FDA WARNING_LETTER - Irie Star LLC - July 06, 2017

On July 6, 2017, the FDA issued a Warning Letter to Irie Star LLC, doing business as Blissoma Holistic Skincare and Apothecary, following a May 2017 review of their website, blissoma.com. The FDA determined that five products—Flawless - Equalizing Anti-Blemish Oil Serum, Lavish - Loving Recovery Beta-glucan Mask, Pure - Sensitive Skin Soothing Complex, Smooth A+ - Correcting Serum, and Restore - Deep Healing Oil Serum—are unapproved new drugs.

The products are deemed drugs under sections 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) due to claims on the website indicating their intended use for the cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or function of the human body. Examples of such claims include "anti-inflammatory," "reduces redness and is recommended for the treatment of psoriasis and eczema," "antibacterial," "soothe irritations whether they be from sun, wind, allergies, or chronic inflammatory conditions," "helpful for eczema, dermatitis, chapping, and dryness," "anti-redness," "antimicrobial properties to keep acne and other skin disturbers at bay," "synthesize new collagen," "preventing acne breakouts," and "balance hormones."