FDA WARNING_LETTER - Pharmacy Direct, PDU

On May 18, 2018, the FDA issued a Warning Letter to Pharmacy Direct, Inc. after reviewing their website, www.solaricare.com, in March 2018. The FDA determined that the product Solaricare, marketed through Pharmacy Direct's website (http://www.pharmacydirect.com) and Amazon storefront (https://www.amazon.com/dp/B00WING7PE?th=1), is an unapproved new drug.

The claims made on these websites, such as "SOLARICARE only contains one intredient [sic] Polypodium Leucotomos ... Used ... for treating skin disorders such as psoriasis, eczema, polymorphic light eruption and sunburn," establish the product's intended use in the diagnosis, cure, mitigation, treatment, or prevention of disease, classifying it as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)].

Solaricare is not generally recognized as safe and effective for its stated uses, making it a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)]. Introducing or delivering a new drug into interstate commerce without prior FDA approval violates sections 301(d)