Bio Wellness 444 LLC

This letter is to advise you that on March 10th, 2025 the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including on your website, biowellness444.com, where your “Silver Bullet elite douche” and “Silver D elite douche” drug products are available for purchase in the United States without a prescription. We also reviewed your social media on Instagram at “biowellness444,” which directs consumers to your website to purchase your products.

“Silver Bullet elite douche” and “Silver D elite douche” 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,) 21 U.S.C. 355(a), 331(d). These violations are described in more detail below.

“Silver Bullet elite douche” and “Silver D elite douche” 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 “Silver Bullet elite douche” and “Silver D elite douche” 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:

“Why Silver Bullet Elite Douche? Colloidal silver has been used for over 2,000 years to relieve the symptoms of various health condition including the effects of viruses and bacterial infections. Silver Bullet incorporates colloidal silver containing 0.8 nanometers with 99% bioactive silver ions… [from product label]

“…Biowellness 444 stands out-largely due to our proprietary blend of powerful, all-natural with only 2-ingredients: ·Colloidal Silver: Known for its potent antibacterial effects…” [from your product website]

“Check out my douche, the elite douche, it’s a formula of colloidal silver, which has been used for thousands of years to combat all strands of bacteria…so if you have any issues with bacterial vaginosis or yeast infections use my douche you’ll see immediate results…” [transcription from your Instagram social media page video]

“Hey ladies, if you have any issues down there such as bacterial vaginosis or yeast infections check out my product, the elite douche. That’s the three-day cleanser, the one-day cleanser and it will give you immediate relief…” [transcription from your Instagram social media page video]

“Frequently Asked Questions (FAQs)…What makes your product so different from the other products on the market? We are the only Douche Product on the market that contains the combination of Colloidal Silver and Tea Tree Oil...” [from your product website]

“Testimonials… ‘This product is amazing! I had the onset of a yeast infection and tried this product for instant relief. I’m very prone to UTI’s and yeast infections. I’ve never felt relief as quickly as I did after first use…” [from your product website]

“Tea tree oil and colloidal silver are better together…Combining these two, natural antibiotics has proven to be make them [sic] more effective at killing microorganisms...” [from your product website]

Based on the above labeling evidence “Silver Bullet elite douche” and “Silver D elite douche” 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, “Silver Bullet elite douche” and “Silver D elite douche” 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).

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 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 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.