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WARNING LETTER

November 17, 2025

RE: 716013

Hiren Gaglani:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://navafresh.com/ in September 2025. The FDA has observed that your website offers “Dr. Patels Measles Tablets,” “Mans-Pachak Vati,” “Adel-54 Heart Care Drops,” “Ayuvardhak Sutta Yog,” “Parkikyor Tablets,” “Tri-Origin Ayurveda Diabetic Tablets,” “Ayuvision Herbal Eye Drop,” “Adel-17 Eye Care Drops,” “Haslab Mamira Eye Drops,” and “Rheumacare Capsules” (hereinafter Navafresh products) for sale in the United States. In addition, FDA has obtained a sample of your “Rheumacare Capsules” product. Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). Furthermore, your “Rheumacare Capsules” product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. 352, and introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

The results of the FDA laboratory testing of two lots of “Rheumacare Capsules” demonstrate that this drug product is adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B), because the presence of lead in the amounts identified by FDA raises significant safety concerns and demonstrates that the product has not been manufactured and processed in a manner that conforms to CGMP requirements.

Your Navafresh products are especially concerning from a public health perspective. As described below, the labeling of your unapproved “Dr. Patels Measles Tablets,” “Mans-Pachak Vati,” “Adel-54 Heart Care Drops,” “Ayuvardhak Sutta Yog,” “Parkikyor Tablets,” and “Tri-Origin Ayurveda Diabetic Tablets” drug products includes claims to cure, mitigate, treat, or prevent serious and/or life-threatening conditions such as cancer, diabetes, and measles, and may cause consumers to forgo, delay, or discontinue medical treatments that have been found safe and effective for such conditions through the FDA review process. In addition, your unapproved “Ayuvision Herbal Eye Drop,” “Adel-17 Eye Care Drops,” and “Haslab Mamira Eye Drops” products are concerning because ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.

Unapproved New Drug and Misbranding Violations

Based on a review of your website, your Navafresh products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:

Dr. Patels Measles Tablets

On the webpage https://navafresh.com/products/dr-patels-homeopathic-measles-tablets-natural-relief-for-sneezing-thin-nasal-discharge-watery-eyes-cough-and-febrile-condition-effective-support-for-all-stages-of-the-disease-25-gm:

• From the product packaging:
  o In the name of the product – “14 MEASLES”
  o “Indications: Sneezing and thin discharge from nose, eyes are watery, cough & febrile condition. It is of good help in all stages of the disease.”
• “Description
  o “SNEEZING RELIEF: Dr Patels Homeopathic Measles Tablets offer natural relief for sneezing, a common symptom of measles.”
  o “THIN NASAL DISCHARGE MANAGEMENT: These tablets help manage thin nasal discharge, reducing congestion and promoting clearer nasal passages. This relieves discomfort and allows for easier breathing during the course of measles.”
  o “WATERY EYES SOOTHING: The homeopathic formulation in these tablets helps soothe watery eyes, relieving eye discomfort”

Mans-Pachak Vati

On the webpage https://navafresh.com/products/manspachak-vati-250-gm-anyedyshka-jwargalgandarbudgranthiudarvruddhiadhimaansfeverlymphadenitistumor:

• “Description . . .
  o Galgand (goitre)
  o Arbud (cancer)
  o Udarvruddhi (abdominal swelling)”
• “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. Galgand (Goiter): Mans-Pachak Vati is believed to be useful in addressing goiter (Galgand), a condition characterized by the enlargement of the thyroid gland in the neck. Arbud (Cancerous Growth): It may have properties that can help manage certain cancerous growths (Arbud), potentially aiding in reducing the size of tumors.”

Adel-54 Heart Care Drops

On the webpage https://navafresh.com/products/adel-54-heart-care-dropspack-of-3:

• From the product packaging:
  o “Useful adjuvant for prevention of coronary disease and for follow up support after a heart attack.”
• “Description . . . This carefully selected blend of natural ingredients aims to promote cardiovascular well-being, address factors related to heart function, and contribute to the maintenance of a healthy circulatory system.”

