Inspections, Compliance, Enforcement, and Criminal Investigations

La Bella Figura 7/21/16

  

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

Public Health Service
Food and Drug Administration
 
Chicago District Office
Central Region
550 W. Jackson Blvd., 15th Floor
Chicago, IL 60661
Telephone: (312) 353-5863          
FAX: (312) 596-4187 

 

July 21, 2016
 
WARNING LETTER 
 
CHI-7-16
 
 
VIA UPS OVERNIGHT DELIVERY
SIGNATURE REQUIRED
 
Victoria Fantauzzi & Karen King, Founders
La Bella Figura, LLC
(b)(6)
Chicago, IL 60625
 
Re: CMS#498458
 
Dear Mses. Fantauzzi and King,
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http://www.labellafigurabeauty.com/ in May 2016 and has determined that you take orders there for the products Crema Virtuosa Night Cream, Daily Elements Defense Facial Oil, Jardin de Fleurs Skin Revitalizer, and Modern Radiance Concentrate. The claims on your website establish that the products are 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 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 intended to affect the structure or function of the 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:
 
Crema Virtuosa Night Cream
  • Key actives: Sangre de Drago Extract an antiviral oligomeric proanthocyanidin exhibiting therapeutic antiviral benefits and a production of active oxygen radicals suppressing degradation of DNA from free radicals.
Daily Elements Defense Facial Oil
  • “[E]asily absorbed due to its small molecular structure increasing circulation… rebuild cell structure and support new growth…”
  • “Rosehip CO2 and Pomegranate CO2 seed oils help rebuild collagen.”
Jardin de Fleurs Skin Revitalizer
  • “Honeysuckle, Jasmine, Rose Damascena and Carrot Seed Hydrosols aid in reducing skin inflammation…”
  • “Helichrysum, Licorice Root and Plantain Leaf …stimulate active cell growth.”
  • “Skin Type: …new collagen promotion.”
Modern Radiance Concentrate
  • “[S]timulate new collagen growth while also protecting and repairing skin from oxidative damage.”
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.
 
If you need additional information or have questions concerning any products distributed through your website, please contact the FDA.  Please respond in writing to Russell Riley, Compliance Officer, Food and Drug Administration, 550 W. Jackson Blvd., 15th Floor, Chicago, IL 60661. Refer to the Unique Identification Number (CMS# 498458) when replying. If you have questions regarding the content of this letter, please contact Mr. Riley via email at Russell.riley@fda.hhs.gov or by phone at (312) 596-4219.
 
 
Sincerely,
/S/                                                                                                                                   
William R. Weissinger                                               
District Director
 

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