‌ 

Good Manufacturing Practices, or GMP’s, are well known for people in the medical device and pharmaceutical industries. Many people, however, are unaware of how critical a role they play in other consumer product industries such as cosmetics. The cosmetics industry is unique in that cosmetics are FDA regulated, but not FDA approved. The FDA defines cosmetics as any products that are intended to cleanse, beautify, or alter appearance.[1] So, if the FDA does not approve these products, how can they regulate them and what does that entail?

The FDA regulates cosmetics under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). The main purpose of these two laws is to ensure that cosmetic products are made and labeled in a way that is safe for public health. The FD&C act considers the following situations adulterations of cosmetics, and consequently could initiate an enforcement action against a manufacturer:

  • The cosmetic product contains any poisonous substance
  • There is dirt, decomposed, or otherwise extraneous material in the product
  • The product was prepared, packed, or held under unsanitary conditions
  • The product’s container is composed of poisonous substances
  • The product contains unsafe color additives or other substances

Misbranding is also a major concern for cosmetics manufacturers, as the FDA considers any violation of the FD&C Act and FPLA a criminal offense. In short, although cosmetics do not require any sort of premarket approval from the FDA, they are still heavily regulated and require robust GMP’s. Additionally, cosmetic manufacturers should be maintaining and documenting all of their controls via their Quality Management System (QMS).

There has been a noticeable uptick in cosmetic products hitting the shelves in the past year or so, bringing more attention to the industry from the FDA. EMMA International’s team of FDA compliance experts has successfully helped cosmetic manufacturers implement GMP’s and maintain compliance, without putting an overdue burden on their organization. Give us a call at 248-987-4497 or email info@emmainternational.com to see how we can help your organization today!


[1] FDA (n.d.) Cosmetics Overview retrieved on 10/26/2021 from: https://www.fda.gov/industry/regulated-products/cosmetics-overview#:~:text=The%20FDA%20defines%20a%20cosmetic,attractiveness%2C%20or%20altering%20the%20appearance.

Madison Wheeler

Madison Wheeler

Director of Technical Operations - Ms. Wheeler serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Ms. Wheeler also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Ms. Wheeler holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.

More Resources

FDA Adverse Event Reporting 

FDA Adverse Event Reporting 

When reporting an Adverse Event to the Food and Drug Administration (FDA) the best method is to utilize the FDA Adverse Event Reporting System (FAERS). FAERS is a database that contains adverse event reports, product quality complaints that led to an adverse event, and medication error reports1. All FAERS reports are easily accessible to the public. 
De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.

Ready to learn more about working with us?

Pin It on Pinterest

Share This