WARNING LETTER
Fancy Drops Beauty LLC
MARCS-CMS 688469 —
October 24, 2024
Delivery Method:
Via Email
Product:
Drugs
Recipient:
Fancy Drops Beauty LLC
1942 Broadway Suite 314C
Boulder
,
CO
80302
United States
hello@fancydrops.co
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
WARNING LETTER
October 24, 2024
RE: 688469
Dear Fancy Drops Beauty LLC:
This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://fancydropsbeauty.com/ in July 2024 and has observed that your website offers “Fancy Drops Color Changing Solutions Eye Drops” in various colors
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(hereinafter referred to as “Fancy Drops products”) for sale in the United States. As described below, your Fancy Drops 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 331(d).
Your Fancy Drops products are especially concerning from a public health perspective. Ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.
Based on a review of your website, your Fancy Drops 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 from your website https://fancydropsbeauty.com/ that establish the intended use of these products as drugs include, but may not be limited to, the following:
On the webpage https://fancydropsbeauty.com/:
“Lighten & Brighten Dark Your Eye Color, Speed Up the Eye Color Changing Process.”
On the webpage https://fancydropsbeauty.com/pages/reviews
An image of a bottle of Fancy Drops with the quote “CAN’T BELIEVE FANCY DROPS CHANGED MY EYE COLOR”
Customer review from 02/20/2024: "No blurry vision or pain. About in 3 months it will be noticeable. It works but slow. I can see the differences, now I have blue eye color, like icy blue. I like the result. Thanks!”
Customer review from 05/17/2024: “I’ve had brown eyes for years, and they were blue when I was born! Now, after 5 months, I bought it hoping for green eyes and it works well. It has changed my eyes, and now having green eyes is what I’m most excited about.”
Customer review from 02/22/2024: “I have been using this product for almost 6 months now and I can confidently say that it works for me. I’ve always wanted blue eyes and this Fancy Drops product really made my eye color fade from the dark brown it was in the beginning, slowly to blue”
On the webpage https://fancydropsbeauty.com/pages/about-us:
“Our Eye Color treatments harness the natural properties of plants that work in tandem with proven science to promote clean and gentle color changing process.”
“We are committed to creating thoughtful, modern Color Changing treatments that serve to empower and embrace natural beauty.”
On the webpage https://fancydropsbeauty.com/pages/icy-grey-creative:
“Our Fancy Drops products work by inhibiting the production of Melanin, other pigmentation, and Tyrosinase. But that's not all, our products go beyond this, working at cellular level to Inhibit the enzymes and underlying mechanisms responsible for producing and stimulating pigment-producing cells, [g]iving you a new eye color based on new lower levels of pigmentation.”
“By inhibiting the expression of Melanin and other pigmentation, you increase the color expression of lighter tones, (such as blues, greens, hazels, and light honey shades) and the overall lightness of your eyes.”
Your Fancy Drops products are not generally recognized as safe and effective (GRASE) for the above referenced uses and, therefore, these products 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 legally 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). No FDAapproved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for Fancy Drops 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).
The violations cited in this letter are 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 any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. 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. 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. 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
U.S. Food and Drug Administration
______________________
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Fancy Drops products are offered in the following colors: Light Green, Light Blue, Turquoise, Hazel, Sterling Grey, Honey, Dark Green, Dark Blue, Amber, and Purple.
Content current as of:
11/05/2024
Regulated Product(s)
Drugs