New Warning Letter from FDA

Malibu, CA-based Osea Internacional has been issued a warning letter by the US Food and Drug Administration (FDA) following a review of the brand’s (http://oseamalibu.com). The FDA contends that the company’s Blemish Balm, Essential Corrective Complex, Brightening Serum, and Sea Vitamin Boost are being marketed as drugs under sections 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 21 U.S.C. § 321(g)(1)(C)].
 
Examples of some of the website claims flagged by FDA were:
 
Blemish Balm
▪“[H]ealing blend of Cypress, Juniper, and Rosemary essential oils, known for their antibacterial, antiseptic and anti-inflammatory properties.”
▪“Blemish Balm reduces inflammation…”
▪“A proprietary base of three seaweeds combined with a unique blend of Cypress, Juniper, and Rosemary essential oils…reduces inflammation, regulates sebum production, heals…”
▪“Rosemary [an ingredient in the product] helps strengthen the capillaries…It helps to prevent age-related skin damage by safeguarding a protective protein called HSP70. The role of this protein is to reduce damage to skin caused by stress, free radicals, and other toxins.”
▪“Saccharomyces/Copper Ferment [an ingredient in the product]…It has been shown to stimulate tissue-repair…”
▪“Saccharomyces Zinc Ferment [an ingredient in the product]…Saccharomyces/Zinc ferment peptide…promotes wound healing.” 
Essential Corrective Complex
▪“Contains Tea Tree, White Thyme and Juniper which all have powerful natural antiseptic and antibacterial properties.”
▪“How it Works: A naturally antibacterial, anti-fungal, and antiseptic complex to effectively treat blemishes, cold sores, insect bites and ingrown hairs.”
▪“Essential Oil of Tea Tree [an ingredient in the product] has antiseptic properties that make it a gentle method of controlling skin irritations and infections such as acne, cold sores, athlete's foot, insect bites and minor cuts, scrapes, and scratches.”
▪“White Thyme [an ingredient in the product] helps stimulate circulation and has powerful antiseptic, bactericidal and insecticidal properties.”
Brightening Serum
▪“How it Works: Bearberry Leaf is a natural skin lightener that works by actively inhibiting skin’s melanin production. It has been proven to be highly effective for lightening age spots, freckles, sun spots, Melasma…” 
Sea Vitamin Boost
▪“USDA Certified Organic Gigartina Algae bolsters immune response …It also has been found effective for skin ailments such as psoriasis, eczema, and herpes.”
▪“Pomegranate Extract has been shown to boost collagen production…”
▪“Red Wine Extract, loaded with resveratrol…contains anti-viral and anti-fungal properties.”
▪ “Wine Polyphenols Proline (Red Wine Extract) [an ingredient in the product]…stimulate the production of elastin and collagen cells…bioactive polyphenols…prolong cell life for a dual preventative and curative…action.”