Improved FDA Oversight of Microbiological Safety to Ensure Cosmetic Compliance and Safety

February 23, 2015 By

Cosmetic compliance and safety falls under the purview of the FDA. They have recently provided information to improve oversight with respect to microbiological safety.

While the FDA does not currently provide approval to cosmetic products or ingredients before they are sold to consumers, they must not be considered adulterated or misbranded: the legal responsibility is on the companies or individuals who manufacturer or distribute the cosmetics to ensure that they are safe for public use. This includes ensuring that the products are properly labelled, and prepared, packed, and stored in such a way that they are not contaminated.

Harmful microorganisms can be introduced to a product in a number of ways, including:

  • Contaminated raw materials, water or other ingredients
  • Poor manufacturing conditions
  • Ingredients that encourage growth of microorganisms, without an effective preservative systemThe FDA is continuously improving its knowledge of the most common contaminants and exploring ways to update and improve the current detection methods, and will monitor to ensure cosmetic compliance and take action against cosmetics that do not comply with the law.

It is also important that claims made for cosmetics are intended to enhance the appearance and provide an effect on the surface of the skin. Cosmetics can not claim to cure, mitigate, treat, or prevent a disease or condition: such claims would cause them to fall under the Drug category and be regulated as such.

The FDA posts Warning Letters that are issued to companies whose products are adulterated or contaminated, or whose labels or advertising fail to comply with the established Cosmetic Regulations. These can be viewed by the public, and detail what deficiencies were found with the product as well as the actions that the FDA would take if the issue is not resolved.

dicentra can provide Cosmetic Regulatory Consulting for products in the U.S. and Canada to assist with cosmetic compliance. We can assist with the creation of compliant labels and marketing materials, and 3rd Party Auditing of current Standard Operating Procedures.

dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of foods, dietary supplements, natural health products, cosmetics and OTCs. We can be reached at 1-866-647-3279 or