WARNING LETTER
Ayuryoga, Inc.
MARCS-CMS 628168 —
May 19, 2022
Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
Nikhil Gupta
Ayuryoga, Inc.
332 Springtown Road
New Paltz
,
NY
12561
United States
Contact@ayuryoga.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
WARNING LETTER
VIA EMAIL
May 19, 2022
Nikhil Gupta
Ayuryoga, Inc., d/b/a Kottakkal Ayurveda USA
332 Springtown Road
New Paltz, NY 12561
Contact@ayuryoga.com
RE: 628168
Dear Mr. Gupta:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.kottakkalusa.com/, which redirects to https://www.kottakkal.shop/, in March 2022 and has observed that you take orders there for various ayurvedic products, including but not limited to “Arjuna Arishtam,” “Ashtavargam Kwatham,” “Ashwagandha Arishtam,” “Draksha Arishtam,” “Dasamulaharitaki Leham,” “Amritamehari Churnam,” “Ashoka Arishtam,” “Brahmi Caps,” “Chandraprabha Vatika,” “Dadimashtaka Churnam,” “Dhanwantaram (101) Softgel Capsule,” “Kshirabala Oil,” and “Lohasinduram (7) Capsules” (hereinafter referred to as your “Kottakkal ayurvedic products”). We have also reviewed your Facebook, Instagram, LinkedIn, and Twitter social media websites at the Internet addresses https://www.facebook.com/kottakkalayurvedausa, https://www.instagram.com/kottakkalayurvedausa/, https://www.linkedin.com/company/kottakkalayurvedausa and https://twitter.com/Kottakkal_USA, respectively; these social media websites direct consumers to your website at https://www.kottakkal.shop/ to purchase your products. The claims on your website and social media websites establish that your Kottakkal 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 Kottakkal 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 Kottakkal ayurvedic products as drugs include, but may not be limited to, the following:
Arjuna Arishtam
On the product webpage for “Arjuna Arishtam,” https://www.kottakkal.shop/products/arjuna-arishtam:
•    “Arjuna Arishtam is a liquid . . . used to support the healing of diabetes, leucoderma and skin disorders. . . . improves heart function and reduces high blood pressure.”
•    “Indications[:] Chronic fatigue[.] Chronic respiratory problems[.] Mild to moderate hypertension[.] Anemia[.] Throat related diseases[.] Cardiac disorders[.] Heart diseases[.]”
On the blog post titled, “Managing High Blood Pressure with Ayurveda,”
1
https://www.kottakkal.shop/blogs/healing-with-kottakkal-ayurveda/managing-high-blood-pressure-with-ayurveda?fbclid=IwAR1usiUno4Y09aw5B9u0uk%E2%80%A6:
•    “Ayurveda has solutions for managing high blood pressure. . . . THREE PRODUCTS TO HELP HIGH BLOOD PRESSURE . . . Arjuna Arishtam supports healthy heart function and reduces high blood pressure.”
Ashtavargam Kwatham
On the product webpage for “Ashtavargam Kwatham,” https://www.kottakkal.shop/products/ashtavargam-kwatham:
•    “Ashtavargam Kwatham. . . relieving joint stiffness”
•    “Indications[:] . . . Numbness[.] Arthritis[.] Rheumatism[.] Paralysis of different etiology[.] Ischemic disorders[.]”
Ashwagandha Arishtam
On the product webpage for “Ashwagandha Arishtam,” https://www.kottakkal.shop/products/ashwagandha-arishtam:
•    “Ashwagandha Arishtam . . . heal sexual disorders, relieve depression . . . This arishtam and remedies premature ejaculation and erectile dysfunction”
•    “Indications[:] . . . Arthritis[.] Epilepsy[.] Emaciation[.] Hemorrhoids. Neurological disorders[.] Recurring fainting or episodes of unconsciousness[.]”
Draksha Arishtam
On the product webpage for “Draksha Arishtam,”  https://www.kottakkal.shop/products/draksha-arishtam:
•    “Draksha Arishtam . . . heals respiratory diseases. . . . relieves symptoms of gastritis and hyperacidity. . . . cure skin diseases resulting from a Pitta Dosha imbalance.”
•    “Indications[:] Colds[.] Coughs[.] Constipation[.] Asthma[.] Throat infections. Chest injuries[.] Tuberculosis[.] Chronic Obstructive Pulmonary Disease (COPD)[.]”
Dasamulaharitaki Leham
On the product webpage for “Dasamulaharitaki Leham,” https://www.kottakkal.shop/products/dasamulaharitaki-leham:
•    “Dasamulaharitaki Leham . . . support the treatment of respiratory ailments and urinary bladder disorders. . . . used to remedy chronic inflammatory conditions, fevers, emaciation, rheumatoid arthritis, bleeding diseases and liver diseases”
•    “Indications[:] Generalized edema[.] Genito-urinary diseases[.] Splenomegaly[.] Ascitis[.] Hypertension[.]”
