Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26th Avenue SE, Suite 210
Bothell, WA 98021
In reply refer to Warning Letter SEA 15-05
John A. Landforce, President
2211 NW Nicolai Street
Dear Mr. Landforce:
Your firm manufactures numerous products that are presented as cosmetics including: Tamanu Butter, Neem Butter, (b)(4) Blue Green Algae Antibacterial Toner, (b)(4) Leave-In Conditioner & Detangler, Zinc Oxide, Salicylic Acid Powder, Rooibos Tincture and Tea Tree & Vinegar Facial Toner. Based on their labeling, these products are drugs as defined by section 201(g)(1)(B) and/or section 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)] because they appear to be intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or are intended to affect the structure or any function of the human body. The marketing of these products with claims evidencing these intended uses violates the Act.
Examples of some of the claims observed either on product labels or your website include:
- “Tamanu Oil is a natural cosmetic ingredient traditionally used to treat burns, blisters, psoriasis, dry skin, acne, eczema, bites, stings, age spots, & rheumatism. . . . Tamanu also contains a unique fatty acid called calophyllic acid, and an antibiotic lactone and non-steroidal anti-inflammatory agent called calophylloide. These are a few of the components that make Tamanu so effective in promoting the generation of healthy tissue in the dermis, epidermis and hydrodermis.”
- “This butter has been known to help with skin disorders and rashes, which makes it a great butter for formulating healing balms and lip products.”
- “Neem Oil is a natural cosmetic ingredient traditionally used in Ayurvedic medicine to treat a host of ailments problems [sic], including acne, inflammation, burns, blisters, wounds, bites and stings. The azadirachtin in Neem oil is also a potent natural insecticide which has made Neem Oil popular in flea and lice repellant personal care products.”
- “Neem is used widely in India as an antibacterial, antiviral, antifungal, antiseptic, and antiparasitic agent in toiletries, soap, toothpaste and skin/hair care products.”
- “[A]nti-inflammatory and anti-bacterial . . . aids in treatment and prevention of acne.”
- “Willow Bark has long been known for the analgesic and anti-inflammatory qualities of its active ingredient, salicin, which is metabolized by the body into salicylic acid. In fact, the common pain reliever and fever reducer, Aspirin, also known as acetylsalicylic acid, was originally isolated from Willow Bark. . . . Salicylic acid is also a key ingredient in skin care products formulated to treat acne.”
- “Willow Bark Tincture is a cosmetic ingredient often used for its natural preservative and anti-inflammatory properties.”
- “Salicylic Acid . . . It is used externally as an antiseptic agent, as well as an antifungal agent and skin sloughing ingredient. It is commonly used in the treatment for removal of warts in the form of an Occlusal. Salicylic Acid also is currently used for its anti-aging properties . . . Naturally occurring in White Willow Bark . . . .”
- “Use regularly to help avoid head lice . . . Use (b)(4) Leave-In Conditioner & Detangler along with these other natural lice elimination and prevention products . . . Our patented formula of enzymes kills lice on contact.”
- “[P]rotectant against skin irritation, such as diaper ointments, as well as in products formulated to soothe irritation associated with minor cuts, scrapes, burns and chapped skin. . . . Zinc Oxide's reflective and opacifying properties make it effective in blocking UV radiation in sun screens.”
- “[A]nti-irritant and anti-inflammatory properties.”
On the search results page for “Rooibos Tincture,” your website contains the following claims:
- “[R]ecommended for wide range of ailments including skin problems such as eczema, diaper rash and acne . . . .”
- “[A]ntimicrobial properties”
- “[C]ontains a mimic of the enzyme Super Oxide Dismutase (S.O.D.), an antioxidant which attacks the free radicals . . . .”
- “[U]sed for its antioxidant, anti-inflammatory and antimicrobial properties. . . . may prevent DNA damage and inflammation by its anti-oxidative activity. . . . has long been used . . . to treat skin and digestive complaints.”
- “Tea Tree and Vinegar Toner is the perfect combination for acneic skin. . . . Our toner is . . . especially beneficial in combating acne.”
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the reoccurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Your written response should be sent to the following address: U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021, to the attention of Katherine L. Arnold, Compliance Officer. Should you have any questions concerning this letter, you can contact Ms. Arnold at 425-302-0437.