FDA’s drug approval requirements are designed to protect patients by ensuring, among other things, that drugs are safe and effective for their intended uses. These unapproved injectable drugs are particularly concerning because they inherently present greater risks to patients because of how they are administered,” said Donald Ashley, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research. “These products are further concerning given that they are labeled to contain potentially toxic ingredients intended for injection directly into the body. These warning letters reflect our continued commitment to patient safety.”
Among the injectable products produced by one warned company, World Health Advanced Technology, is “Enercel Plus.” This product, said the FDA, is “further concerning” since its label claims it contains the venom of Lachesis Mutus, a venomous snake in the pit viper family. Many other potentially toxic ingredients were named in the labels for the dozens of products included in the four letters, including formulations made up of strychnine, mercury, deadly nightshade and lead.
In the case of Viatrexx, the letter follows a September 2019 inspection of the Canadian firm’s facility in Beloeil. There, inspectors found failure to validate aseptic and sterilization processes, poor aseptic technique, and problems with media fill and filter suitability. Operators at the facility were also observed with exposed facial skin and bare hands adjacent to the ISO 5 aseptic processing hood; other deficiencies included inadequate monitoring, cleaning, and disinfecting systems for aseptic areas.
The injectable homeopathic drug products marketed by Viatrexx did not undergo endotoxin and particulate matter testing, said the warning letter. The inspection found that Viatrexx did not have validated sterility test methods or suitable media for sterility testing.
Claims made for several injectable products with such names as “Connectissue, “Prolo,” “MuSkel-Neural” and “Mesenchyme,” said the FDA, “demonstrate that they are drugs, as defined by section 201(g) of the FD&C Act, 21 USC 321(g).” Viatrexx had not submitted applications to FDA for any of these products, all of which were deemed in the warning letter to be new drugs under 21 USC 321(p).
Medinatura, a New Mexico-based firm, markets a variety of injectable drug products claiming to treat injuries and pain and to provide “non-specific immune defense” and to “restore bowel function,” among other claims. Hervert Pharmaceuticals, based in Colorado, was similarly warned for making claims that its herbal injectable products improve “painful nerve conditions,” “lymphatic edema,” and “mild depressive states,” among other claims. As with Biotrexx, the FDA found the products of these two firms and those of World Health Advanced Technology to be new drugs for which no applications had been submitted.
Three of the warned firms were marketing injectable drugs made by foreign manufacturers who previously had been placed on import alert, preventing the drugs from entering the US.
The injectable products that are the subject of the warning letters are marketed as homeopathic drugs. However, notes the FDA in the letters, “Homeopathic drug products are subject to the same regulatory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or approval.”
FDA also noted that “No currently marketed drug products labeled as homeopathic have been approved by the FDA for any use… Drugs labeled as homeopathic may also cause significant and even irreparable harm If they are poorly manufactured.”


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