Stellalife, Inc.
FDA issued a warning letter to Stellalife, Inc. (Northbrook, IL) on September 16, 2025, after reviewing the company's website and social media accounts and finding that five homeopathic oral care products — including the VEGA Oral Care Recovery Kit, gels, and rinses — were being marketed as unapproved new drugs. The products' labeling and online claims described intended uses to treat, mitigate, or cure disease conditions (e.g., mucositis, periodontal disease, post-surgical wound healing, xerostomia from radiation therapy) without an approved FDA application, violating sections 505(a) and 301(d) of the FD&C Act. FDA also flagged heightened public health concern because the products target vulnerable populations including children and post-surgical patients, and because prior lots were recalled for microbial contamination. The agency demanded written corrective action within fifteen working days and warned that failure to comply may result in seizure or injunction.
Flagged claims (12)
Clinical reports showed anti-fungal properties and effectiveness in the treatment of mucositis in conjunction with VEGA gel.
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.
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.
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
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.
MICROBIOTIC THERAPY: Reduces bacteria that cause periodontal disease.
FAST ACTING: Natural relief for dental surgeries . . . mouth ulcers . . . mucositis, thrush, lesions
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.
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.
kill bacteria that cause periodontal disease.
Independent antimicrobial studies showed the rinse efficacy against the anaerobic bacterial load in half for over 3 hours after a single application.
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.
Required actions (2)
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.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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