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In my ongoing effort to teach as many people as I can to understand the ins and outs of the pet food industry - this month I want to explain some of

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

the fine print on your pet food label.

Minerals are a required ingredient in human diets as well as diets for our pets. Copper, Iron and Zinc are c

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

Examples of combination products may in

mmon minerals found in pet foods. Just as they are - copper, iron, and zinc are basically rocks, very difficult for anyone or any pet to utilize. S

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

ience has developed several ways to introduce minerals into the body (human and pet) for better absorption thus benefiting the individual far more.

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

his scientific development is called chelating or proteinating and it's actually been around for years. Through the chelating or proteinating proces

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

Combination pro

minerals are absorbed about 60% better than just the minerals alone.

So why am I sharing this ‘fine print’ on the pet food label with you? Well, i

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

t is so simple and so beneficial for a pet food manufacturer to add chelated or proteinated minerals - any manufacturer that doesn’t, in my opinion i

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

cutting corners. And it leaves me with the feeling that if they cut this corner which is so simple to avoid, what other corners are they cutting?

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

don’t like that feeling. Notice on your pet food label, way down on the list of ingredients the minerals. You are looking for minerals that read ‘

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

opper proteinate’ or ‘chelated copper’. If you see just the mineral listed, your pet is sort of like Charlie Brown at Halloween saying ‘I got a rock’

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

And one more thing in the fine print…it’s called friendly bacteria. Although ‘friendly bacteria’ sounds a little scary, the reason for it lies in

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

Following aspects would a

your pets’ intestinal system. A large portion of your pets’ immune system is found within the intestinal system. So keeping the immune system healt

dd to the challenges in developing combination products:

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

y helps to keep the animal itself healthy. This friendly bacteria is similar to what’s found in yogurt however in pet food it is introduced in a fas

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

ion that the cooking process doesn’t destroy. It’s a very simple benefit of science. Yet again, just like with minerals, many pet food manufacturer

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

don’t take the little added effort to provide our pets with them. Looking at the fine print on your pet food label, this time you are looking for l

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

ngthy, scientific words like Lactobacillus Acidophilus or Bifidobacterium Thermophilum. Probably one of the words at the National Spelling Bee Champ

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

Professional from academic institutions, pharmaceutical industries, health care indust

ionship!

Again with the known scientific data as to the benefit of friendly bacteria, why would a pet food manufacturer not provide them to pets? I

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

they don’t it would appear they are cutting corners again.

Thanks for listening! I hope everyone has a wonderful June. This is my birthday month,

.

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

o I’m looking forward to a little celebrating with family and friends. But regardless of getting another year older (the only bad thing about birthd

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

Companies that provide selfless information through particip

ys!), I will be watching the pet food industry like a hawk and providing you with any updates you need to know. Until next month or the next message

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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