Inspections, Compliance, Enforcement, and Criminal Investigations
Diapro, Inc. (dba Diapro USA Inc)
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
October 17, 2008
via Federal Express
Jon A. Gentile
Diapro, Inc. (dba Diapro USA Inc)
2657 Windmill Parkway #275
Henderson, Nevada 89074
Dear Mr. Gentile:
This is to advise you that the Food and Drug Administration (FDA) has review your website at the Internet address www.diaprousa.com and has determined that the product "Diapro All Natural PentosePlus" is promoted for conditions that cause the product to be a drug under section 201 (g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 V.S.C. § 321 (g)(1)(B)].
The therapeutic claims on your website establish that the product is a drug because it is 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 the claims observed on your website include:
"In a recent study, pumpkin pentose, the active ingredient in PentosePlus provides a decrease in hemoglobin Alc levels in 71% of patients being tested. In addition to this dramatic result, there was a 20% decrease in blood sugar levels in 63% of the patients tested. These results make PentosePlus a significantly effective product."
The title of the article, "Eating pumpkins helps diabetics," which is posted in the "Library of Science" section of your website and accompanied by a link to a page where consumers can order Diapro All Natural PentosePlus.
Numerous statements made within the "Eating pumpkins helps diabetics" article, including:
"Recent studies show that pumpkin can help repair damaged pancreatic cells in diabetic rats, boosting levels of insulin-producing beta cells and insulin levels in the blood. Diabetics and those prone to diabetes should, therefore, consider adding pumpkin or a pumpkin product to their daily diet, the researchers said."
"Pumpkin extract is potentially a very good product for pre-diabetic persons, as well as those who have already developed diabetes,' said lead author Tao Xia, of the East China Normal University. He added that' ... pumpkin extract could drastically reduce the amount of insulin they need to take."
" ... 36% increase in plasma insulin was observed in diabetic rats fed pumpkin compared to the untreated rats .... The percentage of insulin-positive cells (beta-cells) in pumpkin fed diabetic rats fed was just 8%lower than in normal rats (Journal of the Science of Food and Agriculture 2007, 87, 1753)."
"The diabetes-induced rats used in this study represent type I diabetes, but the researchers believe the pumpkin extract may also play a role in type II diabetes. Xia said ... We believe that the pumpkin fruit extracts should have a hypoglycaemic role in both Type I and II diabetes by improving insulin sensitivity and increasing plasma insulin levels, he said."
On the page of your website entitled, "20 reasons why you should not take pumpkin extract": "If you prefer being Obese ..." and "If you irresponsibly take no measures for your child becoming one of the 1 out of 2 children that will get diabetes in their life ...."
Your website also contains disease claims in the form of testimonials, including:
"My sugar level was registering around 220 pretty regularly. After taking PentosePlus my sugar level dropped an average of 40 points. I haven't had to be restrictive with carbs, and I can have the occasional [sic] splurge without throwing everything into turmoil!"
"I just wanted to say thank you for making a non-side effect product to help lower blood sugar: I only have to use my insulin 50 percent of the time since I've been taking your pentose plus..."
"... I started taking Diapro 2 weeks ago and since that time my blood sugar levels have went [sic] from the 430's to the 230's. So now I have found a product that actually does what it claims to do ...."
"Since I have been taking Diapro, for the first three weeks I have seen my blood sugar levels go from 240 to 140. Thanks to Diapro I hope to reduce my medication in a few months..."
"... I'm sold on PentosePlus. I went to the doctor and was diagnosed with Type 2 diabetes. And after 30 days I have no signs of diabetes and am going to keep taking PentosePlus..."
"... I tried the pentose pills that a friend recommended me to try and ever since then I did not need to take insulin shots. I was truly amazed with the outcome of these pills ... I would recommend anyone out there that is experiencing diabetes problems..."
These claims are supplemented by the metatags used to bring consumers to your website through Internet searches. The metatags include: '"diabetes medicine" and "insulin.
"Dear Sir, I observed that when I started taking Diapro it changed a lot for me: My blood sugar is now normal and I don't need to worry. The color of my feet and my ankles has no more pain at all. I can tell Diapro helps me a lot because I do not feel the pain I felt before...."
Your product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a new drug 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 product "Diapro All Natural PentosePlus" is also misbranded within the meaning of section 502(f)(1) of the Act in that labeling of this drug 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 labeling. The unlawful disease treatment and prevention claims on your website were too numerous to list in this letter. In addition, other promotional materials may be evidence of a product's intended use. For example, if the seller of a product uses a scientific publication describing the use of a product in treating or preventing disease to promote the product to consumers, the scientific publication is evidence of the product's intended use as a drug. At the March 2008 Expo West trade show in Anaheim, CA, an FDA representative collected a copy of an article entitled "Research and Development of Pumpkin Pentose 'Golden Pumpkin' Electuary," which was being distributed at your firm's promotional booth. Testimonials from diabetes patients who have used your product are reproduced in the margins of this article, and
the text of the article also includes statements that could cause your product to be a drug, such as: "We find surprisingly that pentose is the best energy supplementing agent for replacement of glucose in diabetic's body, which we have been searching for many years." 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 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.
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]. Also, federal agencies are advised of the issuance of all Warning Letters about drugs so that they may take this information into account when considering the award of contracts.
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 response should be directed to U.S. Food and Drug Administration; Attn: Carl Lee, Compliance Officer; 1431 Harbor Bay Parkway, Alameda, CA 94502. You may reach Carl Lee at (510) 337-6737.
Barbara J. Cassens
San Francisco District