Inspections, Compliance, Enforcement, and Criminal Investigations

Emmbros Overseas Lifestyle PVT LTD. 2/5/19

 

  

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WARNING LETTER
 
 
VIA OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
 
February 5, 2019
 
Emmbros Overseas Lifestyle PVT LTD.
Sahil Mehta, Director
Plot 296, Industrial Area
Phase - 2
Panchkula, Haryana India
 
 
RE: 565631
 
Dear Mr. Mehta:         
                                   
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at the Internet addresses www.ayurvediccure.com, www.musclexp.com, www.nourishvitals.com, and www.stbotanica.com in September and October 2018 and has determined that you take orders on your websites for your products Morpheme Remedies Arthcare Plus, Morpheme Remedies Cinnamon, Morpheme Remedies Diabeta Plus, Daily Vital Multivitamin, Morpheme Remedies Fenugreek, Morpheme Remedies Garlic, Morpheme Remedies Guduchi, Morpheme Remedies Memocare Plus, Morpheme Remedies Mind Plus, Morpheme Remedies Mucuna Pruriens, Nourish Vitals Seed & Fruit Mix, and St. Botanic Fish Oil. FDA also reviewed your social media websites at www.facebook.com/AyurvedicCureRemedies, www.twitter.com/ayurvedichub, www.plus.google.com/+Ayurvediccureremedies, and www.youtube.com/user/ayurvedicremedies/, each of which contains links to your website www.ayurvediccure.com. The claims on your websites establish that your products are drugs 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 they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products 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 claims observed on your websites that provide evidence that your products are intended for use as drugs include the following:
 
On your www.ayurvediccure.com website,
 
On the webpage titled “Morpheme Arthcare Plus Caps”:
  • “If you are suffering from joint pain & inflammation, the recommended dosage is 2 Arthcare Capsules…”
  • “HOW ARTHCARE CAPSULES IS [sic] USEFUL?” [Shallaki, Gokshur, Guggul, Devdaru, and Nirgundi are ingredients in Arthcare Plus]
o   “Shallaki… In clinical trials, positive results were noticed in patients suffering from Crohn’s disease, Chronic Colitis, Rheumatoid Arthritis etc.”
o   “In traditional medicine, Gokshur was used mainly for its analgesic effect”
o   “Guggulu … is known for its analgesic property”
o   “Devdaru … is helpful in reducing chronic inflammation, as it contains analgesic and anti-inflammatory properties”
o   “Nirgundi … is highly recommended for people suffering from osteoarthritis. The herb helps in arresting or slowing down bone density. … Various studies have established the analgesic and anti-inflammatory properties of this herb.”
 
