Monday, August 26, 2019

How the FDA Causes Confusion Between Drugs and Cosmetics

With so many cosmetics products on the market today, how are customers aware of the promise made, in fact, delivered. Although the FDA (Food and Drug Administration) has no control over cosmetic formulations they do have control over manufacturers' demands for their products. The FDA has very specific guidelines to separate cosmetics from drugs. If the claim of a particular product results in a change in the structure or function of the body or if the product promises to treat or cure the condition then it is considered to be non-cosmetic by the FDA. Although some products look like cosmetics, the FDA considers them drugs. Examples are sunscreen and deodorants. Although they do not look like medicines on the surface, according to FDA guidelines they alter the structure (prevent sunburn) or stop drying (functioning) and, therefore, are under medication guidelines.

Once a product falls into the drug category, and this includes OTC or over the counter, only FDA-approved ingredients for use in treating certain conditions may be used to make specific claims. The simplest example is that if I make acne treatment creams that contain ingredients not approved by the FDA for acne treatment, then I will not be able to claim that my cream is "Anti-Acne Cream". Once a product has been defined as a drug or OTC, then the product label listing the ingredients must be divided into two categories, Active ingredient and Inactive ingredients. Active ingredients need to be sorted in the order of concentration while inactive ingredients are listed in alphabetical order. For cosmetics where no claims need to be made that may mislead the consumer into believing that the product has drug-free properties, it does not part with the active ingredients and does not appear on the label. These ingredients should be labeled to reduce concentration and not alphabetically.

The problem with most cosmetics emerging in the market today is that they are making claims that will classify them as medicine and not cosmetics. Most cosmetics in the market are in violation of FDA guidelines but the FDA has no source of interest in stopping this practice. Examples of cosmetics that claim to use marketing phrases such as anti-wrinkles, anti-aging, getting rid of dark circles under the eyes, reducing swelling, thick lips, etc., are in clear FDA violation. Obviously, no cosmetics can stop the aging process and if manufacturers want to sell cream, serum, or fluids that claim to alter their body structure such as eliminating wrinkles, spots or dark circles they must submit clinical studies following the same rules and regulations. who administers the new drug. Obviously, it's easier to make a false claim then spend millions of dollars involved in a clinical study and hope you don't get caught, at least before you make your millions.

Another area that the FDA is trying to regulate is not just what the manufacturers say about the product but the effect it has on the product. The simplest example of this misinformation can be seen with the sunscreen. Just look at your local pharmaceutical shelves and see sun protection products that offer a high SPF or sunburn factor of 70. The FDA has struggled with addressing this information error. Consumers consider that sun lotion with SPF 30 offers twice as much protection as one with SPF 15. This is, unfortunately, a false assumption. Sun cream with SPF 30 offers only 3% increase in sun protection when compared to someone with SPF 15. There is no increase in sun protection products with SPF above 30, but it certainly makes a great selling tool for products with SPF height.

It is up to consumers to educate themselves and have realistic expectations of their cosmetic products. Many studies show that the ingredients contained in certain cosmetics have a good effect. If a company wants you to buy their product, they should offer information on their website tab that provides abstract clinical evidence that confirms their claim. Mother's rule should always be Caveat Emptor, let the buyer be careful.







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