WARNING LETTER
Santhigram Kerala Ayurvedic Co. of U.S., Inc.
MARCS-CMS 625892 —
May 19, 2022
Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
Gopinathan Nair
Santhigram Kerala Ayurvedic Co. of U.S., Inc.
1503 Finnegans Lane
North Brunswick
,
NJ
08902
United States
contact@santhigram.us
santhigram@gmail.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Dear Mr. Nair:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address http://www.santhigram.us in March 2022 and has observed that you take orders there for various ayurvedic products, including but not limited to “Smokers Kit/Respiratory Care Kit” (also referred to as “Respiratory Care Kit” on your social media websites), “Immunocare Kit,” “Dadimadi Ghrutham,” “Dasamoolarishtam,” “Maha Tiktaka Ghrutham,” “Padoladi Ghrutha,” “Ashwagandha,” “Triphala,” “Garlic,” “Eladi Taila,” “Jathyadi Ghrutham,” and “Jatyadi Keram” (hereinafter referred to as your “Santhigram ayurvedic products”). We also have reviewed your Facebook and Instagram social media websites at the Internet addresses https://www.facebook.com/santhigramusa and https://www.instagram.com/santhigramusa/, respectively; these websites direct consumers to your website at https://santhigram.us to purchase your products. In addition, we observed that your “Smokers Kit/Respiratory Care Kit” and “Immunocare Kit” are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.
1
The claims on your website and social media websites establish that your Santhigram ayurvedic products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). You can find the FD&C Act and FDA regulations through links on FDA’s home page at www.fda.gov.
Unapproved New Drugs
Based on a review of your websites, your Santhigram ayurvedic 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 function of the body. Examples of claims observed on your website and social media websites that establish the intended use of your Santhigram ayurvedic products as drugs included, but are not limited to, the following:
Smokers Kit/Respiratory Care Kit
On the product webpage for “Smokers Kit/Respiratory Care Kit,”
https://www.santhigram.us/products/smokers-kit-respiratory-care-kit/pages/home:
• “SMOKERS KIT/RESPIRATORY CARE KIT[,] Category: COVID CARE KIT”
• “It is designed to activate protective measures against bronchial or lung tissue damage and to energize, cleanse and soothe the body . . . This kit will Revitalize your Respiratory System”
• “Agastya Rasayana is a quality remedy of traditional Ayurveda for Respiratory problems. It eases breathing, reduces chest congestion, reduces attacks of asthma, sharpens immune response in the body against microbes.”
• “ANU THAILAM (Ayurvedic Nasya Oil) . . . It also helps in all types of nervous disorders, which occurs due to the dysfunction of the brain cells.”
• “Talisapatradi is an ayurvedic herbal preparation in the form of powder which is highly effective in combating both upper and lower respiratory tract infections like the common cold, triggering of bronchitis, and Asthma, dry or productive cough, etc. It inhibits the growth of infections thus preventing infection and helps to treat chronic obstructive pulmonary diseases.”
• “ARJUNA CAPSULES . . . helps to lower blood pressure.”
• “DHANWANTARAM TABLET . . . Dhanwantaram Gulika is traditional ayurvedic medicine in tablet form used for diseases of Digestive system, Respiratory system, and Cardio-vascular system. It is used in conditions like dyspnoea [sic], anorexia, inflammatory conditions, etc. It gives relief in bloating, flatulence, hiccups, and also it helps relieve discomfort like breathlessness, acidity, nausea.”
2
Immunocare Kit
On the product webpage for “Immunocare Kit,”
https://www.santhigram.us/products/immunocare-kit/pages/home:
• “Category: COVID CARE KIT”
• “Chyawanprash is well-known to build stamina and muscle mass. . . . It slows down the ageing process, Increases the memory power . . . boosts your immunity level thus lower the infections and inflammations.”
• “AMLA CAPSULE . . . It boosts the immune system by building the body’s natural defence [sic] to fight infections.”
• “ASHWAGANDHA CAPSULE . . . It helps to . . . relieve stress, anxiety & depression.”
• “Anu Thailam is one of the most effective Ayurvedic medicated oil which helps to improve memory. . . . It also helps in all types of nervous disorders, which occurs due to dysfunction of the brain cells.”
• “CURCUMA LONGA CAPSULES . . . used for conditions involving pain and has excellent anti-inflammatory and antiseptic properties. It is also useful in depression, high cholesterol. Helpful in heartburn, inflammatory bowel disease, memory loss, stress and anxiety[.]”
3
Dadimadi Ghrutham
On the product webpage for “Dadimadi Ghrutham,”
https://www.santhigram.us/products/dadimadi-ghrutham/pages/home:
• “It is widely used as medicine and also in preparatory procedure called snehakarma for the treatment of heart diseases, anemia, piles, spleen diseases, cough and asthma. . . . It is also used in the treatment of infertility in women.”
Dasamoolarishtam
On the product webpage for “Dasamoolarishtam,” https://www.santhigram.us/collections/arishtam/products/dasamoolarishtam:
• “Indication: Useful in indigestion, lack of taste, respiratory conditions, fistula . . . vomiting, anemia, liver diseases, skin diseases, haemorrhoids [sic], urinary tract conditions, cough, jaundice.”
