Advice Pool - Health and Fitness

Soy has become the darling of nutritional conscious consumers throughout the world. It’s popularity is growing by leaps and bounds. Millions of people are us

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

ing soy on a daily basis, but, don’t you think it’s time to find out just what soy is and what it does to your body? It’s time for some straight talk about so

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

Examples of combination products may in

y.

Vegetarians and health enthusiasts have known for years that foods rich in soy protein offer a good alternative to meat, poultry, and other animal-based pr

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

oducts. As consumers have pursued healthier lifestyles in recent years, consumption of soy foods has risen steadily, bolstered by scientific studies showing he

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

alth benefits from these products. Last October, the Food and Drug Administration gave food manufacturers permission to put labels on products high in soy prot

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

Combination pro

ein indicating that these foods may help lower heart disease risk.

As with health claims for oat bran and other foods before it, this health claim provides co

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

nsumers with solid scientific information about the benefits of soy protein and helps them make informed choices to create a “heart healthy” diet. Health claim

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 encourage food manufacturers to make more healthful products. With soy, food manufacturers have responded with a cornucopia of soy-based wares.

No sooner ha

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

d FDA proposed the health claim regulation, however, than concerns arose about certain components in soy products, particularly isoflavones. Resulting question

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

s have engulfed the regulation in controversy.

This came as no surprise to Elizabeth A. Yetley, Ph.D., lead scientist for nutrition at FDA’s Center for Food S

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

afety and Applied Nutrition . “Every dietary health claim that has ever been published has had controversy,” she says, “even the relationship of saturated fat

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

Following aspects would a

to a healthy diet.”

While the controversy may seem confusing to the consumer giving it casual consideration, a careful review of the science behind the rule r

dd to the challenges in developing combination products:

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

eveals a strict divide between what FDA allows as a health claim based on solid scientific research and related issues that go well beyond the approved stateme

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

nts about health benefits of soy protein.

What’s known is that all foods, including soy, are complex collections of chemicals that can be beneficial for many

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

people in many situations, but can be harmful to some people when used inappropriately. In that simple fact lies much of the scientific dilemma—when do data sh

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

ow a food is safe and when do they show there could be problems?

Scientists agree that foods rich in soy protein can have considerable value to heart health,

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

Professional from academic institutions, pharmaceutical industries, health care indust

a fact backed by dozens of controlled clinical studies. A yearlong review of the available human studies in 1999 prompted FDA to allow a health claim on food l

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

abels stating that a daily diet containing 25 grams of soy protein, also low in saturated fat and cholesterol, may reduce the risk of heart disease.

“Soy by i

.

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

tself is not a magic food,” says Christine Lewis, acting director of the Center for Food Safety and Applied Nutrition’s Office of Nutritional Products, Labelin

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

Companies that provide selfless information through particip

g and Dietary Supplements. “But rather it is an example of the different kinds of foods that together in a complete diet can have a positive effect on health.”

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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A business researching and developing a new product normally designs it first and the estimates the cost to determine the final price. If the cost - and the resulting price - are too high, the product will go back to the drawing board for more revisions, delaying the introduction of the new product.

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