Hepatitis C: FDA Sunday
Chronic Illness and Unscrupulous Websites
Today on this blog it's "FDA Sunday". For the male audience last week was "NFL Sunday", so sorry you missed it.
Small Note Of No Importance: The truth is this blogger doesn't understand NFL anything, so I might have exaggerated about last Sundays article. If you're having difficulty locating the entry please email me and I will do a search resulting with no actual information, Thank you
Today on this blog it's "FDA Sunday". For the male audience last week was "NFL Sunday", so sorry you missed it.
Small Note Of No Importance: The truth is this blogger doesn't understand NFL anything, so I might have exaggerated about last Sundays article. If you're having difficulty locating the entry please email me and I will do a search resulting with no actual information, Thank you
What is of importance on this Sunday, the 14th day of November?
Chronic hepatitis C and those questionable websites profiting from individuals suffering with chronic illness.
Therapy for Hepatitis C is an arduous treatment regimen currently with a less then desirable success rate. The majority of people infected with HCV seek out medical treatment while others search for a more alternative approach, however both groups may turn to the Internet.
The latter group of people seeking an alternative may find themselves a prime target for online medical quackery. The Internet is full of sophisticated marketing ploys with snake oil salesmen ready to take advantage of the numerous people in this unfortunate situation. The operating method used by these unscrupulous websites is to prey on the fear or uncertainty when diagnosed with a chronic illness. As humans we have an innate ability for survival at any cost. With these emotions in place it isn't uncommon to justify a few unrealistic expectations. Hence we begin a search that may lead down the path to a potentially dangerous result.
Chronic illness is a good investment for any entrepreneur especially when all ethics are effectively dismissed. Thousands of these all-purpose, herb selling, self promoting salesmen; are waiting online to finance their new enterprise.
A company can't sell their product unless they find an audience, but how can they do that, other then advertising? They create a website projecting a false impression of authenticity by peppering the site with information and or health advice. On some of these sites they cite a case study, completely void of any substantial credentials.
I find it discouraging and harmful that people who suffer with chronic hepatitis c are being directed by search engines to these commercial and profitable websites. However, there is assistance to sort out these dubious claims. On the FDA's website the public can access warning letters discharged to the owners of these websites, supplied by the CDER Freedom of Electronic Information office. The information listed below is only a sampling of what is available, for additional violations see the FDA's website .
A company can't sell their product unless they find an audience, but how can they do that, other then advertising? They create a website projecting a false impression of authenticity by peppering the site with information and or health advice. On some of these sites they cite a case study, completely void of any substantial credentials.
I find it discouraging and harmful that people who suffer with chronic hepatitis c are being directed by search engines to these commercial and profitable websites. However, there is assistance to sort out these dubious claims. On the FDA's website the public can access warning letters discharged to the owners of these websites, supplied by the CDER Freedom of Electronic Information office. The information listed below is only a sampling of what is available, for additional violations see the FDA's website .
October 12, 2010Nature’s Health Co.
Hepatitis A, B, C and Herbs (milk thistle seed “helps relieve symptoms of acute and chronic hepatitis, hepatocirrhosis, fatty liver, damage of liver")
WASHINGTON—FDA issued a warning letter to Nature’s Health Co. LLC, Salt Lake City, in late September, after the agency determined the company was promoting several of its dietary supplements on its website using health claims that cause the products to be considered drugs. According to the agency, a range of products carry therapeutic claims that position the products to be used in the cure, mitigation, treatment or prevention of disease.
WASHINGTON—FDA issued a warning letter to Nature’s Health Co. LLC, Salt Lake City, in late September, after the agency determined the company was promoting several of its dietary supplements on its website using health claims that cause the products to be considered drugs. According to the agency, a range of products carry therapeutic claims that position the products to be used in the cure, mitigation, treatment or prevention of disease.
