On Tuesday the U.S. Food and Drug Administration announced that it had issued warning letters to four manufacturers for selling unapproved homeopathic drug products, including a number of injectable drug products, that put patients at risk and violate federal law. The manufacturers are required to notify the FDA within 15 days of receiving the letters, which were dated June 11, of the specific steps they’re taking to correct violations.
The warning letters target homeopathic products, or “new drugs”, that aren’t FDA-approved or generally recognized as safe and effective for their labeled uses. The injectable products are of special concern because, unlike topical or ingested drugs, products injected directly into the body bypass the body’s natural defenses, which means dangerous toxins and microorganisms have greater opportunity to cause serious or life-threatening harm.
Arnica, which is used to treat muscle pain and stiffness and bruising and swelling from sports injuries, is probably the most well-known product mentioned in the FDA warning letters.
What Are Homeopathics?
Founded by German physician Samual Hahnemann (1755-1843), homeopathy is an alternative medical practice based on the principles of “like-cures-like” and less is more. In homeopathic practice, if a substance causes particular symptoms in a healthy person, it’s thought to be useful in diluted form as treatment for those symptoms. Homeopathic products can contain ingredients derived from minerals, plants, healthy or diseased animal or human sources, and chemicals.
These drug products are subject to the same regulatory requirements as other drugs regarding adulteration, misbranding, and approval. There are currently no FDA-approved drugs labeled as homeopathic, despite often being marketed online and in retail stores as safe, natural, and effective alternatives.
While these products are generally highly diluted, some have been found to contain harmful ingredients. Caution is advised, as products labeled homeopathic may not be safe or effective.
List of Homeopathic Drugs Included in FDA Warning Letters
The following manufacturers were cited for these new drugs “not generally recognized as safe and effective.” Viatrexx was also cited for manufacturing issues.
Hervert Pharmaceuticals
Concerns: Labeled ingredients include “nux vomica” (contains strychnine, a poison used to kill rodents), and “plumbum aceticum” (lead).
Arnica
Calmvalera comp.
Gelsemium comp.
Hepar comp.
Lymphaden comp.
MediNatura
Concerns: Labeled ingredients include “mercurius solubilis” (mercury) and “embryo totalis suis” (porcine embryo).
Zeel Injection Solution
Traumeel Injection Solution
Engystol Injection Solution
Neuralgo Rheum Injection Solution
Lymphomyosot X Injection Solution
Spascupreel Injection Solution
Viatrexx (8046255 Canada Inc.DBA Viatrexx)
Concerns: Labeled ingredients include “nux vomica”, “rectum”, and “belladonna” (deadly nightshade). Firm exhibits significant violations of good manufacturing practice regulations.
ANS/CNS
Articula
Mesenchyme
Connectissue
MuSkel-Neural
Ouch
Ithurts
Adipose
Systemic Detox
Hair
Neuro 3
Infla
Collagen
Prolo
Lymph 1
GI
Neuro
Arthros
Male+
Immunexx
Relief+
Intra-Cell
Facial
World Health Advanced Technologies
Concerns: Labeled ingredients include “Lachesis Mutus” (snake venom). Products claim to cure, mitigate, treat, or prevent serious conditions such as tuberculosis, hepatitis, and lung cancer.
Enercel Plus
Enercel Plus IM
Enercel AM
Enercel Forte
Enercel Max
Enercel Mist-Nasal
Enercel Mist Nebulizer
Enercel PM
Vanicel