Inspections, Compliance, Enforcement, and Criminal Investigations

Face Naturals 9/20/16

  

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

Public Health Service
Food and Drug Administration
 College Park,  MD  20740 

 

WARNING LETTER
SEPT 20, 2016
 
VIA EXPRESS DELIVERY
 
Christy Pair, Founder
Face Naturals
8 Stockmar Road
Villa Rica, GA 30180
 
Re: CMS#501680
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http://facenaturals.com/ in July 2016 and has determined that you take orders there for the products Citrus Squeeze Body Cleanser, Crème Brulee Body Butter, Organic Chocolate-Raspberry Body Butter, Organic Unscented Body Butter, Coconut Chai Body Scrub, Sweet Fennel Natural Tooth Cleanser, Super Fruit Facial Toner, Purify Facial Cleanser, and Oatmeal Honey Silk Organic Bar Soap. The claims on your website establish that the products are drugs under sections 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 21 U.S.C. § 321(g)(1)(C)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or articles intended to affect the structure or any function of the human body.  As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.  You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov
 
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
 
Citrus Squeeze Body Cleanser
  • “Lemon, a powerhouse of vitamin C…with its antibacterial properties, and boosts collagen production…It also lightens age spots…”
  • “Limes …reduce bacteria, which greatly improves the skin’s immunity against infection.”
  • “Another benefit oranges includes their antidepressant qualities…”
Crème Brulee Body Butter 
  • “Organic vanilla has antibacterial properties to provide relief from abrasions by killing germs that facilitate acneic growth. It also soothes burns, wounds, and cuts…” 
Organic Chocolate-Raspberry Body Butter
  • “Organic chocolate contains antioxidants called flavinols, which aid your skin in protecting itself from harmful UV rays, …”
  • “By increasing blood flow…” 
Organic Unscented Body Butter
  • “Organic shea butter is a powerhouse… has natural anti-inflammatory properties that can take the sting out of insect bites.” 
Coconut Chai Body Scrub
  • “Its antibacterial properties fight off fungi, bacteria, and viruses…with a strong immunity to deflect environmental damage”
  • “Organic chai offers its anti-inflammatory properties that help heal skin abrasions, as well as antioxidants that fight skin cancer…” 
Sweet Fennel Natural Tooth Cleanser 
  • “Fennel has anti-carcinogenic agents…” 
Super Fruit Facial Toner
  • “Organic pomegranate contains compounds that inhibit the enzymes responsible for cartilage destruction.” 
Purify Facial Cleanser 
  • “Peppermint has anti-inflammatory, antiseptic …antimicrobial properties…”
  • “Tea tree oil, a powerful immune stimulant, fights off bacteria, fungi, and viruses…” 
Oatmeal Honey Silk Organic Bar Soap
  •  “It also relieves itchiness, and treats acne and the irritation caused by poison ivy or chicken pox.”
  • “It offers relief for conditions such as rashes, eczema, psoriasis, and burns.” 
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the 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 FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. 
 
This letter is not an all-inclusive statement of violations associated with your products or their labeling, and we have not attempted to list here all of the products that are promoted on your website for intended uses that cause them to be drugs.  It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.  We advise you to review your website, product labels, and other labeling for your products to ensure that the claims you make for your products do not reflect intended uses that cause the distribution of the products to violate the Act.
 
We request that you take prompt action to correct all violations associated with your products, including the violations identified in this letter. Failure to do so may result in enforcement action without further notice. The Act authorizes injunctions against manufacturers and distributors of illegal products and seizure of such products.
 
Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.
 
You should direct your written reply to Dehlia Young, Compliance Officer, Division of Enforcement (HFS-608), Office of Compliance, Center for Food Safety and Applied Nutrition, 5001 Campus Drive College Park, MD 20740. If you have any questions regarding this letter, you may contact Ms. Young via email at dehlia.young@fda.hhs.gov. Please reference # 501680 on any submissions and within the subject line of any emails to us.
 
Sincerely,
/S/
William A. Correll
Director
Office of Compliance
Center for Food Safety
      and Applied Nutrition

 

Page Last Updated: 10/21/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English