WARNING LETTER
AMBI Enterprises LLC
MARCS-CMS 628367 —
April 13, 2022
Product:
Drugs
Recipient:
Recipient Name
David Lennarz
AMBI Enterprises LLC
10411 Motor City Drive
Bethesda
,
MD
20817-1008
United States
consumercare@ambi.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
WARNING LETTER
Date: April 13, 2022
Dear Mr. Lennarz:
This letter concerns your firm’s distribution of drug products to bleach and/or lighten the skin. AMBI® SKINCARE Fade Cream OILY SKIN and AMBI® SKINCARE Fade Cream NORMAL SKIN drug products are unapproved new drugs 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 are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of such products 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
AMBI® SKINCARE Fade Cream OILY SKIN and AMBI® SKINCARE Fade Cream NORMAL SKIN are drugs as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are 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 they are intended to affect the structure or any function of the body. Specifically, these products are intended for use as skin bleaching products.
Examples of the claims observed on your product labels and labeling from your website https://ambi.com, where products are available for purchase, that provide evidence of the intended use(s) (as defined in 21 CFR 201.128) of your products include, but may not be limited to, the following:
AMBI® SKINCARE Fade Cream OILY SKIN
“Fades dark spots for even, natural skin tone . . .
Drug Facts
. . . Hydroquinone 2% . . .
Purpose
. . . Skin Bleaching Agent . . .
Uses
. . . For the gradual fading of dark (brownish) skin discolorations such as freckles, age and liver spots or pigment that may occur in pregnancy or from the use of oral contraceptives . . . An advanced formula that effectively fades dark spots and skin discolorations to help restore your natural skin tone. You will begin to see results in as little as 2 weeks and results improve with continued use. This targeted treatment contains a unique triple-action formula, which combines the following: . . .
Hydroquinone
. . . a dermatologist recommended ingredient to safely fade dark spots” [from your “AMBI Fade Cream OILY Skin” product label]
“AMBI® Fade Cream Oily Skin effectively and safely fades unwanted dark marks without changing your natural skin tone. You will begin to see results in as little as two weeks and results will improve with continued use. . . . This targeted treatment contains . . .
Hydroquinone-
a dermatologist-recommended ingredient to safely fade dark spots” [from your website https://ambi.com/collections/best-sellers/products/ambi-fade-cream-for-oily-skin]
AMBI® SKINCARE Fade Cream NORMAL SKIN
“Fade Cream . . .
Drug Facts
. . . Hydroquinone 2% . . .
Purpose
. . . Skin Bleaching Agent . . .
Uses
. . . For the gradual fading of dark (brownish) skin discolorations such as freckles, age and liver spots or uneven pigment that may occur in pregnancy or from the use of oral contraceptives . . . An advanced formula that visibly fades dark spots and skin discolorations for an even, natural skin tone. You will begin to see results in as little as 2 weeks and results improve with continued use. This targeted treatment contains a unique triple-action formula, which combines the following: . . .
Hydroquinone
. . . a dermatologist recommended ingredient to safely fade dark spots” [from your “AMBI Fade Cream NORMAL SKIN” product label]
“AMBI® Fade Cream Normal Skin effectively and safely fades unwanted dark marks without changing your natural skin tone. You will begin to see results in as little as two weeks and results will improve with continued use. . . . This targeted treatment contains . . .
Hydroquinone-
a dermatologist-recommended ingredient to safely fade dark spots” [from your website https://ambi.com/collections/best-sellers/products/ambi-fade-cream-for-normal-skin]
AMBI® SKINCARE Fade Cream OILY SKIN and AMBI® SKINCARE Fade Cream NORMAL SKIN are skin bleaching drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, which governs nonprescription drugs marketed without an approved application. Specifically, these skin bleaching products fall 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 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.
1
Thus, AMBI® SKINCARE Fade Cream OILY SKIN and AMBI® SKINCARE Fade Cream NORMAL SKIN 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 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 AMBI® SKINCARE Fade Cream OILY SKIN and AMBI® SKINCARE Fade Cream NORMAL SKIN. Accordingly, these skin bleaching drug products are unapproved new drugs and their 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, AMBI® SKINCARE Fade Cream OILY SKIN and AMBI® SKINCARE Fade Cream NORMAL SKIN are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because they are deemed as such under section 505G(a)(4) of the FD&C Act, 21 U.S.C. 355h(a)(4), and because they are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but are not the subject of applications approved under section 505 of the FD&C Act, 21 U.S.C. 355, and do 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 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/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.
Content current as of:
04/19/2022
Regulated Product(s)
Drugs