---

---

---

WARNING LETTER

May 30, 2025

RE: 709332

Dear Nerissa Irving:  

This letter is to advise you that on April 2, 2025 the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including on your website at the internet address thelotusfreshline.com where your “LOTUS FRESH™ intimate/flora gel” and “LOTUS FRESH™ v-gel moisturize & balance” drug products are available for purchase in the United States without a prescription.

“LOTUS FRESH™ intimate/flora gel” and “LOTUS FRESH™ v-gel moisturize & balance” drug 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, the act), 21 U.S.C. 355(a), 331(d). These violations are described in more detail below.      

Unapproved New Drug Violations

“LOTUS FRESH™ intimate/flora gel” and “ LOTUS FRESH™ v-gel moisturize & balance” (hereinafter “Intimate/flora gel” and “V-gel,” respectively) 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.

Examples from the “Intimate/flora gel” and “V-gel” product labeling, including your website listed above, that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the products as drugs include, but may not be limited to, the following:

“Intimate/flora gel”
“A herbal vaginal gel for fighting yeast and chronic bacteria vaginosis…” [from your product website]
    
“Colloidal silver: is a suspension of silver particles in liquid. It is known for its antimicrobial properties, which can help in controlling infections…· May act as an antiseptic agent, helping to prevent infections. · Could help in reducing inflammation and promoting healing.” [from your product website]

“V-gel” 
“A *colloidal silver vaginal gel for pH balancing, odor, itching, vaginal bacteria…*Colloidal silver is a natural antibiotic that treats yeast infections, bacterial vaginosis, and vaginal itching.” [from your product website]

“Intimate/flora gel” and “V-gel”
“The Vaginal Benefits of Colloidal Silver: A Natural Solution for Intimate Health… One ingredient that has gained significant attention for its antibacterial and soothing properties is colloidal silver. Known for its ability to support healing and combat infections, colloidal silver is a game changer in the world of feminine wellness…What is Colloidal Silver? Colloidal silver is a liquid solution containing tiny, suspended particles of pure silver. Long celebrated for its antimicrobial properties, colloidal silver has been used for centuries to fight bacteria, fungi, and viruses. …Colloidal silver has natural antibacterial properties that help target harmful bacteria without disrupting the good bacteria essential for vaginal health.” [from your product website]

Based on the above labeling evidence “Intimate/flora gel” and “V-gel” are over-the-counter (OTC) colloidal silver-containing drug products intended for use in the treatment of vaginal infections. The Agency has determined that any OTC drug product containing colloidal silver ingredients or silver salts that is labeled, represented, or promoted for the treatment and/or prevention of any disease is regarded as a new drug within the meaning of section 201(p) of the FD&C Act, and that all such products are deemed to be new drugs and require an approved new drug application or abbreviated new drug application under section 505 of the FD&C Act to be lawfully marketed according to 21 CFR 310.548(b).

No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355 are in effect for these products. Thus, “Intimate/flora gel” and “V-gel” are unapproved new drugs marketed in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a). Introduction or delivery for introduction of these products into interstate commerce violates section 301(d) of the FD&C Act, 21 U.S.C. 331(d).

Conclusion  
 
The violations cited in this letter are not intended to be an all-inclusive list 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 15 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 product is 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 15 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 and include your firm name in the subject line of your email.

Sincerely, 
/S/
CAPT Tina Smith 
Office Director 
Office of Unapproved Drugs and Labeling Compliance 
Office of Compliance 
Center for Drug Evaluation and Research  
Food and Drug Administration