For example, products Cardiac Balance I and II and Notoginseng are promoted under a subhead “Stroke & Herbs" with claims discussing control of arrhythmia, prevention of platelet aggregation, and dissolving blood clots. Personal testimonials are also included under the subhead, related to patients with diagnosed coronary artery disease who took the Cardiac Balance products for six months and “symptoms disappeared or alleviated significantly."Other sections and products include Osteoporosis and Herbs (Shark Cartilage “keeps tumors from growing"); High Blood Pressure and Herbs (rubber tree has a “relaxant effect on coronary artery"); Hepatitis A, B, C and Herbs (milk thistle seed “helps relieve symptoms of acute and chronic hepatitis, hepatocirrhosis, fatty liver, damage of liver"); Multiple Sclerosis and Herbs; Anti-Diabetes; CancerEase (Cell Balance “reduces the viability of tumors"); Parkinson Disease and Herbs; Gonorrhea and Herbs (“Baicalein can restrain the activity of Neisseria gonorrhoeae, which is the causative agent of gonorrhea"); and Urinary Balance. FDA added, “The unlawful disease treatment and prevention claims on your website were too numerous to list in this letter."FDA noted the products have not been approved as safe and effective for the referenced uses by the agency as new drugs.
Further, as the products are offered for conditions that are not amenable to self-diagnosis, the labeling bears inadequate directions for use, causing them to be misbranded. The agency advised the company to promptly correct any violative marketing, as failure to do so could result in enforcement action including possible seizure of products and injunctions against the company and its distributors.
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Vaccine critic "Dr. Bob" Sears blasted again.
Rahul K. Parikh, M.D., has looked closely the irresponsible advice given by "Dr. Bob" Sears in his book, The Vaccine Book." The book's centerpiece is "Dr. Bob's Alternative Schedule," which spreads vaccines over 21 visits instead of the standard 13. Parikh notes that Sears repeatedly uses "soft science, circular logic, rumors, and outright falsehoods" and that his book is "nothing more than an anti-vaccine book blanketed in a soft, sympathetic and homespun style." [Parikh RK. Face-off with the bestselling vaccine guru. Salon.com, Oct 13, 2010] Last year, in a stinging editorial, Paul Offit, M.D. and a colleague pointed out that Sears's schedule is dangerous because it significantly increases the time during which children are susceptible to vaccine-preventable diseases. [Offit P, Moser CA. The problem with Dr Bob's alternative vaccine schedule. Pediatrics, Jan 2009]
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September 2010
Enriching Gifts International
Lightning Colloidal Silver™: "naturally anti-bacterial, anti-viral, anti-germicidal and anti-fungal."
"Some of the symptoms known to respond well to sterol [ingredient in the product] supplementations are: Cancer (breast, colon, prostate), Rheumatoid Arthritis, Hepatitis C, HIV…"
MILES CITY, Mont.—Enriching Gifts International received a not-so-welcome gift from FDA in early September in the form of a warning letter, notifying the company that the agency had serious concerns with the marketing of several of its dietary supplement products. FDA’s Sept. 8 warning letter noted it had reviewed the company’s websites and determined the way several products are promoted positions them as drugs, as they appear to be positioned to cure, mitigate, treat or prevent diseases.
Specific products were promoted in marketing files on the Enriching Gifts website, and on the on the EnzymesForDigestion.com website, an online store affiliated with the company, using claims including:
Plant Enzymes: "treatment of both Type I and Type II diabetes," "fights cardiovascular problems," "fights cancer," and "for use against H.I.V. and A.I.D.S."
Sterol Max: "has been shown to have powerful healing effects on cancer, AIDS, tuberculosis…" and "Some of the symptoms known to respond well to sterol [ingredient in the product] supplementations are: Cancer (breast, colon, prostate), Rheumatoid Arthritis, Hepatitis C, HIV…"
Aloe Ace-Max™: "important in preventing and treating arteriosclerosis, heart disease and Parkinson’s disease," "direct anti-bacterial and anti-viral effect," and "powerful healing effect on AIDS, cancer."
Pro Biotic with FOS™: "kill parasitic bacteria just like antibiotics."
Metabolic Complete™: "protection of the body against the development of cancer and heart disease."
Heart Algae™: "may significantly reduce your risk of developing heart disease and many forms of cancer."
Lightning Colloidal Silver™: "naturally anti-bacterial, anti-viral, anti-germicidal and anti-fungal."
Sterol Max: "has been shown to have powerful healing effects on cancer, AIDS, tuberculosis…" and "Some of the symptoms known to respond well to sterol [ingredient in the product] supplementations are: Cancer (breast, colon, prostate), Rheumatoid Arthritis, Hepatitis C, HIV…"
Aloe Ace-Max™: "important in preventing and treating arteriosclerosis, heart disease and Parkinson’s disease," "direct anti-bacterial and anti-viral effect," and "powerful healing effect on AIDS, cancer."
