Inspections, Compliance, Enforcement, and Criminal Investigations

Annemarie Gianni Skin Care LLC 7/15/16

  

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

Public Health Service
Food and Drug Administration
 
New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
Phone 781.587.7500
Fax 781.587.7556
 
 
WARNING LETTER
CMS # 495979
 
 
VIA UNITED PARCEL SERVICE
 
July 15, 2016
 
Annmarie & Kevin Gianni, Founders
Annmarie Gianni Skin Care
181 Marsh Hill Rd.
Orange, CT 06477-3669
  
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http://www.annmariegianni.com/ in May 2016 and has determined that you take orders there for the products Repair Serum, Anti-Aging Eye Cream, and Anti-Aging Serum. 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:
 
Repair Serum
  • “Using vegan stem cells…a new way for your skin to build collagen, repair itself and prevent aging.”
  • “Ideal for treating: Sun spots, age spots, acne scarring, Hyperpigmentation” 
Anti-Aging Eye Cream
  • “[S]upports the synthesis of new skin fibers, sweet iris boosts cell regeneration…”
  • “Soothes and reduces redness and irritation”
Anti-Aging Serum 
  • “This serum will increase skin hydration by inhibiting hyalurondase…”
  • “The life everlasting flower extract helps prolong and regenerate the skin cell.”
  • “Sunflower seed extract adds UV protective qualities as well as essential fatty acids.”
  • “Flaxseed is very high in lignans that support cell communication.”
  • “Rosacea”
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. You may respond in writing to the Food and Drug Administration, One Montvale Ave. Stoneham, MA. 02180 (Attn: CAPT Diane M Prince).  If you have any questions about the contents of this letter, please contact Diane Prince at 781-587-7442.
                                                                                    
 
Sincerely,                                                       
/S/                                                                                                                                   
Joseph S. Matrisciano
District Director
New England District Office
 

Page Last Updated: 07/21/2016
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