First Response to FDA's Warning Letters

Nutrex Responds to FDA DMAA Warning Letter

"FDA said DMAA is in fact not safe because it narrows the blood vessels and arteries, which can lead to elevated blood pressure, shortness of breath, tightening of the chest and/or a possible myocardial infarction (heart attack).

"To this, Nutrex offered seven studies that it said support the view that DMAA is reasonably expected to be safe under its intended conditions of use...

"Further, Nutrex pointed to the millions of doses that consumers have used over the years to show when used as directed, dietary supplements containing DMAA have a record of safety."

Read More: http://www.naturalproductsinsider.com/news/2012/05/nutrex-responds-to-fda-dmaa-warning-letter.aspx

Is there really a "free market" health care clinic out there?

FYI:  Heard about this on an internet podcast interview and checked it out.  A group of 40 surgeons and anesthesiologists bought an old hospital that was up for sale and turned it into a "surgery center" that they have complete control over, including the real estate end of it, the most efficient use of staff, and the elimination of wasteful operating room practices "that non-profit hospitals have no incentive to curb."  Plus, they have the lowest hospital infection rate anywhere, with two years in a row having .001% compared to a national infection rate of 2.6%.

Fees for the surgeon, anesthesiologist and facility are all included in one low price. There are no hidden costs, charges or surprises.  The physician-owned and managed facility deals in cash or self-pay health insurance only, no credit cards, no personal checks, no tax dollars, no grants, no state or federal monies attached to it at all.  They have been accredited by the AAAHC ever since 1998, and because of all this combined, their surgery prices are VERY, very low, low enough that "medical tourism" that usually goes outside the USA is bringing foreigners into the USA! 

Canadians, etc., who have "free health care" but have to wait in line for 3 years for surgery, are coming to this free-market facility in Oklahoma City, Oklahoma for their surgery, happily paying out of pocket.  An example given on the podcast interview was that carpal tunnel surgery has a total one lump sum of $2750.00, paid upfront before surgery.   Some people having had the carpal tunnel surgery have been able to file with their insurance company when they got back home, and the insurance company paid them the "standard out of network reimbursement fee," which sometimes gave the patient more than they paid for the surgery.  The Oklahoma City Surgery Center's highest surgery prices, out of all provided services, are for spine-lumbar problems and a tubal reversal, both of which are under $10,000.

During the live interview, one of the founders, Dr. Keith Smith, MD. (they are all conventional medical doctors performing conventional medical services) stated that they do "horse trading" with the poor who call them, finding out what the poor people are willing to pay, and then set their prices accordingly, being totally transparent.  "We have been delivering affordable care at the prices listed on our website for four years now. Our pricing has been used by patients to leverage area hospitals to lower their prices."  Dr. Smith continued that this policy of price honesty angers and scares those who prefer to be tied to the "free" health-care industry that includes government-owned hospitals/doctors being the boss instead of the patient being the boss, and gives hope to those who can see that this same kind of free-market health care could become the wave of the future for more medical professionals and patients to enjoy!

http://www.surgerycenterok.com/index.php

Fake "Dietary Supplements" with Bacteria & Dead Babies as ingredients

1.  (summary article)http://www.naturalnews.com/035823_Korea_babies_pills.html#ixzz1uhAAV0Fd

2.  (includes video) http://www.dailymail.co.uk/news/article-2140702/South-Korea-customs-officials-thousands-pills-filled-powdered-human-baby-flesh.html

(NaturalNews) Customs officials in South Korea were horrified to discover recently that there is an active, underground drug trade involving powdered, dead babies. Numerous sources confirm that thousands of capsules containing dead baby remains in powdered form were confiscated in recent months in South Korea after travelers tried to smuggle these supposedly "cure-all" drugs in from China.

According to reports, corrupt medical personnel in China are selling aborted and still-born baby corpses to medical companies, which then secretly store them in people's home refrigerators. When it comes time for processing, these companies then retrieve the bodies, dry them in microwaves, and grind them into powder, which is then injected into capsules.

In order to disguise this utterly nauseating and savage practice, these morally depraved opportunists add herbs and other materials to the capsules in order to avoid detection by investigators and customs officials. But apparently this tactic has failed, as more than 17,000 capsules falsely labeled as "stamina boosters" have already been confiscated since August 2011.

"Ethnic Koreans from northeast China who now live in South Korea are those who were mostly intending to use the capsules or share them with other Korean-Chinese," said a customs official to the U.K.'s Daily Mail. "They are normally brought into South Korea in luggage or posted by international mail."

Some segments of the Chinese population purportedly believe that human placental tissue is medicinal, and that consuming it will improve blood supply and circulation. But it appears as though within this segment, that belief has been perverted to also include dead baby flesh as well. And unless inspectors keep a close eye on all incoming and outgoing luggage and packages, the practice will more than likely continue.

Beyond the moral implications of the practice, officials also warn of very serious health implications as well. According to reports, the pills, which are primarily coming from four Chinese cities -- Jilin, Yanji, Tianjin, and Qingdao -- often contain deadly "super" bacteria that can make individuals very sick.

"As we analyzed the DNA, its DNA sequence is 99.7 percent to 99.9 percent coincided to humans'," said a customs official involved with conducting analyses on the capsule powder. "Super-bacteria and other viruses and bacteria, which are harmful to the human body, have been detected."

