Department of Health and Human Services' logo Department 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

2009-DT-14

May 7, 2009

CERTIFIED MAIL
RETURN RECEIPT REQUEST

Jess Kraft
Samglo Enterprises
19785 West 12 Mile Road, #827
Southfield, MI 48076

WARNING LETTER

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:

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:

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

This page was posted on January 31, 2010.

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