08.11.16
The FDA’s outgoing mail department has been busy. The agency has issued several warning letters for claims made by several skin care companies—including Freeze 24-7 (owned by TPR Holdings), Peter Thomas Roth, MiN, Lavian and Finally Pure —which the agency contends make them 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)].
The letter sent to TPR Holdings, LLC followed reviews of the company’s Freeze 24-7 website in May and July. FDA contends that claims on the brand’s website establish that Freeze 24-7 Instant Targeted Wrinkle Treatment product is a drug because it is intended to affect the structure or function of the human body.
Specifically, FDA flagged the following website claims:
Freeze 24-7 Instant Targeted Wrinkle Treatment
• “A natural alternative to Botox and other potentially harmful (and costly) Invasive procedures.”
• “Gynostemma is a pure plant extract, which acts to help microcirculation, and assists GABA in communicating its muscle relaxation message.”
• “Freeze 24-7 products incorporate our Age Less Technology which releases Topical Muscle Relaxers (TMRs).
• “Freeze 24-7 products incorporate our patent-pending Age-Less Technology, which includes the ingredient, GABA (Gamma Aminobutyric Acid). GABA is produced in the body as a natural muscle relaxant, just as melatonin is produced as the body’s natural sleep inducing agent. When used in conjunction with other key ingredients found within our proprietary complex, GABA works to help diminish the appearance of fine lines and winkles on the facial area quickly, safely, and effectively with no side effects – just results.”
• “Offers alternatives to Botox, Restylane and other sometimes harmful, costly and invasive procedures.”
Peter Thomas Roth Labs LLC was also cited for claims following website reviews in May 2016 and and July 2016 realted to its Un-Wrinkle Turbo Line Smoothing Toning Lotion and Mega-Rich Intensive Anti-Aging Cellular Eye Crème.
According to FDA, the cited website claims include:
Un-Wrinkle Turbo Line Smoothing Toning Lotion
• “A blend of 18 neuropeptides and peptides – work to help send signals to skin to help activate anti-aging mechanisms that help the appearance of deep wrinkles and expression lines.”
• “Under Benefits: 24 Karat Gold – helps soothe and has been known to provide anti-inflammatory benefits”
Mega-Rich Intensive Anti-Aging Cellular Eye Crème
▪ “Under Benefits: SYN-COLL - Peptide that mimics the body's own mechanism to produce collagen”
▪ “Tetrapeptide and Oligopeptide - Peptides that work synergistically to help promote collagen production while helping to stimulate fibroblast cells in the skin”
Lavian Ltd., based in Hicksville, NY, was also cited for reviews in May and July, specifically for its Smooth Lip Volumizer, Empower MP6 Anti-Wrinkle Treatment, and Resurgent Stem Cell Firming Activator.
Smooth Lip Volumizer
• “An excellent alternative to medically administered treatments.”
• “Vitamin A: Useful for regenerating skin and encouraging cellular renewal… used in the treatment of psoriasis.”
• “Vitamin C: collagen boosting Vitamin C, also works to strengthen capillary walls for firm skin tone. Shown to help control hyperpigmentation and to enhance the skin’s immune system.”
• “Vitamin E: excellent anti-inflammatory effects…”
Empower MP6 Anti-Wrinkle Treatment
▪ “Safe and non-toxic, topical alternative to injections”
▪ “Containing the two newest multi-peptides Argireline® and Matrixyl 3000… effectively stimulate the synthesis of its own collagen”
▪ “Matrixyl 3000: Increases and promotes collagen synthesis”
Resurgent Stem Cell Firming Activator
▪ “The key function for skin tissue stem cells is to continuously regenerate brand new skin…”
▪ [R]everse skin damage through the stimulation of new skin from the stem cell reservoirs.”
▪ “By allowing the stem cells to increase their potency and promote cell regeneration, tissue is reconstructed to a denser quality and more elastic skin.”
