Warning letter · FDA Warning Letters, Historical Archive

Emmbros Overseas Lifestyle PVT LTD.: FDA Warning Letter 565631 (Feb 5, 2019)

Agency action: Feb 5, 2019Record ID: fda_warning_-13b053b6d6792bbc
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What happened

Original notice title

Emmbros Overseas Lifestyle PVT LTD. MARCS-CMS 565631, February 05, 2019

From the archived source record

The pre-clinical studies of the herb [guduchi] has shown diverse pharmacological activities such as… antiulcer … anti-inflammatory, hypoglycemic, anti-diabetic and anti-cancer activity. The reports have shown that guduchi can benefit people suffering from uraemia, urinary calculi, mental disorders and liver disorders.” Under the “Research” tab on the webpage titled “Morpheme Guduchi (Tinospora Cordifolia)” [according to your web page, Tinospora cordifolia is a synonym for guduchi]: “…Tinospora cordifolia reduces the risks of infections.” “In about 60% HIV positive patient [sic], intake of Tinospora cordifolia extract reduced the various symptoms of the disease.” “The anti-tumor effect of Tinospora cordifolia has been proved in experimental studies. Botanica Fish Oil, and a graphic that states: o “Benefits of Fish Oil” “Anti-inflammatory” “Treats Crohn’s disease” “Lowers high triglycerides” “Helps premature infants with catch-up growth” “Can help treat depression” “Can decrease atherosclerosis” “Can lower the risk of cancer” “Used to treat schizophrenia and attention deficit hyperactive disorder” “Can help lower blood pressure” “Can be used to treat kidney disease” The above claims from your Twitter page are also repeated on your Google+ page at www.plus.google.com/+Ayurvediccureremedies, which provides links to your website at www.ayurvediccure.com. 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). Botanic Fish Oil fail to bear adequate directions for their intended use and, therefore, the products are 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)].

What the official notice says to do

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Status and source details

Status recorded in the archive
Historical warning letter; closeout not established by annual index
Source checked
Jul 16, 2026
Record revision
a174f1ce3d79

This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.

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What is affected

Product
About Us; Arthcare capsule: remedy for any kind of arthritic condition; Diabeta: capsules for fighting diabetes mellitus; Diabeta Plus blends powerful natural anti-hyperglycemic ingredients…; Research; Health Benefits of Almonds … Regulate Cholesterol Level … Prevent Heart Diseases; Benefits of Fish Oil; 8 Home Remedies For Diabetes; Morpheme Remedies Cinnamon; Morpheme Remedies Diabeta Plus; and Morpheme Remedies Mucuna Pruriens (Kapikachhu) for disease treatment and prevention and; which states “Health Benefits of Almonds … Regulate Cholesterol Level … Prevent Heart Diseases; Nourish Vitals Seed & Fruit Mix
Company
Emmbros Overseas Lifestyle PVT LTD.
Lot / identifier
The source does not specify this field.
Market / distribution
The source does not specify this field.