10.21.16
The US Food and Drug Administration paid a visit to Bioque Technologies, Inc. & Vouray, Inc. in Blacksburg, VA and didn't like what it found. According to the FDA, Vouray Serum HA and Vouray Serum K1 both make drug claims. Some examples, taken from the company's website, include:
Serum UC
- “Our Ultra 20% Anhydrous Vitamin C Serum supports the skin's use of oxygen to boost the natural cell metabolism…and capillary function…”
- “Replenishes Vitamin C levels to support the continued production of collagen and elastin”
Serum RV-EGF Serum
- “…[S]erum RV performs better than cosmetic injections…”
- “Easy, natural alternative to pricey injections!”
Day Skin Defense
- “[A]n all-natural powerful defense against damaging sun rays…”
- “Works all day to protect your skin from harmful…DNA damage…”
On the Vouray Website and Serum HA product label
Serum HA
- “Promotes the production of collagen and elastin”
- “Promotes blood microcirculation…”
On the Vouray Serum K1 label
Serum K1
- “Banish bruises and prevent unsightly scars with Serum K1”
On the Bioque website
Serum XL
- “[T]he BOTOX alternative that packs a peptide punch”
- “Argireline, a peptide that serves as a natural muscle relaxant, builds up in facial muscles over time…This key ingredient destresses facial muscles beneath the deepest layer of skin to reduce tightening around cavities caused by collagen and elastin deterioration, stopping the process that furrows and puckers the outer layer of skin into wrinkles.”
- “Better than a needle? You betcha.—Get all the benefits without invasive toxins, the potential risk, and the high price tag. Plus, Serum XL goes where paralyzing injections can’t.”
- “#1 Botox TM Alternative, 30% multipeptide serum.”
C-Plus Moisturizing Cream
- “[C]ollagen-stimulation superstar…”
- “Best collagen producer—Vitamin C is essential to the active production of collagen. And CPlus really revs up your skin cells…”
Serum Rejeuvenate
- “A…antiaging serum that utilizes…Intensive Penetrating Complex…which helps activate collagen and elastin and repairing damaged proteins…Intensive Penetrating Complex encourages healthier skin cell replication for long-term repair and help protect healthy cells from future damage…”
Adulterated Cosmetics
But FDA went further in its warning letter, noting that even if Serum RV-EGF Serum, Day Skin Defense, Serum HA, Serum K1, Serum XL, C-Plus Moisturizing Cream, Serum Rejuvenate, and Multi-Peptide Anti-Wrinkle Serum products did not have claims which make them unapproved new drugs, the products, and any other cosmetic products manufactured at the site, are adulterated cosmetics within the meaning of section 601(c) of the Act [21 U.S.C. § 361(c)].
Specifically, FDA noted that the conditions and practices observed and documented during the inspections caused the products to be adulterated within the meaning of section 601(c) of the Act in that the products have been prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth, or whereby they may have been rendered injurious to health. It is a violation of section 301(a) of the Act [21 U.S.C. §331(a)] to introduce or deliver for introduction into interstate commerce an adulterated cosmetic.
Specifically, FDA noted that the conditions and practices observed and documented during the inspections caused the products to be adulterated within the meaning of section 601(c) of the Act in that the products have been prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth, or whereby they may have been rendered injurious to health. It is a violation of section 301(a) of the Act [21 U.S.C. §331(a)] to introduce or deliver for introduction into interstate commerce an adulterated cosmetic.