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US FDA publishes Nanotechnology Guidance for Industry Documents

Implementing the recommendations from its 2007 Nanotechnology Task Force Report, the US Food and Drug Administration (FDA) published on 24 June 2014 three final guidance documents as well as one draft guidance document for nanotechnology applications in regulated products, including cosmetics and food substances. The documents ‘reflect the FDA’s current thinking’ and contain nonbinding recommendations for industry.

In the Final Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology, the FDA identifies 'Points to Consider' when determining whether a product involves the use of nanotechnology. The agency also considers the existing framework for safety assessment to be ‘sufficiently robust and flexible’ to address nanomaterials.

In the Final Guidance for Industry: Safety of Nanomaterials in Cosmetics, the FDA recommends that safety assessments for cosmetic products containing nanomaterials addresses a number of factors, including physicochemical characteristics, agglomeration and size distribution, and potential routes of exposure; the guidance invites manufacturers to consult the FDA on safety assessment issues.

Manufacturers are also invited to consult the FDA regarding changes in the manufacturing process of a food substance; in the Final 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, the FDA presents its views on the assessment of 'the impact of a significant manufacturing process change on the safety and regulatory status of a food substance'.

Finally, a draft guidance on food for animals gives recommendations for industry submissions of Food Additive Petitions to the Agency. In the current version, the Draft Guidance for Industry: Use of Nanomaterials in Food for Animals encourages early contact the FDA’s Center for Veterinary Medicine (CVM) when making use of nanotechnologies in animal food. This draft guidance is open for comments until 10 September 2014.


Follow this link to access all of the FDA documents:

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