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Recently, there has been quite a bit of discussion over the safety of the use of parabens as a preservative in cosmetics. Before addressing the augments, let’s look at what parabens are. Our first so

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

urce for information is the Food and Drug Administration.

The FDA defines parabens as “the most widely used preservatives in cosmetic products. The most common parabens used in cosmetic products are

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

Examples of combination products may in

methylparaben, propylparaben, and butylparaben. Typically, more than one paraben is used in a product, and they are often used in combination with other types of preservatives to provide preservatio

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

n against a broad range of microorganisms.” It should be noted, however that the FDA does not have authorization to approve cosmetic ingredients, with the exception of color additives so cosmetic man

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

ufacturers may use any ingredient they choose, except for a few ingredients that are prohibited by regulation. The exception to this rule is if the cosmetic ingredient is adulterated. Under the Food

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

Combination pro

Drug and Cosmetic Act, adulterated is defined as “if, among other reasons, it bears or contains any poisonous or deleterious substance which may render it injurious under the labeled conditions of us

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

e, or under customary or usual conditions of use.”

In 1984, the Cosmetic Ingredient Review (an industry-sponsored organization that reviews cosmetic ingredient safety and publishes its results in op

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

n, peer-reviewed literature. The FDA participates in the CIR in a non-voting capacity) reviewed the safety of methylparaben, propylparaben, and butylparaben and concluded they were safe for use in co

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

smetic products at levels up to 25%. Usually, parabens are used at a fraction of that level. In 2005, after a great deal of reexamination, the CIR determined that there was no reason to change its or

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

iginal conclusion on the safety of parabens as a preservative.

However, in 2004, an article in The Journal of Applied toxicology revealed a study which found parabens in breast tumors. According to

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

the FDA, the study did not determine that parabens caused cancer, just that parabens act like estrogen, mimicking your body’s own hormones which can have endocrine-disrupting effects when introduced

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

Following aspects would a

into the bloodstream and the FDA currently has declared that, “there is no reason for consumers to be concerned about the use of cosmetics containing parabens. However, the agency will continue to ev

dd to the challenges in developing combination products:

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

aluate new data in this area. If FDA determines that a health hazard exists, the agency will advise the industry and the public, and will consider its legal options under the authority of the FD&C Ac

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

t in protecting the health and welfare of consumers.”

According to Dr. Elizabeth Smith, “It is a known medical fact that estrogen stimulates breast cancer” and that “anything absorbed through the sk

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

n may be as high as 10 times the concentration of an oral dose” similar to the absorption of hormones in a birth control patch.

Additional debate occurs when parabens are found in organic skin care

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

products. The National Organic Program prohibits chemical preservatives in products that are labeled “organic”. Most organic formulations have lengthy but limited shelf lives as a result of abstainin

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

Professional from academic institutions, pharmaceutical industries, health care indust

g from adding chemical (read paraben) preservatives as compared to cosmetics which add preservatives.

While a few cosmetic companies will argue that the level of a harmful chemical in any one produc

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

t is not enough to harm you, based on studies of chemical exposure in adults, most cosmetic products are used on a daily basis and need to be monitored for the exact amount absorbed into the system.

.

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

Regardless of FDA findings, many cosmetic companies currently have decided to discontinue the use of parabens as a preventative measure. The debate on the safety of the use of parabens continues, but

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

Companies that provide selfless information through particip

it is evident that more information is necessary to determine the safety of paraben use in cosmetics. The common sense approach to chemical use says "an ounce of prevention is worth a pound of cure.

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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