January 2022

Although the FDA does not have a list of tests explicitly required for cosmetics/personal care products, it does hold manufacturers and distributors responsible for ensuring that their product is “safe when consumers use [the product] according to the directions in the labeling or in the customary or expected way.”

This statement consolidates the language from the Federal Food, Drug, and Cosmetics Act of 1938 that prohibits the interstate commerce of adulterated or misbranded cosmetic products.

Adulterated products include products that contain any “poisonous or deleterious substance(s)” as well as products that contain microbial contamination.  At the ‘Questions and Answers on the Cosmetic Microbiological Safety Public Meeting,’ the FDA indicated that microbial contamination is the most frequent reason for cosmetic recalls. This is likely due to the variety of ways microbial contaminants can be introduced into cosmetics, which includes ingredients, packaging, manufacturing processes, and consumer use after sale.

To confirm microbiological safety during the manufacturing process, aerobic bacteria, yeast, and mold counts as well as tests for objectionable microorganisms are recommended for each batch of product. Preservative (Antimicrobial) Efficacy Testing is also recommended to address low-level contamination introduced during manufacturing and various levels of contamination that can be introduced during use of the product. Manufacturers and distributors are also responsible for ensuring that products are not misbranded. Misbranding includes false or unsubstantiated information, including shelf-life claims. Microchem offers both real-time and accelerated stability testing across a wide array of temperature, humidity, and light exposure.

Bringing cosmetic and personal care products to market can be overwhelming and the lack of clarity regarding testing requirements can be frustrating. Microchem works as a partner with its cosmetics clients to ensure the testing they conduct is necessary and routine.

If you are interested in learning more about testing beauty or personal care products, please contact our lab.