FDA WARNING_LETTER - Schwabe North America, Inc.

The FDA issued a Warning Letter to Schwabe North America, Inc. and Nature's Way Products, Inc. regarding their "Umcka" line of products, including various ColdCare and Cold+Flu formulations. The FDA reviewed the companies' websites (www.naturesway.com and www.umcka.com) and product labeling.

The FDA determined that the Umcka products are unapproved new drugs and are misbranded. The websites and labeling make claims indicating the products' intended use for the mitigation or treatment of common cold, flu, bronchitis, sinusitis, and rhinitis, as well as their symptoms. These claims, such as "shortens duration and reduces severity of throat, sinus and bronchial irritations" and "tackle both cold and flu viruses," classify the products as drugs under the Federal Food, Drug, and Cosmetic Act.

The active ingredient, Pelargonium sidoides, is not recognized as safe and effective for its labeled uses and is not included in the OTC drug monograph for "Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products." Furthermore, Pelargonium sidoides is not listed in the Homeopathic Pharmacopeia of the United States (HPUS), meaning the Umcka products are not considered homeopathic drugs under FDA's Compliance Policy Guide.

The FDA also found the products to be misbranded because they are considered prescription drugs due to their intended uses requiring diagnosis and treatment by a physician, but their labels