WARNING LETTER
Vedame Oils LLC dba UMA Oils MARCS-CMS 525122 —
- Delivery Method:
- UPS
- Recipient:
-
Recipient NameShrankhla Upadhyay
- Vedame Oils LLC dba UMA Oils
723 N. Doheny Dr.
Beverly Hills, CA 90210
United States
- Issuing Office:
- Los Angeles District Office
United States
Division of Human and Animal Food Operations West V | |
WARNING LETTER
UNITED PARCEL SERVICE
SIGNATURE REQUIRED
July 18, 2017
Shrankhla Upadhyay, Founder WL # 525122-17
Vedame Oils, L.L.C.
dba UMA Oils
723 N. Doheny Dr.
Beverly Hills, CA 90210
Dear Ms. Shrankhla Upadhyay:
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.umaoils.com/ in May 2017 and has determined that you take orders there for the products Deep Nourish Extreme Dryness Treatment, Total Rejuvenation Night Face Oil, Deeply Clarifying Face Mask, and Deep Clarifying Blemish Spot Treatment. The claims on your website establish that these 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 321(g)(1)(C)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease and/or are intended to affect the structure or 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:
Deep Nourish Extreme Dryness Treatment:
- “Pure and potent botanicals deliver dramatic healing benefits that are powerful enough to combat eczema…”
- “[P]atchouli essential oil [(an ingredient in this product)] relieves inflammation and combats bacteria.”
Total Rejuvenation Night Face Oil:
- “[C]hamomile essential oil [(an ingredient in this product)] is packed with azulene, a powerful anti-inflammatory agent, for diminished scars and redness.”
- “Powerful anti-inflammatory and anti-bacterial agents combat redness...”
Deeply Clarifying Face Mask:
- “Natural antibacterial agents like turmeric, clove and neem [(ingredients in this product)] destroy acne-causing bacteria…”
- “[P]revent future breakouts and eliminate blackheads.”
- “[O]range peel and cinnamon [(ingredients in this product)] stimulate cellular regeneration to fade acne scarring, while nourishing botanicals like natural camphor and mint [(ingredients in this product)] minimize inflammation.”
- “[K]illing acne-causing bacteria...”
Deep Clarifying Blemish Spot Treatment:
- “[F]ormula of tea tree, juniper berry, and clary sage essential oils [(ingredients in this product)] to target blemishes by penetrating the skin’s surface and killing bacteria at its source. Its anti-inflammatory and mildly numbing properties diminish swelling and redness, reduce cystic acne pain, and accelerate healing.”
- “Use this treatment at the first sign of a blemish, as it is very effective at every stage — even on blemishes that have not fully surfaced.”
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:
Matthew Walburger, Acting Director Compliance Branch
Food and Drug Administration
HAF Division West 5, HFR-PA1500
1431 Harbor Bay Parkway
Alameda, CA 94502
If you have any questions about the contents of this letter, please contact Rochelle A. Rolnik, Compliance Officer, via email at rochelle.rolnik@fda.hhs.gov or by phone at (949) 608-4496.
Please reference CMS number 525122 in your response.
Sincerely,
/S/
Darlene Almogela, Acting Division Director
Office of Human and Animal Foods
Division 5 West
US Food and Drug Administration
cc:
David Mazerra, Ph.D.
Chief, Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue - MS 7602
P.O. Box 997413
Sacramento, California 95899-7435