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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Samglo Enterprises 5/7/09

   

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

Public Health Service
Food and Drug Administration
  Detroit District Office
300 River Place
Detroit, MI 48207
Telephone: (313) 393-8100
FAX: (313) 393-8139

WARNING LETTER
2009-DT-14

May 7, 2009

CERTIFIED MAIL
RETURN RECEIPT REQUEST

Jess Kraft
Samglo Enterprises
19785 West 12 Mile Road, #827
Southfield, 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: www.nu-liver.com, www.hepatitisc-remedy.com, 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 (www.nu-liver.com, 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 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.”
• “[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, 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 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…”
• “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 slowed
o Cell death, fibrosis and fatty infiltration of the liver tissue were diminished
o 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. Givens
District Director
Detroit District Office

Cc:
Jesse Kraft
Samglo Enterpriises
27920 Arlington Drive
Southfield, MI 48076