Inspections, Compliance, Enforcement, and Criminal Investigations
Syntec Nutraceuticals, Inc 3-13-2009
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Minneapolis District Office
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7114
FAX: (612 )334-4142
March 13, 2009
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
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:
SynOPC and SynOPC-X
• "OPC Benefits ... Antimicrobial activity... Anti-inflammatory properties"
• In Health Watch Spotlight on OPCs".o "Hay fever a recent study found that OPC significantly reduced the symptoms of chronic hay fever, including sneezing and nasal discharge. OPCs suppress the release of histamine, but unlike antihistamines they do not result in drowsiness."
o "Cardiovascular disease OPCs can reduce the oxidation of LDL cholesterol, thereby preventing the formation of plaques in arteries. These plaques are responsible for blocking blood vessels and causing heart attacks by acting like aspirin and inhibiting platelet aggregation."
o "Another study reported that subjects with nearsightedness and associated eye disorders experienced a 90% improvement in symptoms."
o "Cancer OPCs can selectively destroy cancerous cells. For instance, OPCs incubated with breast, colon, lung, and stomach cancer cell lines reveal a selective toxicity for the cancerous cells but not normal cells. OPCs also regulate liver enzymes involved in the metabolic activation of potential carcinogens. Interestingly, it has been found that OPCs can reverse the damage inflicted on normal human cells by chemotherapy drugs."
o "Type 2 Diabetes OPCs are believed to exert an insulin-like effect on cells. One study revealed that grape seed extract reduced blood glucose levels in diabetic rats, and increased glucose uptake in muscle and fat cells."
Your website also contains disease claims in the form of personal testimonials, including:
• "I used to have hay fever that was really severe all, year long. My eyes were constantly itchy and watery. These allergies weren't. seasonal and I had them all the time - I hated it! Then one of my friends introduced me to SynOPC. After using it my eyes were no longer itchy and watery, and my eyesight improved. My son also had hay fever that improved after taking SynOPC...' J. Muy, Signal Hill, CA"
• "SynPhyto-K contains...
Konjac Konjac contains a beneficial fiber glucomannan... [S]tudies have shown that glucomannan decreases cholesterol and can help diabetics control their blood sugar...
Seabuckthorn... [R]esearch has shown that it can... decreas[e] cholesterol levels...
Wolfberry(Goji) Research has shown that wolfberry can help... reduce blood sugar levels...
Nataria.... It also provides cardiovascular benefits, including the ability to reduce lipid and cholesterol levels. Other therapeutic effects include the reduction of blood sugar levels in diabetics...
• "In a study published in 1997, resveratrol was found to inhibit the three stages of tumor cell growth, thus helping to reduce the risk of cancer. Since then, increasing evidence has shown that resveratrol inhibits the growth of cancer cells in the human prostate and breast, and can help prevent the development of skin cancer.... SynGevity is a highly concentrated resveratrol supplement..."
• In "Health Watch Spotlight New Evidence that Resveiatrol Prevents Cancer" : "In addition to prostate cancer, resveratrol has been shown to prevent breast cancer, intestinal cancer, and stomach cancer in animal models. Resveratrol, is effective against cancer because it has been proven to fight all three stages of cancer development initiation, promotion and progression... Resveratrol is one of the main substances in red wine that protects against heart disease... SynGevity is one of the most concentrated resveratrol formulas available on the market."
• In the description of its ingredients:o Bromelain "Many studies have shown that bromelain inhibits a process called 'platelet aggregation'... if platelets end up forming a clot within a blood vessel a heart attack or stroke can develop."
o Auricularia "It is effective in decreasing total cholesterol and LDL ("bad cholesterol") levels, as well as preventing the formation of blood clots"
o Alpha lipoic acid "[A)lpha lipoic acid has been shown to prevent atherosclerosis and coronary artery disease.... It has also been shown to prevent high blood pressure and reduce cholesterol levels in animals."
o Red rice yeast "Since the 1970s, human studies have reported that red rice yeast lowers total cholesterol, LDL..."
o Nattokinase "It has been used for over 1000 years in Japan to treat cardiovascular disease."
o Selenium "[C]ardiovascular disease has been thought to be linked to a dietary deficiency of selenium. In an analysis of 25, studies it was discovered that as selenium concentration in the body increase, the risk of heart disease decreases. "Specifically, a 50% increase in selenium concentrations was associated with a 24% reduced risk of coronary events."
