Fully Exposed

I hear time and time again..."The FDA doesn't regulate cosmetics." 

"Beware! Beauty products are unsafe and unregulated."

False and false.

In the U.S.., to ensure the safety of cosmetic products, the U.S. Food and Drug Administration (FDA) regulates the cosmetics industry. Using science-based information, the FDA has broad regulatory authority under the Food, Drug and Cosmetic Act (FD&C Act) passed by Congress in 1938 and amended many times since.

Here is where the confusion occurs. Unlike drugs, the FDA does NOT approve cosmetics (see Cosmetic vs. Drug). It is the legal obligation and responsibility of the manufacturer to assure that their cosmetic product is safe when used under customary conditions and that the product is appropriately labeled. The law states that it is illegal to sell adulterated or misbranded cosmetics.

What is an adulterated cosmetic?

An adulterated cosmetic is one that...

1. contains any poisonous or harmful ingredient, which may be harmful when the product is used as described on the label.
2. contains any filthy, putrid, or decomposed substance.
3. is packaged, prepared or manufactured in unsanitary conditions where it may be contaminated with microbial organisms or any substance that renders the product harmful to the consumer.
4. is packaged in a container that is composed of poisonous or harmful substances that renders the product harmful to the user.
5. is not a hair dye but contains an unsafe color additive as determined by the FD&C Act.

What is a misbranded product?

The FD&C Act defines a misbranded product as ont that...

1. contains misleading or false information on the label.
2. does not contain the name and place of the business of the manufacturer, packer or distributor on the label, the quantity of contents in terms of weight or measure.
3. does not contain any prominently displayed required information in an easy to read and understood fashion by an ordinary individual under customary condition of use.
4. is packaged in a misleading container.
5. is a color additive and does not fulfill the packaging and labeling requirements of such color additives.
6. has packaging and labeling in violation of the Poison Prevention Packaging Act of 1970.

The FDA has the right to enforce any of these regulations. FDA inspectors can inspect any cosmetic manufacturing plant or office at any time without notice. The FDA has the authority to:

• Restrict or ban cosmetic ingredient usage for safety reasons.
• Mandate warning labels on cosmetic products.
• Issue warning letters to manufacturers, packagers or distributors.
• Seize illegal products.
• Stop unlawful activities.
• Prosecute violators of these laws.
• Collaborate with companies to implement product recalls.

Although the FDA doe not "approve" cosmetics, the FDA absolutely regulates the industry. Enjoy your cosmetics!

We've all seen ads proclaiming that a skincare product is "free-from" some particular ingredient: a brilliant scare tactic that implies that the product is now safer because it is "free-from" that particular ingredient. Let's take the commonly used, most studied class of preservatives called parabens, for example. 

To prevent contamination, all water-based products (which include the vast majority of facial and body moisturizers) require a preservative. Without one, mold and bacteria spoils the product in less than two weeks. 

Stories in the media accuse parabens of having negative health effects, of being harmful endocrine disrupting chemicals. Yes, parabens may have estrogenic activity. But their estrogenic activity is magnitudes weaker that the natural phytoestrogens found in soy products, flaxseed, and tomatoes - foods we consume every day. Fact is, parabens have not been proven to be toxic in human beings when used in approved doses of less than 1%. 

A poorly designed 2014 British study found parabens in breast tumor tissue samples. The author herself clarified that the study never concluded that the parabens caused the tumors. Media and consumer advocacy groups created a firestorm, perpetuating this erroneous conclusion. Fake news! A completely unnecessary consumer demand for paraben-free products was born. 

But the one important question remains, one that consumers are unlikely to even think to ask. What alternative preservative is being used in those skincare products that are "free-from" parabens? Has the paraben preservative been replaced with DMDM Hydantoin, a formaldehyde-releasing preservative (not terrible unless you have an allergy to it or are eczema-prone)? Or is phenoxyethanol or iodopropynl butylcarbamate being used? The safety of these chemicals is not as well documented at that of parabens as they are all less studied alternatives. 

A skincare product with "free-from" on the label may tell you what's NOT in the product, but it says nothing about the safety of the product. Don't be fooled!