08.22.17
The Food and Drug Administration sent two letters in as many days to two companies—Skin 2 Spirit, LLC, Newtown, PA, and Moon Valley Natural Products, LLC, Deming, WA—for violations of the Cosmetic Act.
FDA, after reviewing Skin 2 Spirit website (http://www.skin2spirit.com) in April 2017 contends the company is marketingits Shea Body Butter Creme, Magnesium Oil, Organic Caffeine Eye Whip, Advanced Hyaluronic Acid Antiaging Serum, Organic Bioclear Pink Grapefruit Acne Face Wash, Organic Bioclear Pink Grapefruit Face Toner, and Organic Coconut Rose Face Whip 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/or 321 (g)(1)(C)].
Examples cited by FDA include:
Organic Caffeine Eye Whip
• "Caffeine Extract, known for increasing circulation ... "
• "ROSE HIP SEED OIL [(an ingredient in your product)]: Supports the keratin migration cycle that is responsible for the natural regeneration of skin cells and can increase renewed cells in the epidermis."
• "CUCUMBER PEEL EXTRACT [(an ingredient in your product)]: ... has antiinflammatory ... properties."
Advanced Hyaluronic Acid Antiaging Serum
• "Hyaluronic Acid has recently been used to create Hylaform Gel, an FDA Approved injectable material that aestheticians and plastic surgeons predict will replace collagen injections because the risk of reaction is lower (most collagen being of bovine origin) and Hylaform Gel is more effective, and the results last longer than those of collagen injections."
Organic Bioclear Pink Grapefruit Acne Face Wash
• "Addition of CLOVE [(an ingredient in your product)], an antiseptic, and CAYENNE [(an ingredient in your product)], an anti-inflammatory ingredient that helps soothe redness, fade dark spots and promotes healing of Acne scars."
• "Also includes WILLOW BARK [(an ingredient in your product)], a 100% pure and natural way to help stop Acne in its tracks! Willow Bark, or Salicin, is a derivative of Salicylic Acid, the key additive in many skin-care products for the treatment of acne."
• "WILLOW BARK [(an ingredient in your product)] ... reduce inflammation, soothes pain."
• "PINK GRAPEFRUIT ESSENTIAL OILS [(an ingredient in your product)] ... reduce oil production."
• "CLOVE [(an ingredient in your product)] ... Has antibacterial properties, and some of its primary components are known to be toxic to Propionibacterium Acnes bacteria."
• "CAYENNE [(an ingredient in your product)] ... anti-inflammatory."
• "WITCH HAZEL [(an ingredient in your product)] ... reduces oil production."
Organic Bioclear Pink Grapefruit Face Toner
• "ORGANIC ROSE HYDROSOL [(an ingredient in your product)] ... helps to regulate sebum, and its antibacterial properties can be helpful in the prevention of acne."
• "ORGANIC ALOE [(an ingredient in your product)] ... reduce inflammation and swelling. Aloe vera also reduces redness."
• "LAVENDER ESSENTIAL OIL [(an ingredient in your product)] ... Balances oil production ... "
• "TEA TREE OIL [(an ingredient in your product)] ... Destroys bacteria that cause Acne flare-ups."
Organic Coconut Rose Face Whip
• "LICORICE ROOT [(an ingredient in your product)], which has excellent antiinflammatory properties ... "
• "ROSE HIP SEED OIL [(an ingredient in your product)] ... Supports the keratin migration cycle that is responsible for the natural regeneration of skin cells and can increase renewed cells in the epidermis."
• "VITAMIN C [(an ingredient in your product)] ... skin whitening agent ... "
• "Licorice extract [(an ingredient in your product)] can inhibit the melanogenesis and is thus used also as skin whitening agent."
FDA also had issue with claims regarding Magnesium Oil listed on the site.
Moon Valley Natural Products’ warning letter, dated Aug. 11, came after FDA conducted an inspection of the firm’s manufacturing facility between Feb. 14, 2017, through Feb. 28, 2017 and collected finished product labeling as well as after a review of its website.
Examples of some of the website claims, as cited by FDA, were:
Muscle Rub
Box Label:
· “[D]eeply penetrate into muscles and joints to warm and comfort sore areas”
· “Massage into over-taxed muscles, sprains, strains, arthritic joints, or any other aches and pains…”
Product Brochure:
· “[D]eeply penetrate into sore muscles and joints to warm and comfort sore areas”
Your website www.moonvalleyorganics.com/collections/natural-health-beauty/products/muscle-rub states:
· “[D]eeply penetrate into sore muscles and joints to stimulate circulation and relieve minor aches and pains.”
Rejuvenating Rub
Your website www.moonvalleyorganics.com/collections/natural-health-beauty/products/body-heal states:
· “[T]emporary relief to minor aches and pains and bruised areas”
· “[R]elaxing the body from throbbing head to aching toe”
· “Great for relieving headaches…”
PsoriaSoothe
Box Label and Product Brochure:
· “[S]oothe itchy, dry and flaking skin”
Your website www.moonvalleyorganics.com/collections/natural-health-beauty/products/psoriasalve states:
· “[S]oothe itchy, dry and flaking skin”
Furthermore, the product name “PsoriaSoothe” suggests the product is intended for psoriasis.
