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WARNING LETTER

WL 609701

Dear Mr. Trivedi:

This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.ayurdiatonic.com in October 2020, and has determined that you take orders there for the product “Heritage of Ayurveda Dia-Tonic Incudil Herbal Dietary Supplement”. We have also reviewed your social media website at www.facebook.com/diatoniclife/, which directs consumers to your website www.ayurdiatonic.com, where you take orders for your product. The claims on your websites establish that the product is a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.

Examples of some of the website claims that provide evidence that your product is intended for use as a drug include:

On your product page for Dia-Tonic Incudil at http://www.ayurdiatonic.com/products/:
- “Helps to inhibit the formation of skin cancer, Displays anti-tumor effects on breast, lung, nose and throat cancer.”
- “Helps in blood sugar control.”
- “Helps liver to recover from alcohol and drug damage.”

On the product label image on your product page http://www.ayurdiatonic.com/products/:
- “DiaTonic Incudil helps in . . . healing wounds . . . [and] Improving blood sugar level & free from risk of hypoglycemia.”

On your home page www.ayurdiatonic.com:
- “DiaTonic Includil helps in . . . healing wounds. . . . It acts as an antibiotic whenever required.”
- “It helps eliminate food allergies”
- “Our research includes continuous process of improving our product to achieve various stages of diagnosis, treatment, and prevention.”
- “Ayur Dia Tonic is the only product of its kind … to help fight various conditions”

The video, “Watch Our TV Commercial”, which is posted on your website home page www.ayurdiatonic.com, includes claims on its graphic such as:
- “To control diabetes and its side effects Dia-Tonic Herbal Dietary Supplement” – side effects listed as stroke, blindness, slow healing, heart disease, kidney damage and nerve damage

The video at the top of your Facebook page, https://www.facebook.com/diatoniclife/, includes claims on its graphic such as:
- “DiaTonic Includil helps in . . . Improving blood sugar level & free from risk of hypoglycemia Helps in blood sugar control.”
- “DiaTonic Includil helps in . . . it helps eliminate food allergies and replenish digestive enzymes.”
- “DiaTonic Includil helps in . . . Helps liver to recover from alcohol and drug damage”
- “DiaTonic Includil helps in . . . healing wounds . . . It acts as an antibiotic whenever required.”

Your product and gallery pages on your website provide links to individual ingredient pages for ingredients in your product Dia-Tonic Incudil. Examples of claims for ingredients in your product are included below:

On the Azadirachta indica (Neem) page at http://www.ayurdiatonic.com/ingredients/azadirachta-indica:
• “Bark - is useful in . . . leprosy. skin diseases, eczema . . . malarial fevers. wounds. Ulcers . . . tumour. tubercular glands, anorexia, vomiting. dyspepsia. intestinal worms, amenorrhoea, lumbago. haemorrhoids . . . syphilis.”
• “Leaves - are useful in . . . leprosy . . . leuooderma [sic], . . . ophthalmopathy, intestinal worms. dyspepsia. ulcers. tuberculosis, . . . eczema and malarial a. intermittent fevers. Ten. leaves and flowers are used as prophylactic against to prevent fever etc.”

On the Fenugreek (Fenugreek) page at http://www.ayurdiatonic.com/ingredients/fenugreek:
• “Seeds - are good for fever, asthma, . . . Diarrhoea . . . anaemia, cancer . . . tuberculosis, gout, rheumatism, . . . anorexia, cough, bronchitis and colonitis.”