On a July 13, 2016, post from your Facebook social media website,  https://www.facebook.com/kottakkalayurvedausa:
•    “Dasamulaharitaki Leham is an Ayurvedic herbal jam used to support the treatment of respiratory ailments, debilitating diseases, urinary bladder disorders, hoarseness of voice, bleeding diseases, urinary infections, gulma, anemia and liver diseases. It is rich in nutrition and clears the bowels.”
•    “Dose: 2 – 10 grams once or twice a day, or as directed by an Ayurvedic doctor.”
Amritamehari Churnam
On the product webpage for “Amritamehari Churnam,” https://www.kottakkal.shop/products/amritamehari-churnam:
•    “Amritamehari Churnam . . .  powerful herb reduces high blood sugar levels”
•    “Indications[:] Diabetes[.]”
On the webpage titled, “Balancing High Blood Sugar with Ayurveda,”
2
https://www.kottakkal.shop/blogs/healing-with-kottakkal-ayurveda/balancing-high-blood-sugar-with-ayurveda:
•    “Amritamehari Churnam . . . for people suffering with high blood sugar. . . actions are antidiabetic and antihyperglycemic . . .  normalize the blood glucose level. . . stimulates the pancreas to release more insulin.”
On a July 13, 2016, post from your Facebook social media website https://www.facebook.com/kottakkalayurvedausa:
•    “Amritamehari Churnam is an Ayurvedic herbal powder used to heal Diabetes mellitus and relieve its symptoms. This powerful herb reduces high blood sugar levels”
Ashoka Arishtam
On the product webpage for “Ashoka Arishtam,” https://www.kottakkal.shop/products/ashoka-arishtam:
•    “Ashoka Arishtam . . . used to heal menorrhagia, fevers and bleeding hemorrhoids. Ashoka Arishtam acts as well as a hemostatic.”
•    “Indications[:] Fever[.]. . . Heavy menstrual bleeding[.] Dysmenorrhoea (painful periods)[.] Anorexia[.] Bleeding hemorrhoids[.]”
On an April 3, 2014, post from your Facebook social media website
3
https://www.facebook.com/kottakkalayurvedausa:
•    “Ashoka Arishtam is a liquid Ayurvedic remedy used to heal menorrhagia, fevers, bleeding hemorrhoids and more. It acts as a as well as a hemostatic.”
Brahmi Caps
On the product webpage for “Brahimi Caps,” https://www.kottakkal.shop/products/brahmi-caps:
•    “Brahmi Capsules are used to help relieve insomnia, increase memory retention and improve concentration. . . . well-known for its ability to reverse the aging process. It is also has [sic] powerful antidiabetic, antioxidant and antiaging properties.”
•    “Indications[:] Dementia[.] Seizure disorders[.] Learning disabilities[.]”
Chandraprabha Vatika
On the product webpage for “Chandraprabha Vatika,” https://www.kottakkal.shop/products/chandraprabha-vatika:
•    “Chandraprabha Vatika . . . acts as an aphrodisiac, antimicrobial and antiaging remedy. . . . relieving constipation, eczema and eye infections.”
•    “Indications[:] Constipation[.] Eczema[.] Urinary tract infections[.] Respiratory diseases[.] Difficulty urinating[.] Urinary calculi[.] Dermatitis[.] Liver and spleen diseases[.]”
On the webpage titled, “Ayurvedic Guidance for Polycystic Ovarian Syndrome,”
4
https://www.kottakkal.shop/blogs/healing-with-kottakkal-ayurveda/ayurvedic-guidance-for-polycystic-ovarian-syndrome:
•    “Chandraprabha Vatika: is a tonic for the reproductive system and acts as a muscle relaxant due its [sic] anti-spasmodic action. It can help correct hormonal imbalance and helps regulate the menstrual cycle. Chandraprabha Vati is especially helpful when used in combination with Ashoka Arishtam.”
Dadimashtaka Churnam
On the product webpage for “Dadimashtaka Churnam,” https://www.kottakkal.shop/products/dadimashtaka-churnam:
•    “Dadimashtaka Churnam. . . used to cure malabsorption disorders and amoebic dysentery. . . . used to relieve symptoms of indigestion, malabsorption syndrome and diarrhea. Dadimashtaka is also useful in healing respiratory conditions like a chronic cough.”
•    “Indications[:] Irritable Bowel Syndrome (IBS) [.] Malabsorption disorders[.] Amoebic dysentery[.]”
Dhanwantaram (101) Softgel Capsule
On the product webpage for “Dhanwantaram (101) Softgel Capsule,” https://www.kottakkal.shop/products/dhanwantaram-101-softgel-capsule:
•    “Useful for. . . conditions of arthritis, paralysis, skeletal and neuromuscular conditions. Promotes, healthy postpartum care for mothers.”
•    “Indications[:] Arthritis[.] Paralysis[.] Skeletal diseases[.] Neuromuscular diseases[.]”
