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  5. Clinical Formula LLC - 628372 - 04/13/2022
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WARNING LETTER

Clinical Formula LLC MARCS-CMS 628372 —

Product:
Drugs
Recipient:
Recipient Name
Ken Kutanakit
Clinical Formula LLC

888 W 16th Street
Newport Beach, CA 92663-2802
United States

Clinical2k@aol.com
Issuing Office:
Center for Drug Evaluation and Research | CDER

United States

WARNING LETTER

Date: April 13, 2022

Dear Mr. Kutanakit:

This letter concerns your firm’s manufacturing of a drug product to bleach and/or lighten the skin. Clinical Formula™ Bleaching Lotion drug product is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the Federal Food Drug & Cosmetic Act (FD&C Act), 21 U.S.C. 355(a), and is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of such a product into interstate commerce is prohibited under sections 301(d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a). These violations are described in more detail below.

Unapproved New Drug and Misbranded Drug Violations

Clinical Formula™ Bleaching Lotion is a drug as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, this product is intended for use as a skin bleaching product.

Examples of the claims observed on your product label that provide evidence of the intended use(s) (as defined in 21 CFR 201.128) of your product include, but may not be limited to, the following:

“BLEACHING LOTION . . . Skin Lightener . . . Drug Facts . . . Hydroquinone 2% . . . Purpose . . . For Bleaching of Hyperpigmented Skin. . . . Uses: . . . For bleach-ing of hyperpigmented skin conditions such as chloasma, melasma, freckles, and other forms of melanin hyperpigmentation.” [from your Clinical Formula™ Bleaching Lotion product label]

Clinical Formula™ Bleaching Lotion is a skin bleaching drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, which governs nonprescription drugs marketed without an approved application. Specifically, this skin bleaching product falls under section 505G(a)(4) of the FD&C Act, 21 U.S.C. 355h(a)(4), as added on March 27, 2020 with the enactment of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), because it is 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 3301. Thus, Clinical Formula™ Bleaching Lotion is deemed to be a new drug under section 201(p)(1) of the FD&C Act and subject to the requirement to have an approved new drug application for marketing under section 505 of the FD&C Act, 21 U.S.C. 355, beginning on September 23, 2020.2

No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for Clinical Formula™ Bleaching Lotion. Accordingly, this skin bleaching drug product is an unapproved new drug and its introduction or delivery for introduction into interstate commerce violates section 505(a) of the FD&C Act, 21 U.S.C. 355(a).

Introduction or delivery for introduction of such a product into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d).

Moreover, Clinical Formula™ Bleaching Lotion is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee) because it is deemed as such under section 505G(a)(4) of the FD&C Act, 21 U.S.C. 355h(a)(4), and because it is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355, and does not comply with the requirements under section 505G of the FD&C Act, 21 U.S.C. 355h.

The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Conclusion

The violations cited in this letter are not intended to be an all-inclusive list of violations regarding your products nor is the skin bleaching/skin lightening drug product named in this letter intended to be an all-inclusive list of products you have manufactured, registered, and/or listed in FDA’s electronic drug registration and listing system (eDRLS), or introduced into interstate commerce. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence and the occurrence of other violations. It is your responsibility to assure that your firm complies 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 any violations may result in legal action without further notice, including, without limitation, seizure and injunction.

Failure to address violations of the FD&C Act may be cause for FDA to withhold approval of requests for export certificates and approval of pending new drug applications or supplements listing your facility as a supplier or manufacturer.

This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot completely address violations within 15 working days, state your reasons for delay and schedule for completion.

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.

Please direct your email response to Office of Unapproved Drugs and Labeling Compliance at the following email address to FDAADVISORY@fda.hhs.gov and include your firm name in the subject line of your email.

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 On August 29, 2006, FDA issued a proposed rule (71 FR 51146) setting forth a determination that OTC skin bleaching drug products, including but not limited to those that contain hydroquinone as an active ingredient, are not generally recognized as safe and effective.

2 Section 505G(a)(4) of the FD&C Act, 21 U.S.C. 355h(a)(4), authorized FDA to take action before September 23, 2020 to extend the period during which a drug subject to that section may be marketed without an approved new drug application if the Agency determined that such an extension is in the interest of public health. However, FDA did not make such a determination for skin bleaching products

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