Pro Biotic with FOS™: "kill parasitic bacteria just like antibiotics."
Metabolic Complete™: "protection of the body against the development of cancer and heart disease."
Heart Algae™: "may significantly reduce your risk of developing heart disease and many forms of cancer."
Lightning Colloidal Silver™: "naturally anti-bacterial, anti-viral, anti-germicidal and anti-fungal."
*Because Colloidal Silver is promoted for liver health and HCV, I included this video. The HCV community is aware of the dangers of Colloidal Silver but the newly diagnosed may not be.
As the products have not been recognized as safe and effective for the prevention and treatment of diseases, they are therefore positioned as "new drugs" in the eyes of FDA, which may not be marketed without prior agency approval. FDA’s warning letter noted the items are also misbranded, as the labeling fails to bear adequate directions for use.
Green tea claims triggers two FDA warning letters.
The FDA has issued two warning letters related to claims made for green tea products. One ordered Unilever Americas to stop claiming that its Lipton Green Tea 100% Naturally Caffeinated product has a significant cholesterol-lowering effect and is "a naturally rich source of antioxidants." The other ordered Cadbury Adams USA to stop claiming that its Canada Dry Sparkling Green Tea Ginger Ale was "enhanced with 200 mg of antioxidants from green tea and vitamin C."August 2010
FDA Issues Warning on ‘Miracle’ Liquid
August 2, 2010Even with this forceful warning, the product website is still live and it is full of the most unreal claims I’ve seen in any online marketing scheme:
WASHINGTON—FDA issued a warning regarding a product known as Miracle Mineral Solution (MMS) or Miracle Mineral Supplement, an oral liquid that, when used as directed, produces an industrial bleach. The agency stated it has received several serious adverse event reports (AERs), including severe nausea, vomiting, and life-threatening low blood pressure from dehydration. It recommends consumers immediately cease use of the product and dispose of it.
MMS is distributed on Internet sites and online auctions by multiple independent distributors. Although the products share the MMS name, the look of the labeling may vary. The product instructs consumers to mix the 28 percent sodium chlorite solution with an acid such as citrus juice. This mixture produces chlorine dioxide, a potent bleach used for stripping textiles and industrial water treatment. High oral doses of this bleach, such as those recommended in the labeling, can cause nausea, vomiting, diarrhea, and symptoms of severe dehydration. In addition, the product is often marketed with multiple health claims, relating to its purported ability to support the immune system and fight conditions ranging from the common cold to cancer.
FDA is continuing its investigation into the product, and may pursue civil or criminal enforcement actions. It also asked consumers and health care professionals to report adverse events to FDA through its MedWatch program.
MMS is distributed on Internet sites and online auctions by multiple independent distributors. Although the products share the MMS name, the look of the labeling may vary. The product instructs consumers to mix the 28 percent sodium chlorite solution with an acid such as citrus juice. This mixture produces chlorine dioxide, a potent bleach used for stripping textiles and industrial water treatment. High oral doses of this bleach, such as those recommended in the labeling, can cause nausea, vomiting, diarrhea, and symptoms of severe dehydration. In addition, the product is often marketed with multiple health claims, relating to its purported ability to support the immune system and fight conditions ranging from the common cold to cancer.
FDA is continuing its investigation into the product, and may pursue civil or criminal enforcement actions. It also asked consumers and health care professionals to report adverse events to FDA through its MedWatch program.
AcaiPure (an acai berry supplement) as a weight-loss product and Colopure (a "colon cleansing" product) as an aid for preventing cancer.
Court orders halt to supplement scam. At the FTC's request, a U.S. district court has ordered Arizona-based Central Coast Nutraceuticals, Inc. (CCN) and its owners to temporarily halt a scheme that allegedly scammed consumers out of at least $30 million in 2009 alone through deceptive advertising and unfair billing practices. Since 2007, victimized consumers have flooded law enforcement agencies and the Better Business Bureau with more than 2,800 complaints about the company. The FTC has charged CCN, Graham D. Gibson, Michael A. McKenzy, and four related companies with deceptively advertising AcaiPure (an acai berry supplement) as a weight-loss product and Colopure (a "colon cleansing" product) as an aid for preventing cancer. The defendants were also charged with deceiving prospective buyers by offering "free" or "risk-free" trial offers that opened the door to unauthorized credit card charges. The court order imposes an asset freeze, and appoints a temporary receiver over the defendants while the FTC moves forward with its case to stop the company's improper conduct. [Court orders Internet marketers of acai berry weight-loss pills and "colon cleansers" to stop deceptive advertising and unfair billing practices. FTC news release, August 16, 2010] The FTC Web site features one of CCN's deceptive television ads.
