Are Personal Care Products & Toiletries Regulated by the FDA???

There is ongoing controversy regarding the safety of the products we apply to our skin each and every day. How can we be sure that the products we purchase are safe? Are these products regulated by the FDA? If these products are not “FDA approved”, does this mean that they are not safe?

If you have questions such as these, please read below as I address each of these concerns.

What is the FDA?

The Food and Drug Administration (FDA) is responsible for protecting the public health by ensuring the safety, efficacy, and security of drugs, and by ensuring the safety of food and cosmetics.

What is considered a drug product?

 

 

The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines drugs by their intended use. These are “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles intended to affect the structure or any function of the body of man or other animals” [FD&C Act, sec. 201(g)(1)].

What is considered a cosmetic? 

 

The FD&C defines a cosmetic by its intended use. These are “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” [FD&C Act, sec. 201(i)]. 

 Can a product be both a cosmetic and a drug?

If a product has more than one intended use, then it may be classified as both a cosmetic and a drug. Examples of these types of products include an antidandruff shampoo, antiperspirant deodorant, or makeup products that claim to protect the skin from the sun.

The easiest way to distinguish a cosmetic from a drug product is by reading the product labels. If the product makes therapeutic claims to cure, treat, or prevent a disease, then it is a drug product and requires approval from the FDA before entering the market. If the product only makes claims to cleanse or promote attractiveness, then this product is considered a cosmetic. Under the FD&C Act, cosmetic products do not require FDA approval.

How do I know if my cosmetic products are safe?

Manufactures of cosmetic and personal care products must adhere to “Good Manufacturing Practices” (GMP) guidelines that have been provided by the FDA. These practices assure cosmetic products are not injurious to its users, do not contain filth, do not contain non-certified color additives, and is manufactured under sanitary conditions. In addition, these practices assure cosmetic products do not contain false or misleading labeling.

 If you have concerns regarding the safety of the products you use, feel free to reach out to your personal care companies and ask how they are adhering to the GMPs. 

 

References: www.fda.gov