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Welcome to my blog. I'm a lawyer intrigued by legal issues in the fashion industry.  When I'm not working, I'm exploring new places, wines, and beauty products.

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Don't do drugs... unless it's SPF


Let's talk about the Food and Drug Administration ("FDA").  The FDA is a consumer protection agency that regulates things such as food, drugs, and to a small degree, cosmetics.  The FDA defines a drug as a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.  Products that fall under this definition are subject to certain regulations under the FDA's hand, including pre-market testing for safety and effectiveness, manufacturing facility registration with the FDA, product-related injury reports to be given to the FDA, and good manufacturing practices ("GMP") followed during manufacturing.  These regulations are costly in both time and in money.  On average, it takes 12 years and over $350 million to get a prescription drug from the laboratory onto the pharmacy shelf. 

Over-the-counter drugs can be less burdensome if the product is not using a "new" ingredient.  The FDA has something like a recipe book, which contains all active ingredients the FDA has approved for certain usages in certain dosages.  If an over-the-counter product is to use one of these ingredients in line with the FDA-approved uses and dosage, that alleviates quite a bit of testing required for the brand.  The other regulations, including registering manufacturing facilities, injury reports, and GMP, still must be followed, and are not cheap.  

Now let's talk about cosmetics.  The FDA defines a cosmetic as an article intended to be rubbed, poured, sprinkled, or sprayed on… the human body... for cleansing, beautifying, promoting attractiveness, or altering the appearance.  It might surprise you to learn that the FDA does not approve cosmetics before they go to market in the United States.  The FDA does regulate the sale of false or misleading labeling of cosmetics, as well as adulterated (containing poisonous or extremely harmful chemicals) cosmetics, but even these regulations are not doing their job.  I'll write more about that topic later. 

An example of a cosmetic that is considered a drug would be face powder containing sunscreen.  Sunscreen products are considered a drug because they “prevent sunburn, protect the skin against harm from the sun and prevent skin damage through overexposure to the sun.”  So any product claiming to contain “sunscreen,” “SPF,” an “SPF value,” or similar, will be considered a drug for purposes of the FDA and must comply with the above-described drug regulations.  SPF actually stands for Sun Protection Factor, which is a rating strictly regulated by the FDA.  You probably know the number that comes after SPF on a bottle tells you how long you can stay in the sun without burning, caused by ultraviolet B ("UVB") rays.  However, these are not the same rays that cause signs of aging or skin cancer.  Those rays are known as ultraviolet light A ("UVA") rays.  The FDA does not currently regulate UVA products, only UVB, so just because a product claims to contain sunscreen does not mean you are getting full protection.  That is up to you.  Check out your products to see whether they offer UVA and UVB protection.  

There is a "third" category of products that don't quite fall under a drug but some believe do not fall under the above definition of a cosmetic, either.  Those are referred to in the industry as a cosmeceutical.  A cosmeceutical is a cosmetic that claims to have some sort of medicinal affect, such as anti-aging, plumping, or color-correcting.  The FDA does not recognize this term, and these products slip through the cracks of drug and cosmetic regulation, resulting in essentially little-to-no regulation.  Do you know what's in your skincare product that claims it is "natural"?  The terms "natural", "dermatologist-tested," and "hypoallergenic" as it applies to cosmetics and cosmeceuticals, have no legal standard, meaning the government does not regulated these claims.  These words can be used as marketing, without having to conform to any specific requirements of its contents, ingredients, or how its product was produced or manufactured.

This leads to an issue I've repeatedly found while researching the FDA as it applies to cosmetics.  That is, misleading claims.  As I mentioned earlier, the FDA can and should be regulating misleading claims on cosmetics, but what does that even mean?  Would you be mislead into thinking a product that contains "SPF" or sunscreen was protecting you from the sun, wrinkles caused by sun exposure, and sun cancer and not merely just the burns the sun can cause?  What about if a product said it was natural but you turn it over to find 20+ ingredients you cannot pronounce?  The lack of regulation by the FDA in our cosmetics is an issue, since studies show that consumers generally believe cosmetic product claims.  Furthermore, when looking at regulatory agencies in other parts of the world, it raises the question of whether less regulation is more.  In the EU, the cosmetic regulatory body has banned over 1,300 products for use in cosmetics.  In the U.S., only 11 of those products have been banned.  Considering the makeup and skincare craze that is evident today, maybe the FDA should be paying more attention to what goes into these products and what is being used as marketing that may confuse consumers, even sophisticated ones.

What do you think?  Do you think the FDA should regulate ingredients allowed in our cosmetic and skincare products?  Should they do more to regulate "claims" about cosmetic and skincare products?  Is there enough information out there for consumers to make educated decisions themselves? 

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