Maha Tiktaka Ghrutham
On the product webpage for “Maha Tiktaka Ghrutham,”
https://www.santhigram.us/products/maha-tiktaka-ghrutham/pages/home:
• “It is used as medicine and also in preparatory procedure called snehakarma for the treatment of skin diseases, bleeding disorders, bleeding piles, herpes, gastritis, gout, anemia, blisters, schizophrenia, jaundice, fever, heart diseases, menorrhagia. It is highly effective in chronic diseases.”
Padoladi Grutha
On the product webpage for “Padoladi Grutha,”
https://www.santhigram.us/products/padoladi-ghrutha/pages/home:
• “Patoladi Ghrita benefits: It is widely used as medicine and also in preparatory procedure called snehakarma for the treatment of abscess, fever, infections, skin diseases, diseases of ear, nose and throat and eye diseases[.] It is useful in psoriasis, eczema, dermatitis, allergic hives, tinea infection.”
Ashwagandha
On the product webpage for “Ashwagandha,”
https://www.santhigram.us/products/aswagandha/pages/home:
• “Category: SINGLE DRUG CAPSULE . . . Anxiety[,] Depression[,] Muscle fatigue and neck/back stiffness[,] Insomnia[,] Diabetic neuropathy[,] Erectile dysfunction and low sperm count, premature ejaculation . . . Benefits: Reduces bodyweight, decreases cholesterol levels”
On your Facebook and Instagram social media websites   https://www.facebook.com/santhigramusa and https://www.instagram.com/santhigramusa/, respectively:
• December 4, 2020 postings: “Ashwagandha can help your body manage stress. Helps in: Anxiety[,] Stress[,] Diabetes[,] Fatigue[,] Pain[,] Rheumatoid arthritis . . . It boosts brain function . . . Fight symptoms of depression,” accompanied by a graphic including the text, “Ashwagandha . . . It can boost brain function, lower blood sugar and cortisol levels, and help fight symptoms of anxiety and depression.”
Triphala
On the product webpage for “Triphala,”
https://www.santhigram.us/products/triphala/pages/home:
• “Benefits: Triphala has several health benefits, such as; regulation of blood pressure, lowers cholesterol, solves digestive problems, reduce body weight, relief from constipation, boost energy, reduces inflammation, enhances skin, prevent cancer, stimulates hair growth and treats dandruff, prevents viral and bacterial infections and has anti-allergic properties.”
Garlic
On the product webpage for “Garlic,” https://www.santhigram.us/products/garlic/pages/home:
• “Benefits: Useful in high cholesterol and high blood pressure, in common cold, upper respiratory tract infections, mild bronchitis, and rhinitis, and to relieve cough and congestion, atherosclerosis, enlarged prostate, diabetes, gastrointestinal (GI) disorders.”
Eladi Taila
On the product webpage for “Eladi Taila,”
https://www.santhigram.us/products/eladi-taila/pages/home:
• “Indication . . . It is used in hair treatment for skin diseases like allergic dermatitis, ring worm infection, urticaria. It is useful in scabies, erysipelas and cattarh. . . . It is used for external application for skin detox treatment. It is used in defective teeth, diseases of gums and mouth, ear ache and boils.”
Jathyadi Ghrutham
On the product webpage for “Jathyadi Ghrutham,”  https://www.santhigram.us/products/jathyadi-ghrutham/pages/home:
• “FOR EXTERNAL USE INDICATION[,] deep seated wounds and ulcers, non healing wound with secretions. . . . Indication: Female infertility”
Jatyadi Keram
On the product webpage for “Jatyadi Keram,” https://www.santhigram.us/products/jatyadi-keram/pages/home:
• “Indication: It heals wounds quickly. It is used to apply externally over non healing wounds, sinus, blisters, abscess, bite wounds. It is also useful in burns. It is applied over infected skin diseases such as Hand Foot and Mouth Disease, eczema, syphilis etc. Doctors prescribe this for the treatment of cracked heels, cracked nipples, External hemorrhoids, anal fissure.”
Your Santhigram ayurvedic products are also “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 for use under the conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, new drugs may not be introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
Conclusion
This letter is 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. While FDA has mentioned specific Santhigram ayurvedic products in this letter, there are drug claims being made on your website and social media websites for a wide range of your products. As such, the cited violations in this letter should not be viewed to apply solely to the specific products mentioned in this letter. 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 result in legal action including, without limitation, seizure, and injunction.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address 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 cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. 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.
Your response should refer to unique identifier CMS 625892 and 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.
Sincerely,
/S/
Carolyn E. Becker
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
1
There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS. Secretary of Health and Human Services, Determination that a Public Health Emergency Exists (originally issued Jan. 31, 2020, and subsequently renewed), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx. In addition, on March 13, 2020, there was a Presidential declaration of a national emergency in response to COVID-19. Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020), available at https://trumpwhitehouse.archives.gov/presidentialactions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/. We request that you take immediate action to cease the sale of any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.
2
Similar claims, including images of your “Respiratory Care Kit,” also were found on December 1, 2020, postings on your Facebook and Instagram social media websites.
3
Similar claims, including images of your “Immunocare Kit,” also were found on December 2, 2020, postings on your Facebook and Instagram social media websites.
Content current as of:
05/24/2022
Regulated Product(s)
Drugs