Thursday, October 20, 2016

Anti-Aging Skin Series Post 4: What Is A Cosmetic Product?

The last post in the "Anti-Aging Skin Series" was tying up loose ends regarding the "function of skin".  In order to proceed to evaluate the effectiveness of a given anti-aging skin care product, we have to be able to validate the product first.  A given product will have claims associated with it that provide clarity as to the treatment on your skin.  Further, the ingredient list will provide the evidence that chemists can use to validate the claims.  Above all, to begin with, we must distinguish between a cosmetic product and other products.  What are the "other products"?  The other products are those whose claims fall outside the range of cosmetics.  Usually, these have to have approval by various agencies such as the "Food and Drug Administration."

Usual Disclaimer:

For some readers the material might be too elementary ( or too much detail).  I would challenge you to think deeply about the simplicity of the descriptions and also I will include links for you too (on the side with greater detail).

Overall Effect/Aim Of A Cosmetic Product

The overall aim of a cosmetic product is to provide the following:

1) Sense of effect

2) Desired effect

3) Manufacturer's claimed effect

After reading the above three effects you might be somewhat confused.  The following question might emerge as a result:

Why are all three not the same or a combined effect?

The reason lies within the claim of the product.  If I (a scientist) were to use a product with a claim, I would be looking to validate the claim.  Evidently, according to the "Chemist's Corner" that is only part of the achieved mission.  Why?  The most important statement from a cosmetic chemist is the following:

If the product does not make the person feel better, then the product designers of the product have failed.


Yes.  Even if the product fulfills the claim listed on the container (marketed as) and validated by the ingredients list?

The most important person to satisfy is the customer.  Which is one reason why I am breaking down the initial blog post into digestible bits.

Alternatively, the cosmetic industry understands this and can extend the claims (in fraudulent cases) in order to achieve the overall goal: satisfy the customer.  Once a customer is satisfied, then the message spreads about the success of the product and sales increase as a result.  Meanwhile, harm done to consumer propagates without understanding the nature of the fraudulent claim causing alarm.  There are regulatory procedures for a cosmetic product.  In the section below, the differences between a cosmetic product and a drug are highlighted.

What Is A Cosmetic Product?

To answer the question in the simplest terms, lets consult 'Wikipedia' for a definition of 'Cosmetics'.  An excerpt is shown below taken from the page:

Cosmetics, also known as make-up, are substances or products used to enhance the appearance or fragrance of the body. Many cosmetics are designed for use on the face and hair. In the 21st century, women generally use more cosmetics than men. They are generally mixtures of chemical compounds; some being derived from natural sources (such as coconut oil), and some being synthetics.[1] Common cosmetics include lipstick, mascara, eye shadow, foundation, rouge, skin cleansers and skin lotions, shampoo, hairstyling products (gel, hair spray, etc.), perfume, and cologne.
In the U.S., the Food and Drug Administration (FDA), which regulates cosmetics,[2] defines cosmetics as "intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body's structure or functions". This broad definition includes any material intended for use as a component of a cosmetic product. The FDA specifically excludes soap from this category.[3]

Relatively simple right?

Depending on who you ask, the definition can vary slightly or to a large extent.  A cosmetic product is a mixture of compounds.  Further, the "active ingredient" involved in the product is not necessarily correctly indicated on the label of the product.  Why do I mention this last statement?

Further, the FDA definition of a cosmetic product as indicated in the excerpt above specifies that the product CANNOT change the body's structure or functions.  That is extremely important to understand about skin care products.  Why?  Because, the claim may be specifying a change that falls into the category.  Can I point out an example of this?  Yes!

In the very first blog post which motivated the "Anti-Aging Skin Series," an excerpt was presented by Dr. Zoe Draelos regarding the efficacy and mode of action for "glycan skin care creams":

Dr. Draelos said the goal of glycan creams is to provide sugars or transform existing sugars to allow older cells to behave like younger cells. In theory, this would allow the skin to produce more collagen and heal better after injuries, including burns and cuts. Dr. Draelos notes one added benefit of glycan creams is that they are considered safe to apply to the skin because sugars are the body’s fuel.

