Inspections, Compliance, Enforcement, and Criminal Investigations

Enessa Inc 9/1/16

  

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

Food and Drug Administration
 
Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
Telephone: 949-608-2900
           FAX: 949-608-4415 

 

WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
September 1, 2016
                                                            WL # 44-16
Michelle Ornstein, Founder
Enessa Inc.
4489 W Pico Blvd
Los Angeles, CA 90019-4244
 
Dear Ms. Ornstein:
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.enessa.com/ in July 2016 and has determined that you take orders there for the products Plant Cell Lifting Serum, Lyco-Silk Powder, Nori Body Butter – Lemon Verbena, Nori Body Butter – Rose Geranium, Seaweed Nourishing Gel- Geranium, Diminish-Rosacea Treatment, Plant Cell Eye Cream, Rose Tamanu Elixir, and Monoi Soothing Cleanser. 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:
 
Plant Cell Lifting Serum
  • “[U]sing plant cell actives…to stimulate cell repair. These plant cells…repair the skin at a cellular level…”
  • “[P]omegranate Extract and Neroli Essential Oil promote skin cell regeneration.”
  • “Stimulates collagen production and improves circulation.” 
Lyco-Silk Powder
  • “[C]alm irritated skin due to acne, eczema, insect bites or any other skin rashes”
  • “Excellent to control excess sebum production…”
Nori Body Butter – Lemon Verbena and Nori Body Butter – Rose Geranium 
  • “Nori Leaf Extract…stimulates cellular metabolism…”
  • “[A]nti-inflammatory properties help to sooth the skin, while Comfrey Leaf Extract promotes tissue repair…”
  • “Rose Geranium essential oil …excellent for eczema…”
Seaweed Nourishing Gel- Geranium
  • “[I]mprove micro-circulation and promote tissue regeneration”
  • “Black Cumin Seed Oil… is anti-inflammatory”
  • “Oat Beta Glucan promotes fibroblast growth and collagen synthesis…”
Diminish-Rosacea Treatment 
  • “Diminish-Rosacea…”
  • “This effective blend of anti-inflammatory essential oils…is formulated to reduce skin irritation and diminish redness due to Rosacea. Can also be used for eczema.” 
Plant Cell Eye Cream 
  • “Organic Essential Oils… act as an anti-inflammatory…” 
Rose Tamanu Elixir
  • “Chamomile Essential Oil- known to be an anti-inflammatory, reduces swelling…” 
Monoi Soothing Cleanser
  • “[L]amineria extracts stimulate blood circulation and eliminate toxins. Organic essential oils of Lavender and Petit Grain are highly antiseptic…”
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.
 
Please send your written response to:
 
Kelly Sheppard
Director, Compliance Branch
Food & Drug Administration
Los Angeles District Office
19701 Fairchild
Irvine, CA 92612
 
If you need additional information or have questions concerning any products distributed through your website, please contact the FDA. If you have any questions about the contents of this letter, please contact Daniel W. Cline, Compliance Officer at 949-608-4433 or Daniel.Cline@fda.hhs.gov.
 
 
Sincerely,
/S/
CDR Steven E. Porter, Jr.
Director, Los Angeles District

 

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