The FDA: Cosmetics, Essential Oils & Dietary Supplements (Part 1)

There’s been a lot of misunderstandings, misinterpretations, miscommunications (you get it) over what the US Food & Drug Administration (FDA) allows (or regulates) versus what they approve. I felt it was my duty to clear some things up…what can I say?

Part 1 covers cosmetics. Part 2 covers essential oils, and Part 3 covers dietary supplements.

First off, what does regulate and approve mean exactly?

When the FDA regulates something they are allowing it within certain guidelines. They may provide documents called guidance documents that outline the parameters.

For example, they can regulate the labeling requirements of certain products, meaning they will clearly state what can and can’t go on a label, but they may or may not approve that actual product or the label itself.

When the FDA approves something that means they need to receive certain safety data in order to make the decision on whether the product can be put into use or on the market. Examples: drugs, biologics, and certain medical devices

With all of that said, here is a question to ponder before moving on:

Do you think the FDA approves, regulates, or both with regards to cosmetics?

One more thing before you answer this question, let’s examine what the FDA definition is for cosmetics:

The FDA definition for cosmetics is as follows:

Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance. So, included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup, cleansing shampoos, perms, hair colors, deodorants, etc, however, it does not include soap oddly enough.

So, back to the question – do you think the FDA approves, regulates, or both with regards to cosmetics?

Answer: Regulates only – they do not approve cosmetics. At. All. They do not subject cosmetics to premarket approval like drugs, biologics, and certain medical devices. The FDA regulates cosmetics under two acts: 1) the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 2) the Fair Packaging and Labeling Act (FPLA).

This brings me back to when I was an independent consultant with a previous skincare products company. I don’t know if some of the consultants were being deceitful on purpose or just didn’t know any better, but some a lot of them were telling their customers that their products were FDA approved.

Now, a cosmetic can be FDA approved ONLY if it is also considered a drug. Examples include toothpastes that contain fluoride, antiperspirant deodorants, and moisturizers and makeup using the term sunscreen. Other than that no FDA approval exists for just plain old cosmetic products.

The FDA does approve color additives and maintains a list of prohibited ingredients. So, if your cosmetic contains an FDA approved color additive and it doesn’t contain anything from their list of prohibited ingredients then it’s OK according to their standards.

So who makes sure that the product is safe? Oh yeah, that’s the manufacturer’s responsibility, not the FDA.

What?!?!

Yes, the FDA leaves it up to the manufacturer to make sure the product is safe AND companies do not have to share that safety information with the FDA.

This is where your detective skills come into play. This is where you, the consumer, must do your due diligence and read your labels very carefully.

There are so many toxic ingredients being used today in our cosmetics (also known as personal care products), that have been linked to such things as cancer, infertility, asthma, allergies, and hormone disruption. Some of those ingredients include:

– Fragrance: a term used on labels everywhere. Anytime a company uses the term fragrance it could mean hundreds more chemicals not listed on the label. Companies can pretty much use whatever they want in their fragrance and they do not have to disclose the contents at all to anyone. Fragrance is considered a trade secret under the Fair Packaging and Labeling Act. Unless the label specifically states where the fragrance came from (ex: essential oils) be very careful.

– Parabens: Parabens are used in products like lotions, shampoos, deodorants, and makeup to prevent microbes from growing. They can be absorbed through the skin, blood and the digestive system and have been found in biopsies from breast tumors.

– Phthalates:  Since many companies tend to only use phthalates in their fragrance formulations you may not necessarily see them listed individually on product labels. Products that probably use phthalates the most are perfumes and colognes.

– Hydroquinone: Hydroquinone is commonly found in products marketed to lighten the skin (mostly to women of color) and is one of the most toxic ingredients still used in cosmetics. It can also be found in hair conditioners and nail glue. On the label you might also see it listed as tocopheral acetate, tocopheral, tocopheral linoleate, and other ingredients with the root “toco”.

And don’t be fooled by the term “natural” either for a product. It has no real meaning and can be placed on any product label. Still read the ingredients.

All of this kind of makes you want to go check out your product labels, huh?

Have you looked at the labels of your favorite personal care products lately?

To learn more about the FDA and the regulations of our food & products check out my FREE workshop.