Ayuvardhak Sutta Yog

On the webpage https://navafresh.com/products/ayuvardhak-sutta-yog-upper-respiratory-track-infections-immunity-booster-and-builder-copd-breathlessness-harshness-of-voice-and-throat-cough-cold-sinusitis-rhinitis-tonsillitis-ayurvedic-medicine-product-chew-able-30-tablets:

• From the product packaging:
  o “Indications: Quit Smoking, Upper Respiratory Tracft [sic] Infections, COPD, Breathlessness, Harshness of Voice and Throat, Cough Cold, Sinusitis, Rhinitis,”
• “Description
  o COUGH COLD SINUSITIS RHINITIS
  o ASTHMA
  o SEASONAL THROAT INFECTION ALLERGY
  o HARSHNESS OF VOICE
  o SMOKERS [sic] COUGH”

Parkikyor Tablets

On the webpage https://navafresh.com/products/xovak-pharma-ayurvedic-parkikyor-helps-naturally-60-tablets-pack-of-2:

• From the product packaging:
  o In the product name – “Parkikyor Parkinson’s”
  o “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. Recover digestive fire and flush out toxins from the body [.] Improves muscle strength and physical endurance.”
• “Description
  o Helps to the [sic] boost cognitive ability
  o Improve muscle strength and physical endurance.
  o Combat stress and have quality sleep”

Tri-Origin Ayurveda Diabetic Tablets

On the webpage https://navafresh.com/products/tri-origin-ayurveda-diabetic-tablets-supports-sugar-control-for-diabetes-60-tabs:

• From the product packaging:
  o In the product name – “DIABETIC TABLETS”
  o “DIABETIC TABLETS helps [sic] control blood sugar … For Daibetes [sic] Care”
• “Description . . . Formulated with Gudmar, Mamejavo, Indrajav, Karela, Jamun, Methi, Kalijiri, Kadu Kariyatu, Amla, Harde, Neem leaves, and Giloy for effective sugar control.”
• “A safe and natural ayurvedic medicine for managing diabetic sugar levels”
• “Experience the holistic power of Tri-Origin Ayurveda Diabetic Tablets, designed to support sugar control for individuals managing diabetes care.”
• “[M]aintain your diabetic sugar/blood sugar levels with these better diabetic care tablets”

Ayuvision Herbal Eye Drop

On the webpage https://navafresh.com/products/ayuvision-herbal-eye-drop-for-relieves-dryness-irritationredness-itching-daily-use-eye-drop-10ml-pack-of-6:

• From the product packaging:
  o “Uses: Useful in blurred vision and improves eye sight.”
• “Description . . . Relieves Eye Dryness, Strain & Fatigue, Reduces Irritation & Itching and the Eye Drop Also Provides Eye Care from Harmful Environmental Pollutants.”

Adel-17 Eye Care Drops

On the webpage https://navafresh.com/products/adel-17-eye-care-dropspack-of-3:

• From the product packaging:
  o “Supports the treatment for blurry, cloudy vision caused due to cataract or glaucoma as part of a complex treatment.”
• “Description . . . The drops may be designed to alleviate common eye discomforts such as dryness, irritation, and redness.”

Haslab Mamira Eye Drops

On the webpage https://navafresh.com/products/haslab-mamira-eye-drop-pack-of-3-acute-or-chronic-conjunctivitisphotophobiablurring-visionred-eyeseye-soreeye-infectionlifestyle-problems:

• “Description
  o Acute or chronic conjunctivitis
  o Muco-purulent, stringy.[ ] Photophobia.
  o Eye strain and fatigue Dull pain with burning
  o Dry and irritated eyes Blurring vision releived [sic] by winking
  o Redness and inflammation”

Rheumacare Capsules

From the product 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.”
• “Rheumacare reduces all type [sic] of joint pain, swelling, stiffness and improve [sic] the efficiency of the joint.”
• “The main active princple [sic] Mahayogaraj Guggulu, with Trayodasang Guggulu, Maharasnadi kwath extract, Shallaki, Methi and Nirgundi having [sic] very good analgesic and Anti-inflammatory action. Their rapid action on joints reduces the pain, swelling and increases the joint mobility.” 
• 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. It is [sic] tonic for [sic] musculoskeletal system, improves [sic] joint movement and stability. Long term use of Rheumacare is safe and can prevent the bony deformities.”
• Indication: Osteoarthritis, Rheumatoid arthritis, Sciatica, Synovitis, Frozen shoulder, Ankylosing Spondylitis, Gout, Painfull [sic] nervine [sic] disorder etc.”