▪ “Aligisium C Activates epidermal regeneration & targets damage done by free radical agents”
MiN New York, New York was cited for claims related to its Calming Facial Oil, ProEnzyme Facial Cleanser, ProEnzyme Facial Scrub, and Complex Age Defying Moisturizer, following FDA reviews in May and July.
These claims includeded:
Calming Facial Oil
• “La Nuit Douce's calming facial oil …that uses frankincense to balance hormones…”
• “Neroli promotes cell growth.”
• “Myrrh has anti-inflammatory and anti-anxiety properties…and have anti-bacterial properties.”
ProEnzyme Facial Cleanser AND ProEnzyme Facial Scrub
▪ “[P]romotes cellular metabolism by stimulating Pyruvate production, ATP synthesis, and DNA and proteins synthesis in the energy cascade in skin cells.”
Complex Age Defying Moisturizer
▪ “Natural sun protection. Ultra-hydrating formula encourages healthy cell regeneration.”
▪ “[P]romotes cellular metabolism by stimulating Pyruvate production, ATP synthesis, and DNA and proteins synthesis in the energy cascade in skin cells.”
Finally Pure, LLC, based in Wasilla, Alaska, was issued a similar warning letter following a website review in May 2016 related to its Toner for All Skin Types, Unscented Day Cream for All Skin Types, Unscented Day Cream for Extra Sensitive Skin, Unscented Day Cream for Dry/Mature Skin, and Lemongrass Herbal Sore Muscle Massage Oil.
Examples included:
Toner for All Skin Types
• “Antibacterial, antiviral, antifungal and antiparasitic”
• “Organic Calendula: Soothing herb with many skin restorative benefits; antiseptic; aids in tissue regeneration by stimulating collagen production process, and helps in the formation of new blood vessels.”
• “[A]nti-inflammatory”
• “Helps to strengthen capillary walls”
• “Organic Aloe Vera: . . . aids in the skin cell renewal process and collagen production . . . which helps to accelerate skin repair and reduce inflammation.”
• “Organic Witch Hazel Hydrosol: . . . anti-inflammatory properties . . . reduce swelling.”
• “Organic Chamomile (German): . . . antiseptic . . . anti-inflammatory properties; helps to strengthen capillaries . . . promote tissue regeneration”
Unscented Day Cream for All Skin Types
▪ “The combined Organic ingredients of Red Raspberry Seed Oil (SPF 30-50), Carrot Seed Oil (SPF 30) and Shea Butter SPF 6-10) assist in providing natural sun protection.”
▪ “Aloe Vera: Aids in stimulating the growth of new skin tissue, increasing circulation and drawing immune cells to the affected areas.”
▪ “Aids in stimulating collagen production”
▪ “Promotes skin repair and cell regeneration”
▪ “[L]ightens dark or age spots”
▪ “Hyaluronic Acid (Sodium Hyaluronate): . . . Its many functions include aiding in tissue repair . . . supporting collagen and elastin.”
Unscented Day Cream for Extra Sensitive Skin
▪ “The combined Organic ingredients of Red Raspberry Seed Oil (SPF 30-50), Carrot Seed Oil (SPF 30) and Shea Butter SPF 6-10) assists in providing natural sun protection.”
▪ “The combination of these botanicals . . . stimulates . . . cell regeneration abilities.”
▪ “Aids in the collagen production process”
▪ “Hyaluronic Acid (Sodium Hyaluronate): . . . Its many functions include aiding in tissue repair . . . supporting collagen and elastin.”
Unscented Day Cream for Dry/Mature Skin
▪ “The combined Organic ingredients of Red Raspberry Seed Oil (SPF 30-50), Carrot Seed Oil (SPF 30) and Shea Butter SPF 6-10) assist in providing natural sun protection.”
▪ “The combination of these botanicals . . . stimulates . . . cell regeneration abilities.”
▪ “Aids in stimulating collagen production”
▪ “Hyaluronic Acid (Sodium Hyaluronate): Its many functions include aiding in tissue repair . . . supporting collagen and elastin.”
Lemongrass Herbal Sore Muscle Massage Oil
• “Organic Herb Arnica (Arnica Montana), which has been used for centuries to reduce inflammation and soothe sore muscles.”
