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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Europharma Co., Inc. 4/24/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Minneapolis District Office
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142 

 

April 24, 2013
 
 
WARNING LETTER
 
 
Via UPS Overnight Delivery                                 
Refer to MIN 13 - 17
 
 
Terrence J. Lemerond
President
EuroPharma Co., Inc.
955 Challenger Drive
Green Bay, Wisconsin 54311-8348
 
Dear Mr. Lemerond:
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your web site at the Internet address www.europharmausa.com in February 2013 and has determined that the products Calm Kids, CholestCaps, CuraMed 375 mg, CuraMed 750 mg, Curamin, Mental Advantage, Tri-Iodine, and Viragen products are promoted for conditions that cause the products to be 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). The therapeutic claims on your web site establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act. You may find the Act and our regulations through links on FDA’s home page at http://www.fda.gov
 
Examples of some of the claims observed on your website www.europharmausa.com include:
 
Calm Kids
Claims found in article titled “Help Children with Attention Deficit-Hyperactivity Disorder (ADD OR ADHD),” which is found by following a link from the Calm Kids page on your www.europharmausa.com web site:
 
  • “For ADD/ADHD focus look for a formula with these ingredients: [an ingredient list that is identical in both ingredients and amounts to what is provided on the Calm Kids page on your www.europharmausa.com web site].”
  • “There are many nutrients, including DMAE, L-tyrosine, taurine, phosphatidylserine, grape seed [ingredients declared in the Calm Kids formula], and specific vitamins which have been shown to be of benefit in the treatment of ADHD.”
  • “In clinical trials of children with ADD, phosphatidylserine was able to improve attention and reduce symptoms. In fact, 11 of 18 children receiving phosphatidylserine had no further ADD symptoms at all.”
 
CholestCaps
Claims found in article titled “HEART HEALTH A Natural Alternative to Allergy Medicines, Statin Drugs and Immune Enhancement,” which is found by following a link from the CholestCaps page on your www.europharmausa.com web site:
 
  • “[. . .] Indian Gooseberry [ingredient in CholestCaps formula] [. . .] reduces symptoms of allergies, particularly hay fever [. . .].”
  • “Indian Gooseberry is credited with a number of useful pharmacological properties justifying its prime position as a natural medicine in the Indian culture.  [. . . including] hypolipidemic and anticancer properties.”
  • “[. . .] Indian Gooseberry has proven beneficial in all the disease conditions tested so far [. . .].”
  • “Cholesterol management through plant extracts is a very attractive option and a number of such botanicals are available. In the relative efficacy, Indian Gooseberry, based on clinical evidence, probably leads the list.”
  • “[. . .] Indian Gooseberry provides several significant healthy [sic] benefits.  It manages cholesterol properly minus the side effect of drugs, reduces the incidence of allergies (hay fever) by up to 75% [. . .] and provides chemoprevention and chemotherapeutic activities.”
 
Claims found in article titled “HEART HEALTH Stop – Or Reverse – Heart Disease, Naturally,” which is found by following a link from the CholestCaps page on your www.europharmausa.com web site:
 
  • “When I see patients who have symptoms of heart disease, I immediately begin a program to address the cause [. . .].  One of my favorite natural treatments is Indian gooseberry [an ingredient in CholestCaps], or amla.”
  • “[. . . H]elping my patients avoid, or reverse, heart disease with the use of natural supplements like amla [. . .].”
 
Claims found in article titled “HEART HEALTH Stroke Prevention and Recovery… Naturally!” which is found by following a link from the CholestCaps page on your www.europharmausa.com web site:
 
  • “Indian Gooseberry (Emblica officinalis):  In terms of effectiveness, Indian Gooseberry, also known as “Amla” [. . .] helped [. . .] reduce inflammation [. . .].”
  • “I recommend a strong 25:1 extract of Indian Gooseberry. This concentrated power will help you [. . .] reduce the risk of stroke dramatically.”
 
