Cosmeceuticals

The definition of a constituent to be used for cosmetic purposes defines it as a care substance that is purposed to enhance the appearance and the odor of the human body without any requirements for medical benefits. On the other hand the definition of pharmaceuticals says that they are substances intended to address medical problems and conditions of the human body and the skin without specific references to the appearance and the odor.

What are Cosmeceuticals?

The recent research developments have resulted in skincare products that may incorporate medical properties and therefore a new term was necessary to define them. This term is cosmeceuticals and the full definition of the word implies cosmetic products containing active biological ingredients that provide benefits similar to benefits provided by pharmaceuticals and drugs. The entire concept is completely new and at this time the manufacturers of such products face many problems with the existing rules and legislature.

A point to be made here is to distinguish the term cosmeceuticals from the term nutricosmetics. Cosmeceuticals refers only to products that are used externally like ointments, creams, lotions and other such configurations. Nutricosmetics refers to similar substances that can be taken orally.

 

FDA Rules and the legislation

The Food and Drug Administration is supposed to abide by the provisions of the Food, Drug and Cosmetic Act that is in effect. According to these provisions a substance can be either a drug or a cosmetic or a combination, therefore the term “cosmeceutical” is not recognized.

If a product has medical properties it must be approved by FDA according to the definition of the above Act which clearly states that any substance that has the ability to treat, cure, mitigate or even prevent disease or otherwise affect the function and structure of the human body must be treated as a drug and therefore be reviewed intensively.

On the other hand cosmetics are not subject to review by the FDA as long as they do not fall under the above provisions. And  the major problems for the manufacturers of cosmeceuticals is that if the general public perceives these products as similar to pharmaceuticals they must undergo through full quality control and approvals as medical compounds and not circulate as cosmetics.

The practices

To avoid inquiries, trials and possible punishment by the Federal Trade Commission companies manufacturing cosmeceuticals take extra special care in labeling these products so that there can be no misperception that they have any medical value whatsoever. Any claims, even remote, that a cosmetic can provide a therapeutic value, must be accompanied by every sort of scientifically based research that proves the truthfulness of the claim.

Unfortunately, the term has been used for advertising and marketing purposes and has resulted in much controversy as to whether it has led to false beliefs from the general public even though the products have been carefully labeled. This debate is ongoing including the allegations that manufacturers of cosmeceuticals have taken advantage of the medical properties of their products and offered them at higher prices than they should.

Financial benefits to the manufacturers

The process of testing a drug through FDA is both costly and time consuming. Every review must be completed before a product is released and this means great strain to the financials of the manufacturer under review. In pharmaceutical compounds this cost is included in the final retail price of the product and this is part of the reason that they are so expensive.

On the other hand this process is not required for cosmetics and therefore no such cost is to be included in their price. The allegation that the manufacturers of cosmeceuticals gain financial profit from the marketing and advertising the term has resulted from the belief that companies that produce substances with medical properties take advantage of these properties and include a cost indicating that they have been tested and therefore their price is higher.

While it is possible for a product claiming to provide such properties to have undergone various levels of testing in the laboratories of the manufacturer or through independent clinical studies to substantiate a claim for a medical property, the law clearly states that it is illegal to sell these products without proper FDA approval.

Conclusion

Until the debate about the medical value of cosmeceuticals is resolved and new legislation is passed to regulate the testing and sale of the products, it is wise to abide by the directions of the FDA which state that any substance that has been advertised or marketed under this term is not to be considered as having any substantial medical value.

Meanwhile many independent dermatologists support the idea of smart shopping. Meaning that every product that falls under this category is thoroughly sampled and tested through medical or professional supervision before any implementation for treatment of any skin condition is considered.

The real trick is to convince the general public that this is not about the competition trying to fight a beneficial product. This is about making sure that a product is safe to use without any side-effects, irritation or other problems to the skin and without any ill effects to an underlying medical condition that may have not yet been detected and may worsen with the intake of the biological agents that provide the medical value.

There may be some dispute to the above statement by the fact that many homemade products are in fact cosmeceuticals and there is ample proof that they are safe to use. The balancing concern is that homemade products are made from ingredients the people can be sure of. How sure can they be for ingredients of products from companies frequently accused for environmental or health violations?

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