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

Public Health Service
Food and Drug Administration
Seattle District
Pacific Region

 


22201 23rd Drive SE
Bothell, WA 98021-3421
Telephone: 425-486-8788

April 6, 2006

VIA FED-EX

In reply refer to Warning Letter SEA 06-25

Ms. Greta Armstrong
Risingsun Health Alternatives and Herbs
Division of McAdam Health Enterprises
105 South 9th Street
Livingston, Montana 59047

WARNING LETTER

Dear Ms. Armstrong:

This letter concerns Cansema Salve Deep Tissue; Cansema Black Salve; Bla-Cansema Hoxy Type Black Salve w/Lugol's Iodine; Bla-Can Black Salve; Bla-Cansema Type Black Salve For Pets; Bla-Cansema Graviola Tonic III (capsules and liquid); Bla-Cansema Bloodroot Capsules; and Can-sema Bloodroot Internal Tincture marketed by Risingsun Health Alternatives, on your Internet websites www.risingsunhealth.com and www.bloodrootproducts.com.

According to these websites, the salve, capsules, and tonics are sold as topical and oral treatments for the various forms of cancers, heart disease, high blood pressure, diabetes, and numerous other life threatening diseases. Ordering instructions and a price list for the products are provided on the website. Consumers are directed to select the desired products and are provided with a secure payment processor to facilitate payment by credit card to Risingsun Health Alternatives.

The intended uses of Cansema Salve Deep Tissue; Cansema Black Salve; Bla-Cansema Hoxy Type Black Salve w/Lugol's Iodine; Bla-Can Black Salve; Bla-Cansema Type Black Salve For Pets; are conveyed on the Internet site. These include statements such as:

Cansema Salve Deep Tissue

Cansema Black Salve

Bla-Cansema Hoxy Type Black Salve w/Lugol's Iodine

Bla-Can Black Salve

Bla-Cansema Type Black Salve For Pets

The intended uses of BlaCansema Graviola Tonic III (capsules and liquid); Bla-Cansema Bloodroot Capsules; and Can-sema Bloodroot Internal Tincture are also conveyed on the Internet site. These include statements such as :

Based on the claims cited above, Cansema Salve Deep Tissue; Cansema Black Salve; Cansema Type Deep Tissue; Bla-Cansema Hoxy Type Black Salve w/Lugol's Iodine; Bla-Can Black Salve; Bla-Cansema Type Black Salve For Pets; Bla-Cansema Graviola Tonic III (capsules and liquid); Bla-Cansema Bloodroot Capsules; and Cansema Bloodroot Internal Tincture are "drugs" as defined by 21 U.S.C. § 321(g). Moreover, all of these products are either "new drugs" or "new animal drugs" as defined by 21 U.S.C. § 321(p) and 21 U.S.C.§ 321(v) respectively, because there is no evidence that they are generally recognized as safe and effective for the intended uses conveyed in their labeling.

Furthermore, Cansema Salve Deep Tissue; Cansema Black Salve; Bla-Cansema Hoxy Type Black Salve w/Lugol's Iodine; and Bla-Can Black Salve are topical products and cannot be dietary supplements because they are not intended for ingestion, but rather to bypass the alimentary canal by direct absorption through the skin. The Act defines the term, "dietary supplement" in 21 U.S.C. § 321(ff)(2)(A)(i) to mean a product that is "intended for ingestion . . .." Consequently, topical products intended to enter the body directly through the skin or mucosal tissues are not "dietary supplements." For these products, both disease and structure/function claims cause them to be new drugs.

Under 21 U.S.C. § 355(a), a "new drug" may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved drug application is in effect for the drug. The distribution of Cansema Salve Deep Tissue; Cansema Black Salve; Bla-Cansema Hoxy Type Black Salve w/Lugol's Iodine; Bla-Can Black Salve; Bla-Cansema Graviola Tonic III (capsules and liquid); Bla-Cansema Bloodroot Capsules; and Can-sema Bloodroot Internal Tincture; are in violation of 21 U.S.C. § 355 and prohibited by 21 U.S.C. § 331(d). The Bla-Cansema Type Black Salve For Pets is adulterated under 21 U.S.C. § 351(a)(5), because it is unsafe under 21 U.S.C. § 360b, since it is a new animal drug and there is no FDA-approved new animal drug application in effect for the drug.

In addition, Cansema Salve Deep Tissue; Cansema Black Salve; Bla-Cansema Hoxy Type Black Salve w/Lugol's Iodine; Bla-Can Black Salve; Bla-Cansema Graviola Tonic III (capsules and liquid); Bla-Cansema Bloodroot Capsules; and Can-sema Bloodroot Internal Tincture are misbranded under 21 U.S.C. § 352(f)(1) because their labeling fails to bear adequate directions for the uses for which they are being offered, and they are not exempt from this requirement under 21 CFR § 201.115.

The violations described above are not intended to be an all-inclusive list of your firm's deficiencies. It is your responsibility to ensure that all drug products manufactured and distributed by your firm comply with federal laws and regulations. Federal agencies are advised of the issuance of all warning letters about drugs and devices so that they may take this information into account when considering the award of contracts.

You should take prompt action to correct the listed violations. Failure to do so may result in regulatory action without further notice. Possible actions include seizure, injunction, and/or prosecution.

You must notify this office in writing within 15 working days of receipt of this letter as to the steps that you have taken to correct the above-listed violations, and the steps taken to assure that similar violations will not recur. If corrective action can not be completed within 15 working days, state the reason for the delay and the time within which the corrections will be made. Further, if your firm does not manufacture the products, your reply should also include the name and address of the manufacturer. If the firm from which you receive the products is not the manufacturer, please include the name of your supplier, in addition to the manufacturing firm.

Your response should be directed to the Food and Drug Administration, Seattle District Office, 22201 23rd Drive SE, Bothell, Washington, 98021-4421, to the attention of Lisa M. Althar, Compliance Officer.

Sincerely,

/s/
Charles M. Breen
District Director

This page was posted on May 3, 2006.

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