CuraMed 375 mg and 750 mg
Claims found in article titled “PAIN and INFLAMMATION The Healing Power of Curcumin,” which is found by following a link from the CuraMed (750 mg) page on your www.europharmausa.com web site:
 
  • “Today, we extract curcumin [primary ingredient in CuraMed] from turmeric to use as a natural medicine for cancer, Alzheimer’s disease, arthritis, and many other chronic diseases.”
  • “This specialized [curcumin] extract is truly amazing [. . .] for its ability to slow the development of Alzheimer’s disease, and prevent and treat cancer, arthritis, and other painful and debilitating diseases.”
  • “In a recent study comparing curcumin to NSAIDs (non-steroidal anti-inflammatory drugs), curcumin was found to be more potent than aspirin, ibuprofen, naproxen, and several others.”
  • “Curcumin and Cancer [. . .] Curcumin has clearly been shown to prevent and inhibit cancer development in a number of studies. By stimulating immunity, we can kill cancer cells and stop them from multiplying, reduce inflammation, and improve detoxification so we can eliminate cancer cells.”
  • “Curcumin has the potential to treat many different types of cancer. Positive research results involving curcumin have been seen with breast, ovarian, pancreatic, prostate, colon, and lung cancers. [. . .] MD Anderson Hospital researchers have reported that curcumin has potent anticancer properties. They say it may prove effective for both prevention and treatment.”
 
Claims found in article titled “BLOOD SUGAR Your Protocol for Fighting Diabetes,” which is found by following a link from the CuraMed (750 mg) page on your www.europharmausa.com web site:
 
  • “Curcumin [primary ingredient in CuraMed], a potent nutrient from the plant turmeric, is one of the best natural anti-inflammatory herbal extracts in the world. In fact, it is as potent at reducing inflammation as prescription drugs. [. . . C]urcumin was compared to the drug rosiglitazone (Avandia), and found to [. . .] be equally as effective as the drug in reducing insulin resistance and inflammation.”
  • “[. . . I]mproved insulin response and normalized blood glucose levels. Curcumin may protect against other problems associated with diabetes, as well:  breakdown of eye tissue, potential brain damage, nerve pain (neuropathy), and heart disease.”
 
Curamin
 
Claim found in the “Curamin – Safe and Effective Pain Relief” brochure, which is found by following a link from the Curamin page on your www.europharmausa.com web site:
 
  • “Curamin® was developed using four high-powered ingredients, each of which has pain-relieving properties.”
 
Claims found in article titled “PAIN & INFLAMMATION Curcumin [an ingredients in Curamin]:  The All in One Solution,” which is found by following a link from the Curamin page on your www.europharmausa.com web site:
 
