WARNING LETTER
Oneness Labs
MARCS-CMS 608918 —
October 06, 2020
Delivery Method:
Overnight Delivery
Product:
Drugs
Recipient:
Oneness Labs
18400 Von Karman Ave, Suite 1000
Irvine
,
CA
92612
United States
info@onenesslabs.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
WARNING LETTER
October 6, 2020
RE: 608918
Dear Oneness Labs:
This letter is to advise you that the United States Food and Drug Administration (FDA) has reviewed your website at the Internet address www.onenesslabs.com and has determined that you have taken orders there for the products “Oneness Labs Homeopathic Skin Tag & Mole Remover” and “Oneness Homeopathic Skin Tag & Mole Remover Extra Strength” (hereinafter referred to as “Oneness Labs Homeopathic Skin Tag & Mole Remover products.”) In addition, FDA has observed that you also sell “Oneness Labs Homeopathic Skin Tag & Mole Remover” on the website www.amazon.com. Based on our review, these products are unapproved new drugs which you have been marketing directly to consumers. The introduction or delivery for introduction of unapproved new drugs into interstate commerce is prohibited under sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic (FD&C) Act, 21 U.S.C. 355(a) and 331(d).
Your Oneness Labs Homeopathic Skin Tag & Mole Remover products are especially concerning from a public health perspective because they are labeled to contain the ingredients bloodroot (
Sanguinaria canadensis
) and zinc chloride. Both substances are known corrosive agents. The combination of bloodroot and zinc chloride results in a corrosive topical agent capable of indiscriminately damaging healthy and diseased tissue alike and forming eschar (sloughed dead tissue). The tissue necrosis caused by topical application of products containing such ingredients (often referred to as "black salves") is well-documented.
1
In addition, FDA has concerns about products marketed over-the-counter (OTC) directly to consumers for the removal of moles.
2
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 your 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.
Examples of claims on your product labels and website that provide evidence of the intended use (as defined by 21 CFR 201.128) of your Oneness Labs Homeopathic Skin Tag & Mole Remover products include, but may not be limited to, the following:
“Oneness Labs Homeopathic Skin Tag & Mole Remover”
From the website www.onenesslabs.com:
"Oneness Labs Homeopathic Bloodroot Removal Cream"
“And, here’s why our product works: Bloodroot is an all-natural and powerful antioxidant and anti-inflammatory root compound which aids in extracting the unwanted tag from the root. Galangal Root enhances blood circulation, heals skin burns and reduces the size of lumps or growths under the skin. Chaparral Root is used in Ayurveda to alleviate rheumatic pain and chronic skin disorders. Dulcamara is known for its natural antibacterial properties commonly used for skin therapy treatment. Thuja Occidentalis relieves painful joint and muscle tension. Calcarea Carbonica treats a variety of skin disorders such as acne and ringworm. Antimonium Crudum clears unsightly and irritating skin and nail conditions such as warts and moles. . . . This powerful combination of wholesome, time tested ingredients makes the world’s best skin tag, wart and mole remover.”
From the product labeling:
“Skin Tag & Mole Remover”
“Naturally removes skin tags, moles, and warts”
“Q. Can I use this bloodroot paste on flat moles?[,] A. Yes, it does get rid of flat moles . . ..”
“Oneness Labs Homeopathic Skin Tag & Mole Remover Extra Strength”
From the website www.onenesslabs.com:
“Advanced Homeopathic Skin Tags, Mole & Warts Removal Cream”
“Everyone wants clear and smooth skin, so we created a homeopathic remedy that’s the most effective mole and skin tag removal product on the market.”
“Made by Mother Nature: Our extra strength combination of Bloodroot . . . and more plant extracts and herbal ingredients will successfully eliminate those pesky skin tags, moles, and even warts!”
“Rapid Results without Downtime for Surgery . . . This removal cream works quick – anywhere from 3-10 days is typical.”
“Here’s why our product works: Bloodroot is an all-natural and powerful antioxidant and antiinflammatory root compound which aids in extracting the unwanted tag from the root. Galangal Root enhances blood circulation, heals skin burns and reduces the size of lumps or growths under the skin. Chaparral Root is used in Ayurveda, a 3000-year-old Indian holistic healing system, to alleviate rheumatic pain and chronic skin disorders. DMSO is commonly used topically to decrease pain and speed the healing of wounds, burns, and muscle and bone injuries. Ducamara is known for its natural antibacterial properties commonly used for skin therapy treatment. Thuja Occidentalis relieves painful joint and muscle tension. Calcarea Carbonica treats a variety of skin disorders such as acne and ringworm. Antimonium Crudum clears unsightly and irritating skin and nail conditions such as warts and moles. . . . This potent, extra-strength formula combination of wholesome, time-tested ingredients makes the world’s best skin tag, wart and mole remover.”
From the product labeling:
“SKIN TAG & MOLE REMOVER”
These claims for your Oneness Labs Homeopathic Skin Tag & Mole Remover products demonstrate that they are drugs, as defined by section 201(g) of the FD&C Act, 21 U.S.C. 321(g), because they are intended to cure, mitigate, treat, or prevent disease and/or intended to affect the structure or function of the body.
Your Oneness Labs Homeopathic Skin Tag & Mole Remover products are also “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect. There are no FDA-approved applications in effect for your Oneness Labs Homeopathic Skin Tag & Mole Remover products. Thus, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
We recognize that your aforementioned products are labeled as homeopathic drugs. Under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term “drug” includes articles recognized in the official
Homeopathic Pharmacopeia of the United States
(HPUS), or any supplement to it. Homeopathic drug products are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or approval.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that you comply with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. 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. If you cannot complete corrective actions within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent by email 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
Thambi, L, K Konkel, I Diak, et al., 2020, Cosmetic Disfigurement from Black Salve. Drugs Ther Perspect (accessible at https://rdcu.be/b7K13).
2
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)).
Content current as of:
10/13/2020
Regulated Product(s)
Drugs