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WARNING LETTER

November 17, 2025

RE: 716644

Neena Chowdary Koganti:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://swadesii.com/ in September 2025. The FDA has observed that your website offers “Deekshant Thyroid Tablet,” “Hepatina Syrup,” “Dr. Vasishth's Guduchi Tinospora cordifolia ghan Tablets,” “Bico 14 Haslab,” “Singhnad Guggul (A.S.S.),” “Repl Dr. Advice No. 69 Measales (Measles),” “Baryta Carbonicum 200 CH,” “Elaneer Kuzhambu,” “WG-5 Gold Drops,” and “WG-6 Gold Drops” (hereinafter Swadesii 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 Swadesii products are especially concerning from a public health perspective. As described below, the labeling of your unapproved “Deekshant Thyroid Tablet,” “Hepatina Syrup,” “Dr. Vasishth's Guduchi Tinospora cordifolia ghan Tablets,” “Bico 14 Haslab,” “Singhnad Guggul (A.S.S.),” “Repl Dr. Advice No. 69 Measales (Measles),” “Baryta Carbonicum 200 CH,” “WG-5 Gold Drops,” and “WG-6 Gold Drops” drug products includes claims to cure, mitigate, treat, or prevent serious and/or life-threatening conditions such as measles, cancer, diabetes, stroke, Alzheimer's, 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 “Elaneer Kuzhambu,” drug product is concerning because ophthalmic drug products, which are intended for administration into the eyes, generally 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 Swadesii 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:

Deekshant Thyroid Tablet

On the webpage https://swadesii.com/products/ambic-deekshant-thyroid-60-tabs:

• From the product packaging:
  o In the name of the product – “Thyroid Tablet”
  o “Hypothyroidism
  o Helps in activating thyroid glands”
• “Description:
  o [N]atural ingredients that are [ ] highly effective in improving the health of the thyroid and avoiding thyroid infections.
  o [E]nhance the immune system and fights seasonal pathogens.
  o It is among the most effective antibacterial . . . help in the efficient functioning of thyroid hormone.
  o With the power of Ambic Deekshant thyroid tablets, you can get your way to a healthier thyroid.
  o This is an effective ayurvedic tablet for thyroid that will help you achieve healthier thyroid hormone levels.”

Hepatina Syrup

On the webpage https://swadesii.com/products/bhargava-hepatina-syrup

• From the product packaging:
  o “Liver Tonic”
• “Description:
  o Bhargava Hepatina Syrup is helpful in the treatment of liver problems such as jaundice and fatty liver.
  o It aids in the improvement of digestive functions and the treatment of hepatocellular jaundice and liver damage as a supportive therapy.
  o It contains Chelidonium majus, a herb that aids in the clearance of toxins from the body and is especially beneficial in the treatment of liver issues.”

Dr. Vasishth's Guduchi

On the webpage https://swadesii.com/products/dr-vasishths-guduchi-30-tabs

• “Modulates the immunity – Guduchi has been reported to modulate the abnormal immunity as happens in auto-immunity (where the immune cells attack own cells).
• It is thus useful in auto-immune disorders, including – Rheumatoid arthritis, psoriasis, SLE, lichen planus, IBD, multiple sclerosis, alopecia areata and type-I diabetes. . . .
• It is used for the management of liver disorders – Hepatitis, jaundice, abnormal liver enzymes, fatty liver, and early cirrhosis.
• Useful in acid peptic diseases – Guduchi has been reported to inhibit the excessive production of gastric acid. . . . 
• It is useful in the management of various kidney disorders – Early / reversible kidney failure, nephritis and nephrotic syndrome.”

Bico 14 Haslab

On the webpage https://swadesii.com/products/haslab-homeopathy-bico-14-biochemic-compound-tablets:

• “Description: . . .
  o It helps in all stages of disease and fevers of unknown origin; dry, hard, painful, itchy cough with sore chest.
  o [M]anage measles problems.”
• “Key Benefits:
  o It may help to reduce sneezing and watery discharge from the nose and eyes with fever
  o [H]elp to boost your immune system
  o [P]revent catarrhal affections
  o It can help to condition dry, hard, painful, itchy cough with sore chest”

Singhnad Guggul (A.S.S.)

