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

Public Health Service
Food and Drug Administration
  Minneapolis District Office
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7114
FAX: (612 )334-4142

March 13, 2009

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Refer to MIN 09-13

Joseph Wang, PhD, President
Edward Yeh, Chief Executive Officer
Syntec Nutraceuticals, Inc.
4941 Allison Parkway
Vacaville, California 95688

WARNING LETTER

Dear Dr. Wang and Mr. Yeh:

This is to advise you that the Food and Drug, Administration (FDA) reviewed your website at the Internet address www.syntecworld.com in February 2009 and has determined that your "SynOPC," "SynOPC-X" "SynPhyto-K,""SynGevity," "CardioCare," and BoneCare" products are promoted far 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 these products are intended to be used as 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 claims observed on your website include:

Further, your website cites a number of articles under the heading "References" regarding the use of your product ingredients for treatment or prevention of cancer and other 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 Title 21, Code of Federal Regulations, 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 your products for disease treatment and prevention on your website:

Your products are not generally recognized as safe and effective for the above referenced uses and therefore they are new drugs as defined in section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the United States 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 "SynOPC," "SynOPC-X," "SynPhyto-K," "SynGevity," "CardioCare," and "BoneCare" products are also misbranded within the meaning of section 502(f)(1) [21 U.S.C. § 352(f)(1)] of the Act in that the labeling for these drugs fails to bear adequate directions for use.

This letter is not intended to be an all-inclusive review of your website, other labeling, and, the products that your firm markets. It is your responsibility to ensure that all labeling for products distributed by your firm are in compliance with the Act and its implementing regulations. The Act and FDA regulations are available on FDA's web site at www.fda.gov.

You should take prompt action to correct the violations cited in this letter and to 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 15 working days of receipt of this letter as to the specific steps you have taken to correct the violations noted above and to ensure that similar violations will not occur. Include any documentation necessary to show that correction has been achieved. 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 completed.

We also recommend that you review your promotional literature and product catalog which you sell and distribute to your distributors. As discussed with Dr. Wang during FDA's inspection of your firm's facility located at 186 E. Madison Street, Hillsboro, Wisconsin, on August 7, 8 and 11, 2008, much of this promotional literature includes unlawful disease claims. These claims are similar to the ones cited in this letter.

For example, your product catalog promotes your "CardioCare" product with the following disease claims:

Your written reply should be sent to the attention of Compliance Officer Tyra S. Wisecup at the address on the letterhead.

Sincerely,

/S/

W. Charles Becoat
Director
Minneapolis District

This page was posted on January 31, 2010.

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