Handelnine Global, LLC dba Navafresh
FDA issued a warning letter to Handelnine Global, LLC dba Navafresh (South Plainfield, NJ) after reviewing its website in September 2025 and finding ten products — including Ayurvedic, homeopathic, and herbal preparations — marketed as unapproved new drugs for serious conditions such as cancer, diabetes, measles, Parkinson's disease, and arthritis. Laboratory testing of 'Rheumacare Capsules' revealed lead contamination at approximately 7,000 times the permitted daily exposure limit, plus preliminary findings of mercury, strychnine, brucine, and arsenic, rendering the product adulterated and misbranded. FDA cited violations of FD&C Act sections 301(a), 301(d), 502, and 505(a) and warned that failure to respond may result in seizure or injunction. The company was directed to notify FDA in writing within fifteen working days of corrective steps taken.
Flagged claims (17)
SNEEZING RELIEF: Dr Patels Homeopathic Measles Tablets offer natural relief for sneezing, a common symptom of measles.
So, Rheumacare is the drug of choice for Osteoarthritis and Rheumatoid arthritis to reduce pain and swelling. Rheumacare is [sic] disease modifying agent, mainly for Rheumatoid arthritis.
Acute or chronic conjunctivitis
Indications: Quit Smoking, Upper Respiratory Tracft [sic] Infections, COPD, Breathlessness, Harshness of Voice and Throat, Cough Cold, Sinusitis, Rhinitis,
DIABETIC TABLETS helps [sic] control blood sugar … For Daibetes [sic] Care
Arbud (Cancerous Growth): It may have properties that can help manage certain cancerous growths (Arbud), potentially aiding in reducing the size of tumors.
A safe and natural ayurvedic medicine for managing diabetic sugar levels
Indication: Osteoarthritis, Rheumatoid arthritis, Sciatica, Synovitis, Frozen shoulder, Ankylosing Spondylitis, Gout, Painfull [sic] nervine [sic] disorder etc.
Anyedyshka Jwar (Fever of Unknown Origin): This Ayurvedic formulation may be beneficial in managing fevers of unknown origin (Anyedyshka Jwar) and assisting in the alleviation of fever-related symptoms.
Long term use of Rheumacare is safe and can prevent the bony deformities.
Useful adjuvant for prevention of coronary disease and for follow up support after a heart attack.
Uses: Useful in blurred vision and improves eye sight.
Indications: Sneezing and thin discharge from nose, eyes are watery, cough & febrile condition. It is of good help in all stages of the disease.
Parkikyor helps Rejuvenate brain tissues, Enhance the functions of brain, boost cognitive ability, promote mental clarity and elevate mood, Lessen tremors, relax muscles, ease stiffness and aches.
Supports the treatment for blurry, cloudy vision caused due to cataract or glaucoma as part of a complex treatment.
missing lead declaration on Rheumacare Capsules label
Rheumacare is the Combination of non-steroidal anti-inflammatory, analgesic and disease modifying drugs. Rheumacare is very effective to treat all type [sic] of arthritic conditions.
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 lead to regulatory or legal action including, without limitation, seizure and injunction.
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