At a press conference announcing the FTC action, a VISA official stated that his company took aggressive action after the number of complaints from dissatisfied customers mounted. Under VISA's regulatory program, when requests for chargebacks (forced refunds) reach 1% of sales, sellers are pressured to modify their sales practices, but the CCN case was complicated because the company changed names several times. In a subsequent interview, another VISA representative told Dr. Stephen Barrett that more than half the companies that generate excessive chargebacks sell "nutraceuticals" (dietary supplements), but VISA's regulatory activity is focused on sales practices rather than product claims.
At a press conference announcing the FTC action, a VISA official stated that his company took aggressive action after the number of complaints from dissatisfied customers mounted. Under VISA's regulatory program, when requests for chargebacks (forced refunds) reach 1% of sales, sellers are pressured to modify their sales practices, but the CCN case was complicated because the company changed names several times. In a subsequent interview, another VISA representative told Dr. Stephen Barrett that more than half the companies that generate excessive chargebacks sell "nutraceuticals" (dietary supplements), but VISA's regulatory activity is focused on sales practices rather than product claims.
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Stem cell experts launch consumer-protection site.
The International Society for Stem Cell Research (ISSCR) has launched a closer look at STEM CELL treatments with information geared to help consumers make rational decisions about stem cell treatment. The new site contains a handbook of basic information that includes questions that consumers should ask a prospective clinic and discuss with a trustworthy physician. ISSCR is also querying English-speaking clinics and hopes to list which ones do or do not provide evidence that appropriate oversight and other patient protections are in place for the treatments they offer. The site invites people to submit names of clinics they want reviewed.
Power Balance products debunked.
Device Watch has examined the hype used to promote Power Balance products, which are claimed to improve balance, flexibility, strength and overall wellness. The marketers say that their wrist bands and other products contain holograms that have been "embedded with naturally occurring frequencies found in nature that have been known to react positively with the body's energy field." The marketers use demonstrations in which they purport to test whether people get stronger when wearing a product. However, the techniques used are similar to applied kinesiology muscle-testing, which relies on suggestibility. Last year, an Australian television program conducted double-blind tests that demonstrated that the tester could not determine which of six people carried a card containing the hologram. Despite the absurdity of the products, the Ovarian Cancer Research Fund is "partnering" with Power Balance to help raise funds for ovarian cancer research. [Hall H. Power Balance products: A skeptical look. Device Watch, Aug 24, 2010]
HON complaint filed against Cleveland Clinic Web site.
" The article claims that reiki is "useful" in treating all types of cancer, fertility issues, Parkinson's disease, psychological illnesses, fibromyalgia, chronic pain, digestive problems, and stress-related diseases. The article also claims that reiki treatment may detoxify the body, stimulate the immune system, apply universal life-force energy to the body, stimulate bone healing, increase vibrational frequency, and dissolve energy blockages.
Dr. Stephen Barrett has notified Health On the Net (HON) Foundation officials that the Cleveland Clinic Web site contains an article about reiki therapy that violates the HON Code of Conduct for medical and health Web sites.
HONcode Principle 4 requires that, "Where appropriate, information contained on this site will be supported by clear references to source data." Principle 5 states: "Any claims relating to the benefits/performance of a specific treatment . . . will be supported by appropriate, balanced evidence in the manner outlined in Principle 4." The article claims that reiki is "useful" in treating all types of cancer, fertility issues, Parkinson's disease, psychological illnesses, fibromyalgia, chronic pain, digestive problems, and stress-related diseases. The article also claims that reiki treatment may detoxify the body, stimulate the immune system, apply universal life-force energy to the body, stimulate bone healing, increase vibrational frequency, and dissolve energy blockages. Reiki is one of several nonsensical methods commonly referred to as "energy healing." These methods are based on the idea that the body is surrounded or permeated by an energy field that is not measurable by ordinary scientific instrumentation. Reiki practitioners claim to facilitate healing by strengthening or "balancing" the alleged force. In a traditional reiki session, the client lies down or sits fully clothed. The practitioner's hands are placed lightly on or just above the client's body, palms down, using a series of positions that are held until the practitioner feels that the flow of "energy" has slowed or stopped.
