WARNING LETTER
Haloderm, Inc.
MARCS-CMS 608852 —
October 06, 2020
Delivery Method:
Via Overnight Delivery
Product:
Drugs
Recipient:
Recipient Name
Mr. Alexander Putris
Haloderm, Inc.
7040 Avenida Encinas, Suite 104
Carlsbad
,
CA
92011
United States
info@haloderm.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
WARNING LETTER
October 6, 2020
RE: 608852
Dear Mr. Putris:
This letter is to advise you that the United States Food and Drug Administration (FDA) has reviewed your website at the Internet address www.haloderm.com and has determined that you take orders there for the products “HaloDerm Regular Homeopathic Mole & Skin Tag Remover” and “HaloDerm Advanced Homeopathic Mole & Skin Tag Remover” (hereinafter referred to as “HaloDerm products”). Based on our review, these products are unapproved new drugs which you are 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 HaloDerm products are 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 pre-cancerous.
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 HaloDerm products include, but may not be limited to, the following:
From the website https://haloderm.com:
"Fast Natural Mole & Skin Tag Remover".
“Removes Every Type of Mole or Skin Tag . . . Light Moles[,] Dark Skin Tags[,] Flat Moles[,] Skin Tags[,] Raised Moles . . . Bothered by ugly moles or skin tags? . . . ‘This stuff is magic! Applied it to 1 mole and 3 skin tags before bed and they fell off in the shower the next day!’ . . . Imagine applying this unique cream to your mole or skin tag and the next day it’s falling off! . . . Old or new, big or small, flat or raised, it doesn’t matter . . . Over 93,000 people have safely removed their moles & skin tags with Haloderm. . . Haloderm Regular[,] Removes Up To 4 Moles & Skin Tags[,] See Results After 7-10 Days . . . Haloderm Advanced[,] Removes Up to 8 Moles and Skin Tags[,] See Results In As Little As 8 Hours”
"This herbal infused, easy to use topical remedy is scientifically formulated to work on every mole or skin tag on your face and body".
"HaloDerm® Mole & Skin Tag Remover | Works on All Moles & Skin Tags".
From the products’ labeling:
“Homeopathic Mole & Skin Tag Remover[,] Thousands of happy users have gotten rid of moles & skin tags, now it’s your turn! Naturally removes moles & skin tags”
“Q. Does HaloDerm work on flat moles? A. It does get rid of flat moles but flat moles require exfoliating with the provided toothpick to be more precise and avoid scratching any surrounding skin.”
"ALL NATURAL Mole & Skin Tag Corrector"
These claims for your HaloDerm 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 Haloderm 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 Haloderm 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 HaloDerm 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. 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. 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 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
cc:
Mr. Alexander Putris
Haloderm, Inc.
6940 Waters End Dr.
Carlsbad, CA 92011
___________________________
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