Re: Pomegranate, cancer, and the FDA

[Guest guest]

It looks like Moss is now asking for us to pay to read his newsletters. The link

below is denying access.

Louise

Cancer Decisions® - POM Wonderful in Trouble - Part I

http://www.cancerdecisions.com/content/view/447/2/lang,english/

[Guest guest]

He has a link to sign up for his free newsletter, maybe can't access unless

you're signed up. Here's the article.

POM WONDERFUL IN TROUBLE

It has now been seven years since the Journal of the National Cancer Institute

asked, rhetorically, if pomegranate were " nature's power fruit. " There have now

been at least 30 scientific articles on the anticancer potential of pomegranate.

One company, Pom Wonderful, has been spending some of its hard-earned money

furthering research in this field. Their " reward " came February 23, 2010 when

the US Food and Drug Administration (FDA) issued a scathing 10-page warning

letter, declaring POM Wonderful juice to be an unproven " drug, " and demanding

that the company stop providing health information relating to pomegranate on

the company Web site.

According to the warning letter, " FDA's review found serious violations of the

Federal Food, Drug, and Cosmetic Act. " To understand this, you have to follow

FDA's reasoning process. Each bottle of POM Wonderful juice understandably gives

the company's Web address, www.pomwonderful.com. This Web site then cites

various scientific studies that support the idea that pomegranate juice is a

healthful beverage. According to FDA logic, this constitutes advertising. In

regard to prostate cancer, the company states the following:

" In a clinical study involving 46 men with rising PSA after prostate cancer

treatment (surgery or radiation) who consumed 8 ounces of POM Wonderful 100%

Pomegranate Juice daily over two years, PSA doubling time increased from 15 to

54 months....PSA doubling time is an indicator of prostate cancer progression. "

These are truthful statements, derived from a 2006 phase II clinical trial

conducted at the University of California, Los Angeles (UCLA). There were 14

coauthors on this study, which was published in Clinical Cancer Research

(Pantuck 2006).

But according to FDA, the mere act of citing a scientific study automatically

constitutes a form of advertising and turns an innocuous and healthful drink

into a drug. Why? " When scientific publications are used commercially by the

seller of a product to promote the product to consumers, " they say, " such

publications may become evidence of the product's intended use....The citation

implies treatment or prevention of a disease. "

POM Wonderful is not just a drug, but a " misbranded drug. " Why? Because,

according to FDA, " POM Wonderful 100% Pomegranate Juice and POMx products are

offered for conditions that are not amenable to self-diagnosis and treatment by

individuals who are not medical practitioners; therefore, adequate directions

for use cannot be written so that a layperson can use these drugs safely for

their intended purposes. Thus, your products are misbranded...in that the

labeling for these drugs fails to bear adequate directions for use. "

In other words, a person with prostate cancer cannot possibly 'treat' his own

cancer because he is not a medical practitioner. Pomegranate juice is intended

for use by the general public. Therefore no adequate label could be written for

it, since de facto no layperson could possibly understand or interpret such

instructions.

Truly, this whole situation with FDA has gotten out of hand. It would require

the writings of a great satirist, such as a Swift or a Kurt Vonnegut,

to capture the absurdity of the situation. A harmless juice, which has already

demonstrated some huge health benefits, is arbitrarily reclassified as a drug,

and then declared " misbranded " because no patient (other than a medical doctor)

is by definition allowed to treat cancer, even his own.

Meanwhile, FDA avoids a few larger problems that in a saner world might capture

its attention. I could mention a couple of dozen of them, but will simply point

out that E. coli bacteria are running rampant through the entire food supply. In

November there was a recall of 546,000 pounds of contaminated ground beef in

Connecticut, Maine and Massachusetts. This was only the tip of a huge iceberg of

truly dangerous food products. But people who are trying to improve the health

of the public are maligned and hampered by governmental agents.

--Ralph W. Moss, Ph.D.

My comment is here's another instance of FDA intimidating an innocent company

trying to do public good and I've had enough of it. This will change when WE THE

PEOPLE demand it changes and get relentless about it. We need a campaign to root

the FDA criminals out and a total overhaul of the agency.

>

> Cancer Decisions® - POM Wonderful in Trouble - Part I

>

> http://www.cancerdecisions.com/content/view/447/2/lang,english/