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Salves sold by Long Life Unlimited called out for drug claims.
February 13, 2018
By: Christine Esposito
Editor-in-Chief
Following a website review, the US Food and Drug Administration (FDA) has issue a warning letter to Long Life Unlimited, LLC, stating that the Lima, OH firm is selling products on its website, including topicals, marketed as drugs. Several products were cited by the agency in its first warning letter pf the year, including Long Life topical products Rapha Remedy and Rapha Remedy w/ p73 Wild Oregano. The claims on Long Life’s website, www.longlifeunlimited.com establish that the products are drugs under section 201(g)(1)(B) and/or (g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B) and/or (g)(1)(C)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease, and/or because they are articles (other than food) intended to affect the structure or any function of the body of man or other animals. According to FDA, examples of some of the website claims that provide evidence that the products are intended for use as drugs include: Rapha Remedy · “Rapha Remedy can be used as a soothing salve for treatment of the symptoms resulting from: “Eczema and Rosacea “Cracked, Dry, Itching and Burning Skin “Dandruff “Bed Sores and Sores from quadriplegic conditions “Chicken Pox, Shingles and Blisters “Diaper Rash “Cold Sores and Canker Sores “Psoriasis “Dermatitis “Sunburn and Peeling Skin from tanning “Athlete's Foot and Nail Fungus “Sore, Dry Heels. Helps soften tough, rough skin on feet “Warts, Moles, Skin Tags “Cuts, Bruises and Spider Veins “Skin Discoloration, Brown spots (hormonal, pregnancy and liver spots) “Elasticity to Scars and Skin “Sagging, Wrinkled, Aging Skin “Red and Blood Spots, White Spots, Sties and Dry Eye Lids “Stretch Marks (also aids in prevention), Scarring, Deep cuts in cuticles and Hangnails “Burns from Radiation “Frost Bite and can help protect your skin from the cold weather “Muscle fatigue and tension “Measles, Hives and Insect Bites “Jock Itch “Nasal Polyps “Strengthens Dry Nails” Rapha Remedy w/ p73 Wild Oregano · “Rapha Remedy with P73 Wild Oregano Oil can be used as a soothing salve for treatment of the symptoms resulting from: “Gangrene “MRSA and Staph “Parasites Basal, Squamous-cell Carcinoma and Melanoma cells” · “Rapha Remedy with P73 Wild Oregano Oil can also treat all of the same symptoms as the Original Rapha Remedy, some of which include: “Eczema “Cracked and itching skin “Dandruff “Bed sores “Chicken pox “Diaper rash “Cold sores “Psoriasis “Dermatitis “Sunburn “Athlete's foot” FDA, in its letter told the firm that its products (specifically Balance 600, Cancer Protocol, D-Limonene, Vitamin C, Buffered TR, Multi Forte Plus, Natural Beta Carotene, Natural Vitamin E, Omnizyme, Thymus, Selenium Chelate, Super 15, Super B-100, Rapha Remedy, and Rapha Remedy w/ p73 Wild Oregano products) are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, Balance 600, Cancer Protocol, D-Limonene, Vitamin C, Buffered TR, Multi Forte Plus, Natural Beta Carotene, Natural Vitamin E, Omnizyme, Thymus, Selenium Chelate, Super 15, Super B-100, Rapha Remedy, and Rapha Remedy w/ p73 Wild Oregano products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)].
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