FDA WARNING_LETTER - Magni Co

The FDA issued a Warning Letter to The Magni Group, Inc. dba Magnilife after reviewing their website, magnilife.com, identifying violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to several marketed products.

Five products, "Diabetic Neuropathy Foot Cream," "Fibromyalgia Relief Tablets," "Sciatica Relief Tablets," "Tinnitus Relief Tablets," and "Urinary Incontinence Relief Tablets," are deemed misbranded under sections 503(b) and 301(a) of the FD&C Act. These products, despite being represented as homeopathic, are considered prescription drugs due to their intended use for conditions requiring physician diagnosis and treatment. Their labels fail to bear the "Rx only" symbol, as required by section 503(b)(4). The FDA clarifies that homeopathic drugs are subject to the same regulatory requirements as other drugs and must comply with section 503(b) to fall under the Agency's enforcement policies for homeopathic drugs.

Additionally, "Diabetic Foot Cream," "Diabetic Hand & Body Cream," "Fat Dissolver Cream," "Lung Cream," "Sciatica Pain Relief Cream," and "Shingles Recovery Cream" are classified as unapproved new drugs and misbranded drugs. These products are considered "new drugs" under section 201(p) because they are not generally recognized as safe and effective for their intended uses, and