WARNING LETTER

ISIS.GOLD MARCS-CMS 679948 — July 25, 2024

Delivery Method:: Via Email
Product:: Drugs

Recipient:: Recipient Name

Michelle Golde; ISIS.GOLD; 205 E. Butterfield Road #313
Elmhurst, IL 60126
United States; legal@isis.gold

Issuing Office:: Center for Drug Evaluation and Research (CDER); United States

WARNING LETTER

July 25, 2024

RE: 679948

Dear Michelle Golde:

This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.isis.gold/ in February and March 2024 and has observed that your website offers numerous chemical peel drug products, including “TCA 100% Trichloroacetic Acid” and “Whitening SA Peels” for sale in the United States. As described below, your “TCA 100% Trichloroacetic Acid” and “Whitening SA Peels” (labeled to contain salicylic acid 30% and various “whitening agents" including hydroquinone) products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 301(d).

The Agency is concerned about potent chemical peel products that are available to be purchased and used by consumers. Such products pose a public health risk because they can cause skin injuries such as burns on the area of application, wounds, pain, swelling, and scarring. FDA has received adverse event reports of injuries involving use of such products, some of which required emergency room care, specialty care from a dermatologist, and/or surgical intervention.

Unapproved New Drug

Based on a review of your website, your “TCA 100% Trichloroacetic Acid” and “Whitening SA Peels” products 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. Examples of claims observed on your website, https://www.isis.gold, that establish the intended use of these products as drugs include, but may not be limited to, the following:

On the product webpage for “TCA 100% Trichloroacetic Acid,” https://www.isis.gold/product/tca-peel-100-percent/:

• “REMOVES:
o Thick Dead Skin
o Fine Lines & Wrinkles
o Deep Pock Marks
o Tattoos
o Warts
o Genital Warts
o Skin Tags
o Acne Scars
o Melasma & Hyperpigmentation”

On the product webpage for “Whitening SA Peels,”https://www.isis.gold/product/salicylic-acid-whitening-peels/:

• “BENEFITS:
o Peels Skin Like Saliclear
o Whitens/Bleaches Skin
o Anti-aging: Removes Wrinkles & Smooths Skin”

Your “TCA 100% Trichloroacetic Acid” and “Whitening SA Peels”¹ products are not generally recognized as safe and effective (GRASE) 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). Subject to certain exceptions not applicable here, new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, 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 pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, in effect for these products. Accordingly, 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).

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 injunction. Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct these 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 action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. 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, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov.

Sincerely,
/S/
Tina Smith, M.S
Captain, U.S Public Health Service
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

______________________

1 OTC skin bleaching products falls under section 505G(a)(4) of the FD&C Act, 21 U.S.C. 355h(a)(4), because they are subject to a determination to be not generally recognized as safe and effective (GRASE) in a proposed rule that is the most recently applicable proposal issued under 21 CFR part 330. On August 29, 2006, FDA issued a proposed rule (71 FR 51146) setting forth a determination that OTC skin bleaching drug products are not generally recognized as safe and effective. This August 29, 2006, proposed rule is the most recent applicable FDA proposal issued under 21 CFR 330 with respect to skin bleaching OTC drug products. Thus, such products are deemed to be new drugs under section 201(p)(1) of the FD&C Act and subject to the requirement to have an approved new drug application under section 505 of the FD&C Act, U.S.C. 355, beginning on September 23, 2020.