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The word ‘natural’ is purely a marketing term and in no way designates a product as being superior in any way to anything not using the t

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

erm—i.e. foods can be labeled as ‘natural’ whether it is or not.

There are three categories of food that are definitely ‘unnatural,’—exc

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

Examples of combination products may in

totoxins, trans fatty acids and sugar substitutes such as aspartame.

Excitotoxins (MSG) that excite the neural pathways in the brain are

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

anything, but natural. These excitotoxins fire between two neurons until the pathway is de-activated—a.k.a. dead. They trick the brain in

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

o thinking the food tastes good, when it does not. Enough excitotoxins cause lesions to form in the brain. No one can afford to kill brai

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

Combination pro

cells. Therefore, such words like MSG and natural flavors are ‘deadly.’ Excitotoxins can even be found in baby food.

Trans fatty acid

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

are getting a lot of press lately and are found in about 40% of all processed foods. This includes most of your favorite snacks—cookies,

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

potato chips, pretzels and popcorn—especially microwave popcorn. Jeffrey Aron, MD states, “Trans fatty acids produce insulin resistance

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

obesity, heart disease, autoimmune disease, and depression. Look for partially hydrogenated vegetable oil, vegetable shortening or hard

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

ned vegetable oil on the label.

Aspartame, released on an unassuming American public (and banned in most of the world by the FDA after 1

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

years of testing that could not prove its safety.) Aspartame metabolizes in the body into methanol, a.k.a. wood alcohol. This creates f

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

Following aspects would a

rmaldehyde—a known carcinogen—in the liver which is quite deadly and pickles your organs, similar to work done by a funeral director. Die

dd to the challenges in developing combination products:

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

soda and sweets are loaded with aspartame under the guise of NutraSweet and Equal. Every U.S. restaurant offers NutraSweet and Equal alo

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

g with sugar. However, restaurants are offering what people are demanding. If everyone stopped using NutraSweet, Equal or sugar, it wou

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

d soon disappear from restaurant tables. Taking it one step further, if people stopped buying NutraSweet, Equal and Sugar, the manufactu

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

ers would be out of business in thirty-days.

Food manufacturers love these three major health hazards because they extend shelf life, tr

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

Professional from academic institutions, pharmaceutical industries, health care indust

ck people into thinking the food tastes good and have fewer calories—but at what price? Are you willing to sacrifice your liver, kidneys

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

heart and other vital organs to satisfy a ‘palate’ that food manufacturers created when you were fed baby food loaded with excitotoxins?

.

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

Forewarned is forearmed, therefore, read labels and a book or two. If you can’t pronounce it or don’t know what it is, don’t buy the pr

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

Companies that provide selfless information through particip

duct. Your best bet is to use organic products and eat few processed foods. You will be glad you did as you notice your improved 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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