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U.S. Department of Health and Human Services

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Enforcement Actions

Vitasalus, Inc. 03-Jun-08

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

Public Health Service
Food and Drug Administration

 

Detroit District
300 River Place
Suite 5900
Detroit, MI 48207
Telephone: 313-393-8100
FAX: 313-393-8139


CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER
2008-DT-08

June 3, 2008

Robert Cloutier
Nu-Gen Nutrition, Inc
Vitasalus. Inc
Equinox Products, LLC
1301 Rankin Dr
Troy, MI 48083

Dear Mr. Cloutier:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your websites at the Internet addresses www.cancerchoices.com, www.equinoxproducts.com, www.nu-gen.com, www.squalamine.com, www.rationalwellnessgroup.com and www.vitasalus.com and has determined that the products "Ocean Treasure Coral Calcium,""Colostrum," "Electrolyte Formula (Cantron)," "Ellagenol," "Squalamax," "Ultramarine Omega-3TM Virgin Salmon Oil Gelcaps" and "Ultramarine Shark Liver Oil" 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 websites include:

Colostrum

• "Lactoferrin [listed as one of the components of colostrum on www.squalamine.com]
- an antiviral, anti-bacterial, anti-inflammatory ... protein with therapeutic effects in cancer..."

• "According to Clark and the well-known naturopathic physician, Dr. Bernard Jensen colostrum has a therapeutic role to play in ... cancer...." [reference omitted]

• "Medical studies show Colostrum: ... [i]s rich in TgF-B which supports Cancer therapy...."

• "Lactoferrin has similarly been reported to possess anti-cancer activity."

• "The mix of immune and growth factors in colostrum can inhibit the spread of cancer cells." "Colostrum Lactalbumin has been found to be able to cause the selective death (papooses) of cancer cells, leaving the surrounding non-cancerous tissues unaffected" [reference omitted]

• "Bovine colostrum contains TgF-B which . . .[i]nhibits cell growth of human Osteosarcoma (cancer) cells (75% inhibition)." [citing Drs. Tokuyama and Tokuyama; Cancer Research Inst. Kanazawa Univ. Japan]

Further, the "References" section of the Colostrum page of your website cites a number of articles about studies of your Colostrum products or their ingredients. These articles concern the use of the products or their ingredients for treatment or prevention of diseases. 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 Colostrum for disease treatment and prevention on your website:

• Majumdar, A.S., et al., Protective properties of anti-cholera antibodies in human colostrum. Infect. Immun 1982. 36:p. 962965

• "Stephan, W., et al., Antibodies from colostrum in oral immunotherapy. J. Clin. Chem. Clin. Biochem. 1990. 28: p. 19-23."

• "Kohl, S. et al., Human colostral cytotoxicity: antibody-dependent cellular cytotoxicity against herpes simplex infected cells mediated by colostral cells. Journal of Clinical Laboratory Immunology, 1, pp. 221-224."

Ellagenol

• (Under the heading "Frequently Asked Questions About Ellagenol") "The Raspberry Revolution - The miracle berry that helps fight cancer"

• "Influential scientists such as Dr. Daniel Nixon of the Hollings Cancer Institute (Medical University of south Carolina, USA).... ha[ve] shown that cancer cells (of many types) exposed to ellagic acid levels corresponding to specific amounts of eating fresh raspberries underwent a natural cell death.... Dr. Nixon has also shown that human cervical cells infected with human papilloma virus ... are also killed by the same concentration of ellagic acid. This is important because human papilloma viruses are considered to be the main cause of cervical cancer."

Electrolyte formula (Cantron)

• "[T]housands of people have taken [Cantron] . . .[and the cure rate is reported to be as high as 80% ("cure" meaning one of two things: The total disappearance of cancell [sic] symptoms. and traces of cancer cells or five years survival with an excellent quality of life)."