  • “[Curcumin. . .] can be used to treat almost every disease or illness, including:  Cancer [. . .] Heart Disease [. . .] Bronchitis and Asthma [. . .] Depression [. . .] Alzheimer’s disease [. . .] Rheumatoid Arthritis [. . .] Irritable Bowel Syndrome [. . .] Diabetes [. . .] Leukemia [. . .] Cirrhosis [. . .] Psoriasis [. . . .]”
  • “[Curcumin . . .] is such a powerful anti-inflammatory. We know that almost all chronic diseases – from diabetes to heart disease to arthritis to Alzheimer’s disease – have something in common:  unchecked, destructive inflammation. [. . . N]atural curcumin reduces inflammation through its effects on multiple inflammation targets.”
  • “Because of this anti-inflammatory activity, as well as its ability to kill tumor cells, increase activity of protective antioxidants such as glutathione, and modulate tumor growth cell factors, curcumin is effective against hundreds of diseases [. . .].”
  • “[Curcumin . . .] can suppress breast, prostate, liver, skin, colon and lung cancer.”
  • “Curcumin has also been shown to increase the activity of cancer drugs and to decrease drug resistance in cancer cells (meaning it helps cancer drugs kill tumors more efficiently).”
  • “Researchers believe that curcumin works similarly against all types of cancer, so no matter what kind of cancer you may have curcumin can be helpful.”
  • “[. . . R]esearchers found that curcumin protected against the effects of a high cholesterol diet just as effectively as lovastatin, preventing the inflammatory changes that lead to plaque buildup (and eventually, a heart attack) [. . .].”
  • “The hallmarks of osteoarthritis are cartilage destruction and inflammation – two conditions that curcumin is able to prevent.”
  • “[. . . I]n a recent clinical study that looked at a combination of bioavailable curcumin and boswellia (also an excellent natural anti-inflammatory) or the prescription drug celecoxib (Celebrex®) in the treatment of patients with arthritis, the herbal combination worked better than the drug, with no side effects!”
  • “[. . . C]urcumin was compared to the drug rosiglitazone (Avandia), and found to be equally as effective in reducing insulin resistance, inflammatory markers, and fats in the bloodstream.12 Other studies looking at the effects of curcumin in models of diabetes have found similar results:  improved insulin response and reduced blood glucose levels.13, 14 Additionally, other scientific studies have found that curcumin may protect against other problems associated with diabetes, such as breakdown of eye tissue, potential brain damage, nerve pain (neuropathy), and heart disease.15-18
  • “Because of the known anti-inflammatory effects of curcumin, researchers are now looking at its effects in treating AD. [. . . N]ot only does curcumin protect brain cells from damaging inflammation, in experimental models of Alzheimer’s disease, curcumin was able to reduce beta amyloid levels and shrink the size of accumulated plaques by over 30%!”
  • “[. . . I]t has been theorized that [curcumin] may also be helpful in relieving depression.”
  • “In an experimental model of diabetes, both oral and topical curcumin were able to speed wound repair and healing.  [. . .]  And finally, curcumin has shown promise at reducing inflammatory skin conditions such as psoriasis, eczema, as well as skin cancer.”
  • “Curcumin has also shown promise in treating many other diseases and conditions, including obesity…allergies, pancreatitis, and more.”
  • “Today, we extract curcumin from turmeric to use as a natural medicine for treating cancer, Alzheimer’s disease, arthritis, and many other chronic diseases.”
 
Mental Advantage
Claims found in article titled “BRAIN HEALTH What Causes Alzheimer’s?” which is found by following a link from the Mental Advantage page on your www.europharmausa.com web site:
 
  • “Curcumin [an ingredient in Mental Advantage] has been shown to bind to plaque-forming beta-amyloid. It can not only help stop the accumulation of beta-amyloid fragments, but it has even been shown to promote their destruction.  In fact, in a study using a model of Alzheimer’s disease, curcumin reduced the size of beta-amyloid plaques by 30% in just one week! [. . . I]t was more effective at stopping the formation of plaques than many experimental drugs that are being tested as potential AD treatments.”
  • “Both rosemary and Spanish sage concentrated plant oils [two ingredients in Mental Advantage] are acetylcholinesterase inhibitors [. . .]. This is similar to how the prescription drug works, but without the serious adverse effects. [. . .] Low levels of acetylcholine are associated with Alzheimer’s disease. These oils are able to help keep acetylcholine levels from declining. [. . .] When this plant oil was given to people with Alzheimer’s disease, their attention and focus improved and many of their other symptoms were reduced.”
 
