FDA’s July Warning Letters To Skin-Care Marketers Continue To Surface

Add Menscience Androceuticals, La Bella Figura and Healing Scents to the list of skin-care marketers hit with FDA warning letters in July. The agency’s policy is to wait for warning letter recipients to acknowledge receipt before posting the communications to its website.

FDA is still publishing warning letters that issued to cosmetics marketers in July, when at least 13 companies were taken to task for unapproved drug claims, primarily on skin-care offerings.

The latest such warnings posted to FDA’s website cite three companies with e-commerce-driven platforms for disease-treatment and body structure/function claims made on their websites.The claims exceed cosmetic parameters established by the Federal Food, Drug and Cosmetic Act, FDA says.

The recipients are Menscience Androceuticals, which specializes in skin care and “advanced nutrition products” uniquely designed for men’s needs; La Bella Figura, LLC, a marketer of “hand-crafted” skin and beauty products; and Healing Scents, owned and operated by “a home-grown green business artisan.”

Highlighted violations include claims about treating skin conditions such as acne, psoriasis and eczema, as well as hyperpigmentation and inflammation (see table below).

Statements of this type have become routine targets for the agency’s enforcement personnel in district offices, where the majority of cosmetic-related warning letters have been emanating of late (Also see "Michael Todd, ‘Where Science Meets Nature,’ Meets FDA Warning Letter" - HBW Insight, 17 Aug, 2016.).

FDA also flags promises of accelerated cell renewal and collagen production, consistent with other warning letters to cosmetics firms over the past year (Also see "Avoid An FDA Warning Letter: A Compliance Tool For Cosmetic Claims" - HBW Insight, 30 Aug, 2016.).

Menscience, which touts its offerings as “dermatological-grade,” is scolded for various ingredient claims suggesting muscle-paralyzing effects and increased blood circulation, while La Bella Figura rubbed the agency the wrong way by implying that its night cream may be useful in “suppressing degradation of DNA.”

Other standout claims that require revision, according to FDA, include Healing Scents’ assertion that neem – such as that in its Neem Seed Oil – has been linked in studies to malaria suppression, and that its Hypertension Massage Formulas contain ingredients that can lower pressure.

The agency also lists violative claims on a number of Healing Scents herbal products, which the company positions as treatments for various medical ailments. Links in the following table lead to FDA’s warning letters in full.

FDA published all three warnings Sept. 6 as part of its weekly enforcement update. The agency’s policy is to wait for warning letter recipients to acknowledge receipt before releasing the communications to the public.

After receiving a warning letter, recipients have 15 business days to provide FDA with a detailed account of measures they are taking to correct the violations and prevent future reoccurrences.

Claims Violations Cited In FDA Warning Letters
Recipient (Date)	Cosmetic Product/Unapproved Drug Claims
Menscience Androceuticals (July 18)	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.”
La Bella Figura, LLC (July 21)	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 “Easily 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”; “New collagen promotion.” Modern Radiance Concentrate “Stimulate new collagen growth while also protecting and repairing skin from oxidative damage.”
Healing Scents (July 29)	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.”