Cosmetic and Skincare Products are not Actively Approved by the FDA

The FDA does not have to pre-approve products before they hit the shelves.

The Good, The Bad, and The Ugly
Under the Federal Food, Drug, and Cosmetic Act, the FDA is not required to approve cosmetic ingredients, with the exception of synthetic color additives, before products hit the shelves¹.

They do, however, regulate labels to make sure no claim is obscenely false, and at worst, all claims are mostly correct.

There is some quantitative testing (the kind you might do with a chemistry set), but it’s mostly a qualitative quick check (an objective observation) of the ingredient list. Even if products were put through the full gamut of testing by the FDA, the publication of the results is not required. It is largely up to the product’s parent company to more rigorously ensure the safety and efficacy of the products it releases. [Side note: I purposefully chose “releases” over “produces.” Some companies don’t manufacture the products they sell. More on this later.]

The FDA refers to the label screening process as controlling for adulteration or misbranding². In my experience, these are arbitrary words that give a name to a process that ultimately doesn’t do that much for consumers.

The regulation process does make sure consumers have an approximate idea of what the product contains, and how it should be used. The process, however, does not require labels to provide exact information about the product, or the ingredients contained within. Personal care marketers often exploit this inexactness to create attractive product claims.

The Scariest Part
It’s in the inexact regulation of the quality and amount of each ingredient used that personal care companies find the wiggle room to make vague and silly claims about their products. These claims are never 100% untrue (wow, too many negatives). Rephrase: these claims may be true. To what extent and by what mechanism they are true, consumers have no method of direct, unbiased verification. It’s a total guessing game.

Par exemple: The label “Cruelty Free” may mean individual ingredients and trial batches were tested on bunnies, but at least we know the final product was not. The claim of “Paraben Free” sounds lovely, but may mean that some scary replacement preservatives are floating about your lotions and potions. Both claims are smokescreens. But both are worthy of FDA approval. Yikes. 

In my opinion, vague labels are just as dangerous as adulterated or misbranded labels. But the FDA is only on the lookout for the latter.

What it Means for Products
Products are not tested by the FDA for their safety as final, whole systems of ingredients. Individual ingredients may be tested at different stages of the product development process, but their exact functionality and amount used in final products are neither verified by the FDA nor made accessible to consumers. It is up to the goodwill of the parent company and investigative grit of consumers to fill in the gaps.

Should anything go amiss (mind you, after the product has been distributed and sold), the FDA may retroactively open an investigation into the product’s safety. This regulation process is mostly reactive, and only mildly proactive.

What it Means for You
Any regulation that does happen is needed. I’m glad it exists—even if only to a small extent. But full testing and approval is necessary. If only because you have better things to do than run assays on your favorite products. I don’t even do that, and I’m the chemistry geek here.

I’ll leave you with this important distinction: Within the confines of the ingredient list, you are never being outright lied to. But nor are you reliably given a complete, clear answer as to what is in your products. Even if the list was verifiable and accurate, you as a consumer are not given a guide to understand what those ingredients mean for you. There’s no numbers, no symbols, no charts, and no hope of understanding what’s really going on your skin.

The Bottom Line
The cosmetic industry asks forgiveness rather than permission when it comes to the use (or lack thereof) of some ingredients, leaving room for some misleading product claims to be legally made. You are not being outright lied to, but you’re not always given the full truth about the products either. That’s just not gucci. You deserve so much more.

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Source Links

  1. U.S. Food and Drug Administration: Cosmetics Q&A<https://www.fda.gov/Cosmetics/ResourcesForYou/Consumers/ucm135709.htm>

  2. U.S. Food and Drug Administration: Laws & Regulations<https://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074162.htm#What_kinds>