New Skin Care

Exactly What is a Drug and What is a Cosmetic

 

when is it a drug as opposed to a cosmetic


With the myriad of cosmetic products on the market today how does the consumer know which promises made, in fact, are delivered. Although the FDA (Food and Drug Administration) does not have oversight over the formulation of cosmetics they do have control over the claims a manufacturer makes about their products.The FDA has very specific guidelines separating a cosmetic from a drug. If the claims a particular product makes results in a change in the structure or function of the body or if a product promises to treat or cure a condition then it is considered a drug and not a cosmetic by the FDA. Although some products appear to be cosmetics, the FDA considers them drugs. Examples of these are sunscreens and deodorants. Although on the surface they do not appear to be drugs, according to FDA guidelines they change the structure (preventing sunburn) or stop perspiration (function) and therefore, fall under the guidelines for drugs.

Once a product falls into the drug category, and this includes OTC or over the counter drugs, only ingredients approved by the FDA for use to treat a particular condition can be used to make a particular claim. The simplest example would be if I were to manufacture a cream to treat acne containing an ingredient that the FDA did not approve for the treatment of acne, then I would not be able to make the claim that my cream was an “Anti-Acne Cream”. Once a product has been defined as either a drug or an OTC, then the product label listing the ingredients must be divided in two categories, active Ingredients and inactive Ingredients. The active ingredients have to be listed in order of decreasing concentration while the inactive ingredients are listed in alphabetical order. For cosmetics where no claims should be made that might confuse the consumer into believing the product has drug properties no such separation of ingredients into the active and inactive need appear on the label. The ingredients need to only be labeled in order of decreasing concentration and not alphabetically.

The problem with most cosmetics that appear on the market today is that they make claims that would classify them as drugs and not cosmetics.The vast majority of cosmetics on the market are in clear violation of FDA guidelines but the FDA does not have the resources nor the inclination to stop this practice. Examples of cosmetics that make claims using marketing phrases like anti-wrinkle, anti-aging, removes dark circles under the eyes, reduces puffiness, thickens lips, etc., are in clear violation of the FDA. Obviously, no cosmetic exists that can stop the aging process and if a manufacture wants to sell a cream, serum, or fluid that claims to alter the structure of the body like eliminating wrinkles, spots, or dark circles than they must submit clinical studies following the same stringent rules and regulations that govern new drugs. Clearly, it is easier to make false claims then spend the millions of dollars involved in doing clinical studies and hope you do not get caught, at least not before you have made your millions.

Another area that the FDA tries to regulate is not only what the manufacturer says about a product but the impression that a product gives. The simplest example of this misinformation can be seen with sunscreens. Just look on the shelves of your local pharmacy and see sunscreen products offering SPF or sunburn protection factor as high as 70. The FDA has been grappling with how to deal with this misinformation. The consumer assumes that a sun lotion with an SPF of 30 offers twice the protection as one with an SPF of 15. This, unfortunately, is a false assumption. A sun cream with an SPF of 30 only offers an increase in sunburn protection of 3% when in comparison to one with an SPF 15. There is practically no increase in protection in sun care products with SPF’s above 30, but it sure makes for a great selling tool for products with high SPF’s.

It is up to the consumers to educate themselves and have realistic expectations from their cosmetic products. Many studies do show that the ingredients contained in certain cosmetics have a beneficial effect. If a company wants you to buy their products they should offer information on their websites a tab that provides an abstract of the clinical evidence verifying the claims that they are making. The rule of thumb should always be Caveat Emptor, let the buyer beware.