However, Dr. Draelos notes current research has not shown if glycan creams can impact the skin to the extent that skin cell glycans begin to act more youthful. “The theory behind glycans’ impact on anti-aging is very much in its infancy,” said Dr. Draelos. “Currently there are other more proven treatments on the market, such as retinoids, but new research will provide additional targets for anti-aging strategies.”

You will recall that in the first part of the excerpt, Dr. Zoe Draelos describes the loss of glycans as a natural part of aging.   For the moment, a glycan is the intermediate (attached to the outside of the cell) toward making collagen.  As we age, the glycan levels vary and this reduction is thought to be responsible for the loss or reduction in collagen production.

Here is where a skin care product manufacturer might run into difficulty with product claims.  If the manufacturer states that the product enhances the production of collagen, then the product is not a "cosmetic product" and would be classified as a "drug" with different regulatory procedures to jump through to get to market.

Take home message?

The clear distinction between a cosmetic product and a drug is necessary for each of us (as consumers) to understand when seeking to purchase a product for an intended purpose.  Here are two excerpts taken from the "Food and Drug Administration's" website regarding the distinction.  First, the strict definitions of both a "drug" and a "cosmetic product" are shown below:

How does the law define a cosmetic?
The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" [FD&C Act, sec. 201(i)]. Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product. 

How does the law define a drug?

The FD&C Act defines drugs, in part, by their intended use, as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals" [FD&C Act, sec. 201(g)(1)].

Furthermore, it is important to understand that both a "drug" and a "cosmetic product" have completely different "approval" routes.  Here is another excerpt taken from the FDA website regarding the approval routes for the two types of products:

How approval requirements are different ?

Under the FD&C Act, cosmetic products and ingredients, with the exception of color additives, do not require FDA approval before they go on the market. Drugs, however, must generally either receive premarket approval by FDA through the New Drug Application (NDA) process or conform to a "monograph" for a particular drug category, as established by FDA's Over-the-Counter (OTC) Drug Review. These monographs specify conditions whereby OTC drug ingredients are generally recognized as safe and effective, and not misbranded. Certain OTC drugs may remain on the market without an NDA approval until a monograph for its class of drugs is finalized as a regulation. However, once FDA has made a final determination on the status of an OTC drug category, such products must either be the subject of an approved NDA [FD&C Act, sec. 505(a) and (b)], or comply with the appropriate monograph for an OTC drug. (A note on the term "new drug": Despite the word "new," a "new drug" may have been in use for many years. If a product is intended for use as a drug, it must comply with the requirements outlined above.)

Having the knowledge above will allow you as a consumer to understand the various claims of the cosmetic product's manufacturer.  Further, the information above allows you to ask knowledgeable questions as a consumer into the efficacy and justifiable claims made.  And last but not least, you can now help the rest of the world by reporting false claims to the FDA to have the products removed from the market.  Especially, if a given product is causing consumers harm.

Conclusion ...

Over the course of writing the initial blog post which was lengthy, I have now come to realize that the skin care product business is varied in the amount of information presented on the back of each product container.  This will become apparent to the reader (you) in the weeks to come as we continue the series in investigating "anti-aging" products.  Additionally, I am surprised that consumers have so much trust in the cosmetic product market.  When all is said and done, at the end of the day, the consumer is both the market and the safety advocate.

What do I mean by this?

The cosmetic market is run by years of highly successful consumers passing on opinions regarding various products.  These opinions have been unmatched by scientific safety information.  Only after a problem is reported does a product get scrutinized.  Yes, certain ingredients have been approved to incorporate into cosmetic products.  Therein lies the large range in which these companies have to operate and market in.

As we move forward, examples will be shown of "anti-aging" products and the ingredients/claims will be further investigated.  I look forward to having the reader provide input where necessary (or interested) to enhance the quality of the material presented.

Until next time, have a great day!

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