An example of a claim observed on your websites in the form of a testimonial is:

• "My Oncologist said in June of 2003 that I have up to 2 years if I do nothing, or up to 5 years if I let him take out the bottom lobe of my right lung. I decided to take Cantron first. My last spiral cat scan in Sept. only shows scar tissue where the tumor was..."

Squalamax

• "Squalamine destroyed the tumor spreading ability in rabbits by suppressing the growth of new blood vessels needed to support the growth of tumors. Squalamine halted the growth of brain tumors in rats and prolonged the lives of the laboratory animals. At the 1996 annual meeting of the American, Association of Neurological Surgeons in Minneapolis, Dr. Brem commented, 'Our findings present evidence that squalamine may work against brain cancer.' Preliminary studies with certain brain cancer cells (glioma) have been encouraging, and the group plans clinical studies by the second half of 1998."

• "Squalamine, found in shark liver oil, blocks "the in growth of blood vessels into a tumor, and therefore, it block's [sic] the tumor's growth- not because it kills the tumor cells, but it simply cuts off their blood supply if you will" .... Dr. Allen Sill, Johns Hopkins University."

• "Possible benefits of Squalamax: brain tumors, breast tumors, prostate tumors, colon tumors ..."

Ultramarine Omega-3™ Virgin Salmon Oil Gelcaps

• "Ultramarine Omega-3 Virgin Salmon Oil Gelcaps has been reported to help humans, pets; and other animals with the following: . . . Cancer . . . ."

Ultramarine Shark Liver Oil

• "Our research has shown that shark liver oil has a much higher concentration of squalamine, and alkylglycerols than shark cartilage has. These are the active ingredients against cancer" . . . . *Dr Richard Passwater and Neil Solomon, M.D., Ph.D Shark Liver Oil"

In addition, your websites equinox-products.com and cancerchoices.com use a description of the book Shark Liver Oil: Nature's Ainazing Healer, which you also sell, to promote Ultramarine Shark Liver Oil for treatment of cancer. Both Ultramarine Shark Liver Oil and the book are described and offered for sale adjacently on your equinoxproducts.com and cancerchoices.com websites. Clicking, the "Order" icon on the equinox-products.com page takes customers to another page where they can order both the shark liver oil product and the book. which describes the purported efficacy of shark liver oil as a treatment for cancer and other diseases. Clicking on one of the links for your Ultramarine Shark Liver Oil products on your cancerchoices.com website takes customers to another page where they can order the shark liver oil product and the book, which is listed under "Related Item(s). "The description of the book on your webpages is clearly intended to describe the intended use of Ultramarine Shark Liver Oil. For example, the description of the book on your webpage says that it is "[f]illed with documented studies and remarkable case histories--including testimonials from ... cancer patients whose lives were literally transformed through the use of Shark Liver Oil treatments . . . ." Because of the manner in which Ultramarine Shark Liver Oil and the book are co-promoted on your websites, the book is evidence of the product's intended use as a cancer treatment drug and is considered labeling for the product. See 21 U.S.C. § 321(m); Kordel v. United States, 335 U.S. 345 (1948).

Ocean Treasure Coral Calcium

• "Up to 150 diseases have been linked to Calcium Deficiency . . . cancer . . . "

The claims quoted above are supplemented by the metatags used to bring consumers to your websites through Internet searches. The metatags include "cancer markers," "uterine cancer," "ovarian cancer," and "pancreatic cancer."

Your products are not generally recognized as safe and effective for the above referenced conditions and therefore, the products are "new drttgs" 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 "Ocean Treasure Coral Calcium," "Colostrum," "Electrolyte Formula (Cantron)," "Ellagenol," "Squalamax," "Ultramarine Omega-3 TM Virgin Salmon Oil Gelcaps" and "Ultramarine Shark Liver Oil" 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 websites, we noticed that you were promoting other products for disease treatment and/or prevention. 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 webs-ites, 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 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 response should be directed to Judith A. Putz, Compliance Officer at the address above.

Sincerely,

/S/

Joann M. Givens
District Director
Detroit District Office