New FDA Guidance - Cosmetic GMPs

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Updated July 22, 2021

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Cosmetics Guidance Documents - FDA.gov

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Guidance Documents > Guidance for Industry: Cosmetic Good Manufacturing Practices:

" . . . as part of an international harmonization effort with the International Cooperation on Cosmetic Regulations (ICCR), FDA (or we) agreed to consider the current International Organization for Standardization (ISO) standard for cosmetic GMPs (ISO 22716:2007) when revising this guidance. We reviewed ISO 22716 and decided to incorporate, modify, or exclude specific aspects of it into this guidance based on our experience."

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FDA issues draft guidance on nanotechnology

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Updated June 25, 2023:

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GUIDANCE DOCUMENT - Drug Products, Including Biological Products, that Contain Nanomaterials - Guidance for Industry - APRIL 2022 - FDA.gov

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Two draft guidance documents that address the use of nanotechnology by the food and cosmetics industries were issued today by the U.S. Food and Drug Administration.

Nanotechnology is an evolving technology that allows scientists to create, explore, and manipulate materials on a scale measured in nanometers – particles so small that they can not be seen with a regular microscope. The technology has a broad range of potential applications, such as the packaging of food or altering the look and feel of cosmetics.

Press Announcements - FDA issues draft guidance on nanotechnology:


The two draft guidance documents are: “Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives” and “Guidance for Industry: Safety of Nanomaterials in Cosmetic Products.”

The food draft guidance describes the factors manufacturers should consider when determining whether changes in manufacturing processes, including those involving nanotechnology, create a significant change that may:

• affect the identity of the food substance;
• affect the safety of the use of the food substance;
• affect the regulatory status of the use of the food substance; or
• warrant a regulatory submission to FDA.

The cosmetic product draft guidance discusses the FDA’s current thinking on the safety assessment of nanomaterials when used in cosmetic products. Key points include:

• The legal requirements for cosmetics manufactured using nanomaterials are the same as those for any other cosmetics. While cosmetics are not subject to premarket approval, companies and individuals who market cosmetics are legally responsible for the safety of their products and they must be properly labeled.
• To conduct safety assessments for cosmetic products containing nanomaterials, standard safety tests may need to be modified or new methods developed.

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FDA Cosmetics GMP Inspection Checklist - Free

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Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist for Cosmetics

The FDA offers a Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist for cosmetic establishment instructions, that are excerpted from the FDA's Inspection Operations Manual. The FDA checklist may serve as guidelines for effective self-inspection. According to the FDA, a good inspection score means that an establishment follows good manufacturing practice.

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FDA Enforced Laws And Related Statutes

Updated June 28, 2025

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Laws Enforced by FDA - FDA.gov

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Since this blog covers "GMPs (FDA Good Manufacturing Practices) and other regulations," I guess it's only fair to devote a post to the FDA's "Laws Enforced by the FDA and Related Statutes." They post a pretty exhaustive list of laws and statutes, which they categorize in the following way . . .

Federal Food, Drug, and Cosmetic Act (FD&C Act) United States Code (U.S.C.) Title 21, Chapter 9 Cross-reference of FD&C Act and U.S. Code section numbers Amendments to the FD&C Act Other Laws

It should be noted that some of the laws may have been amended since their original date.

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Think Like An FDA Inspector - Be Prepared

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Revised December 16, 2020

Yep, it's important to follow all the regulations. AND, it helps to understand how the FDA inspector will approach your company during an inspection. On the FDA website, several free documents are published as reference material for investigators and other FDA personnel. The documents don't bind the FDA and don't confer any rights, privileges, benefits or immunities for or on any person(s). Basically, they'll help you prepare and anticipate what to expect from an FDA inspector and inspection team. Just be forewarned, it also means that they don't have to follow the suggestions or recommendations mentioned in the inspection guides. Here's a listing of the major categories of inspection guides that are available . . .

"Guide to Inspections of:

• Biotechnology
• Computer Issues
• Devices
• Drugs
• Foods & Cosmetics
• Miscellaneous

Note: These documents are reference material for investigators and other FDA personnel. The documents do not bind FDA and do not confer any rights, privileges, benefits or immunities for or on any person(s). An alternative approach may be used if such an approach satisfies the applicable statutes, regulations or both."

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