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U.S. Department of Health and Human Services

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Enforcement Actions

NaturesAlternatives.com 02-Jun-08

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

Public Health Service
Food and Drug Administration

 

19701 Fairchild
Irvine, CA 92612-2506




WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

June 2, 2008

W/L 17-08

NaturesAlternatives.com
13980 W. Bell Road
Suite 11-488
Surprise, AZ 85374-3800

Dear Sir or Madam:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your websites at the Internet addresses www.naturesalternatives.com and www.essiacformula.com and has determined that the products "African Pygeum Bark," "Brazilian Pau d'Arco Bark," "Burdock Root," "Chinese Astragalus Root," "Chinese Fo-Ti Root," "Chinese Ligustrum (Privet) Fruit," "Cleavers Flowering Herb," "Fresh Venus Flytrap," "Indian Turmeric Rhizome," "Japanese Maitake Mushroom," "Peruvian Cat's Claw Bark (Una de gato)," "Red Reishi Mushroom," "Sheep Sorrel Herb," "Shiitake Mushroom," "Stillingia Root," "Hoxsey's Red Clover/Burdock Plus," "Immun-Essence™ Plus," "Mai-T Mushroom Plus," "Venus' Flytrap/Cat's Claw 50/50," "Native Essense Original™ Dry Tea," "Native Essense™ Plus Dry Tea," "Native Essense™ with Cat's Claw Dry Tea," "Native Essense™ Original Liquid Extract," "Native Essense™ Plus Liquid Extract," "Native Essense™ with Cat's Claw Liquid Extract," "American Ginseng/Kava Kava Plus," "Astragalus/Ligustrum 75/25," "Bilberry/Schizandra Plus," "Black Walnut/Wormwood Plus," "Cat's Claw/Astragalus/Reishi," "Cat's Claw/Pau d' Arco Plus," "Catuaba/Fo-Ti Plus," "Damiana™ Plus," "Dandelion/Milk Thistle Plus," "Devil's Claw/Cat's Claw Plus," "Dong Quai/Fo-Ti Plus," "Echinacean™ Plus," "Gravel Root/Uva Ursi Plus," "Laxa-Tonic™ Plus," "Milk Thistle/Schizandra Plus," "Panax Power Plus™ Ginseng Tonic," "Prosta-Tonic™ Plus," "Red Root/Cleavers Plus," "Slim-Tonic™ Plus," and "SumaCeps™ Plus" 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 these products with these claims violates the Act.

Examples of some of the claims observed on your websites include:

Single Extracts

African Pygeum Bark

• "Also used for . . . cancer of the prostate."

Brazilian Pau d' Arco Bark

• "Scientific studies also show that the active ingredient of Pau d'arco, lapachol, can inhibit tumor growth. It has also been used in healing diseases such as arthritis, asthma, diabetes, gonorrhea, hemorrhage . . . infection, liver ailments, lupus, Parkinson's disease . . ."

Burdock Root

• "Experiments on burdock have shown it to inhibit tumors . . . ."

• "[T]wo Hungarian scientists reported 'considerable anti-tumor activity' in a purified fraction of burdock."

Chinese Astragalus Root

• "[A]stragalus is considered a deep immune tonic that increases . . . the body's ability to produce more immune effector cells (such as T-cells), protecting us from 'pathogens.'"

• "Astragalus root has also been indicated as an aid in the side effects of chemotherapy as well as having the ability to inhibit tumor growth. If taken cumulatively.... it shows marked anti-tumor properties."

Chinese Fo-Ti Root

• "Chinese Medicine also indicates Fo-Ti as . . . being useful for . . . cancer . . . ."

Chinese Ligustrum (Privet) Fruit

• "In Traditional Chinese Medicine, ligustrum is often combined with astragalus root to combat . . . many degenerative ailments such as cancer . . ."

Cleavers Flowering Herb

• "[U]seful in the treatment of ulcers and tumors . . . ."

Fresh Venus Flytrap

• "[A] standardized solution of this plant is used in the treatment of chronic diseases, including most forms of cancer . . . ."

• "In cases of cancer, its proponents claim it works therapeutically to shrink solid tumors . . . ."

Indian Turmeric Rhizome

• "Recent investigations suggest that curcuminoids may be active in the external treatment of certain cancerous conditions . . . ."

Japanese Maitake Mushroom

• "A Maitake extract is being studied in medical clinics in the U.S. for patients with breast and colorectal cancers."

• "In China, an extract of this mushroom demonstrated an anti-cancer effect in 63 patients with lung, stomach, hepatocellular cancers and leukemia."

