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WARNING LETTER

November 17, 2025

RE: 716212

Venkata Vamsi Krishna Kothuri:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://www.distacart.com in September 2025. The FDA has observed that your website offers “SBL Malaria Officinalis Dilution,” “Allen Depression Drops A79,” “Wheezal WL2 Drops,” “Bjain Omeo Asthma Medicated Syrup,” “Dr. Reckeweg R62,” “Lord’s Eyerite Eye Drops,” “Sitaram Ayurveda Elaneer Kuzhamb,” “Dr. M.S. Basu’s Isotine Eye Drop,” and “SBL Euphrasia 10% Eye Drops” (hereinafter Distacart 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 Distacart products are especially concerning from a public health perspective. As described below, the labeling of your unapproved “SBL Malaria Officinalis Dilution,” “Allen Depression Drops A79,” “Wheezal WL2 Drops,” “Bjain Omeo Asthma Medicated Syrup,” and “Dr. Reckeweg R62” drug products includes claims to cure, mitigate, treat, or prevent serious and/or life-threatening conditions such as malaria, gout, asthma, measles, and depression, 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 “Lord’s Eyerite Eye Drops,” “Sitaram Ayurveda Elaneer Kuzhamb,” “Dr. M.S. Basu’s Isotine Eye Drop,” and “SBL Euphrasia 10% Eye Drops” 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 Distacart 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:

SBL Malaria Officinalis Dilution

On the webpage https://www.distacart.com/products/sbl-homeopathy-malaria-officinalis-dilution?variant=41391178743967

• “It is a homeopathic remedy for constipation, gout, etc. It is conventionally used for taking care of Malaria and leg cramps.”
• “Key Benefits:
  o It may help in taking care of malaria and leg cramps
  o may [sic] used to reduce symptoms like chilling and shivering
  o may Assists [sic] in taking care of Live infections, Neuralgia, and Rheumatism
  o may [sic] Beneficial for taking care of inflammation of the eyes with heat, redness, and burning”

Allen Depression Drops A79

On the webpage https://www.distacart.com/products/allen-homeopathy-a79-depression-drops:

• From the product packaging: “Indications: Hopelessness, Low mood, Reduced energy, Appetite disturbance, Loss of libido, Insomnia, Low self-esteem, Suicidal thoughts, unusual fears, Pessimism, Ideas of worthlessness.”

Wheezal WL2 Drops

On the webpage https://www.distacart.com/products/wheezal-wl2-asthma-drops?variant=40335275786399:

• From the product packaging:
  “Asthma
  Relieves Tightening Of The Chest And Opens Airways”

Bjain Omeo Asthma Medicated Syrup

On the webpage https://www.distacart.com/products/bjain-homeopathy-omeo-asthma-syrup?variant=42818832564383:

• From the product packaging:
  “The Homoeopathic [sic] Bronchodilator
  Difficulty in breathing
  Wheezing
  Tightness of the chest
  Asthmatic Cough”

Dr. Reckeweg R62

On the webpage https://www.distacart.com/products/dr-reckeweg-r62-measles-morbillin-drop:

• “Dr. Reckeweg R62 Measles (Morbillin) Drop - 22 ml”
• From the product packaging: “Morbillin - Inflammation of mucous membranes”

Lord’s Eyerite Eye Drops

On the webpage https://www.distacart.com/products/lords-homeopathy-eyerite-eye-drops:

• From the product packaging:
  “Indications:
  o Conjunctivitis
  o Redness of eyes
  o Watering
  o Pain
  o Irritation
  o Dry Eyes”

Sitaram Ayurveda Elaneer Kuzhamb

On the webpage https://www.distacart.com/products/sitaram-ayurveda-elaneer-kuzhambu-eye-drops:

• From the product packaging: “Remedy For All Eye Disease”

Dr. M.S. Basu’s Isotine Eye Drop

On the webpage https://www.distacart.com/products/dr-basus-isotine-eye-drops?variant=41382453215391:

• From the product packaging: “Use in Immature Cataract, Myopia, Hypermetropia, Glaucoma, Diabetic Retinopathy, Macular Degeneration, Retinitis, Pigmentosa, Colour Blindness etc.”

SBL Euphrasia 10% Eye Drops

On the webpage https://www.distacart.com/products/sbl-homeopathy-euphrasia-10-eye-drops?variant=41212397551775:

• From the product packaging:
  “Indication:
  For conjunctivitis, redness of eyes, watering, pain, irritation, photophobia, dry eyes.”

Your Distacart 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 “SBL Malaria Officinalis Dilution,” “Allen Depression Drops A79,” “Wheezal WL2 Drops,” “Bjain Omeo Asthma Medicated Syrup,” “Dr. Reckeweg R62,” “Lord’s Eyerite Eye Drops,” and “SBL Euphrasia 10% Eye Drops” 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 “716212” in the subject line of the email.

Sincerely,
/S/

Brad Pace, JD
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