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U.S. Department of Health and Human Services

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Enforcement Actions

Tattva's Herbs, LLC 09-Jul-08

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

Public Health Service
Food and Drug Administration

 

Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 98021-4421
Telephone: 425-486-8788
FAX: 425-483-4996


July 9, 2008

VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED

In reply refer to Warning Letter SEA 08-25

Peter Bowes
Tattva's Herbs, LLC
902 NE 65th St. Suite D
Seattle, Washington 98115

WARNING LETTER

Dear Mr. Bowes:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.tattvasherbs.com and has determined that the products "Body Pure," "Evening Primrose Oil," "Female Plus," "Organic Ashwagandha," "Organic Mucuna," "Organic Neem," "Premium Turmeric - BCM95 BioCurcumin," "Turmeric Extract - Bulk," "Turmeric Plus," "Prostate Support," and "Organic Ghee" 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 website 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 web site include:

Body Pure

  • "[E]ffective in treating and preventing ... cancer."

  • "[Body Pure h]as anti-cancer ... properties:"

  • "Turmeric [an ingredient in the product] is so powerful that the National Institute of Cancer is developing it as cancer preventive."

Evening Primrose Oil

  • "EPO has been used with some preliminary success in some cancers, principally cerebral gliomas."

Female Plus

  • "This potent formula contains Shatavari .... Shatavari is also know [sic] as Asparagus racemosus .... Asparagus is useful in Cancer ...."

Organic Ashwagandha

  • "Herbal Actions: ... anti-tumor, and anti-cancer."

  • "Aswagandha can be useful for patients with cancer who are being treated with standard chemotherapy."

Organic Mucuna

  • "Traditional uses: ... cancer ... tumors ...."

Organic Neem

  • "Neem products are used for treatment of a whole gamut of diseases, including skin infection, cardiovascular disorder, diabetes and cancer." [citation omitted]

Premium Turmeric - BCM95 BioCurcumin

  • "A wealth of data shows that curcumin and its related chemicals (collectively known as curcuminoids) help to prevent and fight a wide range of diseases--from cancer to cardiovascular disease--through a variety of mechanisms. These include powerful ... chemopreventive (cancer-preventive), and antineoplastic (cancer-fighting) properties." [references omitted]

  • "Properties of Turmeric ... Anti Cancer Activity ..."

  • "Curcuminoids which are found within Turmeric ... may benefit both cancer and aids [sic] patients."

  • "Preferred choice of Seattle Cancer Treatment and Wellness Center."

  • "New research shows that turmeric--and its main bioactive compound, curcumin-has the power to block inflammation, stop cancer, kill infectious microbes ...."

  • "Cancer-Fighting Capabilities Documented: Numerous studies published in peer-reviewed journals detail curcumin's ability to protect against cancer. The National Institute of Cancer is currently spending significant dollars in studying the positive affects [sic] that Turmeric may have both in the prevention of cancer and in the recovery from cancer. New studies indicate it maybe effective in helping the recovery from chemotherapy and radiation treatment. In addition to its capacity to intervene in the initiation and growth of cancer cells and tumors and to prevent their subsequent spread throughout the body by metastasis-curcumin also has been shown to increase cancer cells' sensitivity to certain drugs commonly used to combat cancer, rendering chemotherapy more effective in some cases."

  • Turmeric Extract - Bulk

  • "Properties of Turmeric ... Anti Cancer Activity ..."

  • "Curcuminoids which are found within Turmeric ... may benefit both cancer and aids [sic] patients."

  • "Preferred choice of Seattle Cancer Treatment and Wellness Center"

  • "New research shows that turmeric--and its main bioactive compound, curcumin - has the power to block inflammation, stop cancer, kill infectious microbes ...."

  • "Cancer-Fighting Capabilities Documented: Numerous studies published in peer-reviewed journals detail curcumin's ability to protect against cancer. The National Institute of Cancer is currently spending significant dollars in, studying the positive affects [sic] that Turmeric may have both in the prevention of cancer and in the recovery from cancer. New studies indicate it may be effective in helping the recovery from chemotherapy and radiation treatment. In addition to its capacity to intervene in the initiation and growth of cancer cells and tumors - and to prevent their subsequent spread throughout the body by metastasis-curcumin also has been shown to increase cancer cells' sensitivity to certain drugs commonly used to combat cancer, rendering chemotherapy more effective in some cases."

Turmeric Plus

  • "Properties of Turmeric ...Anti Cancer Activity ..."

  • "Curcuminoids which are found within Turmeric ... may benefit both cancer and aids [sic] patients."

  • "Preferred choice of Seattle Cancer Treatment and Wellness Center"

  • "New research shows that turmeric--and its main bioactive compound, curcumin-has the power to block inflammation, stop cancer, kill infectious microbes ...."

  • "Cancer-Fighting Capabilities Documented: Numerous studies published in peer-reviewed journals detail curcumin's ability to protect against cancer. The National Institute of Cancer is currently spending significant dollars in studying the positive affects [sic] that Turmeric may have both in the prevention of cancer and in the recovery from cancer. New studies indicate it maybe effective in helping the recovery from chemotherapy and radiation treatment. In addition to its capacity to intervene in the initiation and growth of cancer cells and tumors-and to prevent their subsequent spread throughout the body by metastasis-curcumin also has been shown to increase cancer cells' sensitivity to certain drugs commonly used to combat cancer, rendering chemotherapy more effective in some cases."

Furthermore, the "Premium Turmeric - BCM95 BioCurcumin," "Turmeric Extract - Bulk" and "Turmeric Plus" pages of your website provides links to studies and articles about human and animal studies of turmeric for treatment and prevention of various diseases, including cancer. The webpage notes that these articles describe "The Benefits of Turmeric." These links to various studies and articles are evidence of the product's intended use.

The following are examples of links used to market "Premium Turmeric - BCM95 BioCurcumin," "Turmeric Extract - Bulk" and "Turmeric Plus" for disease treatment and prevention on your website:

  • "Turmeric fights breast cancer in mice"

  • "Ongoing clinical studies involving turmeric and cancer"

Prostate Support

  • "Each Capsule contains Saw Palmetto .... Saw Palmetto reduces the risk of Prostate Cancer ...."

  • "The Myristoleic Acid content of Saw Palmetto also directly stimulates the apoptosis and necrosis of Prostate Cancer cells."

Organic Ghee

  • "Benefits of Ghee in the Ayurvedic Science: ... It contains butyric, a fatty acid with antiviral and anti-cancer properties."

The claims quoted above and other evidence of intended use are supplemented by the metatags that you use to bring consumers to your website through Internet searches: The metatags include "cancer treatment" and "alternative cancer treatment."

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 "Body Pure," "Evening Primrose Oil," "Female Plus," "Organic Ashwagandha," "Organic Mucuna," "Organic Neem," "Premium Turmeric - BCM95 BioCurcumin," "Turmeric Extract - Bulk," "Turmeric Plus," "Prostate Support," and "Organic Ghee" 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(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 website, we noticed that you were promoting 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 unlawful disease treatment and prevention claims on your website 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 website, 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.

The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334]. 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.

Please send your written reply to the Food and Drug Administration, Attention: Michael J. Donovan, Compliance Officer, 22201 23rd Drive SE, Bothell, WA 98021-4421. If you have any questions regarding this letter, please contact Mr. Donovan at (425) 483-4906.

Sincerely,

/S/

Charles M./Breen
District Director

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