FDA Warning Letters Sent to Three Firms

The third time is definitely not the charm. The Food and Drug Administration (FDA) recently sent warning letters to StriVectin, Moy-Fincher Medical Group and Skin Authority LLC.

According to the letter sent to StriVectin (following a December 2014 review of its website), FDA said the company takes orders for “Potent Wrinkle Reducing Treatment” and “TL Advanced Tightening Neck Cream,” which appear to be drugs under section 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321 (g)(1) (C)].

Examples of some of the claims on the website, www.strivectin.com include:

Potent Wrinkle Reducing Treatment:

“Clinically proven to change the anatomy of a wrinkle”

“This superb age-fighting serum is super charged with …potent elastin stimulating peptides….”

“Potent elastin-stimulating peptides help enhance skin structure…”

TL Advanced Tightening Neck Cream:

“#1 Selling Neck Cream. Now even more tightening, lifting…”

“[F]eatures breakthrough Gravitite-CF Lifting Complex to restore the elastin fiber architecture, providing noticeable lift and improving resistance to gravity.”

“Breakthrough Gravitite-CF Lifting Complex [an ingredient in your product] contains a  powerful blend of active ingredients that stimulate elastin synthesis…”

According to the FDA letter, StriVectin’s Potent Wrinkle Reducing Treatment and TL Advanced Tightening Neck Cream products are not generally recognized among qualified experts as safe and effective for the above-referenced uses and, therefore, the products are “new drugs” as defined in section 201(p) of the Act [21 U.S.C. § 321(p)].

Moy-Fincher Medical Group received a warning letter from the FDA following a review of its website, www.dnaegfrenewal.com conducted in December. The product in question is DNA Eye Renewal, “appears to be promoted for conditions that cause the product to be drugs under section 201(g)(l)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(C)],” according to FDA’s letter, which was mailed in February.

According to the FDA document, examples of claims on the website include: 

“Beta Glucan: Helps stimulate collagen production for added strength to the dermal matrix …”

“Willowherb … control inflammation.”

“Spanish Lavender … inhibit muscle fibers from contracting … “

“Matrixyl3000 … stimulating the production of collagen, elastic, and hyaluronic acid and decreasing cell damage caused by glycation and inflammation.”

“Tetrapeptide … mimic the activity of the youth hormone thymopoietin … reinforcing the cutaneous immune defenses in the skin … stimulate the growth of new cells in the epidermis.”

More recently Skin Authority, LLC, Carlsbad, CA, was issued a warning letter from the FDA following a March review of its website. In its review, FDA contends Skin Authority’s  “Wrinkle Reversing Serum,” “Moisturizing Lift Cream,” “VitaD Fortified Topical Elixir,” “Reviving Eye Brightener,” “Coffee Almond Scrub,” and “Bamboo Ginseng Scrub,” appear to be promoted for uses that cause the products to be drugs under section 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(C)]. 

Examples of some of the claims on the website include:

Wrinkle Reversing Serum

“TGF-b(1-3) (Transforming Growth Factor Beta) to help stimulate collagen, to help inhibit cellular breakdown…”

“PDFG (Platelet Derived Growth Factor) to help activate wound healing fostering new skin growth, to help reduce scar tissue, and to help form stronger blood vessels.”

“GM-CSF (Granulocyte-Macrophage Colony- Stimulating Factor) to help restore blood cell response to the breakdown of skin structure, to help counteract infection (e.g., acne), to help even-out discolored appearance (e.g., hyperpigmentation), to help reduce inflammation (e.g., Rosacea)…”

“Interleukins (IL3, IL6-8) …improve anti-inflammatory response.”

Moisturizing Lift Cream:

“Skin Growth Factors/Human Fibroblast Conditioned Media – Four essential skin proteins stimulate collagen, inhibit cellular breakdown, increase cell growth, and enable cells to locate nutrients fostering faster skin growth, stronger blood vessel formation, reduce infection, calm inflammation…”

“Glycolic Acid – Helps open follicles and reduce oil production.”

“Green Tea Extract – Potent anti-inflammatory agent helps reduce inflammation and prevents collagen breakdown by inhibiting the collagenase enzyme.”

VitaD Fortified Topical Elixir:

“Vitamin D3 (cholecalciferol) – Helps reduce inflammation, calm irritation…”

“Oligopeptide Complex –Inhibits tyrosinase activity which is a leading cause of spots and uneven skin tone.”

“Vitamin K – Stimulates blood flow to reduce inflammation…”

“Retinol (.01%) – …collagen stimulator.”

Reviving Eye Brightener:

“Vitamin K – Stimulates blood flow…”

“Arnica – Reduces swelling…”

“Green Tea Extract – Potent anti-inflammatory agent helps reduce inflammation and prevents collagen breakdown by inhibiting the collagenase enzyme.”

“Ginseng Root Extract & Bioflavoids – Strengthen capillaries to increase microcirculation blood flow. Strengthen elastin and the collagen structure for firmer texture while reducing inflammation and redness.”

“Ginko Biloba – Helps stimulate and improve circulation…”

Coffee Almond Scrub:

“[D]ecrease the formation of cellulite while tightening and shrinking blood vessels to help reduce the appearance of spider veins.”

“Coffea Arabatica (Coffee) Seed Powder – Micronized coffee effectively stimulates circulation…”

“Caffeine – Stimulates lipolysis in the cellulite cells…”

“Zea Mays (Corn) Cob Powder – …improves microcirculation…”

“Olea Europaea (Olive) Seed Powder – …vasodilatation properties to increase circulation and promote detoxification.”

Bamboo Ginseng Scrub:

“[S]timulate circulation…”

“Aloe Barbadensis (Aloe Vera) Extract – Calms inflammation with an anesthetizing response.”

“Panax Ginseng Root Extract – Strengthen capillaries to increase microcirculation blood flow. Strengthen elastin and the collagen structure for firmer texture while reducing inflammation and redness.”

“Further invigorate the circulatory and lymphatic system…”