"Reiki treatment may detoxify the body, stimulate the immune system, apply universal life-force energy to the body, stimulate bone healing, increase vibrational frequency, and dissolve energy blockages."
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Cleveland Clinic removes irresponsible reiki article.
Shortly after Dr. Stephen Barrett complained to the Health On the Net (HON) Foundation, the Cleveland Clinic Web site deleted an article which had stated that "reiki treatment may detoxify the body, stimulate the immune system, apply universal life-force energy to the body, stimulate bone healing, increase vibrational frequency, and dissolve energy blockages." HONcode Principle 4 requires that, "Where appropriate, information contained on this site will be supported by clear references to source data." Principle 5 states: "Any claims relating to the benefits/performance of a specific treatment . . . will be supported by appropriate, balanced evidence in the manner outlined in Principle 4." In recent years, HON has become tougher in asking Web sites that display its seal to either substantiate challenged claims or remove them. After noting that the reiki article had been removed, Barrett asked HON to look at seven more articles on the Cleveland Clinic site.
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Stem cell clinic operator cited.
In 2009, William C. Rader, M.D. was cited by the Medical Board California and ordered to pay a $1,500 fine for violating advertising regulations and practicing under the name "Medra" without having a valid Fictitious Name Permit (FNP). An FNP is not the same as a fictitious business name statement, a local business permit, or registration with a city or county government. Having a city/countyĆ¢€level permit or registration does not exempt a physician from the medical board's FNP requirement. This year, Rader obtained FNPs for Medra (incorporated 1997), Medstem (incorporated 2005), and The Dulcinea Institute. He is also set up a private corporations called The Fetal Stem Cell Institute, Inc. (2006), and a private foundation called the Cutting-Edge for Medical Invention Foundation (2001).
Since 1997, Rader has operated a stem cell clinic, initially in the Bahamas and currently in the Dominican Republic. Last year, BBC's Panorama criticized Rader's activities. One part of the Panorama report—titled "Stem cells and miracles—described the operation of his clinic and another clinic in China operated by others. Another part—titled "MS patient: The search for 'a cure'"—shows how Rader tried to pressure a woman who had multiple sclerosis to undergo his treatment. The complete broadcast can be viewed on YouTube.
Since 1997, Rader has operated a stem cell clinic, initially in the Bahamas and currently in the Dominican Republic. Last year, BBC's Panorama criticized Rader's activities. One part of the Panorama report—titled "Stem cells and miracles—described the operation of his clinic and another clinic in China operated by others. Another part—titled "MS patient: The search for 'a cure'"—shows how Rader tried to pressure a woman who had multiple sclerosis to undergo his treatment. The complete broadcast can be viewed on YouTube.
This is from 2009 but still very relevant to this entry.
Nu-Liver
2009
2009
amglo Enterprises 5/7/09
Department of Health and Human Services
Public Health ServiceFood and Drug Administration
Detroit District Office 300 River PlaceDetroit, MI 48207 Telephone: (313) 393-8100FAX: (313) 393-8139
Department of Health and Human Services
Public Health ServiceFood and Drug Administration
Detroit District Office 300 River PlaceDetroit, MI 48207 Telephone: (313) 393-8100FAX: (313) 393-8139
WARNING LETTER2009-DT-14
May 7, 2009
CERTIFIED MAILRETURN RECEIPT REQUEST
Jess KraftSamglo Enterprises19785 West 12 Mile Road, #827Southfield, MI 48076
May 7, 2009
CERTIFIED MAILRETURN RECEIPT REQUEST
Jess KraftSamglo Enterprises19785 West 12 Mile Road, #827Southfield, MI 48076
Dear Mr. Kraft:
This is to advise you that the Food and Drug Administration (FDA) reviewed your websites in March 2009 at the Internet addresses: http://www.nu-liver.com/ , http://www.hepatitisc-remedy.com/ , http://www.nu-liverpc.com/ and www.storesonline.com/members/459211/hepatitis-c-herbs.htm and has determined that the products “Nu-Liver” and “Nu-Liver PC” 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 websites establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of the products with these claims violates the Act.
