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  5. Ariella Naturals - 632509 - 08/04/2022
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WARNING LETTER

Ariella Naturals MARCS-CMS 632509 —

Delivery Method:
Via Email
Product:
Drugs
Recipient:
Ariella Naturals

9200 Edmonston Rd
Greenbelt, MD 20770
United States

CS@ariellanaturals.com
Issuing Office:
Center for Drug Evaluation and Research | CDER

United States

WARNING LETTER

August 4, 2022

RE: 632509

To Whom It May Concern:

This letter is to advise you that the United States Food and Drug Administration (FDA) has reviewed your website at the Internet address tryariella.com in August 2022 and has determined that you take orders there for “Ariella Skin Tag Remover & Mole Corrector and Repair Lotion Set” (hereinafter “Ariella Set”) and “Ariella Skin Tag Remover and Mole Remover 2 pcs” (hereinafter “Ariella”). The claims on your website establish that “Ariella Set” and “Ariella” are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d). As explained further below, introducing or delivering this product for introduction into interstate commerce violates the FD&C Act. You can find the FD&C Act and FDA regulations through links on FDA’s home page at www.fda.gov.

There are no over-the-counter (OTC) drugs that can be legally sold for mole or skin tag removal, and FDA has safety concerns about drugs marketed OTC directly to consumers for these uses.1 Moles should be evaluated by a health care practitioner; self-diagnosis and treatment of moles could lead to delayed cancer diagnosis and even cancer progression. Consumers who use such products may forgo, delay, or discontinue medical treatments found safe and effective for diagnosing and treating moles, including those which are potentially cancerous or precancerous. FDA has issued a consumer warning noting that products marketed for removing moles and other skin lesions can cause injuries and scarring.2

Unapproved New Drugs

Based on our review of your website, “Ariella Set” and “Ariella” are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body.

Some examples of claims and evidence observed on your website that establish the intended use of your product as a drug include, but may not limited to, the following:

“Ariella Set”

  •  “MOLE CORRECTOR SKIN TAG REMOVER”
  • “FAST & EFFECTIVE: In most cases, skin tags and moles will fall off naturally within 7-10 days. We created this formula with the goal of helping people feel & look their best!”
  • “EASY TO USE: It’s specially designed to be easy to use, you can remove skin tags in the privacy of your own home.”
  • Photos of moles improving with Ariella Set treatment, such as provided in your “HOW TO USE” and “BEFORE & AFTER” photos and descriptions

“Ariella”

  • “Skin Tag Remover and Mole Remover”
  • “EFFECTIVE SKIN TAG REMOVAL: Our Skin Tag removal pen attacks each Skin Tag. A Skin Tag will begin to die within 3-5 days of initial application of the liquid and with consistent treatment, most skin tags will be eliminated within several weeks without scars.”
  • “SKIN TAG REMOVER: Skin tags on the face or body can be annoying, bothersome & even embarrassing, but with this unique product, you can get rid of them for good!”
  • Photos of moles improving with Ariella treatment, such as provided in your “Before & After” photos

“Ariella Set” and “Ariella” are not generally recognized as safe and effective for their above referenced uses and therefore are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). There are no FDA-approved applications in effect for your products. The introduction or delivery for introduction into interstate commerce of these products without an approved application violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Conclusion

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and/or injunction.

Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.

Your response should be sent to U.S. Food and Drug Administration, Center for Drug Evaluation and Research/Office of Compliance/Office of Unapproved Drugs and Labeling Compliance by e-mail to FDAADVISORY@fda.hhs.gov.

Sincerely,
/S/
Carolyn E. Becker
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

________________________

1 Such agency concerns were reflected in the OTC final monograph for wart remover drug products (now a final administrative order under section 505G of the FD&C Act), which specifically warns against the use of OTC topical wart remover products on moles and birthmarks. (See 55 FR 33246, 33255 (Aug. 14, 1990); also see 45 FR 65609, 65611 (Oct. 3, 1980)).

2 FDA Consumer Update “Products Marketed for Removing Moles and Other Skin Lesions Can Cause Injuries, Scarring,” available at: https://www.fda.gov/consumers/consumer-updates/products-marketed-removing-moles-and-other-skin-lesions-can-cause-injuries-scarring.

 
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