Tri-Iodine
Claims found in article titled “THYROID AND IMMUNE SUPPORT IODINE: The Forgotten Medicine” (both in English and Spanish), which is found by following a link from the Tri-Iodine page on your www.europharmausa.com web site:
 
  • “Iodine [primary ingredient in Tri-Iodine] was effective for everything: [. . .] destroy bacteria, viruses, and pathogens; and to prevent cancer.”
  • “Thirty years ago, when iodine consumption was much higher than it is now, one in 20 women developed breast cancer. Women in Japan, consuming high amounts of dietary iodine, have much lower rates of breast cancer and thyroid problems.”
  • “Iodine’s anti-cancer function [. . .].”
  • “Supplemental iodine has been found to improve symptoms of fibrocystic breast disease.”
  • “The following conditions are routinely treated with iodine [. . .] with effective results [. . .] breast disease, diabetes [. . .] ovarian cysts, migraine headaches, fibrocystic breasts, thyroid disorders and vaginal infections.”
 
The article titled “THYROID AND IMMUNE SUPPORT IODINE: The Forgotten Medicine” also contains the following disease claim that is in the form of a personal testimonial:
 
  • “[. . . A]s I started to use larger amounts of iodine (12.5-50 mg/day) to achieve whole body sufficiency, I began to see positive results in my patients. Goiters and nodules of the thyroid shrank [sic], cysts on the ovaries became smaller and began to disappear [. . .]. [. . .T]hose with chronic illnesses that were having a difficult time improving began to notice many of their symptoms resolving.”
 
Viragen
Claims found in article titled “COLD AND FLU Natural Flu Fighters,” which is found by following a link from the Viragen page on your www.europharmausa.com web site:
 
  • “[. . . V]ery effective flu and bacteria fighters. A great combination to battle viruses uses Ravensara (Ravensara aromatica), Myrtle (Myrtus communis), Thyme (Thymus saturoides), and Bay Leaf (Laurus nobilis) concentrated plant oils [the four primary ingredients in Viragen].”
  • “[. . . R]avensara actually destroys bacteria and viruses [. . .].”
  • “Ravensara oil taken internally as a chemotyped plant oil is one of my top recommendations for treating all types of bacterial, viral, or fungal illnesses – from common colds and the flu to yeast overgrowth, pneumonia, ear infections, sinus infections, and more.”
  • “Myrtle essential oil [. . .] held its own against Mycobacterium tuberculosis, the primary cause of tuberculosis [. . .].”
  • Thymus saturieoides is [. . .] a strong antibacterial, fighting a variety of strains, including Staphylococcus aureus (the cause of staph infections) and Escherichia coli [. . .].”
  • “Bay has been shown to fight methicillin-resistant Staphylococcus aureus (MRSA), and vancomycin-resistant enterococci (VRE).”
  • “Fighting the flu, stopping colds, and battling bacteria doesn’t mean you have to opt for dangerous over-the-counter drugs [. . .].  These four simple ingredients give you a strong defense for the season.”
 
The claims listed above establish that your products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. Based on these claims, your products are drugs within the meaning of section 201(g)(1)(B) of the Act. Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act, 21 U.S.C. § 321(p). New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act, 21 U.S.C. § 355(a). FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.   
 
Furthermore, because these products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use these products safely for their intended uses. Thus, their labeling fails to bear adequate directions for their intended uses, causing your products to be misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1). The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act, 21 U.S.C. § 331(a).
 
This letter is not meant to be an all-inclusive list of violations at your facility or that may exist in any of your product labeling. It is your responsibility to ensure that your products and labeling comply with the Act and its implementing regulations. You should take prompt action to correct the violations described above and prevent their future recurrence.  Failure to promptly correct these violations may result in regulatory action without further notice. Such actions could include seizure and/or injunction. Sections 304 and 302 of the Act authorize the seizure of illegal products and injunctions against manufacturers and distributors of those products, 21 U.S.C. §§ 334 and 332.   
 
You should notify this office in writing within 15 working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations. You should include in your response documentation such as revised labels or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within 15 working days, please explain the reason for the delay and state when you will correct any remaining violations.
 
Your reply should be sent to the attention of Compliance Officer Tyra S. Wisecup at the address on the letterhead. 
 
Sincerely,
/S/ 
Michael Dutcher, DVM
Director
Minneapolis District Office