Examples of some of the claims observed on your websites include:
Nu-Liver (http://www.nu-liver.com/ , http://www.hepatitisc-remedy.com/ , www.storesonline.com/members/459211/hepatitis-c-herbs.htm )
This is to advise you that the Food and Drug Administration (FDA) reviewed your websites in March 2009 at the Internet addresses: http://www.nu-liver.com/ , http://www.hepatitisc-remedy.com/ , http://www.nu-liverpc.com/ and www.storesonline.com/members/459211/hepatitis-c-herbs.htm and has determined that the products “Nu-Liver” and “Nu-Liver PC” 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 websites establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of the products with these claims violates the Act.
Examples of some of the claims observed on your websites include:
Nu-Liver (http://www.nu-liver.com/ , http://www.hepatitisc-remedy.com/ , www.storesonline.com/members/459211/hepatitis-c-herbs.htm )
• “Halt the progression of liver disease”
• “Nu-Liver is a non-toxic formulation of Chinese herbs, is anti-viral, anti-inflammatory…”• “[S]cientifically shown to support the immune system’s natural ability to: lower the Hepatitis C viral load, reduce or normalize liver enzyme levels, and halt disease progression….”
• The URL address http://www.hepatitisc-remedy.com/ where you sell the product suggests that “Nu-Liver” is intended for use in treating or preventing hepatitis C.
Under "Ingredients in 'Nu-Liver Herbal Formula":
• “Sophora Root inhibits viral replication. Lowers viral load. Protects against fibrosis. Reduces destruction of liver cells.”• “Bupleurum root is used in chronic hepatitis, enlarged liver…and reduces inflammation by inhibiting prostaglandin production.”
Under "In-Depth Review of Herbs Used in NU-LIVER":
• “Clinical trials have demonstrated that bupleurum is a safe and effective treatment for hepatitis C and other chronic liver problems.”
Under "Ingredients in 'Nu-Liver Herbal Formula":
• “Sophora Root inhibits viral replication. Lowers viral load. Protects against fibrosis. Reduces destruction of liver cells.”• “Bupleurum root is used in chronic hepatitis, enlarged liver…and reduces inflammation by inhibiting prostaglandin production.”
Under "In-Depth Review of Herbs Used in NU-LIVER":
• “Clinical trials have demonstrated that bupleurum is a safe and effective treatment for hepatitis C and other chronic liver problems.”
• “[P]rivet fruit was found to prevent breakdown of the immune system when cancer patients were given chemotherapy and radiation therapy.”
• “Lycium Berry-Wolfberry Fruit…The fruit can kill many kinds of cancer cells in vitro because it contains germanium which has been demonstrated in Japanese studies to have anti-cancer activity. The berries…can inhibit the precipitation of fat in liver cells and promote the regeneration of the liver.”
• “[L]ovage root is effective in treatment of headaches by decreasing vascular resistance while increasing blood flow in the brain. In recent years, it has been used in the treatment of coronary heart disease and angina pectoris. The herb dilates the capillaries and other blood vessels and thus lowers blood pressure.”
Examples of some of the claims on your websites in the form of testimonials include:
• “I had suffered from fatigue for many years and discovered I had hepatitis c after a routine blood workup. I started on a regimen of interferon recommended by my doctor, but this only made me very sick. . . After going off treatment, I read as much as I could about natural ways to combat my Hep-C, and decided to try your product- Nu-Liver. What a world of difference it has made!”
Nu-Liver PC (www.hepatitisc-remedy.com, http://www.nu-liverpc.com/ )
• “What makes “PC” so special is…its ability to repair injured liver cell membranes that have been damaged from attack by internal and external toxins, especially viruses (i.e. hepatitis c and hepatitis b).
”• “[L]icorice root…acts on the endocrine system and the liver, and has been effective in treating hepatitis and cirrhosis in the Chinese population.”
• “Extensive research has revealed that the ingredients in ‘Nu-Liver PC’ protect the liver against damage from infection due to viral, bacterial and fungal causes…”
• The URL address http://www.hepatitisc-remedy.com/ where you sell the product suggests that “Nu-LiverPC” is intended for use in treating or preventing hepatitis C.