• "Maitake is said to aid in cancer prevention, immune stimulation in people with cancer .... "

Peruvian Cat's Claw Bark (Una de gato)

• "Studies beginning in 1970 and continuing through today suggest it has applications in the treatment of cancer, arthritis, gastritis, ulcers, rheumatism . . . organic depression, bursitis, genital herpes and herpes zoster, allergies, systematic candidiasis, diabetes, lupus, chronic fatigue syndrome . . . numerous bowel and intestinal disorders and those infected with the HIV virus."

Red Reishi Mushroom

• "Here is a small list of some of the things it is claimed to benefit. Cancer, side effects of cancer treatments including radiation, chemo-therapy and surgery . . . ."

Sheep Sorrel Herb

• "Throughout the centuries, the sorrels have appeared in historical archives as a folk remedy for cancer in both Europe and America. In the late 1740's, legislation was introduced in Williamsburg, Virginia that permitted Mrs. Mary Johnson to use this plant as a treatment for cancer."

• "In 1926, the National Cancer Institute received a recipe from Canada citing an old Indian cure for cancer using a paste made with bread and the juice of sheep sorrel, applied externally. Thus, it would appear from early literature that the sorrels were used to treat cancer."

• "Sorrel contains a high amount of nutrients including chlorophyll. . . . The chlorophyll molecules that carry oxygen through the bloodstream may . . . inhibit chromosome damage to effectively block cancer . . . ."

Shiitake Mushroom

• "Shiitake is used for any and all diseases involving depressed immune function, including cancer, AIDS . . . ."

• "It contains a polysaccharide-protein complex that studies have shown to: accelerate degeneration of tumor cells . . . ."

Stillingia Root

• "American Eclectic physicians in the 19th century used it as a treatment for syphilis, tuberculosis and cancer . . . . "

According to your website www.naturesalternatives.com, your "American Ginseng/Kava Kava Plus," "Astragalus/Ligustrum 75/25," "Bilberry/Schizandra Plus," "Black Walnut/Wormwood Plus," "Cat's Claw/Astragalus/Reishi," "Cat's Claw/Pau d' Arco Plus," "Catuaba/Fo-Ti Plus," "Damiana™ Plus," "Dandelion/Milk Thistle Plus," "Devil's Claw/Cat's Claw Plus," "Dong Quai/Fo-Ti Plus," "Echinacean™ Plus," "Gravel Root/Uva Ursi Plus," "Hoxsey's Red Clover/Burdock Plus," "Immun-Essence™ Plus," "Laxa-Tonic™ Plus," "Mai-T Mushroom Plus," "Milk Thistle/Schizandra Plus," "Panak Power Plus™ Ginseng Tonic," "Prosta-Tonic™ Plus," "Red Root/Cleavers Plus," "Slim-Tonic™ Plus," and "SumaCeps™ Plus," and "Venus' Flytrap/Cat's Claw 50/50," as well as all of your Native Essense™ products, contain one or more of the single extracts listed above. As described above, your website lists numerous disease claims for these ingredients.

Formulas

Hoxsey's Red Clover/Burdock Plus

• "Hoxsey's Herbs Heal Cancers"

• "According to eminent botanist James Duke Ph.D., of the U.S. Dept. of Agriculture, all of the Hoxsey herbs have known anti-cancer properties. . . .[f]urthermore, Duke noted, the Hoxsey herbs have long been used by Native American healers to treat cancer . . . ."

• "Medical historian Patricia Spain Ward . . . noted that 'orthodox scientific research has by now identified anti-tumor activity' in most of Hoxsey's plants."

Immun-Essence™ Plus

• "Indicated in all chronic viral infections and auto-immune imbalances such as environmental allergies, candida infections, chronic fatigue syndrome, Epstein-Barr . . . HIV and related immune disorders. Many degenerative diseases such as cancer also fall into this category."

Mai-T Mushroom Plus

• "The benefits shown by clinical trials performed on these mushrooms . . . include: the ability to inhibit many types of tumors . . . aid in cancer prevention . . . support people undergoing chemotherapy . . . ."

• "The Japanese government has officially listed Reishi as an adjunct herb for cancer and clinical reports seem to indicate its usefulness for people that are HIV positive, as well as for those who have Epstein-Barr Virus . . . . "

Venus' Flytrap/Cat's Claw 50/50

• "In Germany, a pharmaceutical extract of Venus' Flytrap is used in the treatment of chronic diseases, including most forms of cancer, ulcerative colitis, multiple sclerosis, all types of herpes infection, chronic arthritis and almost any immune deficiency, including AIDS. Studies of Cat's Claw beginning in the 70's and continuing through today suggest that it has applications in the natural therapy of cancer . . . ."

