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WARNING LETTER

September 16, 2025

RE: 712804

Dear Gennady Sirota:

This letter is to advise you that the United States Food and Drug Administration (FDA or Agency) reviewed your website at the internet address www.stellalife.com in July 2025 and has observed that your website offers products for sale in the United States (U.S.), including the following which are labelled as homeopathic drug products: “StellaLife VEGA Oral Care Recovery Kit,” “StellaLife VEGA Oral Care Peppermint Gel,” “StellaLife VEGA Oral Care Spearmint Rinse,” “StellaLife VEGA Oral Care Peppermint Rinse,” and “StellaLife VEGA Oral Care Coconut Rinse” (hereinafter StellaLife homeopathic drug products). We have also reviewed your social media accounts at https://www.instagram.com/stellalifehealing/, https://www.facebook.com/stellalifeheal and www.youtube.com/@StellaLifeHealing. Your social media accounts direct consumers to your www.stellalife.com website to purchase your products. Based on our review, your StellaLife homeopathic 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) and 331(d), as described below.

Your StellaLife homeopathic drug products are especially concerning from a public health perspective because they are marketed for use in vulnerable populations, i.e., children and patients at high risk for developing an infection, such as those with open oral wounds or postoral surgery. Use of your products in these populations is even more concerning because some of your products have been recalled due to microbial contamination.¹ Introduction of certain types of bacteria to the disrupted oral mucosa in patients with oral disease, undergoing dental surgical procedures, or with compromised immune systems could lead to bacteremia and sepsis.

Based on our review of your labeling, your StellaLife homeopathic drug products are drugs as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended to prevent, treat, mitigate, or cure disease conditions and/or affect the structure or any function of the body. Examples from your product labeling, including on your website and social media accounts that provide evidence of the intended use (as defined in 21 CFR 201.128) of your products as drugs include, but may not be limited to, the following:

On your “StellaLife VEGA Oral Care Recovery Kit” webpage https://stellalife.com/products/stellalife-vega-oral-care-recovery-kit-16oz:

• “IMPROVES RECOVERY: Accelerates healing naturally after dental surgeries such as extractions (including wisdom teeth), dental implants (including all-on-4, all-on-6), bone and connective tissue grafting, LANAP, osseous surgery, crown lengthening, sinus lift, ridge augmentation, and other procedures including SRP.”
• “FAST ACTING: Natural relief for dental surgeries . . . mouth ulcers . . . mucositis, thrush, lesions”
• “DIRECTIONS:
  3•3•3 StellaLife Program: 3 days before, 3 times per day, all 3 products
  Adults and children over 6 years of age. Start 3 days before the surgery or procedure to increase therapeutic levels. Continue after the procedure.”

On your “StellaLife VEGA Oral Care Peppermint Gel” webpage https://stellalife.com/products/vega-oral-gel:

• “StellaLife VEGA Care Gel is an innovative patented technology formulated to accelerate healing, relieve pain & reduce swelling after dental procedures. Doctors have found it effective in managing . . . mucositis”
• “A Product Dental Patients Need After Surgical and Non-Surgical Procedures . . . Supports healing . . . Relieves pain & swelling . . . Oral Ulcers”
• “When do I use StellaLife VEGA Oral Care Gel? Our natural gel has been formulated to work well in open wounds and speed up healing. Dental professionals use it for in-office application immediately after treatment or at post-operative visits. The gel has been found effective in the management of . . . mucositis, and recovery following dental surgical and non-surgical procedures.”

On your “StellaLife VEGA Oral Care Spearmint Rinse” webpage https://stellalife.com/products/stellalife-vega-oral-care-sprearmint-rinse:

• “StellaLife Oral Rinse is a natural, microbiotic product formulated for daily use to hydrate, freshen breath, and promote healthy gums to maintain oral health. The patented rinse supports healing after dental treatment. It is part of oral hygiene to moisturize dry mouth and kill bacteria that cause periodontal disease.”
• “Does it help dry mouth? Yes. It has been helping patients with dry mouth symptoms, including patients who experience xerostomia caused by radiation therapy to the head and neck.”

