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FDA GUIDANCE

For The Cosmetics Industry

Cosmetic Good Manufacturing Practices
Effective December 2023

Cosmetics Guidance Documents

Being involved with all aspects of FDA compliance, for close to a half-century, we have speculated on when the Congress was going issue this FDA Guidance for Cosmetics, and give the FDA the authority to regulate the cosmetic industry. Recently, the FDA has recieved full authority to regulate the cosmetic industry as the FDA regulates the food, drug and medical device industries, and issued the FDA guidance for Cosmetics Industry.

A SHORTENED BREAKDOWN OF THE UPCOMING FDA GUIDANCE FOR THE COSMETICS INDUSTRY.

The summary explains the salient points of the FDA Guidance for Cosmetics; for more detailed information, we recommend contacting the specialists at mdiConsultants, Inc.

Draft Guidance

We estimate the new FDA Guidance for Cosmetic Manufacturers & Distributors will go into effect, beginning December 2023.

This FDA guidance for cosmetics covers many areas of cosmetic manufacturing, and distribution, and should be looked at closely. The FDA provides guidance to the cosmetics industry and other stakeholders as to what constitutes Good Manufacturing Practices (GMP’s) for cosmetics. This FDAGuidance for  Cosmetics also revises the previously available “Cosmetic Good Manufacturing Practices (GMP) Guidelines / Inspection Checklist” with new updates, and clarifications, based on recent FDA experience.

This FDA  Guidance for Cosmetics document is part of an international effort, with the International Cooperation on Cosmetic Regulations (ICCR), as well as the FDA’s agreement to consider elements of International Organization for Standardization (ISO) standard for cosmetic GMP’s (ISO 22716:2007) for inclusion in this guidance.

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Overall: FDA Cosmetics Guidance

FDA’s guidance documents, do not establish legally enforceable responsibilities; however, the guidance documents describe the FDA’s current thinking and should be viewed only as recommendations, unless regulatory or statutory requirements are cited.

The predecessor to the new guidance, FDA’s “Cosmetic Good Manufacturing
Guidelines/Inspection Checklist,” was based on documents and information dating before the early 1990’s. Much of the material in the previous guidance has become outdated.

Additionally, there has been a great deal of progress in developing international consensus standards for cosmetics by the ISO which is a non-governmental organization that develops and publishes international consensus standards. In developing this guidance, FDA has incorporated elements of ISO 22716, as appropriate, and consistent with FDA regulations.

Inroduction

The Federal Food, Drug and Cosmetic Act prohibits the introduction, or delivery for introduction, into interstate commerce of cosmetics that are adulterated or misbranded (Section 301 of the FD&C Act).

  • · A manufacturer can reduce the risk of adulterating or misbranding cosmetics by following the GMP recommendations in this guidance. If so, you can conduct a self-inspection to rate your operations.
  • · Tampering and other criminal, or terrorist activity that can also have a direct impact on your products’ quality. To help minimize these risks we recommend that you consult the FDA guidance document “Guidance for Industry: Cosmetic Processors and Transporters of Cosmetics Security Preventive Measures Guidance.”
Cosmetics manufactuting

Definitions

Documentation creates a mechanism to show how products are manufactured and tested. Documentation should define your organization’s processes and capture every aspect of your manufacturing process. Documentation prevents errors of interpretation or loss of information that may result from reliance on verbal communication. Documentation also allows you to trace where any problems may have occurred and to take appropriate corrective action.

Records should be retained in either paper or electronic format. Records should capture in detail the operations, procedures, deviations from procedures, justifications, instructions (including training), specifications, protocols, reports, methods, precautions, corrections and other measures, and other appropriate information related to GMPs.

Good manufacturing practice(s) (GMP): quality assurance, ensuring products are manufactured to a quality appropriate to their intended use. This concerns both manufacturing and quality control procedures.

The Good Manufacturing Practices (cGMP) include controls in the following areas:
✓ Documentation
✓ Records
✓ Buildings and Facilities
✓ Equipment
✓ Personnel
✓ Raw Materials
• Water
• Color Additives
• Prohibited and Restricted Cosmetic Ingredients
✓ Production
✓ Laboratory Controls
✓ Internal Audit
✓ Complaints, Adverse Events, and Recalls

What this means for you:

If you own or operate a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the United States, you are required to register each facility with U.S. FDA and follow GMP’s for cosmetics. (Foreign companies would be required to have a US Agent. mdi Consultants, Inc. is an official US Agent with the FDA)

This only applies if you are regularly engaging in one or more steps in the making of any cosmetic product by chemical, physical, biological, or other procedures, including manipulation, sampling, testing, or control procedures applied to the product.

perfume bottles

There are exceptions to the facility FDA registration requirement, if an establishment solely performs one or more of the following functions:
✓ Labeling
✓ Relabeling
✓ Packaging
✓ Repackaging
✓ Holding
✓ Distributing
These facilities do not need to register with FDA.

Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry

For other exceptions as well as information required for registration and listing, please see linked guidance:

Draft Guidance

For each cosmetic product, a product listing must also be submitted as part of the registration process of your facility.

Regulations covering the cosmetic industry are available under Title 21 of the Code of Federal Regulations (21 CFR).  These sections are as follows: