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A large quantity of raw material is required to extract pure, natural essential oil. Since natural plant extracts are hard

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

to procure in such large quantities, most oil products in the market contain a mix of chemical substances, or they are dilu

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

Examples of combination products may in

ted with lower quality, commercial-grade oils. Some essential oils are tainted with foreign substances in order to save on

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

roduction costs. For the essential oils to be of true therapeutic value, they should be pure, natural and of the highest qu

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

ality.

Purity is not the factor determining the quality of an essential oil. The quality of plants used and it?s growing c

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

Combination pro

nditions also affect the quality of oil extracted. It is therefore essential to buy oils from reputed growers and distiller

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

s. It is important that companies selling essential oils must analyze their complete line of essential oils to ensure that

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

ach sample measures up to stringent quality standards. The common tests used for quality verification are sensory evaluatio

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

n, color and clarity analysis and laboratory analysis using both gas chromatography and mass spectrometry (GC/MS).

The GC/

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 is the most important tool for identifying and analyzing volatile oils. It helps to ensure that the oils meet high-qualit

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

y standards and are a hundred percent pure. Tests to analyze the components of oils should also be conducted.

A simple way

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

Following aspects would a

to know the quality of an essential oil product is to check whether it has AOC certification, which stands for Appelation

dd to the challenges in developing combination products:

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

'Origine Controlee certification. AOC certification is hard to get and is given only to oil extracted from plants grown in

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

a quality-controlled environment in the high-altitude fields of France. However, there are many products without this cert

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

fication that are also genuine and of a desirable quality.

Many customers buy synthetic essential oils believing them to b

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

e pure. These synthetic oils don?t have any therapeutic use. In fact, some of them may be toxic. Most synthetic oils contai

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

Professional from academic institutions, pharmaceutical industries, health care indust

petroleum-based solvents that are harmful to our health and the environment.

A simple home remedy to distinguish between

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

pure and synthetic essential oil is to put a few sample drops of the oil on a blotting paper. Pure essential oils will not

.

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

eave any residue once they have evaporated, whereas petroleum solvents will. It is advisable to buy good quality, pure esse

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

Companies that provide selfless information through particip

ntial oils even if they are costlier, because buying cheap imitations will defeat the whole purpose of using essential oils

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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