On the webpage titled “Morpheme Cinnamon”:
  • “[Cinnamon] is a source of anti-inflammatory compounds.”
  • “[Cinnamon] is beneficial for people suffering from bacterial and fungal infections.”
Under the “Research” tab on the webpage titled “Morpheme Cinnamon”:
  • “Intake of cinnamon also helps in lowering the total cholesterol, LDL cholesterol and triglyceride levels in people with type 2 diabetes.”
  • “Studies have also shown that cinnamon helps in lowering the blood pressure level. It assists in relaxation of the arteries, which brings down the blood pressure level…”
Under the “Research” tab on the webpage titled “Morpheme Fenugreek Caps”:
  • “Studies have shown that fenugreek seed extract helped in lowering the total cholesterol.” 
On the webpage titled “Morpheme Guduchi (Tinospora Cordifolia)”:
  • “The immunomodulatory property of the plant [guduchi] is used as an adjuvant-therapy to aid recovery from foot ulcers in diabetic patients. In a double-blind randomized study that had 50 patients, the herb [guduchi] was administered for about 18 months, which produced considerably better results with enhancement in wound healing. This indicates the beneficial property of immunomodulation in healing ulcers.”
  • “In hepatitis patients, the herb [guduchi] has shown normalization in the functions of the liver and in rhinitis patients, it showed significant reduction in the signs of allergic rhinitis. 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. It could slow down tumor growth and improve the life span of tissues bearing the tumor.”
  • “,,,Tinospora cordifolia…helps to eradicate bacteria present at the site of the wound…”
  • “The antioxidant effect of the herb [Tinospora cordifolia] coupled with its chemopreventive function against carcinogens helps in improving the effectiveness of Tinospora cordifolia as an adjuvant for cancer treatment.” 
On the webpage titled “Morpheme Memocare Plus”:
  • “‘Bacopa Monnieri’ [an ingredient in your Morpheme Memocare Plus], this herb is recommended by Ayurvedic physicians for providing relief from asthma and epilepsy.”
  • “[Morpheme Memocare Plus] also showed signs of being effectual against Alzheimer’s and other diseases.”
  • “[Morpheme Memocare Plus] helped in reducing anxiety…”
  • “Experimental studies have suggested that the herb helps to reduce seizures.”
  • “This herb helps in providing relief from ulcers, carbuncles, tubercular glands and tumors…”
  • “By… inhibiting neurodegeneration, Winter Cherry or Ashwagandha [an ingredient in the product] benefits people suffering from Parkinson’s disease. The herb also aids in recovering the neurons that are severely damaged by enabling reconstruction of synapses and regeneration of neuritis. Experimental studies have revealed that this amazing property of the herb can help in arresting progression of neurodegenerative diseases and improve the function of the neurons.”
  • “[The ingredient Licorice] is particularly beneficial for the dementia patients suffering from diabetes.”
  • “Laboratory experiments suggest that the principal active constituent of licorice—glabardin may be used to manage Alzheimer’s disease. The herb also helps in reducing depression.”
  • “[The ingredient] Sandalwood is known to reduce depression, [and] anxiety…” 
On the webpage titled “Morpheme Mind-Plus Caps”:
  • “Celastrus panicultatus seed extract [an ingredient] …helps in…reducing amnesia.”
  • “Brahmi [an ingredient] also helps in alleviating anxiety and depression.”
  • “Brahmi helps in reducing risk of Alzheimer’s disease.”
  • “Jatamansi [an ingredient] … is recommended for people suffering from cognitive impairment including Alzheimer’s disease, amnesia, and attention problems.”
  • “Shankpushipi [an ingredient] helps in inhibiting degeneration of the nerve cells and diminishes risk of Alzheimer’s disease.” 
Under the “Research” tab on the webpage titled “Morpheme Mind-Plus Caps”:
  • “The neuroprotective property of Convolvulus pluricaulis [an ingredient] helps in reducing the risk of … Alzheimer’s disease.”
  • “Glycyrrhiza glabra root extract [an ingredient] can be used for managing dementia … and neurodegenerative diseases.”
  • “Centella asiatica [an ingredient] … inhibits synthesis of amloid beta peptide, which leads to cognitive impairment and Alzheimer’s disease.”
  • “Several studies have shown that Ashwagandha [an ingredient] helps in … reversing degeneration of nerve cells and is hence considered beneficial for people suffering from neurodegenerative diseases.”
  • “…Acorus calamus [an ingredient] … [is] effective in … reducing depression…”
On the webpage titled “Morpheme Mucuna Pruiens (Kapikachhu)”:
  • “A study was conducted to investigate the consequences of the extract [of Mucuna Pruriens] on the potency, libido and general mating behavior of male Wister albino-rats. The effects were compared with sildenafil citrate, a standard reference drug.”
  • “Ayurvedic physicians have been using the powdered seed of Mucuna Pruriens since ancient times for improving the symptoms of Parkinson’s disease. Research has proved that the powder of this herb has anti-Parkinson as well as neroprotective [sic] effects in animals.” 
Under the “Research” tab on the webpage titled “Morpheme Mucuna Pruiens (Kapikachhu)”:
  • “60 patients with Parkinson’s disease were given Mucuna pruriens in an open study for twelve weeks. Statistically significant reductions in Hoehn and Unified Parkinson’s disease rating scale scores were seen when the herb was taken continuously for twelve weeks…”
  • “The therapeutic benefits of the seeds of the Mucuna pruriens plant … are widely recommended … for people suffering from Parkinson’s disease…”
  • “Results showed that dose for dose, MPE showed twice the anti-Parkinson action … This study suggests that MPE [Mucuna pruriens endocarp] may contain unidentified anti-Parkinson compounds…”
On your www.morphemeremedies.com website:
 
On the webpage titled “About Us”:
  • “Arthcare capsule: remedy for any kind of arthritic condition”
  • “Diabeta: capsules for fighting diabetes mellitus”
  • “Dilguard: a complete solution to your heart diseases”
On the webpage titled “DIABETA PLUS”:
  • “Mother Nature has given us a number of natural solutions for diabetes management. Diabeta Plus is one such herbal product…”
  • “Diabeta Plus blends powerful natural anti-hyperglycemic ingredients…”
Under the “Research” tab on the webpage titled “DIABETA PLUS”:
  • “Experimental and clinical studies support the anti-diabetes activity of bitter melon [an ingredient in Diabeta Plus].”
  • “Gymnemic acid, the main bioactive constituent of Gymnema sylvestre leaf [an ingredient in Diabeta Plus], possesses powerful anti-diabetes and anti-obesity properties.”
  • “The heartwood of P. marsupium [an ingredient in Diabeta Plus] contains phytochemicals with anti-hyperglycemic activity.”
  • “Researchers have identified a number of phytonutrients inSyzygium cumini [an ingredient in Diabeta Plus] with anti-hyperglycemic property. In experimental studies, anti-hyperglycemic activity has been exhibited by the triterpenes, flavonoids, alkaloids, tannins, saponins and amino acids present in the plant extract. Experimental studies have reported powerful anti-diabetic activity of Syzygium cumini.”
  • “The leaves of Catharanthus roseus [an ingredient] contain alkaloids with anti-diabetic property.”
On the webpage titled “MORPHEME REMEDIES GARLIC 500 MG”:
  • “Allicin, the principal bio active component of garlic, is primarily responsible for the antimicrobial property of the herb.”
  • “Allicin, ajoene and other sulfur containing compounds of garlic can inhibit growth of Candida, Aspergillus and several other fungi.”
On your www.musclexp.com website:
 
