Inspections, Compliance, Enforcement, and Criminal Investigations

Fioravanti Custom Products DBA Essential Wholesale & Labs 11/21/14

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Seattle District
Pacific Region
22215 26th Avenue SE, Suite 210
Bothell, WA 98021
Telephone:      425-302-0340
FAX:               425-302-0402 

 

November 21, 2014
 
OVERNIGHT DELIVERY
SIGNATURE REQUIRED


In reply refer to Warning Letter SEA 15-05

John A. Landforce, President
Fioravanti Custom Products, L.L.C. DBA Essential Wholesale & Labs
2211 NW Nicolai Street
Portland, Oregon 97210

 
WARNING LETTER

Dear Mr. Landforce:
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your manufacturing facility located at 2211 NW Nicolai Street, Portland, Oregon from April 7 to April 24, 2014, and subsequently reviewed product labeling from your website, www.essentialwholesale.com, where products are available for purchase. We received your letter on May 13, 2014, which responded to our Inspectional Observations (Form FDA 483), issued at the close of our most recent inspection on April 24, 2014. After review, we found your response was inadequate because it did not address labeling discrepancies discussed during the inspection.

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 Butter
 
Tamanu Oil is listed as an ingredient of Tamanu Butter. On the information page for “Tamanu Oil” within the “Ingredient Guides” for “Oils & Butters” through the “Education” tab on the “Library” tab accessible from the main page of your website, your website contains the following claims:
  • “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.”
On the product purchasing page for “Tamanu Butter,” your website contains the following claims:
  • “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 Butter
 
Neem Oil is listed as an ingredient of Neem Butter. On the information page for “Neem Oil” within the “Ingredient Guides” for “Oils & Butters” through the “Education” tab on the “Library” tab accessible from the main page of your website, your website contains the following claims:
  • “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.”
On the product purchasing page for “Neem Butter,” your website contains the following claims:
  • “Neem is used widely in India as an antibacterial, antiviral, antifungal, antiseptic, and antiparasitic agent in toiletries, soap, toothpaste and skin/hair care products.”
 
(b)(4) Blue Green Algae Antibacterial Toner
 
The finished product label for (b)(4) Blue Green Algae Antibacterial Toner contains the following claims:
  • “[A]nti-inflammatory and anti-bacterial . . . aids in treatment and prevention of acne.”
Willow Bark Extract is listed as an ingredient of Blue Green Algae Antibacterial Toner as well as Tea Tree & Vinegar Facial Toner. On the information page for “Willow Bark Tincture” within the “Ingredient Guides” for “Naturally Derived” through the “Education” tab on the “Library” tab accessible from the main page of your website, your website contains the following claims:
  • “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.”
On the information page for “Naturally Derived” products within the “Ingredient Guides” through the “Education” tab on the “Library” tab accessible from the main page of your website, your website contains the following claims:
  • “Willow Bark Tincture is a cosmetic ingredient often used for its natural preservative and anti-inflammatory properties.”
The information page for Willow Bark Tincture states that its active ingredient salicin is metabolized into salicylic acid. On the information page for “Salicylic Acid” within the “Ingredient Guides” for “Naturally Derived” through the “Education” tab on the “Library” tab accessible from the main page of your website, your website contains the following claims:
  • “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 . . . .”
(b)(4) Leave-In Conditioner & Detangler
 
The finished product label for (b)(4) Leave-In Conditioner & Detangler contains the following claims:
  • “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.”
Zinc Oxide
 
On the product purchasing page for “Zinc Oxide,” your website contains the following claims:
  • “[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.”
Salicylic Acid Powder
 
On the product purchasing page for “Salicylic Acid Powder,” your website contains the following claims: 
  • “[A]nti-irritant and anti-inflammatory properties.”
Rooibos Tincture

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 . . . .”
On the product purchasing page for “Rooibos Tincture,” your website contains the following claims: 
  • “[A]ntimicrobial properties”
  • “[C]ontains a mimic of the enzyme Super Oxide Dismutase (S.O.D.), an antioxidant which attacks the free radicals . . . .”
On the information page for “Rooibos Tea Tincture” within the “Ingredient Guides” for “Naturally Derived” through the “Education” tab on the “Library” tab accessible from the main page of your website, your website contains the following claims:
  • “[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 & Vinegar Facial Toner
 
On the product purchasing page for “Tea Tree & Vinegar Facial Toner,” your website contains the following claims: 
  • “Tea Tree and Vinegar Toner is the perfect combination for acneic skin. . . . Our toner is . . . especially beneficial in combating acne.”
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. The sale of these products without approved applications violates these provisions of the Act.
 
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your website. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with the Act and applicable FDA regulations. 

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.
 
Sincerely,
/S/ 
Miriam R. Burbach
District Director

 

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