Under Licorice Root [an ingredient]:
• “[A]n acid that has proved to be both anti-bacterial, anti-viral and anti-tussive. Its anti-inflammatory action acts like the steroid ‘cortisone’, but without cortisone’s immune-suppressing side-effects.”• “Licorice . . . promotes healing of this vital organ. The herb’s anti-inflammatory properties help calm hepatitis-associated liver inflammation. It also fights the virus commonly responsible for hepatitis…”
Under Licorice Root [an ingredient]:
• “[A]n acid that has proved to be both anti-bacterial, anti-viral and anti-tussive. Its anti-inflammatory action acts like the steroid ‘cortisone’, but without cortisone’s immune-suppressing side-effects.”• “Licorice . . . promotes healing of this vital organ. The herb’s anti-inflammatory properties help calm hepatitis-associated liver inflammation. It also fights the virus commonly responsible for hepatitis…”
• “Licorice root extract lowers liver cancer rates in hep c patients”
Under Phosphatidylcholine [an ingredient]:
• “'PC’ had the following liver-protective effects:
o Membrane damage was slowedo Cell death, fibrosis and fatty infiltration of the liver tissue were diminishedo Membrane integrity was conserved”
• “When “PC” was orally administered, liver cell membrane damage was slowed, and cell death, fibrosis, and fatty infiltration of the liver tissue were all diminished.
Examples of some of the claims on your websites in the form of testimonials include:
• “My liver enzymes were less than half of what they were only 3 months ago.”
• “'PC’ had the following liver-protective effects:
o Membrane damage was slowedo Cell death, fibrosis and fatty infiltration of the liver tissue were diminishedo Membrane integrity was conserved”
• “When “PC” was orally administered, liver cell membrane damage was slowed, and cell death, fibrosis, and fatty infiltration of the liver tissue were all diminished.
Examples of some of the claims on your websites in the form of testimonials include:
• “My liver enzymes were less than half of what they were only 3 months ago.”
• “[M]y high liver enzymes have returned to normal levels.”
Further, your websites cite a number of articles regarding the use of your products or their ingredients for treatment or prevention of hepatitis. When scientific publications are used commercially by the seller of a product to promote the product to consumers, such publications 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 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 reference citations used to market "Nu-Liver PC" for disease treatment or prevention on your website:
• ”Iino S. Tango T, Matsushima T, Toda G. Miyake K., Hino K., Kumada H. Yasuda K, Kuroki T, Hirayama C, Suzuki H.Therapeutic effects of stronger neo- minophagen C at different doses on chronic hepatitis and liver cirrhosis.Hepatol Res. 2001 Jan 1;19(1):31-40.”
• "Hikino, 'Natural Products for liver diseases' 1988 Economic and Medicinal Plant
• Research Volume 2(39-67))"
.• "Fujisawa Y. Sakamoto, M, Matsushita M, Fujita T., Nishioka K., Glycyrrhizin inhibits the lytic pathway of complement -- possible mechanism of its anti-inflammatory effect on liver cells in viral hepatitis. Microbiol Immunol. 2000; 44(9): 799-804."
• "Wang ZY, Nixon DW. Licorice and cancer, Nutr Cancer. 2001; 39(1):1:11"
The reference citations and other claims are supplemented by metatags used to bring consumers to your websites through Internet searches. Examples of these metatags include “liver disease treatment,” hepatitis C treatment,” “hepatitis C remedy,” “hepatitis remedy” and “liver disease remedy.”
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.
Your products “Nu-Liver” and “Nu-Liver PC” are also misbranded within the meaning of section 502(f)(1) of the Act in that labeling for these drugs fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)].
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials for your product to ensure that the claims you make for your products do not cause them to violate the Act.
You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].
Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be directed to Mr. Steven B. Barber, Director, Compliance Branch, 300 River Place, Suite 5900, Detroit, MI 48207. If you have any questions, you may contact Mr. Barber at 313-393-8110.
Sincerely,
/S/
Joann M. GivensDistrict DirectorDetroit District Office
Cc:Jesse KraftSamglo Enterpriises
27920 Arlington Drive
outhfield, MI 48076
Information About Milk Thistle And Herbs
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November 14, 2010 11:12 PM
I saw nfl sunday,lol