At the same time, some are now lumping the revolting dead baby pills in with all herbal medicine, calling for closer scrutinization of natural medicine. It remains to be seen if the issue is used by political opportunists to further demonize nutritional and dietary supplements.  (emphasis added)

FDA breaks promise - sends out NDI warning letters

FDA had promised to wait until the investigation was final before enforcing any NDI guidelines, BUT on April 24 they sent out warning letters to 10 companies!  They have 15 business days to respond.  Here's an update on several articles covering it:

http://www.anh-usa.org/fda-breaks-promise-on-proposed-new-supplement-rules/ "FDA promised not to enforce the NDI guidance until it was final. Last Friday, they broke that promise."

http://www.naturalproductsinsider.com/news/2012/04/fda-warns-dmaa-marketers.aspx "FDA has not issued a final guidance of for NDIs, but these warning letters show the agency is not putting NDIs on hold while it reviews the 7,000 comments, which totaled 150,000 pages...'It's a little surprising that FDA made NDI a one of the points in light of the fact that they are still pouring through the comments,' Prochnow said. 'That being said, Dan Fabricant and the rest of FDA have not backed off the fact that they believe companies should be filing NDI notifications.'"

http://blog.usfoodsafety.com/2012/04/30/fda-cites-10-dietary-supplement-companies-for-dmaa-use/  "FDA issued warning letters to ten manufacturers and distributors of dietary supplements containing dimethylamylamine, more popularly known as DMAA, for marketing products for which evidence of the safety of the product had not been submitted to FDA...Also referred to as 1,3-dimethylamylamine, methylhexanamine, or geranium extract, the ingredient is in dietary supplements and is often touted as a 'natural' stimulant."

Updated: FDA cracks down on DMAA - but this is just the start, not the end, of the debate, predicts CRN   It’s official, says the FDA. “Synthetically-produced DMAA (1,3-Dimethylamylamine) is not a dietary ingredient and is not, therefore, eligible to be used as an active ingredient in dietary supplements”. Read more here:  http://www.nutraingredients-usa.com/Regulation/Updated-FDA-cracks-down-on-DMAA-but-this-is-just-the-start-not-the-end-of-the-debate-predicts-CRN

http://www.naturalproductsinsider.com/news/2012/05/ahpa-fda-wrong-about-synthetic-botanicals.aspx  "But if the language of the warning letters is read carefully, it appears that the agency does leave room for a synthetic constituent of a botanical to be included as a 'dietary substance for use by man,' so long as that synthetic constituent is 'commonly used as a food or drink' (examples might be synthetic caffeine, or synthetic lycopene)."

Can human genes in rice for making drugs be considered as SAFE food by FDA?

While the FDA is "protecting" us from dietary supplements, here's a report about GMO rice being grown in Kansas that has human genes added to it, allegedly to help "third-world children's diarreah," was already rejected in 2003 due to other chronic diseases it would cause - but approved anyway by the USDA in 2007:

Human genes engineered into experimental GMO rice being grown in Kansas

Wednesday, May 02, 2012 by: Ethan A. Huff, staff writer

http://www.naturalnews.com/035745_GMO_rice_human_genes_Kansas.html#ixzz1tjZ51PAE 

(NaturalNews) Unless the rice you buy is certified organic, or comes specifically from a farm that tests its rice crops for genetically modified (GM) traits, you could be eating rice tainted with actual human genes. The only known GMO with inbred human traits in cultivation today, a GM rice product made by biotechnology company Ventria Bioscience is currently being grown on 3,200 acres in Junction City, Kansas -- and possibly elsewhere -- and most people have no idea about it.

Since about 2006, Ventria has been quietly cultivating rice that has been genetically modified (GM) with genes from the human liver for the purpose of taking the artificial proteins produced by this "Frankenrice" and using them in pharmaceuticals. With approval from the U.S. Department of Agriculture (USDA), Ventria has taken one of the most widely cultivated grain crops in the world today, and essentially turned it into a catalyst for producing new drugs.

Originally, the cultivation of this GM rice, which comes in three approved varieties (http://www.aphis.usda.gov/brs/biotech_ea_permits.html), was limited to the laboratory setting. But in 2007, Ventria decided to bring the rice outdoors. The company initially tried to plant the crops in Missouri, but met resistance from Anheuser-Busch and others, which threatened to boycott all rice from the state in the event that Ventria began planting its rice within state borders (http://todayyesterdayandtomorrow.wordpress.com).

So Ventria's GM rice eventually ended up in Kansas, where it is presumably still being grown for the purpose of manufacturing drugs on 3,200 acres in Junction City. And while this GM rice with added human traits has never been approved for human consumption, it is now being cultivated in open fields where the potential for unrestrained contamination and spread of its unwanted, dangerous GM traits is virtually a given.

"This is not a product that everyone would want to consume," said Jane Rissler from the Union of Concerned Scientists (UCS) to the Washington Post back in 2007. "It is unwise to produce drugs in plants outdoors."

Though receiving tens of thousands of public comments of opposition, many rightly concerned about the spread of GM traits, the USDA approved open cultivation of Ventria's GM rice anyway. This, of course, occurred after the U.S. Food and Drug Administration (FDA) had refused approval for Ventria's GM rice back in 2003 (http://www.kansasruralcenter.org/publications/PharmaRice.pdf).

GM 'pharmaceutical' rice could cause more disease, suggests report

Besides the threat of contamination and wild spread, Ventria's GM rice, which is purportedly being grown to help third-world children overcome chronic diarrhea, may conversely cause other chronic diseases.

"These genetically engineered drugs could exacerbate certain infections, or cause dangerous allergic or immune system reactions," said Bill Freese, Science Policy Analyst at the Center for Food Safety (CFS), who published a report back in 2007 about the dangers of Ventria's GM rice.  You can view that report here:  http://www.centerforfoodsafety.org

Sources for this article include:

http://www.organicconsumers.org/ge/humangene042505.cfm

http://www.washingtonpost.com

http://www.worldwatch.org/node/4956

http://todayyesterdayandtomorrow.wordpress.com