Your Navafresh 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 (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, a new drug 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 “Dr. Patels Measles Tablets,” “Adel-54 Heart Care Drops,” “Adel-17 Eye Care Drops,” and “Haslab Mamira Eye Drops” are labeled as homeopathic drugs. 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.

Furthermore, your “Rheumacare Capsules” product is misbranded under section 502(j) of the FD&C Act, 21 U.S.C. 352(j), because it is dangerous to health when used in the dosage or manner recommended in the labeling. As described below, FDA testing found that the “Rheumacare Capsules” contain approximately 7,000 times the amount of lead otherwise indicative of harmful exposure. Lead is toxic to humans, and there is no known safe level of exposure to lead. Even low levels of lead exposure can cause serious health problems, as described below, particularly in children and fetuses.¹

“Rheumacare Capsules” is also misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). Under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FD&C Act, 21 U.S.C. 321(n), provides that, in determining whether an article’s labeling or advertising “is misleading there shall be taken into account . . . not only representations made or suggested . . . but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations.” The labeling for your “Rheumacare Capsules” product does not declare that the product contains lead, which is a material fact with respect to consequences that may result from the use of this product. As discussed below, lead may pose health risks to consumers which are only compounded by the fact that the ingredient is not declared on the label. The failure to disclose this ingredient in the product labeling renders your “Rheumacare Capsules” product misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). The introduction or delivery for introduction into interstate commerce of this misbranded drug product is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Adulteration Violations

FDA laboratory testing of “Rheumacare Capsules” lot CAM040 and lot CAL079-N found unsafe levels of lead contamination. The individual sample results varied between 9,588ppm and 11,124ppm. Based on a Permitted Daily Exposure (PDE) of 5 μg/day, “Rheumacare Capsules” contain approximately 7,000 times the amount otherwise indicative of harmful exposure.² Furthermore, preliminary results indicate concerning levels of other poisonous materials (e.g., mercury, strychnine, brucine, and arsenic). As a result of excessive lead content, your “Rheumacare Capsules” are adulterated under section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B) because the presence of such substances in the amounts identified by FDA demonstrates that the product has not been manufactured and processed in a manner that conforms to CGMP requirements.

Because certain elemental impurities pose toxicological concerns and do not provide any therapeutic benefit to the patient, their levels in drug products should be controlled within acceptable limits. In general, FDA recommends that the manufacturer of any U.S. marketed drug product follow FDA’s Guidance for Industry Q3D(R2) Elemental Impurities³ recommendations to establish appropriate procedures for identifying and controlling elemental impurities in the drug product based on risk assessment and product-specific considerations.

Lead has no known biological function in humans, and exposure to lead may cause neurological, reproductive, developmental, immune, cardiovascular, and renal health effects. In general, sensitivity to lead toxicity is greater when there is exposure in utero and in children compared to adults.

Conclusion

The violations cited in this letter are 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 lead to regulatory or 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 “716013” in the subject line of the email.

Sincerely,
/S/

Brad Pace, J.D.
Associate Director
Office of Unapproved and Labeling Compliance
Signed on behalf of:

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
Food and Drug Administration

/S/

Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

___________________

1 FDA Updates Warning About Imported Cookware That May Leach Lead: August 2025. See https://www.fda.gov/safety/medical-product-safety-information/fda-updates-warning-about-imported-cookware-may-leach-lead-august-2025.

2 FDA’s Guidance for Industry Q3D(R2) Elemental Impurities (September 2022). See https://www.fda.gov/media/148474/download.

3 FDA’s Guidance for Industry Q3D(R2) Elemental Impurities (September 2022). See https://www.fda.gov/media/148474/download and its companion document Guidance for Industry Elemental Impurities in Drug Products (August 2018).