FDA issues draft guidance on nanotechnology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Two draft guidance documents that address the use of nanotechnology by the food and cosmetics industries were issued today by the U.S. Food and Drug Administration.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Press Announcements - FDA issues draft guidance on nanotechnology:


The two draft guidance documents are: “Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, including Emerging Technologies, on the Safety and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The food draft guidance describes the factors manufacturers should consider when determining whether changes in manufacturing processes, including those involving nanotechnology,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The cosmetic product draft guidance discusses the FDA’s current thinking on the safety assessment of nanomaterials when used in cosmetic products.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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CDC Says Mesothelioma Deaths Increasing

Morbidity and Mortality Weekly Report (MMWR) reports mesothelioma fatalities over the past several years, Malignant Mesothelioma Mortality --- United States, 1999--2005. In a nutshell . . . CDC's National Institute for Occupational Safety and Health (NIOSH) analyzed annual multiple-cause-of-death records for 1999--2005, the most recent years for which complete data are available. For those years, a total of 18,068 deaths of persons with malignant mesothelioma were reported, increasing from 2,482 deaths in 1999 to 2,704 in 2005. The agency expects the number of mesothelioma deaths to peak next year, and to begin to decline, as the improvements in safety and reduction in asbestos use instituted decades ago payoff. The latency period of mesothelioma can be decades long, so even though asbestos is used less widely today, people continue to get mesothelioma due to their exposure in the past. What's concerning is, "Recent studies suggest that carbon nanotubes (fiber-shaped nanoparticles), which are increasingly being used in manufacturing (9), might share the carcinogenic mechanism postulated for asbestos and induce mesothelioma (10), underscoring the need for documentation of occupational history in future cases. Capturing occupational history information for mesothelioma cases is important to identify industries and occupations placing workers at risk for this lethal disease." 

Related Posts: Asbestos.com - HONcode Certified Reputable Mesothelioma Resources Are Nanoparticles Dangerous Like Asbestos? 

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Are Nanoparticles Dangerous Like Asbestos?

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Updated October 15, 2022:

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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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Updated January 9, 2021

Speaking of nanoparticles, you might also be interested in:

Fact check: Lipid nanoparticles in a COVID-19 vaccine are there to transport RNA molecules - Reuters

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More recent news buzz on the topic recently. When I see nanotechnology, or nanoparticles, I'm worrying about whether we're creating a wave of manmade asbestos-like materials and ensuing mesothelioma. I stumbled across this on the NIOSH site, and think you'll find it an interesting read. Coming from NIOSH, I'm more likely to believe what I read, "Approaches to Safe Nanotechnology - Managing the Health and Safety Concerns Associated with Engineered Nanomaterials." The document reviews what is currently known about nanoparticle toxicity, process emissions and exposure assessment, engineering controls, and personal protective equipment. This updated version of the document incorporates some of the latest results of NIOSH research, but it is only a starting point. The document serves a dual purpose: it is a summary of NIOSH's current thinking and interim recommendations; and it is a request from NIOSH to occupational safety and health practitioners, researchers, product innovators and manufacturers, employers, workers, interest group members, and the general public to exchange information that will ensure that no worker suffers material impairment of safety or health as nanotechnology develops. 

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