Inspections, Compliance, Enforcement, and Criminal Investigations

Tata Harper Skincare 8/1/16

  

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 # 498011
                                                                                                           
UNITED PARCEL SERVICE
OVERNIGHT DELIVERY
 
August 1, 2016
 
Tata Harper, Owner
Tata’s Natural Alchemy, LLC
1135 Wooster Road
Whiting, VT 05778
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http://www.tataharperskincare.com/ in June 2016 and has determined that you take orders there for the products Rejuvenating Serum Home & Travel Set, Restorative Eye Crème, Boosted Contouring Eye Mask, Elixir Vitae, Rejuvenating Serum, Be Smitten, and Concentrated Brightening Serum. The claims on your website establish that the products are drugs under section 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(C)] because they are 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:
 
Rejuvenating Serum Home & Travel Set
  • “Decreases wrinkle depth and inhibits muscle fiber contractions with Spanish Lavender and Date Palm Extract”
  • “Stimulates healthy collagen production…” 
Restorative Eye Crème
  • “Proven to topically reduce wrinkle-causing muscle contractions by 95%*” 
Boosted Contouring Eye Mask & Rejuvenating Serum
  • “2 hours: RELAX MUSCLE, 95% of wrinkle-causing muscle contractions decrease*” 
Elixir Vitae
  • 2 hrs: RELAX MUSCLES, Helps relax 100% of muscle contractions 
Be Smitten
  • Spanish Lavender helps inhibit muscle fiber contractions to decrease the look of expression lines.
Concentrated Brightening Serum
  • “A blend of targeted technology…to fighting every stage of the hyperpigmentation process, by helping to inhibit the passage of melanin to the surface…”
  •  “24 hours: REDUCE MELANIN Test studies show a reduction in the skin’s melanin content by 36%*”
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 Maya M. Davis, Ph.D., Compliance Officer, One Montvale Avenue, Stoneham, MA 02180. If you have any questions about the contents of this letter, please contact CO Davis at maya.davis@fda.hhs.gov or 860-240-4289 ex. 25.
 
                                                                                   
Sincerely,
/S/           
Joseph Matrisciano, Jr.
District Director
New England District
 

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