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China has become an exporter of poisons and the poisons are in everything from toothpaste, eggs, teas, medicines, baby foods, herbs, vitamins, pet foods, fish, wheat, rice and who

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

dares do guess what else? Given that the FDA inspects only 1% of food imports and tests only 0.5%, how safe do you think our food supply is?

China is one of the world’s leading

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

producers of rice, corn, wheat, soybeans, vegetables, soybeans and pork. China is also the world’s leading producer of vitamin “C” and B12. Almost all of China’s food exports ha

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ve come under close scrutiny by their trade partners. There have been bans by the EU, Japan and the U.S. What is unknown is what ingredients from China have made their way into

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

he food production process. Even within China there have been reports of massive food poisonings including adults and babies.

According to the China Economic review, “The US rej

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

cts more food shipments from China than from any other country, AFP reported. The Food and Drug Administration (FDA) rejected some 257 Chinese food shipments last month, with at l

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

east 137 labeled "filthy" after testing positive for salmonella or for containing banned ingredients. The FDA seized more than 1,000 shipments of tainted cosmetics, food supplemen

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

s and counterfeit medicine from China last month. Earlier this month, 4,000 pets died in the US from eating tainted pet food imported from China.”(5/21/07).

On Friday, May 25th,

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

fficials in Costa Rica seized more than 350 tubes of toothpaste that contained chemicals found in brake fluid and antifreeze. The toothpaste was made in China. There have been r

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

eported deaths from the use of such products in other countries.

There can be no doubt that all food imports from China must receive closer scrutiny. Is China the only country w

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

th tainted agricultural products? The answer is no and, in fact, the U.S. has had its share of banned agricultural products. The issue is the scope and the nature of the proble

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

. Reports that Chinese tea is dried by using hot exhausts of trucks that run on leaded gasoline is very disturbing. And, the issue seems widespread across the total array of pro

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ducts from China from wheat to toothpaste.

The U.S. must put more money into its food safety and inspection programs. Aside from the immediate threat of poisoned imported foods,

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

who knows what long term effects might emerge from hidden chemicals that have found there way into our food supply? Is it worth the risk to our children and grandchildren to allo

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

them to ingest low level toxins?

The U.S. must alter its food policy. There is no reason to import food into this country. We have been the twentieth century food basket of th

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

e world and if we are not careful, we will become the 21st Century “death basket” of the world. Food is one item where we do not need to globalize. Impending climate changes wil

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

threaten food imports and if we are dependent on those imports, many will needlessly suffer. Once we lose agricultural lands to development, it will be hard to retrieve. Our go

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

l must be to regain our food independence and to strongly support ag-land preservation. We should be thinking along the lines of regionalizing our food production system in the U

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

.S., and not globalization. With fears of spreading contaminations brought on by global warming, the U.S. must give top priority to stabilizing and enhancing our own food product

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

on and position ourselves to help others who will definitely be in need. And, while our food system in not perfect; I would eat American any day over imports from who knows where

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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