FDA Warning Letters Sent To Two Firms

Annmarie and Kevin Gianni, founders of Annmarie Gianni Skin Care, Orange, CT, were sent a warning letter by the Food and Drug Administration (FDA) after reviewing its website in May 2016. In the July 15, 2016 letter , FDA contends the claims made online about the brand’s Repair Serum, Anti-Aging Eye Cream and Anti-Aging Serum establish that the products are drugs under sections 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act.
 
According to FDA, examples of some of the website claims that provide evidence that the products are intended for use as drugs include:
 
Repair Serum
▪  “Using vegan stem cells…a new way for your skin to build collagen, repair itself and prevent aging.”
▪  “Ideal for treating: Sun spots, age spots, acne scarring, Hyperpigmentation” 
Anti-Aging Eye Cream
▪  “[S]upports the synthesis of new skin fibers, sweet iris boosts cell regeneration…”
▪  “Soothes and reduces redness and irritation”
Anti-Aging Serum 
▪  “This serum will increase skin hydration by inhibiting hyalurondase…”
▪  “The life everlasting flower extract helps prolong and regenerate the skin cell.”
▪  “Sunflower seed extract adds UV protective qualities as well as essential fatty acids.”
▪  “Flaxseed is very high in lignans that support cell communication.”
▪  “Rosacea”

In addition, John Robert Insinger, founder of Ageless Aesthetics, Inc. in Aurora, CO, was also issued a warning letter following a review of the company’s website (medik8.us) in June. 

FDA says claims for White Balance Click Intense Brightening Serum, White Balance Click Oxy-R Ultra Brightening Serum, and Growth Factor establish that the products are drugs under the Act.
 
In this case, examples of some of the website claims that provide evidence that the products are intended for use as drugs include:
 
White Balance Click Intense Brightening Serum 
▪  “Proven significant whitening activity of 97.3%*”
▪  “Targets all types of pigmentation concerns: dark spots, age spots, melisma, freckles, and blotchiness and helps to prevent future appearance of pigmentation”
▪  “Linoleic Acid…improving melanin dispersion”
▪  “L-Leucine – inhibits the transport of L-Tyrosine and L-phenylalanine into melanocytes, therefore nurturing it with inhibitive precursor for melanin formation”
▪  “N-Acetyl Glucosamine – skin whitening agent” 
White Balance Click Oxy-R Ultra Brightening Serum  
▪  “The patent-pending stabilisation technology addresses and helps to inhibit the appearance of melanin-based pigmentation (caused by sun damage).”
▪  “Oxyresveratrol (Oxy-R) – Oxy-r is a skin lightening ingredient with patent-pending stablisation technology.”
▪  “Gluconolactone – A poly-lactic acid (PHA) that … break down stubborn melanin deposits. Helps provide protection from UV damage.” 
Growth Factor
▪  “Stimulates production of collagen and elastin (fibroblasts)”
▪  “sh-Oligopeptide-1 (EGF): obtained by biotechnology, triple-filtered and liposome stabilized. Activates the skin receptors stimulating…skin regeneration” 
 
Looking for greater insight into what claims are off limits? Attend Happi's Anti-Aging & Tabletop Exhibition, which is Sept. 20 & 21, 2016 in New Brunswick, NJ.