On a November 11, 2021, post from your Instagram social media website https://www.instagram.com/kottakkalayurvedausa/:
•    “#Dhanwantaram . . . highly effective for breathlessness, severe cough, chronic hiccups, giddiness, nausea, antenatal and postpartum care, neurological pain and fatigue.”
Kshirabala Oil
On the product webpage for “Kshirabala Oil,” https://www.kottakkal.shop/products/kshirabala-oil:
•       “Kshirabala Oil . . .  support the treatment of Vata disorders causing neuromuscular pains, sciatica, spondylosis and paralysis. This herbal oil helps to relieve inflammation and pain. It is used in sciatica, osteoarthritis, myalgia and spondylosis, among many other health issues.”
•    “Indications[:] Arthritis[.] Spondylosis[.] Sciatica[.] Myalgia[.] Neuralgia[.]”
On the webpage titled, “Nourishing Muscles, Joints and Nerves for Strength,”
5
https://www.kottakkal.shop/blogs/healing-with-kottakkal-ayurveda/nourishing-muscles-joints-and-nerves-for-strength?fbclid=IwAR2wn1_oYywAGUn2w%E2%80%A6:
•    “One of the best oils for daily Abhyanga is Kshirabala Oil. . . . made from three highly nourishing ingredients: sesame oil, cow’s milk, and an herb called bala (Sida cordifolia). . . . support damaged bones, muscles, joints, ligaments, tendons and nerves. . . . bala (Sida cordifolia), is a powerful neuroprotective herb. . . .well-known for its nerve rejuvenating properties and alleviating pain caused by irritated nerves. . . .Kshirabala Oil is neuroprotective, nerve tonic, antioxidant, anti-inflammatory, and anti-arthritic.”
•    “Kshirabala oil relieves the following health conditions: Body and facial paralysis • Hemiplegia caused by stroke • Sciatica nerve pain • Vata gynecological disorders . . . • Herpes and shingles nerve pain • Hypospermia (low ejaculate) • Insomnia • Osteoarthritis or Osteoporosis bone pain . . . • Myalgia or muscle pain • Minor vision impairment • Degenerative neurological disorders”
Lohasinduram (7) Capsules
On the product webpage for “Lohasinduram (7) Capsules,” https://www.kottakkal.shop/products/lohasinduram-7-capsule:
•    “Lohasinduram 7 Capsules are used for the Ayurvedic treatment of anemia, splenomegaly, helminthiasis, vomiting and asthma. . . . useful in Ayurvedically treating cardiovascular diseases as well as improving physical strength, immunity, memory and digestion. It is a powerful aphrodisiac as well as a blood purifier.”
•    “Indications[:] Asthma[.] Chronic respiratory problems[.] Anemia[.] Splenomegaly[.] Helminthiasis[.] Vomiting[.]”
Your Kottakkal 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 Kottakkal 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 628168 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
This webpage is also linked from a post on your LinkedIn social media website, which states “#Highbloodpressure does not have to be permanent: #Ayurveda has solutions for managing high blood pressure. When turning the light of Ayurveda onto HBP, there is a priority toward each person’s imbalance and recommendations are made based on the best diet and activities for each person. For a deeper understanding let’s take a closer look at what high blood pressure really is.”
2
This webpage is also linked from a post on your LinkedIn social media website, which states, “Ayurveda calls high blood sugar Madhumeha, which is similar to type 2 diabetes. With type 2, the person lacks the ability to properly use insulin and excess glucose builds up in the blood. The kidneys try to compensate and some of the excess glucose is removed by the kidneys and excreted in the urine. Reduced insulin production and decreased insulin sensitivity are the contributing factors for madhumeha known as Hyperglycemia or high blood sugar.”
3
Similar claims appear on your Instagram post dated July 13, 2016.
4
This webpage is also linked from your Facebook post dated February 21, 2022, which states “Do you suffer from PCOS? Some common symptoms are absent, infrequent, irregular or prolonged menstrual periods, menstrual pain, ovarian cysts, fatigue, mood swings, obesity, miscarriage, headaches, excessive hair growth, darkening of the folds of the skin, acne, depression and anxiety. In Ayurveda, there are multiple herbs and lifestyle changes that can be done to relieve symptoms of PCOS.” Similar claims also appear on your twitter post dated February 21, 2022.
5
This webpage is also linked from your Facebook post, dated January 18, 2022, which states “Ayurveda utilizes a very special therapy that builds strength and nourishes the bones, muscles, joints and nerves and improves flexibility and movement. The therapy is called Abhyanga, which is a full body oil massage followed by steam bathing or warm water bathing. The heat from the warm steam or water helps the oil penetrate deeply into the layers of skin and tissues. When Abhyanga therapy is done daily, there is profound relief from pain, stiffness, inflammation, and nerve degeneration.” Similar claims also appear on a post on your LinkedIn social media website.
Content current as of:
05/24/2022
Regulated Product(s)
Drugs