More Warning Letters from FDA

FDA has issued three more warning letters to company making claims that the agency contends go to far.
 
A letter sent to Federico Sanchez, owner of Miami, FL-based Menscience Androceuticals, came following a review of its website http://www.menscience.com/ in May 2016 where the firm is taking orders for an Anti-Aging Formula. The claims on your website establish that the product is a drug 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)] because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or is intended to affect the structure or any function of the human body
 
Examples of some of the website claims that provide evidence that their product is intended for use as a drug includes:
 
Anti-Aging Formula
▪  “Retinol is widely prescribed by doctors and dermatologists for the treatment of acne, darkened cells and hyperpigmentation, and signs of aging. Retinol is also incorporated into procedures for the vision and immune systems, and assistance in bone growth. Because it is fat-soluble, it is able to absorb into fatty layers of skin to promote greater cell renewal and increases in collagen and elastin production.”
▪  “Peptides utilized in the Anti-Aging Formula are Acetyl Hexapeptide-3 and Palmitoyl Oligopeptides…that block the release of a neurotransmitter which causes facial muscles to tense and wrinkles to appear. Palmitoyl Oligopeptides…encourages collagen production…”
▪  “GABA Relaxes muscles and bodily tissues by inhibiting and controlling nerve impulses. Because of its unique ability to release muscle tension, it is being used in a variety of ways, from treating nerve disorders and epilepsy to promoting hormone growth and as a dermatological-grade ingredient.”
▪  “Hydrocotyle Widely used in Indian herbal remedies to reduce skin inflammation, irritation, itching and burning, and facilitate quicker healing of wounds. Also assists in increasing blood circulation and in the creation of new skin cells. Historically, has been used to treat skin conditions, fever, diarrhea, ulcers and anxiety disorders.”
 
Victoria Fantauzzi and Karen King, founders of La Bella Figura, LLC, Chicago, were also presented with a letter following a review of the company’s website it May. FDA has determinted La Bella Figura’s claims surrounding Crema Virtuosa Night Cream, Daily Elements Defense Facial Oil, Jardin de Fleurs Skin Revitalizer, and Modern Radiance Concentrate establish that the products are drugs. 
 
Examples cited by FDA included:
 
Crema Virtuosa Night Cream
▪  Key actives: Sangre de Drago Extract an antiviral oligomeric proanthocyanidin exhibiting therapeutic antiviral benefits and a production of active oxygen radicals suppressing degradation of DNA from free radicals.
Daily Elements Defense Facial Oil
▪  “[E]asily absorbed due to its small molecular structure increasing circulation… rebuild cell structure and support new growth…”
▪  “Rosehip CO2 and Pomegranate CO2 seed oils help rebuild collagen.”
Jardin de Fleurs Skin Revitalizer
▪  “Honeysuckle, Jasmine, Rose Damascena and Carrot Seed Hydrosols aid in reducing skin inflammation…”
▪  “Helichrysum, Licorice Root and Plantain Leaf …stimulate active cell growth.”
▪  “Skin Type: …new collagen promotion.”
Modern Radiance Concentrate
▪  “[S]timulate new collagen growth while also protecting and repairing skin from oxidative damage.”

In addition, Kathleen Hembree, owner of Healing-Scents, Rockford, IL, was issued a letter following a June 2016 website review at 
http://healingscents.com/index.php wher ethe ocmpany sells Age Spot Eraser, Eczema and Psoriasis Shampoo, Need Seem Oil, Hypertension Massage Formulas Oil or Lotion, Heart Herbs, Cholesterol Regulation Herbs, Diabetes Regulation Herbs, Prostate Healer Herbs, High Blood Pressure Herbs, Respiratory Ailment Herbs, Stomach/Intestinal Herbs. Again, FDA contends claims on the  website establish that the products are drugs.
 
Healing-Scent’s claims cited by FDA included:
 
Age Spot Eraser
▪  “Frankincense essential oil has antibacterial and anti-inflammatory benefits to the skin, making it ideal for acne-prone skin.”
▪  “Lavender essential oil…helps regenerate skin cells so is great for …sun spots, and scarring.”
▪  “Myrrh essential oil… has strong anti-inflammatory properties… Myrrh can also help heal sun damage, chapped skin, rashes, and eczema.” 
Eczema and Psoriasis Shampoo 
▪  “Specially formulated shampoo for those who have Eczema or Psoriasis in the scalp area.”
▪  “The essential oils are “essential” to help control eczema or psoriasis and heal the scalp.”
Neem Seed Oil 
▪  “Neem is anti-viral, anti-fungal, and anti-inflammatory.”
▪  “Neem produces pain-relieving, anti-inflammatory and fever-reducing compounds that can aid in the healing of cuts, burns, sprains, earaches, and headaches, as well as fevers.”
▪  “Several studies of Neem extracts in suppressing malaria have been conducted, all supporting its use in treatment.” 
Hypertension Massage Formulas Oil or Lotion
▪  “These essential oils can lower your blood pressure and help hypertension.” 
 
Want more insight into just what FDA flags when it comes to claims? Attend Happi’s Anti-Aging Conference & Tabletop Exhibition on Sept. 20-21 in new Brunswick, NJ where a special Regulatory Roundtable, moderated by Georgia Ravitz, Esq., will include Ryan Aguillon, Division of Import Operations, US Food and Drug Administration, as well as panelists from FTC and the National Advertising Division.