References - Food and Drink

When I first started hearing about “organic” food, I was a little confused since all food, scientifically speaking, falls into the carbon-based organic category. But, in the

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

world of grocery shopping “organic” specifically refers to foods which meet the U.S. Department of Agriculture’s set of national standards concerning properly certified orga

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

Examples of combination products may in

nic foods. Only products certified by the USDA can be sold as officially “organic” in the U.S. Any producer who neglects to follow these guidelines, and has previous certifi

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

cation by the USDA is fined per offense. So, what we really need to understand is the USDA guidelines.

Ideally, the USDA standards ensure that foods labeled organic are pro

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

uced without the use of pesticides, fertilizers, hormones, additives and other chemicals that conventionally produced dairy, meat, vegetable and fruits may contain.

The USDA

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

Combination pro

has strict regulations for certifying organic fruits, vegetables, and grains. All organic plant products must grow from fields that have been certifiably organic for three y

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

ears or more (without using pesticides, or fertilizers), and post-harvest handling must also be conducted under USDA guidelines. However, a “transitional” label may be given

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

to farms that are converting their farming methods from conventional to organic before the criteria are actually met.

Under meat and poultry guidelines, animals must be rai

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

ed without growth stimulants, hormones or antibiotics to be certified as organic. They must also have access to certified organic pastures outdoors, clean water and bedding,

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

as well as exercise and fresh air. All organic meat and poultry processing plants are regularly inspected by USDA officials. Packing plants must isolate organically raised/fe

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

d animals from conventional herds. Plants that pack organically raised animals must be cleaned to organic specifications, before the product is run.

Dairy products from all

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

Following aspects would a

dairy animals, including cows, sheep and goats may be certified organic. Farmers raising animals for organic dairy production must also adhere to strict guidelines. Animal f

dd to the challenges in developing combination products:

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

ed must be 100% organic, and produced on the farmland, untreated with synthetic fertilizers, fungicides, pesticides and herbicides. The feed must be untreated for at least th

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

ree seasons prior to harvest, before it can be fed to an animal whose milk will be converted into an organic dairy product.

The animals themselves must be raised without dru

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

gs, such as antibiotics and growth hormones. These products include cheese, milk, yogurt, butter, sour cream, ice cream, and cottage cheese. Certified organic milk may neve

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

r be blended or come in contact with non-organic milk. In accordance with standard hygiene, dairy safety procedures, including pasteurization, organic certification also requ

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

Professional from academic institutions, pharmaceutical industries, health care indust

res other specifications: humane treatment of animals, clean water and bedding, exercise, fresh air, and access to an outdoor pasture.

The USDA organic seal also indicates t

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

he exact amount of organic content in the food which ironically never has to be 100%. To be certified organic, the food product need only be 95% organic. Varying degrees of o

.

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

rganic foods are also noted on organic labeled foods with more than one ingredient: organic (at least 95%), made with organic products (70%-95% organic ingredients), less tha

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

Companies that provide selfless information through particip

n 70% organic (containing less than 70% organic ingredients). Other labels note a food’s exclusion from hormones, antibiotics, and other chemicals found in conventional foods

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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References - What is Organic Food?

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