• “This natural vitamin E is known to . . . help skin to recover from scarring and other damage”
The letter sent to TPR Holdings, LLC followed reviews of the company’s Freeze 24-7 website in May and July. FDA contends that claims on the brand’s website establish that Freeze 24-7 Instant Targeted Wrinkle Treatment product is a drug because it is intended to affect the structure or function of the human body.
Specifically, FDA flagged the following website claims:
Freeze 24-7 Instant Targeted Wrinkle Treatment
• “A natural alternative to Botox and other potentially harmful (and costly) Invasive procedures.”
• “Gynostemma is a pure plant extract, which acts to help microcirculation, and assists GABA in communicating its muscle relaxation message.”
• “Freeze 24-7 products incorporate our Age Less Technology which releases Topical Muscle Relaxers (TMRs).
• “Freeze 24-7 products incorporate our patent-pending Age-Less Technology, which includes the ingredient, GABA (Gamma Aminobutyric Acid). GABA is produced in the body as a natural muscle relaxant, just as melatonin is produced as the body’s natural sleep inducing agent. When used in conjunction with other key ingredients found within our proprietary complex, GABA works to help diminish the appearance of fine lines and winkles on the facial area quickly, safely, and effectively with no side effects – just results.”
• “Offers alternatives to Botox, Restylane and other sometimes harmful, costly and invasive procedures.”
Peter Thomas Roth Labs LLC was also cited for claims following website reviews in May 2016 and and July 2016 realted to its Un-Wrinkle Turbo Line Smoothing Toning Lotion and Mega-Rich Intensive Anti-Aging Cellular Eye Crème.
According to FDA, the cited website claims include:
Un-Wrinkle Turbo Line Smoothing Toning Lotion
• “A blend of 18 neuropeptides and peptides – work to help send signals to skin to help activate anti-aging mechanisms that help the appearance of deep wrinkles and expression lines.”
• “Under Benefits: 24 Karat Gold – helps soothe and has been known to provide anti-inflammatory benefits”
Mega-Rich Intensive Anti-Aging Cellular Eye Crème
▪ “Under Benefits: SYN-COLL - Peptide that mimics the body's own mechanism to produce collagen”
▪ “Tetrapeptide and Oligopeptide - Peptides that work synergistically to help promote collagen production while helping to stimulate fibroblast cells in the skin”
Lavian Ltd., based in Hicksville, NY, was also cited for reviews in May and July, specifically for its Smooth Lip Volumizer, Empower MP6 Anti-Wrinkle Treatment, and Resurgent Stem Cell Firming Activator.
Smooth Lip Volumizer
• “An excellent alternative to medically administered treatments.”
• “Vitamin A: Useful for regenerating skin and encouraging cellular renewal… used in the treatment of psoriasis.”
• “Vitamin C: collagen boosting Vitamin C, also works to strengthen capillary walls for firm skin tone. Shown to help control hyperpigmentation and to enhance the skin’s immune system.”
• “Vitamin E: excellent anti-inflammatory effects…”
Empower MP6 Anti-Wrinkle Treatment
▪ “Safe and non-toxic, topical alternative to injections”
▪ “Containing the two newest multi-peptides Argireline® and Matrixyl 3000… effectively stimulate the synthesis of its own collagen”
▪ “Matrixyl 3000: Increases and promotes collagen synthesis”
Resurgent Stem Cell Firming Activator
▪ “The key function for skin tissue stem cells is to continuously regenerate brand new skin…”
▪ [R]everse skin damage through the stimulation of new skin from the stem cell reservoirs.”
▪ “By allowing the stem cells to increase their potency and promote cell regeneration, tissue is reconstructed to a denser quality and more elastic skin.”
▪ “Aligisium C Activates epidermal regeneration & targets damage done by free radical agents”
MiN New York, New York was cited for claims related to its Calming Facial Oil, ProEnzyme Facial Cleanser, ProEnzyme Facial Scrub, and Complex Age Defying Moisturizer, following FDA reviews in May and July.