On the webpage https://swadesii.com/products/patanjali-divya-singhnda-guggul-20-gms

• “Description:
  o Beneficial in chronic rheumatism (arthritis rimutaid), paralysis stroke, arthritis, etc. . . .
  o This is used for all types of vata diseases. This enhances and stimulates the uterus, regulates menstrual disorders, growth of white blood cells in blood, diuretics, mucilage secretory, worm destroyer etc.”
• “Benefits:
  o Useful in rheumatoid . . . arthritis”

Repl Dr. Advice No. 69 Measales (Measles)

On the webpage https://swadesii.com/products/dr-advice-no-69-measaless-lp8kj:

• From the product packaging:
  o In the name of the product – “measles”
• “Description:
  o Helps with symptoms associated with inflammation of the mucous membranes.
  o Helps with symptoms like measles, red rash in measles, and measles outbreaks.
  o Helps with burns, Heat, burning, red and shiny swelling of the diseased organs.
  o Helps to get rid of problems like swelling, heat, and redness of the whole body.”

Baryta Carbonicum 200 CH

On the webpage https://swadesii.com/products/sbl-homeopathy-baryta-carbonicum-dilution:

• “[R]ecommended for old people when they suffer from paralysis and is used in multiple sclerosis of the brain and spinal cord.
• The elderly people have senile dementia, a disorder showing deterioration of mental abilities usually associated with getting old.
• Stroke and Alzheimer's disease are the two most common causes of this deterioration.”

Elaneer Kuzhambu

On the webpage https://swadesii.com/products/vaidyaratnam-elaneer-kuzhambu-z4vxs:

• “[U]sed to help in the treatment of eye ailments and balance the Pitta and Vata doshas to promote eye health.
• This Ayurvedic medicine for eye health helps calm eye irritation and can supplement the treatment of vision problems that are caused by sun, heat and smoke.
• The Ayurvedic eye drops helps safeguard you from eye infections and is used to help treat problems such as corneal ulcer, glaucoma, pterygium and the early stage of cataract.
• It is a natural Ayurvedic formulation that can help in the treatment of conjunctivitis and other eye infections and inflammations.”

WG-5 Gold Drops

On the webpage https://swadesii.com/products/wheezal-homeopathy-wg-5-gold-drops:

• From the product packaging:
  o “Anti Stroke
  o Helps to Restore Blood Flow”
• “Description:
  o Wheezal WG5 Anti Stroke Gold Drop can improve blood circulation and manage circulatory debility.
  o It may also be useful against increased intracranial tension and brain oedema in . . . patients suffering from brain stroke and other brain-related diseases.
  o The drop’s homoeopathic ingredients might also help dissolve blood clots induced by stroke or other related diseases.”

WG-6 Gold Drops

On the webpage https://swadesii.com/products/wheezal-homeopathy-wg-6-gold-drops:

• From the product packaging:
  o “Pancreas Health
  o Supports normal functioning of Pancreas”
• “Description:
  o [H]elp relieve pancreatic disorders and balance the normal functioning of the pancreas.
  o [E]ase associated symptoms like abdominal pain, diarrhoea, and other commonpancreatic disorders.  
  o It may be helpful against a range of pancreatic disorders, including pancreas malfunction, pancreatitis, cystic fibrosis, and pancreatic cancer.”
• “Key Benefits:
  o Helps balance and restore normal functioning of pancreas
  o [U]seful against cystic fibrosis, pancreatic cancer, and other associated pancreatic diseases
  o [E]ase related symptoms like malnutrition, abdominal pain, oily stools, and other problems”

Your Swadesii 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 “Hepatina Syrup,” “Bico 14 Haslab,” “Repl Dr. Advice No. 69 Measales (Measles),” “Baryta Carbonicum 200 CH,” “WG-5 Gold Drops,” and “WG-6 Gold 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.

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 “716644” 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