Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
  Atlanta District Office
60 8th Street, N.E.
Atlanta, Georgia 30309

June 2, 2008

VIA FEDERAL EXPRESS

John Stigaard
Fem Health
Superb Herbs
2379 Red Barn Road
Marietta, GA 30064

WARNING LETTER
(08-ATL-10)

Dear Mr. Stigaard:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your websites at the Internet addresses www.femhealth.com and www.superbherbs.com and has determined that the products "New Sun NKC-C Agaricus Blazei capsules," "New Sun NKC-C Agaricus Blazei Super Concentrate Vial," "New Sun Green Tea," "New Sun Grape Seed Extract," "New Sun LIV Combination," "New Sun Flax Seed Oil," "New Sun Super Sam (Super Sam Generic Samento, Cat's Claw)," "New Sun Vital PR. & BR." and "New Sun Yew/Olive Combination," among numerous other products marketed on your websites, are promoted for conditions that cause the products to be drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)]. 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:

New Sun NKC-C (or Agaricus Blazei NKC-C) capsules and New Sun Agaricus Blazei NKC-C Super Concentrate Vial

www.femhealth.com
www.superbherbs.com

New Sun Green Tea (Green Tea Extract)

www.femhealth.com and www.superbherbs.com
"Green Tea's ability to fight cancer is even more potent and varied than scientists suspected ..."
www.femhealth.com
"Green tea concentrate may help some people boost their metabolic defense against toxins capable of causing cancer ..."

New Sun Grape Seed Extract

www.femhealth.com
www.superbherbs.com

New Sun Flax Seed Oil

www.superbherbs.com
www.superbherbs.com and www.femhealth.com
www.femhealth.com

New Sun LIV Combination Milk Thistle Extract (Liver Detox Cleanse Formula, Liver Cleanse with Curcumin & Silymarin):

www.superbherbs.com
www.femhealth.com

New Sun Super Sam (Super Sam Generic Samento, Cat's Claw)

www.femhealth.com

New Sun Vital PR & BR.(Chinese Breast Health Formula)

www.femhealth.com
In describing your Chinese Herbal Breast Health Formula plus Homeopathic Breast Formula you imply that the ingredients in this product, Chinese medicinal herbs, can treat breast cancer and other diseases. For example, your website makes the following claims: "Chinese medicinal herbs are used to prevent and treat breast challenges with direct antiproliferative effects, antimutagenic activity.... Chinese medicinal herbs are traditionally used to prevent and treat a variety of diseases, including cancer .... Chinese medicine is useful in all stages of the disease to augment the benefits of conventional treatments, to prevent recurrence and metastasis in early stage breast cancer..."

New Sun Yew/Olive Combination

www.superbherbs.coni and www.femhealth.com:
www.femhealth.com:
www.superherbs.com:

Further, the "References" listed for a number of products on your websites cite a number of articles about human and animal studies of the products or their ingredients. The titles of many of these articles concern the use of the products or their ingredients for treatment or prevention of cancer and other diseases. When scientific publications are used commercially by the seller or 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 your products for disease treatment and prevention on your websites:

www.superbherbs.com and www.femhealth.com
www.femhealth.com

The reference citations and other claims quoted above are supplemented by the metatags used to bring consumers to your websites through Internet searches. Examples of the metatags include the following:

www.superbherbs.com: arthritis, high blood pressure
www.femhealth.com: heart disease, cancer, diabetes, arthritis pain

Your products are not generally recognized as safe and effective for the above referenced conditions and therefore, the products are also "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 "New Sun NKC-C Agaricus Blazei capsules," "New Sun NKC-C Agaricus Blazei Super Concentrate Vial," "New Sun Green Tea," "New Sun Grape Seed Extract," "New Sun LIV Combination," "New Sun Flax Seed Oil," "New Sun Super Sam (Super Sam Generic Samento, Cat's Claw)," "New Sun Vital PR. & BR." and "New Sun Yew/Olive Combination" are also misbranded within the meaning of section 502(f)(1) of the Act, in that labeling for these drugs fail to bear adequate directions for use [21 U.S.C. § 352(0(1)].

The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. The disease claims for other products marketed on your websites are too numerous to mention in this letter. 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 products 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 for causing violations of the Act [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 Philip S. Campbell, Compliance Officer, at the address noted in the letterhead. If you wish to discuss this letter, you should contact Mr. Campbell at (404) 253-1280.

Sincerely,

/S/

Mary Woleske, Director
Atlanta District

cc:
Cecilia Salvadori, President
New Sun, Inc.
215 Linda Vista Dr.
Hendersonville, NC 29792

cc:
Associate Director
Division of Advertising Practices
Federal Trade Commission
600 Pennsylvania Avenue, N.W.
Washington, D.C. 20580

This page was posted on July 19, 2010.

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