On your “StellaLife VEGA Oral Care Coconut Rinse” webpage https://stellalife.com/products/stellalife-vega-oral-care-rinse-coconut:

• “MICROBIOTIC THERAPY: Reduces bacteria that cause periodontal disease.
  Recommended by THE DENTAL ADVISOR.
  PROTECTIVE & HEALING: Combined use of the VEGA Oral Care Gel and Coconut Rinse (nine active ingredients) offers many additional benefits like temporary symptoms relief of dry mouth and ulcers caused by mucositis, chronic inflammatory and autoimmune conditions of the oral cavity, daily medication, chemo, and radiation treatments.”
• “StellaLife VEGA Oral Coconut Rinse is a natural, antimicrobial product formulated to hydrate the oral cavity, promote healthy gums, maintain oral health, and freshen your breath. The patented rinse supports healthy healing following oral surgery and periodontal treatment . . . The rinse is also uniquely designed for patients undergoing chemo and radiation treatments and with various oral cavity inflammatory conditions.”

On your “StellaLife VEGA Oral Care Spearmint Rinse” and “StellaLife VEGA Oral Care Peppermint Rinse” webpages²:

• “StellaLife VEGA Oral Rinse is a natural, antimicrobial product formulated to hydrate the oral cavity, promote healthy gums, maintain oral health, and freshen breath. The patented rinse supports healthy healing following oral surgery and periodontal treatment for patients with xerostomia. It is recommended as part of daily oral hygiene due to its antimicrobial properties used to kill bacteria that cause tooth decay and periodontal disease.”

On your “StellaLife VEGA Oral Care Spearmint Rinse,” “StellaLife VEGA Oral Care Peppermint Rinse,” and “StellaLife VEGA Oral Care Coconut Rinse” webpages³:

• “Clinical reports showed anti-fungal properties and effectiveness in the treatment of mucositis in conjunction with VEGA gel. Professional strength. Recommended by the Dental Advisor, dentists, and hygienists.”
• “How effective is StellaLife VEGA Oral Care Rinse? Independent antimicrobial studies showed the rinse efficacy against the anaerobic bacterial load in half for over 3 hours after a single application.”

On your Facebook social media account at https://www.facebook.com/stellalifeheal:

• May 23, 2025 post: Statement in your video clip “Recover faster from Dental Surgery with Opioid-Free Pain Relief. Return to your normal life faster after dental surgery with StellaLife’s Vega Oral Care Recovery Kit 3-3-3 program . . . Many patients report faster recovery with StellaLife’s groundbreaking Intelligent Healing process . . . StellaLife is a safe and natural way to speed up recovery with less pain after dental surgery.”

On your Instagram social media account at https://www.instagram.com/stellalifehealing/:

• July 4, 2025 post: “Their VEGA Oral Care Recovery Kit is my go-to for post-surgical healing, whether it’s after an extraction, bone graft, or even membrane placement. Natural, effective, and gentle — a must-have in recovery care!”

On your YouTube social media account at www.youtube.com/@StellaLifeHealing:

• October 9, 2020 featured video: “In the past I would see wounds opening up, I would see membranes not only exposed but being lost, I would see bone grafts being lost . . . the use of the Oral Care program has just been really spectacular and I love the overall wound healing that I’m seeing.”

Moreover, your StellaLife homeopathic drug products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the above-described conditions prescribed, recommended, or suggested in their labeling. Subject to certain exceptions not applicable here, new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

We recognize that your StellaLife homeopathic drug products are labeled as being homeopathic drugs with active ingredients measured in homeopathic strengths. Under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term “drug” includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or FDA approval.

Conclusion

This letter is 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. Please include your firm name and the unique identifier “712804” in the subject line of the email.

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

_________________________________

1 Your contract drug manufacturer HomeoCare Laboratories, Inc. voluntarily recalled several lots of StellaLife Homeopathic Drug products due to concerns with microbial contamination in June 2023 and June 2024. The June 2024 recall included a press release https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/homeocarelaboratories-inc-issues-voluntary-nationwide-recall-homeopathic-stella-life-oral-care.

2 https://stellalife.com/products/stellalife-vega-oral-care-sprearmint-rinse and https://stellalife.com/products/vega-oralcare-rinse-16oz

3 https://stellalife.com/products/stellalife-vega-oral-care-sprearmint-rinse; https://stellalife.com/products/vega-oralcare-rinse-16oz; and https://stellalife.com/products/stellalife-vega-oral-care-rinse-coconut.