FDA WARNING_LETTER - PA Constans - Minnesota Emu - September 13, 2017

The FDA conducted an inspection of PA Constans – Minnesota Emu's facility on September 11 and 13, 2017, and reviewed their website, emumagic.com. The FDA determined that the company's Emu oil products, including OmegaMagic™ softgel capsules, Premier™ Emu Oil, and Deep Pain Relief™ Concentrated Analgesic Liquid, are unapproved new drugs. This classification is based on claims made on product labels, the website, and testimonials, which indicate the products are intended for the cure, mitigation, treatment, or prevention of disease.

Examples of drug claims include "Anti-inflammatory" for Premier™ Emu Oil, "Analgesic" and "Deep Pain Relief" for Deep Pain Relief™ Concentrated Analgesic Liquid, and testimonials referencing treatment for arthritis, toenail fungus, zoster pain, burns, and skin disorders. These products are not generally recognized as safe and effective for such uses and lack FDA approval, violating sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act.

Additionally, the facility failed to register with the FDA, a violation of section 415 of the Act and 21 CFR Part 1, Subpart H. The FDA requires the company to take prompt action to correct these violations, including removing disease claims from promotional materials and registering the facility within 30 working days.