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Physical & economic harm of not requiring pre-market testing for "cosmeceuticals"

Physical & economic harm of not requiring pre-market testing for "cosmeceuticals"


Despite regulating adulterated and misleading labeling of cosmetics, there is a lot of regulation that is not afforded to cosmetics.  Cosmetic products are not pre-market approved, so you can make a cosmetic product in your basement and sell it to consumers the very next day.  It is voluntary for cosmetic manufacturers to report health complains to the FDA.  While some health complaints may make their way to the FDA directly, that is often not the case.  The FDA does not require cosmetic firms to register their establishments or list their product formulations with the FDA nor are good manufacturing practices required for cosmetic manufacturers.  Moreover, cosmetic ingredients and products are not required to be tested for safety or efficacy.  Finally, the FDA is not authorized to require recalls of cosmetics.  Cosmetic regulation becomes even more muddled – and insufficient – when you consider products that may not fall entirely under the cosmetic definition, but may also be considered a drug, or fall somewhere in between a cosmetic and a drug.

A cosmetic is a product intended to "beautify the face."

A product can fall into both cosmetic and drug categories; that is, the definitions are not mutually exclusive.   A product can be considered a cosmetic if its intended use is to beautify the face, but it may also have a cancer prevention purpose, such as sunscreen, making it a drug as well.   If a product falls into both categories, it must comply with both cosmetic and drug regulations completely.  Can a product fall somewhere in between these two definitions?  Coined the term “cosmeceutical” by the industry, a cosmeceutical is a cosmetic product that has or claims to have some medicinal-like affect, such as anti-aging or color-correcting, but does not rise to the level of a “drug.”  Dermatologist Marie Jhin, MD notes “[c]osmeceuticals will contain active ingredients that are known to be beneficial to humans in some way. . . . [f]or example, vitamin C is a known antioxidant and when this is added to a lotion or cream the product is considered a cosmeceutical.”   Examples of cosmeceutical claims include “plumping,” “reducing fine lines,” and “skin brightening.”  The FDA refuses to legally recognize a cosmeceutical, resulting in these added “affects” sold and marketed with no regulation.   

Whether cosmeceuticals should be considered drugs or otherwise, these products are simply not being regulated as anything other than cosmetics.  John Bailey, during his time as director of the FDA’s office of cosmetics and colors, noted that he believed that the “cosmetic provisions of the statute work very well for traditional cosmetics”, but that he does not “think they work very well for the so-called cosmeceutical, because there are hard questions that need to be asked and are not asked in this setting.”   Without requiring testing and reporting of adverse results, consumers cannot be sure that sufficient testing has been done on products or that these products work as promised. Dr. Jhin, concludes that “[t]he most important thing consumers need to realize is that cosmeceuticals have not undergone rigorous investigation by the FDA, and so you must not take their claims as true or beneficial. . . [t]his is not to say that there isn't any benefit, but it cannot be substantiated by published scientific studies.” 

FDA's purpose is to protect the public health and protect the public economic well-being.

The FDA’s purpose is two-fold: to protect the public health and to protect the public economic well-being. From these two, the FDA has established regulations to protect the safety of cosmetic products and ensuring that consumer expectations are met. In understanding how the FDA’s regulations fall short in the cosmetic field, you need to understand the different types of harms that a consumer can face.  The first, and most obvious, being physical harm.  If a product contains a dangerous chemical or is offered an ingredient at a dangerous level and the consumer suffers some harm to his or her skin or body, there is a clear harm connected to that ingredient and a need for regulation of that ingredient is obvious.  Players in the cosmetic industry, however, argue that cosmetics are one of the safest products out there – very few reports or incidents of severe harm or death when compared with drugs or even food exist. While this argument may be true, it’s also short-sighted; long-term effects of the use of these new ingredients and new technologies have not been tested or if they have, such test results are not required to be shared with the FDA or the public. 

There is another harm that is not being considered in those arguments, and it is economic harm.  While the physical harm of dangerous ingredients is clearly within the purview of the FDA, so too should the deceptive nature of claims made by products alleging to use “effective” ingredients, but at levels that make the ingredients ineffective. 

Take, for example, Alpha hydroxy acids (“AHA”), which are commonly found in anti-aging products because it has been proven to exfoliate the surface of the skin and increase the production of collagen and increase cell turnover.  AHA’s are a type of acid, which industry users consider “a chemical version of a facial scrub.”  The Cosmetic Ingredient Review (“CIR”), an independent review panel, has conducted studies showing that AHA’s are safe in concentrations up to 10% in a pH of 3.5.  Even though these products essentially strip off the top layer of your skin, and therefore alter the structure of the body bringing them squarely within the purview of a drug per the FDA’s definition, they have not been regulated as such and manufacturers make claims on these products that could require their products to undergo all of the drug requirements.  The tricky part is this: AHA’s have been tested, and proven, that they work as promised, stripping the top layer of skin to reveal fresh, plumped skin, but only at certain concentrations and only at certain pH levels.  “A large portion of products in the industry that hype AHA’s . . . as the ingredients that are including are not in a pH that causes the ingredients to be active.” Consumers then are paying a ridiculous amount of money on a product that is ineffective at the level it is being sold, but it is being marketed as containing AHA’s, which is not false.  The effectiveness of AHA’s at the incorrect pH level gives “the same effect as petroleum jelly."

When is the last time you checked the concentration of AHA's in that expensive night cream you pay $120 for?  This is an interesting discussion and one that parties on both sides feel strongly about.  For now, I think becoming generally aware of what types of regulations we have in our products that we give a lot of money to and a lot of trust (in that we put it right on our faces!) is the most important part. 

What do you think?

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