On the webpage titled “Daily Vital Multivitamin”:
  • “There’s a great deal of research that grape seed extract [an ingredient in the multivitamin] is excellent for [a] host of cardiovascular ailments. Grape seed extract might aid in… the case of high cholesterol. Grape seed extract additionally alleviates swelling brought about by injury and improves eye ailments linked with diabetes...”
  • “Ginseng extract [an ingredient in the multivitamin]… has anti-inflammatory properties … It also averts flu and lowers blood sugar…”
Your website also includes disease claims in the form of citations to publications or references. When scientific publications or references are used commercially by the seller of a product to promote the product to consumers, such references may become evidence of the product's intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a product is considered to be a claim about disease treatment or prevention if the citation refers to a disease use and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease. The following are examples of citations on your website used to market Morpheme Remedies Cinnamon, Morpheme Remedies Diabeta Plus, and Morpheme Remedies Mucuna Pruriens (Kapikachhu) for disease treatment and prevention and are thus evidence of your products’ intended use as a drug:
  • Under the “Research” tab on the webpage titled “Morpheme Mucuna Pruiens (Kapikachhu)” on your website www.ayurvediccure.com: “Mucuna pruriens proves more effective than L-DOPA in Parkinson’s disease animal model Ghazala Hussian, Bala V. Manyam *Department of Neurology, Southern Illinois University School of Medicine, PO Box 19230, Springfield, Illinois, USA.”
  • Under the “Research” tab on the webpage titled “Morpheme Cinnamon” on your website www.ayurvediccure.com: “Khan A et al. ‘Cinnamon improves glucose and lipids of people with type 2 diabetes.’ Diabetes Care. 2003 Dec”
Claims made on your Facebook page at www.facebook.com/AyurvedicCureRemedies, which provides links to your website at www.ayurvediccures.com, provide additional evidence that your products are intended for use as drugs: 
 
Posts by your company on your Facebook timeline page include the following:
  • On August 13, 2018: “Morpheme Remedies Garlic 500mg … Helps in decreasing high blood pressure. Helps in reducing inflammation.” 
Additionally, claims on your Twitter page at www.twitter.com/ayurvedichub, which provides links to your website at www.ayurvediccure.com, provide additional evidence that your products are intended for use as drugs: 
 
Posts by your company on your Twitter page include the following:
  • On April 10, 2018, you posted a graphic, which states “Health Benefits of Almonds … Regulate Cholesterol Level … Prevent Heart Diseases.” [Almonds are an ingredient in your product Nourish Vitals Seed & Fruit Mix.]
  • On April 9, 2018 you posted “Benefits of Fish Oil,” a link to your product purchase page for St. 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.
 
Furthermore, claims made on your YouTube channel at www.youtube.com/user/ayurvedicremedies/, which provides links to your website at www.ayurvediccure.com, provide additional evidence that your products are intended for use as drugs: 
  • On your video, “8 Home Remedies For Diabetes” you show the following text:
o   “Cinnamon Powder To Reduce Diabetes”
o   “Fenugreek Seeds To Reduce Diabetes”
 
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the 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 FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 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 C.F.R. § 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 products Morpheme Remedies Arthcare Plus, Morpheme Remedies Cinnamon, Morpheme Remedies Diabeta Plus, Daily Vital Multivitamin, Morpheme Remedies Fenugreek, Morpheme Remedies Guduchi, Morpheme Remedies Memocare Plus, Morpheme Remedies Mind Plus, Morpheme Remedies Mucuna Pruriens, and St. Botanic Fish Oil are 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, Morpheme Remedies Arthcare Plus, Morpheme Remedies Cinnamon, Morpheme Remedies Diabeta Plus, Daily Vital Multivitamin, Morpheme Remedies Fenugreek, Morpheme Remedies Guduchi, Morpheme Remedies Memocare Plus, Morpheme Remedies Mind Plus, Morpheme Remedies Mucuna Pruriens, and St. 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)].
 
The violations cited in this letter are not intended to be an all-inclusive list 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 all products marketed by your firm comply with the Act and its implementing regulations.
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly 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 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 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 written reply should be directed to Shawn Goldman, United States Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions, please contact Mr. Goldman at Shawn.Goldman@fda.hhs.gov.
 
Sincerely,
/S/
William A. Correll, Jr.
Director
Office of Compliance
Center for Food Safety and Applied Nutrition 

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