Native Essense™ Products

Native Essense™ Original Dry Tea, Native Essense™ Plus Dry Tea, Native Essense™ with Cat's Claw Dry Tea, Native Essense™ Original Liquid Extract, Native Essense™ Plus Liquid Extract, Native Essense™ with Cat's Claw Liquid Extract

• "Thousands of people over the years have testified that Rene Caisse's formula has cured their cancer, diabetes, ulcers and many other ailments."

Examples of claims in the form of testimonials include:

• "I was battling lymphoma for 10 years . . . I began taking Native Essense™ Plus and began feeling better right away. After 4 months my blood was normal . . . I still take the Native Essence™ Plus everyday and have now been in remission for over a year."

• "I am glad my wife is taking these herbs (Native EssenceTM tea) . . . . [T]he cancer cells in her blood stream went from 10 to 1.05."

• "My PSA count went down from 6.4 to 3.9 after 3 months and the only thing I did differently was to take the Native Essence™ with Cat's Claw formula."

• "I had colon and rectal cancer and they could do no more for me . . . I could take the radiation no more and they told me the chemo was not reaching the tumor. I started on Native Essence™ . . . a large tumor was expelled and after that about five more smaller ones."

Further, the "Hoxsey's Herbs Heal Cancers" page of your website www.naturesaltematives.com cites a number of publications about your Hoxsey's Red Clover/Burdock Plus product and its ingredients. Many of these publications concern the use of this product and its ingredients for treatment or prevention of cancer. 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 your Hoxsey's Red Clover/Burdock Plus product, as well those ingredients in this product that you market as single extracts, for disease treatment and prevention on your website:

Options: The Alternative Cancer Therapy Book by Richard Walters: 1993, Avery Publishing Group, $13.95 paperback, 120 Old Broadway, Garden City Park, NY 11040.
The Cancer Survivors and How They Did It, by Judith Glassman
• "Does Mildred Nelson Have an Herbal Cure for Cancer?" by Peter Barry Chowka, Whole Life Times, January-February 1984.

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 "African Pygeum Bark," "Brazilian Pau d' Arco Bark," "Burdock Root," "Chinese Astragalus Root," "Chinese Fo-Ti Root," "Chinese Ligustrum (Privet) Fruit," "Cleavers Flowering Herb," "Fresh Venus Flytrap," "Indian Turmeric Rhizome," "Japanese Maitake Mushroom," "Peruvian Cat's Claw Bark (Mia de gato)," "Red Reishi Mushroom," "Sheep Sorrel Herb," "Shiitake Mushroom," "Stillingia Root," "Hoxsey's Red Clover/Burdock Plus," "Immun-EssenceTm Plus," "Mai-T Mushroom Plus," "Venus' Flytrap/Cat's Claw 50/50," "Native Essense Original™ Dry Tea," "Native Essense™ Plus Dry Tea," "Native Essense™ with Cat's Claw Dry Tea," "Native Essense™ Original Liquid Extract," "Native Essense™ Plus Liquid Extract," "Native Essense™ with Cat's Claw Liquid Extract," "American Ginseng/Kava Kava Plus," "Astragalus/Ligustrum 75/25," "Bilberry/Schizandra Plus," "Black Walnut/Wormwood Plus," "Cat's Claw/Astragalus/Reishi," "Cat's Claw/Pau d' Arco Plus," "Catuaba/Fo-Ti Plus," "Damiana™ Plus," "Dandelion/Milk Thistle Plus," "Devil's Claw/Cat's Claw Plus," "Dong Quai/Fo-Ti Plus," "Echinacean™ Plus," "Gravel Root/Uva Ursi Plus," "Laxa-Tonic™ Plus," "Milk Thistle/Schizandra Plus," "Panax Power Plus™ Ginseng Tonic," "Prosta-Tonic™ Plus," "Red Root/Cleavers Plus," "Slim-Tonic™ Plus," and "SumaCeps™ Plus" 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. While reviewing your websites, we noticed that you were promoting many of the products listed above for the treatment and/or prevention of diseases other than cancer and that you were also promoting other products for disease treatment and/or prevention. The disease treatment and prevention claims on your websites that cause your products to be unlawful were too numerous to list 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 [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 written reply should be sent to:

Pamela Schweikert
Director, Compliance Branch
U.S. Food and Drug Administration
19701 Fairchild
Irvine, CA 92612-2506

If you have any questions regarding this letter, please contact MaryLynn Datoc, Compliance Officer, at 949-608-4428

Sincerely,

/S/

Alonza E. Cruse
Director
Los Angeles District