• In "Health Watch Spotlight on Lipoic Acid": "Aipha lipoic acid has been found to have positive effect for a variety of health conditions":
o Diabetes• "Blood-Sugar Management: In vitro, alpha lipoic acid was shown to stimulate glucose uptake by muscle cells in a manner similar to insulin. Several trials in humans have also shown that it improves insulin sensitivity in type 2 diabetics."
• "Diabetic Nephropathy: ....A1pha lipoic acid may be effective in preventing early diabetic renal injury...."
• "Diabetic Neuropathy Alpha lipoic acid has already been used for decades in Europe, for the treatment of diabetic neuropathy...."
o Eye Disorders "In the eye, alpha lipoic acid has been shown to inhibit the formation of cataracts.... Alpha lipoic acid also improves vision in those with glaucoma...."
o Cognitive, Function" Alpha lipoid acid has been shown, to improve cognitive function in patients with Alzheimer's disease and other types of memory dysfunction caused by trauma or stroke...."
o Cardiovascular "Supplementation with alpha lipoic acid can protect the health of the heart by reducing blood pressure and total- cholesterol levels. It also prevents the oxidation of LDL ("bad" cholesterol), which is responsible for the formation of plaques in the arteries. Studies in rabbits have shown that alpha lipoic acid can reduce cholesterol levels up to 40%."
• In "Health Watch Spotlight The Many Benefits of Vitamin D". Additional research shows that Vitamin D can prevent cancers, such as colon and breast cancer.... Optimal vitamin D levels are known to positively influence the following conditions:o Heart Disease
o Inflammatory bowel disease
o Rheumatoid arthritis
...The Institute of Medicine has determined that the Adequate Intake of vitamin D is 200 lU per day for the first 50 years of life, 400 IU per day from 51-70, and 600 IU per day after age 71.... BoneCare contains 200 IU [of vitamin D]...."
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:
SynOPC and SynOPC-X
• "Vinson JA; Mandarano MA, Shuta DL, et al. Beneficial effects of a novel lh136 grape seed roanthocyanidins extract and a niacin-bound chromium in a hamster aterosclerosis [sic] model. Molecular and cellular Biochemistry 2002:240:99-103."
• "Keithley J, Swanson B, et al. Glucomanna and obesity: a critical review. Alternative Therapies in Health and Medicine 2005: 11:30-34."
• "Chen H-L, Sheu WH-H, Tai T-S; et al. Konjac supplement alleviated hypercholesterolemia and hyperglycemia in type 2 diabetic subjects in randomized double-blind trial. Journal of the American College of Nutrition 2003:22.36-42."
• "Jang M, Cai L, Udeani GO, et al. Cancer chemopreventive activity of resveratrol, a natural product derived from grapes. Science 1997:275:218-220."
• "Aziz MH, Kumar R, Ahmad N. Cancer chemoprevention by resveratrol in vitro and in vivo studies and the underlying mechanisms. International Journal of Oncology 2003:23:17-28."
• "Wollin SD, Jones PJ. Alpha-lipoic acid and cardiovascular disease. The Journal of Nutrition 2003:133.3327-3330."
• "Huttunen JK. Selenium and cardiovascular diseases--an update. Biomedical and environmental sciences 1997:10:220-228."
• "Boonen S, Vanderschueren D, Haentjens P, Lips P. Calcium and vitamin D in the prevention and treatment of osteoporosis - a clinical update. Journal of Internal Medicine 2006:259:539-552."
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:
• "CardioCare provides your body with an advanced formulation... [i]ts ingredients can reduce blood pressure and low density lipoprotein (LDL) cholesterol levels."
• In its description of an ingredient: "Alpha lipoic acid: Inhibits oxidation of LDL cholesterol. Helps prevent hypertension"
• Under References: "Wollin SD, Jones PJ. Alpha-lipoic acid and cardiovascular disease. The Journal of Nutrition 2003; 133:3327-3330."
Your written reply should be sent to the attention of Compliance Officer Tyra S. Wisecup at the address on the letterhead.
W. Charles Becoat