FDA WARNING_LETTER - Phi Sciences - August 18, 2018

The FDA conducted an inspection of Phi Sciences in Cottonwood, Arizona, from August 10-18, 2018. The inspection, product labels, and website review revealed serious violations of the Federal Food, Drug, and Cosmetic Act.

The products Mega Hydrate Powder, Mega Hydrate Capsules, and Crystal Energy are deemed unapproved new drugs because website claims and testimonials indicate their intended use for disease cure, mitigation, treatment, or prevention. These products are not generally recognized as safe and effective, lacking FDA approval. Furthermore, they are misbranded as they fail to bear adequate directions for use, being intended for conditions not amenable to self-diagnosis or treatment.

Additionally, these products are adulterated dietary supplements due to Current Good Manufacturing Practice (CGMP) violations. The company failed to establish and follow written procedures for quality control operations (21 CFR 111.103) and for holding and distributing operations (21 CFR 111.453). The firm's October 5, 2018, response regarding creating a procedure manual was deemed insufficient.

The products are also misbranded dietary supplements due to various labeling deficiencies, including failing to list the manufacturer's name and place of business (21 CFR 101.5), incorrect net quantity of contents for Mega Hydrate Powder (21 CFR 101.7(b)(1)), incorrect serving size declarations (21