FDA WARNING_LETTER - Natural Wonder Products Corp - October 01, 2019

The FDA issued a Warning Letter to Natural Wonder Pets and Natural Wonder Remedies concerning the marketing of products for disease treatment in pets. The FDA reviewed websites including www.natural-wonder-pets.com and www.natural-wonder-remedies.com, where products such as Daily Sure Multi-Herbal, Denta Sure, Adadren, and others are promoted and sold.

The FDA determined these products are intended for use in the mitigation, treatment, or prevention of diseases in animals, classifying them as drugs under section 201(g)(1)(B) of the FD&C Act. These products are considered "new animal drugs" under section 201(v) of the FD&C Act because they are not generally recognized as safe and effective. They lack approval, conditional approval, or index listing under sections 512, 571, and 572 of the FD&C Act, rendering them unsafe per section 512(a) and adulterated under section 501(a)(5).

The letter requires the firm to notify the FDA in writing within fifteen working days of receipt, detailing steps taken to correct the violations and achieve compliance. Failure to promptly correct violations may result in enforcement actions, including product seizure and/or injunction.