Inspections, Compliance, Enforcement, and Criminal Investigations

Sheryl Gibbs 7/19/16

  

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

Public Health Service
Food and Drug Administration
 PHILADELPHIA DISTRICT
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
Telephone: 215-597-4390

 

WARNING LETTER
16-PHI-08
 
 
Delivered Via United Parcel Service
 
 
July 19, 2016
 
Sheryl Lynn Gibbs, Founder
Sevani Botanica
315 Overlook Lane
Conshohocken, PA 19428
 
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http://www.sevanibeauty.com/ in May 2016 and has determined that you take orders there for the products Advanced Omega Night Repair Serum, Eye Repair Age Defying Eye Crème, Ageless Eyes Revitalizing Eye Serum, and Hyaluronic Wrinkle Defense. 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:
 
Advanced Omega Night Repair Serum
  • “Rosewood, and Neroli essential oils offer …cellular regeneration…”
  • “Evening Primrose: EFA's reduce inflammation and protects from accelerated aging.”
  • “Neroli blossom: encourages collagen production…” 
Eye Repair Age Defying Eye Crème 
  •  “Lotus blossom, Neroli and Rose: anti-inflammatory, regenerative…” 
Ageless Eyes Revitalizing Eye Serum
  • “[E]ncourage collagen production…”
  • “Evening Primrose: anti-inflammatory…”
  • “Rose Geranium: strengthens capillaries to minimize discoloration”
  • “Helichrysum: Anti-inflammatory…”
Hyaluronic Wrinkle Defense
  • “Ideal for Rosacea too!”
  • “MSM: feeds the formation of collagen and elastin, preventing wrinkles, age spots and redness.”
  • “Panthenol (B5): anti-inflammatory…”
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. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. 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 within which the corrections will be implemented. Your firm's response should be comprehensive and address all violations included in this Warning Letter.
 
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 Joseph A. Morkunas, Compliance Officer, U.S. Food and Drug Administration, 900 U.S. Customhouse, 200 Chestnut Street, Philadelphia, Pennsylvania 19106. If you have any questions about this letter, please contact Mr. Morkunas at (215) 717-3079 or e-mail at Joseph.Morkunas@fda.hhs.gov.
 
 
Sincerely,
/S/ 
Anne E. Johnson
District Director
Philadelphia District
 
 
cc:       Pennsylvania State Department of Health
            132 Kline Plaza, Suite A Harrisburg, PA 17104
            Attention: Director, Division of Primary Care and Home Health Services

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