These claims includeded:
Calming Facial Oil
• “La Nuit Douce's calming facial oil …that uses frankincense to balance hormones…”
• “Neroli promotes cell growth.”
• “Myrrh has anti-inflammatory and anti-anxiety properties…and have anti-bacterial properties.”
ProEnzyme Facial Cleanser AND ProEnzyme Facial Scrub
▪ “[P]romotes cellular metabolism by stimulating Pyruvate production, ATP synthesis, and DNA and proteins synthesis in the energy cascade in skin cells.”
Complex Age Defying Moisturizer
▪ “Natural sun protection. Ultra-hydrating formula encourages healthy cell regeneration.”
▪ “[P]romotes cellular metabolism by stimulating Pyruvate production, ATP synthesis, and DNA and proteins synthesis in the energy cascade in skin cells.”
Finally Pure, LLC, based in Wasilla, Alaska, was issued a similar warning letter following a website review in May 2016 related to its Toner for All Skin Types, Unscented Day Cream for All Skin Types, Unscented Day Cream for Extra Sensitive Skin, Unscented Day Cream for Dry/Mature Skin, and Lemongrass Herbal Sore Muscle Massage Oil.
Examples included:
Toner for All Skin Types
• “Antibacterial, antiviral, antifungal and antiparasitic”
• “Organic Calendula: Soothing herb with many skin restorative benefits; antiseptic; aids in tissue regeneration by stimulating collagen production process, and helps in the formation of new blood vessels.”
• “[A]nti-inflammatory”
• “Helps to strengthen capillary walls”
• “Organic Aloe Vera: . . . aids in the skin cell renewal process and collagen production . . . which helps to accelerate skin repair and reduce inflammation.”
• “Organic Witch Hazel Hydrosol: . . . anti-inflammatory properties . . . reduce swelling.”
• “Organic Chamomile (German): . . . antiseptic . . . anti-inflammatory properties; helps to strengthen capillaries . . . promote tissue regeneration”
Unscented Day Cream for All Skin Types
▪ “The combined Organic ingredients of Red Raspberry Seed Oil (SPF 30-50), Carrot Seed Oil (SPF 30) and Shea Butter SPF 6-10) assist in providing natural sun protection.”
▪ “Aloe Vera: Aids in stimulating the growth of new skin tissue, increasing circulation and drawing immune cells to the affected areas.”
▪ “Aids in stimulating collagen production”
▪ “Promotes skin repair and cell regeneration”
▪ “[L]ightens dark or age spots”
▪ “Hyaluronic Acid (Sodium Hyaluronate): . . . Its many functions include aiding in tissue repair . . . supporting collagen and elastin.”
Unscented Day Cream for Extra Sensitive Skin
▪ “The combined Organic ingredients of Red Raspberry Seed Oil (SPF 30-50), Carrot Seed Oil (SPF 30) and Shea Butter SPF 6-10) assists in providing natural sun protection.”
▪ “The combination of these botanicals . . . stimulates . . . cell regeneration abilities.”
▪ “Aids in the collagen production process”
▪ “Hyaluronic Acid (Sodium Hyaluronate): . . . Its many functions include aiding in tissue repair . . . supporting collagen and elastin.”
Unscented Day Cream for Dry/Mature Skin
▪ “The combined Organic ingredients of Red Raspberry Seed Oil (SPF 30-50), Carrot Seed Oil (SPF 30) and Shea Butter SPF 6-10) assist in providing natural sun protection.”
▪ “The combination of these botanicals . . . stimulates . . . cell regeneration abilities.”
▪ “Aids in stimulating collagen production”
▪ “Hyaluronic Acid (Sodium Hyaluronate): Its many functions include aiding in tissue repair . . . supporting collagen and elastin.”
Lemongrass Herbal Sore Muscle Massage Oil
• “Organic Herb Arnica (Arnica Montana), which has been used for centuries to reduce inflammation and soothe sore muscles.”
• “This natural vitamin E is known to . . . help skin to recover from scarring and other damage”