Confer With

This letter concerns your firm's distribution of a drug product to bleach and/or lighten the skin. Vivant True Tone is an unapproved new drug introduced into interstate commerce in violation of section 505(a) of the 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 a misbranded 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.

Vivant True Tone 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.

Examples from the Vivant True Tone product labeling, including your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of the product as a drug include, but may not be limited to, the following:

" ... this triple-action, targeted corrector serum ... lightens and brightens . .. Ideal for: Hyperpigmentation, Melasma, Dark Spots, Age Spots." [from your website https://conferwith .net/products/bleaching-cream)

"The undisputed champion in the pigment wars is hydroquinone .. . For stubborn pigmentation issues, Vivant's True Tone Serum is at the top of the food chain. This targeted serum combines transformative vitamin A with hydroquinone (2%) .... " [from the Vivant Skin Care website https://www.vivantskincare.com/blogs/hyperpigmentation/foursteps-to-even-tone]

Based on the above labeling evidence, Vivant True Tone is a skin bleaching drug product 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), 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 330.1 Thus, Vivant True Tone 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 Vivant True Tone. 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 products into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d).

Moreover, Vivant True Tone 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).

The violations cited in this letter are not intended to be an all-inclusive list of violations of your product nor are the skin bleaching/skin lightening drug products named in this letter intended to be an all-inclusive list of products you have manufactured, registered, and 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 ensure that your firm complies with all requirements of federal law, including 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 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.

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. Please include your firm name and the unique identifier "707691" in the subject line of your email.