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U.S. Department of Health and Human Services

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Enforcement Actions

USA Golden Vision, Inc. 21-May-08

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

Public Health Service
Food and Drug Administration

 

Los Angeles District
19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900


WARNING LETTER


CERTIFIED MAIL
RECEIPT REQUESTED

May 21, 2008

W/L 12-08

David Tan
Paul Brucato
USA Golden Vision, Inc
2211 S. Hacienda Blvd, Suite 100H
Hacienda Heights, CA 91745-4637

2862 Antisana Pl
Hacienda Heights, CA 91745-5301

Dear Mr. Tan and Mr. Brucato:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.alternative2cancer.com and has determined that the products "SunRecome in Packets" and "SunRecome in Capsules" 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 the products with these claims violates the Act.

Examples of some of the claims observed on your website include:

SunRecome in Packets and SunRecome in Capsules

• "[C]an destroy the enzyme in DNA responsible for cancer cells--without harming healthy cells."

• "[A]nti-tumor product, now known as SunRecome."

• "SunRecome is the only lingzhi product approved by the Chinese FDA for cancer treatment."

• "SunRecome' . . . means 'double excellence' in Chinese, because the product has been shown to inhibit tumor cells while protecting normal body functioning."

• "Newly diagnosed cancer patients take two to four packets each day while undergoing chemotherapy or radiation treatments. Mid- to late-stage cancer patients take four to six packets each day. All clinical patients report marked improvement within 14 days of product use. When patients are free of cancer cells, they continue using SunRecome for four to six months."

• "SunRecome™ helps minimize the toxic side effects of chemotherapy and radiation therapy."

Further, the "Technical Articles" page of your website cites a number of articles about hum an and animal studies of your SunRecome products or their ingredients. With one exception, these articles concern the use of the products or their ingredients for treatment or prevention of cancer and other diseases. Each citation contains a link to the full text of the article, and the webpage invites visitors to read the articles for "details about the health benefits of SunRecome."

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 SunRecome for disease treatment and prevention on your website:

• "Antitumor and Anti-angiogenic Activity of Ganoderma Lucidum Polysaccharides Peptide."
• "Anti-tumor and Immunoregulatory Activities of Ganoderma Lucidum and its Possible Mechanisms:"
• "Antitumor Activity of Ganoderma Lucidum."
• "Chinese Herb Found Effective in Controlling Liver Cancer."
• "Status of Ganoderma Lucidum in United States: Ganoderma Lucidum as an Anti-inflammatory Agent."
• "Role of Ganoderma Supplementation in Cancer Management."
• "Mushrooms May Work Wonders in Cancer Treatment and Prevention."

The reference citations and other claims quoted above are supplemented by the metatags used to bring consumers to your website through Internet searches. The metatags include "cancer treatment," "prostate cancer," "breast cancer," "lung cancer," "colon cancer," "cervical cancer," "liver cancer," "ovarian cancer," "bladder cancer," "thyroid cancer," "kidney cancer," "brain cancer," "stomach cancer," "throat cancer treatment," "alternative cancer treatment," "new treatment cancer herbal treatment," "natural cancer treatment," "cancer pain treatment," "cancer complementary treatment," and "cancer treatment research."

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 "SunRecome in Packets" and "SunRecome in Capsules" 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 another web site you operate (www.goldvitamins.com), 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 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 response should be sent to Pamela B. Schweikert, Director, Compliance Branch, U.S. Food and Drug Administration, Los Angeles District Office, 19701 Fairchild Road, Irvine, CA 91612. If you have any questions about this letter, please contact Compliance Officer MaryLynn Datoc at (949) 608-4428.

Sincerely,

/S/

Alonza E. Cruse
District Director
Los Angeles District

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

Jeff Farrar, DVM, PhD, MPH
Food and Drug Branch
1500 Capitol Ave., MS-7602
P.O. Box 997413
Sacramento, CA 95899-7413