Why Care About Product Safety?

The truth about cosmetic products safety and how it effects you…

Today, I am inspired to write this post after reading the Frequently Asked Question (FAQ) section of the EWG’s Skin Deep Cosmetics Database website. Many are under the impression that the FDA handles product safety with regards to cosmetics, including personal body care. However, the truth is quite different.


“Why should I be concerned about the safety of personal care products? Doesn’t the government regulate them?

EWG’s Response:

“On average, consumers use about 10 personal care products containing 126 ingredients per day. The government does not require health studies or pre-market testing for these products. The Cosmetics Ingredients Review (CIR), the industry’s self-policing safety panel, does not make up for FDA inaction. In 2007 EWG analysis found that over 30 years, the industry panel has reviewed the safety of just 13 percent of the 10,500 ingredients in personal care products.”

The FDA monitors products that are deemed “medicinal,” such as, anything with sunscreen or benzoyl peroxide. The average cosmetic product does not fall under this category. The FDA also requires proper labeling and has the authority to pursue a company for creating products that do not meet product safety guidelines. However, they do not test and approve products prior to going on the market for product safety. Generally, they do not monitor products on a regular basis.

So, what does the FDA do to regulate cosmetic product safety?


Excerpts from their website page titled, “FDA Authority Over Cosmetics.”

 “FDA’s legal authority over cosmetics is different from other products regulated by the agency, such as drugs, biologics, and medical devices. Cosmetic products and ingredients are not subject to FDA premarket approval authority, with the exception of color additives. However, FDA may pursue enforcement action against violative products, or against firms or individuals who violate the law.

Cosmetic firms are responsible for substantiating the safety of their products and ingredients before marketing. Failure to adequately substantiate the safety of a cosmetic product or its ingredients prior to marketing causes the product to be misbranded unless the following warning statement appears conspicuously on the principal display panel of the product’s label:

‘Warning–The safety of this product has not been determined.’ (21 CFR 740.10)

In addition, regulations prohibit or restrict the use of several ingredients in cosmetic products and require warning statements on the labels of certain types of cosmetics.

In general, except for color additives and those ingredients which are prohibited or restricted from use in cosmetics by regulation, a manufacturer may use any ingredient in the formulation of a cosmetic provided that the ingredient and the finished cosmetic are safe, the product is properly labeled, and the use of the ingredient does not otherwise cause the cosmetic to be adulterated or misbranded under the laws that FDA enforces.

Recalls of cosmetics are voluntary actions taken by manufacturers or distributors to remove from the marketplace products that represent a hazard or gross deception, or that are somehow defective. FDA categorizes a firm’s action as a recall (as opposed to a market withdrawal) when it determines that the product hazard or defect represents a violation of the FD&C Act.

FDA is not authorized to require recalls of cosmetics but does monitor companies that conduct a product recall and may request a product recall if the firm is not willing to remove dangerous products from the market without FDA’s written request. Recalls are addressed in Title 21 of the Code of Federal Regulations (CFR), sections 7.40 through 7.59.”

Basically, you are in charge of  monitoring the products you purchase for product safety. It is up to you to know what is in your products and what the effect of their ingredients are. Unfortunately, companies can mislead consumers by not listing small amounts of certain ingredients on their labels which, is allowed by the FDA. In addition, companies are able to list numerous chemicals under the common name, “fragrance,” without listing the chemicals individually. I’ll talk about this particular issue in a future blog post as it deserve one all it’s own.


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