Herbal Heal
Box Label:
· “Our Recipe for Tending Damaged Skin”
· “…recuperating cuts, minor burns and abrasions”
Product Brochure:
· “…soothe…recuperating cuts, minor burns and abrasions. Sting free!”
Your website www.moonvalleyorganics.com/collections/natural-health-beauty/products/wound-aid states:
· “Our Recipe for Tending Minor Wounds”
· “[S]oothe recuperating cuts, minor burns and abrasions”
· “It is free of any stinging ingredients…”
· “Apply to affected area of minor cuts, burns and infections. Great for healing tattoos…”
Peppermint Foot Rub
Product Brochure:
· “[S]oothe skin inflammation…”
Your website www.moonvalleyorganics.com/collections/natural-health-beauty/products/copy-of-rejuvenating-rub states:
· “[P]ain-relieving and anti-inflammatory…”
· “Massage into sore areas of your feet…”
Your website page, “All About Herbs” makes claims about several ingredients including lavender, arnica, and calendula, that are used in your cosmetic products. The claims regarding these ingredients are attributable to any products that contain the ingredients. For example, claims made regarding arnica on your website www.moonvalleyorganics.com/blogs/all-about-herbs include:
· “[U]sed to treat uterine hemorrhage, myocarditis, angina pectoris, and cardiac insufficiency.” These claims, and any potential violations relating to them, would apply to any product containing arnica.
Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of products for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
Muscle Rub
· Review by customer on 02/03/17, “I have osteoarthritis and when my knees or feet are aching…just rub it on & it instantly takes the pain…away”
· Review by customer on 01/02/17, “I always look for products that help stimulate circulation. It is important for the diabetic in my life.”
Rejuvenating Rub
· Review by customer on 01/02/17, “I used the foot rub on my boyfriend who needs…care on his feet and legs (from diabetes 1)…”
· Review by customer on 12/06/16, “I suffer from TMJ it’s a muscle disorder and I would be in debilitating pain if it wasn’t for this cooling rub”
PsoriaSoothe
· Review by customer on 04/14/17, “Soothed my sunburn and my psoriasis”
FDA told Moon Valley Natural Products that its products Muscle Rub and Rejuvenating Rub “are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, Muscle Rub and Rejuvenating Rub fail to bear adequate directions for their intended uses and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 321(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates 301(a) of the Act [21 U.S.C. § 331(a)].”
FDA, after reviewing Skin 2 Spirit website (http://www.skin2spirit.com) in April 2017 contends the company is marketingits Shea Body Butter Creme, Magnesium Oil, Organic Caffeine Eye Whip, Advanced Hyaluronic Acid Antiaging Serum, Organic Bioclear Pink Grapefruit Acne Face Wash, Organic Bioclear Pink Grapefruit Face Toner, and Organic Coconut Rose Face Whip 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/or 321 (g)(1)(C)].
Examples cited by FDA include:
Organic Caffeine Eye Whip
• "Caffeine Extract, known for increasing circulation ... "
• "ROSE HIP SEED OIL [(an ingredient in your product)]: Supports the keratin migration cycle that is responsible for the natural regeneration of skin cells and can increase renewed cells in the epidermis."
• "CUCUMBER PEEL EXTRACT [(an ingredient in your product)]: ... has antiinflammatory ... properties."
Advanced Hyaluronic Acid Antiaging Serum
• "Hyaluronic Acid has recently been used to create Hylaform Gel, an FDA Approved injectable material that aestheticians and plastic surgeons predict will replace collagen injections because the risk of reaction is lower (most collagen being of bovine origin) and Hylaform Gel is more effective, and the results last longer than those of collagen injections."
Organic Bioclear Pink Grapefruit Acne Face Wash
• "Addition of CLOVE [(an ingredient in your product)], an antiseptic, and CAYENNE [(an ingredient in your product)], an anti-inflammatory ingredient that helps soothe redness, fade dark spots and promotes healing of Acne scars."
• "Also includes WILLOW BARK [(an ingredient in your product)], a 100% pure and natural way to help stop Acne in its tracks! Willow Bark, or Salicin, is a derivative of Salicylic Acid, the key additive in many skin-care products for the treatment of acne."
• "WILLOW BARK [(an ingredient in your product)] ... reduce inflammation, soothes pain."
• "PINK GRAPEFRUIT ESSENTIAL OILS [(an ingredient in your product)] ... reduce oil production."
• "CLOVE [(an ingredient in your product)] ... Has antibacterial properties, and some of its primary components are known to be toxic to Propionibacterium Acnes bacteria."
• "CAYENNE [(an ingredient in your product)] ... anti-inflammatory."
• "WITCH HAZEL [(an ingredient in your product)] ... reduces oil production."
