FDA Warning Letters about Products (2018)
The U.S. Food and Drug Administration (FDA) regulates the labeling and sale of foods, drugs, cosmetics, biologicals, and medical devices in interstate commerce. A warning letter is a serious notice to that a marketer appears to be violating federal law and may be subject to enforcement action if the apparent violation continues. Enforcement actions include seizure of goods, injunctions, criminal prosecutions, fines, and imprisonment.
Most sellers do what the FDA requests. In some cases, the product must be removed from the marketplace. In others, marketing can continue as long as the claims to which the FDA objected are stopped. Regardless of the outcome, it is wise for consumers to assume that the product is problematic and should be avoided.
- American Chinese Medical Association (ACMA) / Dr. Bob Wu (6/26/18): ACMA Brain Tumor Treatment, ACMA Breast Cancer Treatment, ACMA Colon Cancer Treatment, ACMA Multiple Myeloma Treatment, and ACMA Lyme Disease Treatment.
- Genetech Inc. / Edwin N. Pinos (11/29/18): Umbilical cord products: ReGen5, ReGen10, and ReGen30
- Homeodynamics LLC / Michael J. Leger (2/20/18): Homeopathic products: Zika Virosinum, Carcinoma Mammae, Brain Whole, Ninox Sculata, Lycopodium Clavatum, Multiple Sclerosis Nosode, Aids Nosode, Botulinum, Dengue Fever
- Results RNA, LLC / David L. Larson, Brian G. Larson (4/18/18): Ultimate Lyme Support Extra Strength, ACS 200 Extra Strength, ACJ Joint Extra Strength, ACZ Nano Extra Strength, ACN Neuro Extra Strength, Allergy Care Extra Strength, MRSA Care Extra Strength, ACS 200 Silver Gel Extra Strength, ACS Nasal Extra Strength, Lubrisine Eye Drops Extra Strength
- Silver Armor / Sue Ann Murray, Darlene R. Dennis (5/17/18): Colloidal silver and other silver products
This page was posted on March 13, 2019.