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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Sun Farm Corporation 21-Jun-06

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

Public Health Service
Food and Drug Administration

 

New England District
One Montvale Avenue
Stoneham, MA 02180
(781) 596-7700
FAX: (781) 596-7896




WARNING LETTER
NWE-16-06W

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

June 21, 2006

Alexander S. Sun, PhD
Sun Farm Corporation
215 Research Drive
Milford, CT 06460

Dear Dr. Sun:

This letter concerns your firm's marketing of the product "Sun Farm Vegetable Soup (SV)," sold as "Freeze-dried SV (DSV)" and "Frozen SV (FSV)," on your website, www.sun.farmcotp.com. According to information on your website, Sun Farm Vegetable Soup is intended to prevent, treat, or cure disease conditions . Statements on your website that document these intended uses include, but are not limited to, the following:

Sun Farm Vegetable Soup (DSV and FSV)

  • "SV's strong anti-cancer activity was demonstrated not just in the murine tumor model, but also in humans. "

  • "NIH Will Consider Funding Strategies for Dr. Sun's Chinese Herbal Anti-Cancer Therapy"

  • "Cure for Cancer in a Bowl of Soup "

  • "A Bowl of Chinese Vegetables a Day May Keep Tumors Away"

  • "Dr. Sun also reported that he had given the soup to a family friend who had three brain lesions. The lesions shrank, then disappeared."

  • "Before starting the soup, Jencks took a test to monitor any malignancy still active in her. They found that one out of the three markers showed low but measurable active malignancy. Six months later, all three markers were negative."

  • "Daily consumption of a soup containing herbs and vegetables used in traditional Chinese medicine was associated with tumor regression and prolonged survival in a pilot study of 14 patients with stage IIIb and IV non?[sic] small cell lung cancer."

  • "The ingredients in the freeze-dried soup contain components such as protease inhibitors, genistein, and isoflavones, which have recognized antitumor and immune-enhancing activities."

  • "SV was first developed for a Stage IV NSCLC patient who is now 83 years old and has been tumor free for the past 13 years."

  • These claims are further supplemented by the metatags that you use to bring consumers to your website. These metatags include "cancer," "anti-cancer," and "lung cancer."

Sun Farm Vegetable Soup is a drug, as defined by Section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. § 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Moreover, this product is a new drug, as defined by section 201(p) of the Act, 21 U.S.C. § 321(p), because it is not generally recognized as safe and effective for its labeled uses. Under sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of Sun Farm Vegetable Soup without such an approved application violates these provisions of the Act

Furthermore, because your product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use this product safely for its intended uses. See 21 CFR § 201.5. Thus, Sun Farm Vegetable Soup's labeling fails to bear adequate directions for its intended uses, causing it to be misbranded under Section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1).

Please refer to, your [redacted] for [redacted]. The label or labeling of an investigational new drug may not bear any statement that is false or misleading and may not represent that the investigational new drug is safe or effective for the purpose for which it is being investigated. See 21 CFR § 312.6. Additionally, pursuant to 21 CFR § 312.7, a sponsor or investigator, or any person acting on their behalf, may not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation, or otherwise promote the drug. A sponsor or investigator also may not commercially distribute or test market an investigational new drug. See 21 CFR § 312.7. Your marketing of Sun Farm Vegetable Soup violates these provisions.

The above violations are not intended to be an all-inclusive list of deficiencies. It is your responsibility to ensure that the drug products that you manufacture or distribute meet all of the requirements of the Act and its implementing 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 must immediately correct these violations. If you do not immediately correct them, you may be subject to enforcement action against you without further notice. The Act provides for the seizure of illegal products and for an injunction against the manufacturer and distributors of illegal products. Individuals and businesses that violate the Act may also be subject to criminal 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 to assure that similar violations will not recur. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be made. Additionally, if your firm does not manufacture the product identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the product is not the manufacturer, please include the name of your supplier in addition to the manufacturer. Address your reply to the U.S. Food and Drug Administration, One Montvale Avenue, 4th Floor, Stoneham, MA 02180, Attention: Ann Simoneau, Compliance Officer.

A description of the new drug approval process can be found on FDA's internet website at http://www.fda.gov/cder/regulatory/applications/default.htm. Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, Maryland 20857.

Sincerely,

/S/

Gail T. Costello
Director, New England District