References - Food and Drink

When discussing whisky the first thing that needs to be know is that there are two legitimate spellings. The Scotts and Canadians spell whisky without the “e”, while the Irish and Ameri

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

cans spell it with an “e” as in whiskey. This should be the first indication that the world of whisky is a very complicated one and has many regional differences in taste and production

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

Examples of combination products may in

. This is part of what makes whisky such an interesting and enjoyable spirit.

Historically it is believed that the Irish were the first to make whiskey, however the Scotts have also la

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

id claim to being the first whisky producers. The Irish used the term “uisce beatha” ("Water of Life" in Gaelic) to describe whiskey, so it must have been important.

Both the Scottish

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

nd Irish make whiskey the same way, except for the malting and distillation process. In Scotland the malted barley is roasted over open peat fires to dry, this results in the grain pick

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

Combination pro

ing up the peat flavour. In Ireland, the malted barely is dried in closed ovens, and is never exposed to the smoke. The process of mashing and fermentation is much the same for both 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

untries. In the distillation step, the Irish, most of the time, distill their product three times, which results in a very pure distillate which makes Irish whiskey exceptionally smoot

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

h. The Scottish distill their product twice and this results in more flavour in the spirit.

In North America there is Canadian whisky and American whiskey, which has a number of region

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

l classifications including Bourbon and Tennessee whiskey. Each product in North America is unique and is regulated by the government. Canadian whisky is the number one imported spirit

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

into the United States and is second in consumption only to vodka.

American whiskey has a number of regulation depending on the definition of the product. Bourbon must be made from fe

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

rmented mash of not less than 51% corn, rye, wheat, malted barely or malted rye grain. It cannot be distilled at a proof higher than 160 and must be stored in new oak barrels at a proof

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

Following aspects would a

of 125 or less. Blended American whiskey must be made from at least 20% whiskey aged two or more years with the remainder made from unaged neutral grain spirit. American corn whiskey m

dd to the challenges in developing combination products:

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

st be made from a minimum mash of 80% corn. Tennessee whiskey follows the same regulations as Bourbon, but is charcoal filtered (Lincoln County Process), so it does not qualify as a bou

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

rbon.

Canadian whisky must be ages for at least three years, but for the most part the Canadian government allows the expertise of the distiller to define the characteristics of the fi

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

nal product so there are no limits on distillation proof or barrel requirements. Any Canadian whisky that is aged for less than four years must have the age listed on the bottle. Most C

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

anadian whisky is aged for six or more years. Canadian whisky is generally a blended spirit. The term “blended” means that the final product is made from a number different types of dis

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

Professional from academic institutions, pharmaceutical industries, health care indust

illed product. For example, a Canadian whisky may be composed of corn, barely, wheat and rye distillates that have been aged in selected used or new oak barrels. Some Canadian producers

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

put all of the grains in one vat and ferment them as a whole and pre-blend and age the distillate. Other producers ferment each grain individually and age each distillate separately an

.

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

d then blend a final product from a mixture of spirits. Most Canadian whisky is distilled twice.

This article has only scratched the surface of the whisk(e)y world. There are many regi

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

Companies that provide selfless information through particip

onal characteristics of whisky and many other counties are producing this fine spirit. It would take a lifetime to explore the complete world of whisky, but it would be a worthy attempt

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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