Warning Letter to McAdam Health Enterprises

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 Deep Tissue Black Salve and deep tissue salves have been used on skin cancers, melanomas, carcinomas, basi[a]1 cells, squamous cells, sarcomas and tumors successfully for years."
"This product is virtually identical to our standard product (Cansema Black Topical Salve), except for the addition of emu oil and pharmaceutical-grade DMSO (USP) . . . to increase the transdermal properties of our regular Cansema for applications where greater depth through the dermal layers is either desireable [sic] or necessary."
"Growths which are on or near any layers of the epidermis (stratum corneum to stratum germinativurn) or dermis (down to the reticular dermis) should still be treated with the regular Cansema product; growths which are found in the hypodermis or underlying tissue will probably require the enhanced transdermal character of this product [Cansema Salve Deep Tissue] to produce favorable results."

Cansema Black Salve

"Black Salves with bloodroot and zinc chloride have been used for years as an alternative treatment for Skin Cancer. Black salve ointment and deep tissue salves have traditionally over the years been used as an alternative for treating skin cancers, melanomas, carcinomas, basi[a]1 cells, squamous cells, sarcomas and tumors."

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

"Bla-Cansema and Hoxy Type Salve with Iodine has a level of transdemiic action that exceeds that of the original formula—but not Bla-Cansema and Hoxv Type Salve - Deep Tissue."
"Bla-Cansema Hoxy Type Black Salve with Lugol's Iodine salves have been used on skin cancers, melanomas, basil [sic] cells, squamous cells, sarcomas and tumors successfully for years."

Bla-Can Black Salve

"This salve doesn't sting the skin as bad as the Cansema type of salves . It still has the salve anti-cancer and tumor characteristics."

Bla-Cansema Type Black Salve For Pets

"Bla-Cansema Black Salve for Pets has been used on skin cancers, melanomas, carcinomas, basil [sic] cells, squamous cells, sarcomas and tumors successfully for years."
"Also, for larger growths (in excess of 1 cm. in cats and dogs; 3 cm. in horses), you may wish to consult with your veterinarian to obtain analgesics (pain killers) to make the early stages of Bla-Cansema use easier for your animal."

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 :

"Bla-Cansema Capsules, Bla-Cansema Tonics, Bla-Can Capsules and Bla-Can Tonics have been used as treatment alternatives for lymphoma, leukemia, breast cancer, brain cancer, lung cancer, brain cancer, skin cancer, kidney cancer, pancreatic cancer, prostate cancer and numerous other forms of cancer."
"Below we list the important herbs which are the basis of the botanical extracts contains in our internal Bla-Cansema products.

Chapparral . . . chapparral's secret is . . . a substance known as NDGA . . . This organic antioxidant is the basis of several recent cancer cures. . .

Red Clover . . . A tea made from red clover blossoms has been widely reported to help reduce tumor size in a great many people ."

"Bloodroot . . . shown antiseptic, anesthetic and anticancer activity . American Indians used the root for . . . astthma, bronchitis, lung ailments, laryngyitis [sic] and fevers."

"Cat's Claw . . . From cancer and aids [sic] to the common cold, Cat's claw has proven effective for many people's needs.

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,