Organic Bioclear Pink Grapefruit Face Toner
• "ORGANIC ROSE HYDROSOL [(an ingredient in your product)] ... helps to regulate sebum, and its antibacterial properties can be helpful in the prevention of acne."
• "ORGANIC ALOE [(an ingredient in your product)] ... reduce inflammation and swelling. Aloe vera also reduces redness."
• "LAVENDER ESSENTIAL OIL [(an ingredient in your product)] ... Balances oil production ... "
• "TEA TREE OIL [(an ingredient in your product)] ... Destroys bacteria that cause Acne flare-ups."
Organic Coconut Rose Face Whip
• "LICORICE ROOT [(an ingredient in your product)], which has excellent antiinflammatory properties ... "
• "ROSE HIP SEED OIL [(an ingredient in your product)] ... Supports the keratin migration cycle that is responsible for the natural regeneration of skin cells and can increase renewed cells in the epidermis."
• "VITAMIN C [(an ingredient in your product)] ... skin whitening agent ... "
• "Licorice extract [(an ingredient in your product)] can inhibit the melanogenesis and is thus used also as skin whitening agent."
FDA also had issue with claims regarding Magnesium Oil listed on the site.
Moon Valley Natural Products’ warning letter, dated Aug. 11, came after FDA conducted an inspection of the firm’s manufacturing facility between Feb. 14, 2017, through Feb. 28, 2017 and collected finished product labeling as well as after a review of its website.
Examples of some of the website claims, as cited by FDA, were:
Muscle Rub
Box Label:
· “[D]eeply penetrate into muscles and joints to warm and comfort sore areas”
· “Massage into over-taxed muscles, sprains, strains, arthritic joints, or any other aches and pains…”
Product Brochure:
· “[D]eeply penetrate into sore muscles and joints to warm and comfort sore areas”
Your website www.moonvalleyorganics.com/collections/natural-health-beauty/products/muscle-rub states:
· “[D]eeply penetrate into sore muscles and joints to stimulate circulation and relieve minor aches and pains.”
Rejuvenating Rub
Your website www.moonvalleyorganics.com/collections/natural-health-beauty/products/body-heal states:
· “[T]emporary relief to minor aches and pains and bruised areas”
· “[R]elaxing the body from throbbing head to aching toe”
· “Great for relieving headaches…”
PsoriaSoothe
Box Label and Product Brochure:
· “[S]oothe itchy, dry and flaking skin”
Your website www.moonvalleyorganics.com/collections/natural-health-beauty/products/psoriasalve states:
· “[S]oothe itchy, dry and flaking skin”
Furthermore, the product name “PsoriaSoothe” suggests the product is intended for psoriasis.
Herbal Heal
Box Label:
· “Our Recipe for Tending Damaged Skin”
· “…recuperating cuts, minor burns and abrasions”
Product Brochure:
· “…soothe…recuperating cuts, minor burns and abrasions. Sting free!”
Your website www.moonvalleyorganics.com/collections/natural-health-beauty/products/wound-aid states:
· “Our Recipe for Tending Minor Wounds”
· “[S]oothe recuperating cuts, minor burns and abrasions”
· “It is free of any stinging ingredients…”
· “Apply to affected area of minor cuts, burns and infections. Great for healing tattoos…”
Peppermint Foot Rub
Product Brochure:
· “[S]oothe skin inflammation…”
Your website www.moonvalleyorganics.com/collections/natural-health-beauty/products/copy-of-rejuvenating-rub states:
· “[P]ain-relieving and anti-inflammatory…”
· “Massage into sore areas of your feet…”
Your website page, “All About Herbs” makes claims about several ingredients including lavender, arnica, and calendula, that are used in your cosmetic products. The claims regarding these ingredients are attributable to any products that contain the ingredients. For example, claims made regarding arnica on your website www.moonvalleyorganics.com/blogs/all-about-herbs include:
· “[U]sed to treat uterine hemorrhage, myocarditis, angina pectoris, and cardiac insufficiency.” These claims, and any potential violations relating to them, would apply to any product containing arnica.
Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of products for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
Muscle Rub
· Review by customer on 02/03/17, “I have osteoarthritis and when my knees or feet are aching…just rub it on & it instantly takes the pain…away”
· Review by customer on 01/02/17, “I always look for products that help stimulate circulation. It is important for the diabetic in my life.”
Rejuvenating Rub
· Review by customer on 01/02/17, “I used the foot rub on my boyfriend who needs…care on his feet and legs (from diabetes 1)…”
· Review by customer on 12/06/16, “I suffer from TMJ it’s a muscle disorder and I would be in debilitating pain if it wasn’t for this cooling rub”
PsoriaSoothe
· Review by customer on 04/14/17, “Soothed my sunburn and my psoriasis”
FDA told Moon Valley Natural Products that its products Muscle Rub and Rejuvenating Rub “are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, Muscle Rub and Rejuvenating Rub fail to bear adequate directions for their intended uses and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 321(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates 301(a) of the Act [21 U.S.C. § 331(a)].”