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Public Health Service
Food and Drug Administration
  19701 Fairchild Irvine, CA 92612-2506

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

June 2, 2008

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

WARNING LETTER
W/L 17-08

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

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

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

Immun-Essence™ Plus

Mai-T Mushroom Plus

Venus' Flytrap/Cat's Claw 50/50

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

Examples of claims in the form of testimonials include:

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:

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

This page was posted on July 19, 2010.

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