New FDA Warning Letter

The US FDA has sent a warning letter to Haddonfield, NJ-based Reviva Labs, Inc.
 
Upon reviewing the firm’s cosmetic product labels following an October 2015 inspection and on its website in March 2016, FDA determined that company claims establish the firm’s Nasolabial Fold Multi-Peptide Cream, Glycolic Acid Oily Skin Daytime Light Cream Moisturizer, Skin Lightener For Day Fade Cream, DMAE Firming Fluid, Collagen Regeneration Cream, Lighten & Brighten Dark Spot Serum, Spider Vein & Rosacea Day Cream W/Vitamin P, and Vitamin K Cream products as drugs under section 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 § 321(g)(1)(C).
 
Examples of some of the product label and website claims that garnered FDA's attention were:
 
Nasolabial Fold Multi-Peptide Cream
 
[Product Label]
•  “Our cream’s complex formula includes…ingredients that can help increase fatty tissue volume to…plum up…”
 
[Website]
•  “Special new peptides and additional ingredients can help increase the volume of fatty tissue.”
•  “[H]yaluronic acid can help…reduce inflammation…”
Glycolic Acid Oily Skin Daytime Light Cream Moisturizer
 
[Product Label]
•  “Reduces blemish-causing bacteria…”
 
[Website]
•  “Reduces blemish-causing bacteria…”
•   [Glycolic acid-an ingredient in your product] “It is used…reduce hyperpigmentation, lessen sun damage…”
Skin Lightener For Day Fade Cream
 
[Product Label]
•  “Results for lightening age spots or discoloration like never before…”
•   “[H]elping to fade dark spots…”
 [Website]
•  “Effective treatment for brown spots and other skin discolorations” 
DMAE Firming Fluid
 
[Website]
•  “DMAE uniquely stimulates muscle tone for firmer, tighter throat and facial areas.”
•  “Acetylcholine is one of the body's major elements responsible for muscle tone. DMAE is known to stimulate acetylcholine, thus helping aging skin achieve improved facial contours.”
•   “DMAE’s firming effects are believed to involve the signaling of acetylcholine in the skin.” 
Collagen Regeneration Cream
 
[Website] 
•  “Stimulating your skin’s own collagen and aiding new collagen production is a different story — and the focus of this cream.”
•  “Its Palmitoyl Tripeptide-5 sends signals to dermal fibroblasts to synthesize new collagen (the peptide isn’t absorbed to reach fibroblasts; it acts like a messenger).”
•  “Coenzyme Q10 (CoQ10 or ubiquinone) has antioxidant and anti-inflammatory effects.”
•  “Coenzyme Q10 can help to stimluate healthy collagen production in the skin, fight free-radical damage (caused by UV exposure)…”
Lighten & Brighten Dark Spot Serum
 
[Website]
•  “Diminish dark spots…”
•  “Kojic acid …is used in cosmetics to lighten skin by inhibiting or interrupting the skin's production of melanin. The production of melanin is what determines skin pigmentation.”
•  “Kojic acid interferes with melanin production, helping to lighten the skin.”
•  “Kojic acid is also known for its…antibacterial, and antifungal properties.”
Spider Vein & Rosacea Day Cream W/Vitamin P
 
[Website]  
•  “Soy benefits the skin by providing antioxidant and anti-inflammatory protection. Studies have shown that a component of soy, known as genistein, has a collagen-stimulating effect. Other compounds found in soy have been linked to increased skin thickness and elasticity. Soy extracts are shown to produce amazing skin rejuvenating benefits externally as well as internally.” 
Vitamin K Cream
 
[Website] 
•  “This special Vitamin K formula helps fade and clear bruises.”
•  “Primarily to help fade and clear bruises, before or after surgery, black and blue marks, etc.”
•  “Also helps treat red, irritated areas on the face, spider veins and rosacea…” 
 
In addition, FDA said its inspection revealed insanitary practices that may lead to insanitary conditions that may cause products to become contaminated with filth or rendered injurious to health. Specifically, FDA said it: ….”observed a box of vitamin E stick sleeves and bulk products….in close proximity to rainwater entering into the warehouse through a broken bay door.”
 
In its letter, FDA said that it had “reviewed your written response, dated November 20, 2015. However, FDA noted that it was “unable to evaluate your response due to lack of supporting documentation.”
 
FDA provided a 15 day period from receipt of letter for Reviva to provide additional documentation.