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WARNING LETTER

November 17, 2025

RE: 716154

VarunKart Group LLC:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://organicwellnesses.com/ in September 2025. The FDA has observed that your website offers “Lord's L 143 Measles Drop,” “Dabur Swarna Bhasma,” “Dr. Willmar Schwabe India Aviaire Dilution,” “Himalaya Pure Herbs Arjuna Cardiac Wellness,” “Muniyal Muniojus Tablets,” “Mohammedia Kalonji Oil,” “Patanjali Divya Godhan Ark (Gaumutra),” “Himalaya Ophthacare Eye Drops” and “Patanjali Drishti Eye Drop” (hereinafter Organic Wellnesses products) for sale in the United States. 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).

Your Organic Wellnesses products are especially concerning from a public health perspective. As described below, the labeling of your unapproved “Lord's L 143 Measles Drop,” “Dabur Swarna Bhasma,” “Dr. Willmar Schwabe India Aviaire Dilution,” “Himalaya Pure Herbs Arjuna Cardiac Wellness,” “Muniyal Muniojus Tablets,” “Mohammedia Kalonji Oil,” and “Patanjali Divya Godhan Ark (Gaumutra)” drug products includes claims to cure, mitigate, treat, or prevent serious and/or life-threatening conditions such as measles, syphilis, tuberculosis, cancer, diabetes, and hepatitis, 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 “Himalaya Ophthacare Eye Drops” and “Patanjali Drishti Eye Drop” drug 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.

Based on a review of your website, your Organic Wellnesses 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:

Lord's L 143 Measles Drop

On the webpage https://organicwellnesses.com/products/lords-l-143-measles-drop-30-ml:

• From the product packaging:
  o “Measles Drops”
• “It is beneficial for measles and fever
  It helps to reduce mild to high temperatures
  It is beneficial for cough, blisters, watery nose, and eyes”

Dabur Swarna Bhasma

On the webpage https://organicwellnesses.com/products/dabur-swarna-bhasma-500-mgs:

• “This ayurvedic medicine improves muscle strength and helps in all diseases like muscular dystrophy.”
• “Specially prescribed in hemiplegia and complete paralysis.”
• “Effectively treat Malabsorption syndrome, dyspepsia, hiccup, anaemia, dyspnoea, asthma, fever, tissue wasting, tuberculosis, impaired intelligence, epilepsy, rupture / weakness of ligaments, heart disease, disease due to Vata dosha, syphilis, poison, loss of memory, mania, psychosis, hoarseness of voice, diseases of skin, senility/progeriasis”
• “Exceptional efficacy in skin ailments and syphilis.”

Dr. Willmar Schwabe India Aviaire Dilution

On the webpage https://organicwellnesses.com/products/dr-willmar-schwabe-india-aviaire-dilution:

• “Dr. Willmar Schwabe India Aviaire Dilution is a powerful homeopathy medicine, recommended for treating tuberculosis.”
• “It is helpful in curing respiratory disorders after measles.”
• “Provides support in treatment of tuberculosis”
• “Relieves difficulties in breathing”

Himalaya Pure Herbs Arjuna Cardiac Wellness

On the webpage https://organicwellnesses.com/products/himalaya-pure-herbs-arjuna-cardiac-wellness:

• From the product packaging:
  o “Regulates circulation”
  o “Arjuna is well known for its beneficial effect on blood circulation.”
• “Arjuna helps in improving coronary artery blood flow, reducing the chances of clot formation and protects the heart muscles.”

Muniyal Muniojus Tablets

On the webpage https://organicwellnesses.com/products/muniyal-muniojus-tablets-100-tabs:

• From the product packaging:
  o “Supportive Therapy for Immune Deficiency Syndrome”
• “Studies have proved that Muniojus reduces viral load.”
• “The ingredients improve host resistance by reducing disease progression and increasing CD cell counts.”
• “Improves non-specific & acquired immunity-deficiency, which is seen in HIV infections”
• “Helps in preventing opportunistic infections”
• “Acts as an antioxidant”

Mohammedia Kalonji Oil

On the webpage https://organicwellnesses.com/products/mohammedia-kalonji-oil:

• “Mohammedia Oil is useful in allergies, joint pains, arthritis stomach problems, kidney pain and infection, headache, falling of hair, piles, earache, dental disease, anaemia, cough, skin diseases, lack of sleep, acidity, constipation etc”
• “Mohammedia Kalonji oil prevents hair loss”
• “Kalonji oil for Asthma treatment”
• “Kalonji oil to cure joint pain”

Patanjali Divya Godhan Ark (Gaumutra)

On the webpage https://organicwellnesses.com/products/patanjali-divya-godhan-ark-gaumutra-450-ml:

• “Divya Godhan Ark is an ancient Ayurvedic medicine made by extracting the goodness from gomutra or cow urine. It has multiple benefits and cures a variety of serious ailments.”
• “It gives you relief from problems of liver and stomach. It cures eczema, controls diabetes and cancer.”
• “Get holistic cure and experience Ayurvedic healing at its best.”
• “Diseases curable by cow urine[:] cancer . . . tumor . . . diabetes . . . dysentery . . . measles . . . high blood pressure . . . syphilis . . . leprosy”

Himalaya Ophthacare Eye Drops

On the webpage https://organicwellnesses.com/products/himalaya-ophthacare-eye-drops-1:

• From the product packaging:
  o “Relieves eye strain, redness and dryness.”
• “Himalaya Ophthacare Eye Drops helps to keep eyes safe.”
• “Honey helps to soothing effect on the eyes.”
• “Damask rose has cooling properties.”
• “Helps to keep the eyes safe”
• “Provides relief to those wearing lenses”

Patanjali Drishti Eye Drop
On the webpage https://organicwellnesses.com/products/patanjali-drishti-eye-drop:

• From the product packaging:
  o “Indication: . . . Eye disorder and Beneficial for eyes”
• “Patanjali Drishti Eye Drop is a very effective eye drop for any kind of eye problem. It is very safe to use ayurvedic medicine which also helps in increasing eyesight.”

Your Organic Wellnesses 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 “Lord's L 143 Measles Drop,” and “Dr. Willmar Schwabe India Aviaire Dilution” drug products 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.

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 “716154” 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