FDA WARNING_LETTER - infinite product company lllp - November 25, 2019

On November 22, 2019, the FDA issued a Warning Letter to InfiniteCBD after reviewing their website and social media in September 2019. The FDA determined that InfiniteCBD markets unapproved new drugs and unapproved new animal drugs containing cannabidiol (CBD), violating the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The human products cited as unapproved new drugs include "Absolute Zero 99%+ CBD Isolate," "Freezing Point CBD Topical Cream," "Afterglow Healing Oil 100mg CBD Total," "Nano Enhancer Pure Nano CBD," "Nano Freezing Point CBD Topical Cream," "Asteroid Gummies," "Sour Asteroid Gummies," "Sweetened Dropper," and "Nano Non Dairy Creamer." These products are considered drugs due to therapeutic claims made on the company's websites, such as treating pain, inflammation, hepatitis, autism, Tourette Syndrome, and cancer. The FDA noted particular concern for "Asteroid Gummies" being marketed for children. These products are also deemed misbranded because their labeling lacks adequate directions for use by a layperson, as they address conditions not amenable to self-diagnosis and treatment.

Furthermore, "Asteroid Gummies," "Sour Asteroid Gummies," "Sweetened Dropper," and "Nano Non Dairy Creamer" are considered adulterated human foods because CBD, an unapproved drug, has been added, and it is not generally recognized as safe (