Department of Health and Human Services
Public Health Service
Office of Compliance
October 12, 2006
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
Wellness Support Network
1449 Marion Dr
Glendale, CA 91205
Dear Mr Held:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.realfoodnutrients.com and has determined that your product WSN® Diabetic Pack is promoted for conditions that cause these products to be drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC 321(g)(1)]. The therapeutic claims on your website establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of this product with these claims violates the Act.
Examples of some of the claims observed on your website include:
- WSN® Diabetic Pack
- "Diabetes Breakthrough Lower your blood sugar, safely and effectively with absolutely NO SIDE EFFECTS!!"
- "Nobel Prize winning technology validates WSN® Diabetic Pack ingredients! Studies show a 31.9% drop in blood sugar levels!"
- "The WSN® Diabetic Pack Breakthrough Benefits* Include:
- Lower Blood Glucose Levels…
- Lower Cholesterol Levels…
- Less Dependency on Medications"
- "Diabetes is a disease that if you don't take effective action against, it simply gets worse. Unfortunately, medications only treat the symptoms and usually do nothing to address the underlying causes. The good news is that cutting-edge science and nutrition have come together to create a truly monumental and natural breakthrough for diabetics. … The reason Foodform® technology works is because it operates at the cellular level and addresses a key problem that every type 2 diabetic has. All type 2 diabetics have a deficiency of key nutrients the body needs to support healthy blood sugar levels. Your cells simply do not process blood sugar like they should. The WSN® Diabetic Pack helps your body metabolize blood sugar more efficiently."
- "This study [of an herbal ingredient in WSN® Diabetic Pack] was done on type 2 diabetics (mildly insulin dependent) and reported an average drop of blood glucose levels of 31.9% and average weight loss of 4.8 pounds in just 30 days!"
- "The staff of Wellness Support Network have over 12 years of experience working with diabetics and the diabetic condition. … We assist them in working out solutions to problems unique to their own case, to ensure they get the results we promise order your WSN® Diabetic Pack below and experience the results for for yourself."
Your website also contains disease claims in the form of testimonials, including:
- "My blood sugar went from 230 to 117 in just 21 days. — James Marshall, Georgia"
- "Barbara Culver, Michigan I was taking 50 units of insulin plus pills twice a day and my blood sugar just kept going up. I was tired all of the time and could fall asleep as soon as I sat down. I also kept gaining weight. Since I've been … using the Diabetic Pack … I have all kinds of energy and my sugar is down in the low 100s also I don't take insulin any more!"
- "Mike Corcoran, California About 60 days ago when I started your program my blood sugar count was at 332. My kidneys were in very poor condition. … Just today I was given my results from my last physical and can report that my blood sugar count is 117 and my kidney funtion[sic] is just slightly elevated above normal (which is a vast improvment [sic] from when I was first diagnosed). … By the way, I forgot to mention … when I was first diagnosed, I weighed over 250 pounds and my blood pressure was high. I now weigh 193 pounds and my blood pressure is normal."
In addition, the name of your product suggests that it is intended for use in the cure, mitigation, treatment, or prevention of diabetes, a disease.
Furthermore, your products are not generally recognized as safe and effective for the above referenced conditions, and, therefore, the products are also "new drugs" under section 201(p) of the Act [21 USC 321(p)]. New drugs may not be legally marketed in the US without prior approval from FDA as described in section 505(a) of the Act [21 USC 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 product "WSN® Diabetic Pack" is also misbranded within the meaning of Section 502(f)(1) of the Act, in that the labeling for these drugs fails to bear adequate directions for use [21 USC 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 website, we noticed that you promoted 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 urge you to review your website, 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.
Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
Please advise this office in writing, within 15 working days of receipt of this letter, as to the specific steps you have taken or will be taking to correct these violations, including the steps taken to assure that similar violations do not recur. Include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.
Your reply should be addressed to Kristen Moe, Compliance Officer, US Food and Drug Administration, Center for Food Safety and Applied Nutrition, Division of Compliance and Enforcement (HFS-607), 5100 Paint Branch Pkwy, College Park, MD 20740-3835. If you prefer to respond electronically, send your e-mail to email@example.com If you have any questions concerning this letter, please contact Ms Moe at 301-436-2064.
Joseph R. Baca
This page was posted on February 12, 2008.