On the Gymnema sylvestre (Gymnema) page at http://www.ayurdiatonic.com/ingredients/gymnema:
• “Plant – is useful in inflammations . . . liver dosaders [sic] . . . hepatosplenomegaly dyspepsia . . . cardropathy . . . asthma, bronchitis”

On the India Gooseberry (Alma) page at http://www.ayurdiatonic.com/ingredients/indian-gooseberry:
• “Fruits - are useful in . . . asthma, bronchitis, cephalalgia . . . peptic ulcer . . . skin diseases. leprosy”

On the Indian Kino Tree (Indian Kino Tree) page at http://www.ayurdiatonic.com/ingredients/indian-kino-tree:
• “Bark and Heartwood - is useful in . . . dysentery, odontalgia, gout. rheumatoid arthritis. cough, sexual debility. asthma. bronchitis”

On the Picrorhiza kurroa (Picrorhiza) page at http://www.ayurdiatonic.com/ingredients/picrorhiza-kurroa:
• “Rhizomes – are useful in . . . leprosy. Skin diseases. cardiac disorders. hypotension, cough, asthma. bronchitis”

On the Terminalia chebula (Chebulic myrobalan) page at http://www.ayurdiatonic.com/ingredients/terminalia-chebula:
• “Fruits -are useful in . . . gout, rheumatism, wounds, ulcers . . . epilepsy . . . cardiac disorders . . . neuropathy”

On the Tinospora cordifolia (Indian tinospora) page at http://www.ayurdiatonic.com/ingredients/tinospora-cordifolia:
• “Stem - is useful in . . . arthritis, anorexia. toxemia, cancer, liver disorders. indigestion”

On the Turmeric (Turmeric) page at http://www.ayurdiatonic.com/ingredients/turmeric:
• “Rhizomes – are useful in . . . leprosy, skin diseases . . . allergic conditions . . . tonsillitis . . . asthma, bronchitis, . . . epilepsy, chronic otorrhoea. ringworm. gonorrhoea”

The claims quoted above are supplemented by metatags used to bring consumers to your website www.ayurdiatonic.com through Internet searches. The metatags are:
- Website Description: “Ayur Dia Life® Herbal Dietary Supplement helps to control diabetes and high blood pressure.”
- Website keywords: “Control Diabetes . . . Control High Blood Pressure . . . Controls Sugar Level . . . Helps in healing of wound”

Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of “Heritage of Ayurveda Dia-Tonic Incudil Herbal Dietary Supplement” for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:

Numerous customer statements referencing a diabetes health claim were observed on your testimonial page www.ayurdiatonic.com/testimonials/. Examples include:
- Review from (b)(6), (b)(7)(C): “This is the very best Blood Sugar Support supplement you can get if you’re trying to beat Type-2 Diabetes once and for all..."
- Review from (b)(6), (b)(7)(C): “I am doctor . . . . The product does an excellent job in controlling my A1C . . . I am happy because my A1C is reduced by 30%...."
- Review from (b)(6), (b)(7)(C): “Dia-Tonic Incudil is a good way to help keep your diabetes undercontrol [sic] without prescription drugs.”

Your “Heritage of Ayurveda Dia-Tonic Incudil Herbal Dietary Supplement” product is not generally recognized as safe and effective for the above referenced uses and, therefore, this product is a “new drug” under section 201(p) of the FD&C Act [21 U.S.C. 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the 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.

A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your “Heritage of Ayurveda Dia-Tonic Incudil Herbal Dietary Supplement” product is intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, “Heritage of Ayurveda Dia-Tonic Incudil Herbal Dietary Supplement” fails to bear adequate directions for its intended use and, therefore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above 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.

You should take prompt action to correct the violations cited in this letter. Failure to correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each steps being taken to prevent the recurrence of violations, as well as copies of related documentation. If you do not believe that your products are in violation of the 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.

Please send your electronic written response to: orahafwest5firmresponses@fda.hhs.gov

Hardcopy response can be sent to:
Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
19701 Fairchild
Irvine, CA 92612

Refer to Unique Identification Number 609701 when replying.

If you have any questions regarding this letter, please contact Kimberly M. Lichter, Compliance Officer, at Kimberly.Lichter@fda.hhs.gov or (949) 608-2967.

Sincerely,
/S/

Darla R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations –West Division 5