FDA Calls Out Claims Made by Blissoma Holistic Skincare

The Food and Drug Administration has sent a letter to Julie Longyear, owner of Irie Star, LLC. (dba Blissoma Holistic Skincare and Apothecary) following a review of the St. Louis-based company’s website (http://www.blissoma.com)  in May 2017. FDA is calling out claims made by the company about several of its products that include serums, mask skin care producs. According to the FDA, the claims on the brand’s website establish that the products are drugs under section 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § § 321(g)(1)(B) and/or 321(g)(1)(C)].
 
FDA listed the followng examples:
 
Flawless – Equalizing Anti-Blemish Oil Serum:
 
·        “The result is a nutritious concoction rich in anti-inflammatory Omega fatty acids …”
·       “Hemp [(an ingredient in your product)] … reduces redness and is recommended for the treatment of psoriasis and eczema.”
·       “Organic Tamanu [(an ingredient in your product)] oil has proven antibacterial, anti- inflammatory and skin rebuilding properties …”
 
Lavish – Loving Recovery Beta-glucan Mask:
 
·        “Beta glucans … are anti-inflammatory”
·       “Organic oils of Baobab, Pomegranate, Perilla, and Pumpkin [(ingredients in your product)] make a synergy to soothe irritations whether they be from sun, wind, allergies, or chronic inflammatory conditions. Each of these oils is known to be helpful for eczema, dermatitis, chapping, and dryness.”
Under Questions and Answers
·       “St. John's wort [(an ingredient in your product)] is anti-inflammatory and analgesic for skin irritations and damage.”
 
Pure – Sensitive Skin Soothing Complex:
·       “100% natural, botanical recipe anti-redness and anti-inflammatory …” 
 
·       “Marshmallow [(an ingredient in your product)] provides soothing mucilage and Plantain leaf infuses reknowned anti-redness abilities. Self Heal comes packed with gentle but effective antimicrobial properties to keep acne and other skin disturbers at bay.”
·       “Heather Flowers [(an ingredient in your product)] provide the anti-allergenic flavonoid Quercetin which also helps synthesize new collagen.”
 
Smooth A+ – Correcting Serum:
 
·        “Cold-extracted Olive Leaf [(an ingredient in your product)] offers a fraction called Oleuropein known for its potent antibacterial and anti-inflammatory effects.”
·       “Niacinamide [(an ingredient in your product)] is included at 4% which is a level proven in studies to be more effective than a 1% clindamycin antibacterial gel at preventing acne breakouts. It maintains ceramide levels …, synthesizes collagen, and evens coloration of the skin.” 

Restore – Deep Healing Oil Serum:
·        “Organic Evening Primrose oil and Pomegranate Oil [(ingredients in your product)] are rich in omega 5, 6, and 9 essential fatty acids including GLA which helps balance hormones, …”
·       “Omega 5 is a rare fatty acid that acts as an… anti-inflammatory,…”
·       “Pomegranate oil [(an ingredient in your product)] also has phytoestrogen to assist with hormone balancing, …”
·       “Tamanu [(an ingredient in your product)] has been used … for its anti-inflammatory, antibacterial, and regenerative properties.”