# Presentation: 697866

## Nanotechnology in Food Additives and Food IngredientsPublic Meeting 

**Office of Food Additive Safety**
**Center for Food Safety and Applied Nutrition **
**Food and Drug Administration**
**September 8, 2008**

## Outline

- Regulatory Background
- Nanotechnology in Food Additives and Food Ingredients
- Purpose of this Meeting
- General Questions
- Specific Questions

## Regulatory Background

- Food and Color Additive Petitions,
- Food Contact Substance Notifications,
- Generally Recognized As Safe (GRAS) Substance Notifications, and
- Foods Derived from Bioengineered Plants Consultations.

**Notes:**
The Division of Petition Review (DPR) oversees the heart and soul of FDA's premarket review program for food ingredients, the safety review of the food and color additive petition. This division is charged with the premarket review of direct food and color additive petitions, such as new sweeteners and antimicrobials for meats, fruits and vegetables. In addition, the color additive petition review program in DPR performs the safety review for color additives used in all FDA-regulated applications, including foods, cosmetics, drugs and medical devices. 
The Division of Food Contact Notifications oversees the premarket review program for food contact substances also called indirect food additives.  These substances include polymers and monomers; Coatings (e.g., on paper, metal); Paper additives; Adhesives; Additives in packaging (e.g., colorants, antioxidants); Ion exchange resins; Boiler water additives; and Food processing equipment (e.g., conveyor belts, seals).
THE DIVISION OF BIOTECHNOLOGY AND GRAS NOTICE REVIEW evaluates notices that are submitted in support of a sponsor's conclusion that a substance is not subject to premarket review and approval because it is GRAS and conducts consultations with industry in regard to the safety and regulatory status of bioengineered foods.   

## Nanotechnology in Food Additives and Food Ingredients

- Nano-structures for improved tastes, color, flavor, texture, and consistency of food,
- Nano-sized or nano-encapsulated nutrients and health supplements for increased absorption and bioavailability,
- Nanomaterials incorporated into food packaging for improved mechanical, barrier, and antimicrobial properties, and
- Nano-sensors for traceability and monitoring the conditions of food during transport and storage.
- Chaudry, Q. et. al., *Food Additives and Contaminants,* March 2008, 25(3), 241 - 258

**Notes:**
Nanostructured low-fat mayonnaise, spreads, and ice cream increase “creaminess”
Nano-coated food with edible films or coatings for food protection
Nano-micelles for increased absorption and bioavailability
Nano-sized vitamins, etc.  I.E.  Nano Lycopene as a food additive (GRAS)
Nano-titanium nitride in PET bottles (FCN 818)
Nano-clay to improve barrier properties
Nano-silver to impart anti-microbial properties

## State of the Science

*“**In light of the current state of the science, an understanding of the interactions of nanoscale materials with biological systems is probably best gained through ****case-by-case**** analysis of specific types of nanoscale materials and of variation in their characteristics.”*

**Notes:**
As seen from the discussion in the plenary, we have determined that an understanding of the interactions of nanoscale materials with biological systems is probably best gained through case-by-case analysis of specific types of nanoscale materials and of variation in their characteristics.  At this time we simply do not have the wealth of scientific knowledge to make safety generalizations.  As you’ll see this case-by-case conclusion is being carried out in many of our regulatory recommendations. 

## Purpose of this Meeting

- To determine what factors the agency should consider in providing guidance on:
- The information and data that may be needed to demonstrate the safety and effectiveness of FDA-regulated products containing nanoscale materials
- Current guidelines and practice
- Need for enhanced or specific guidance

**Notes:**
Taken from the Federal Register Notice
What information is available to inform our regulatory, chemistry, and toxicology guidance?
What regulatory issues arise in the light of nanotechnology?

## Purpose of this Meeting

- To determine what factors the agency should consider in providing guidance on:
- The circumstances under which a product’s regulatory status might change due to the presence or use of nanoscale materials
- Need for formal guidance
- Uncertainties overall regarding nanoscale materials

**Notes:**
Taken from the Federal Register Notice
What information is available to inform our regulatory, chemistry, and toxicology guidance?
What regulatory issues arise in the light of nanotechnology?

## Communicating with FDA

-  Presentations Here
- Public Debate
-  Written Comments to the Docket
- More Detailed Public Input
-  Food or Color Master Files
- Protection of Confidential Information
- FDA as a Consolidator of Knowledge
- Stronger Knowledge Base to Produce Better Guidance

**Notes:**
Taken from the Federal Register Notice
What information is available to inform our regulatory, chemistry, and toxicology guidance?
What regulatory issues arise in the light of nanotechnology?

## General Questions

- What characteristics of nanoscale materials in FDA-regulated products should be identified and evaluated to ensure the safety and, where relevant, effectiveness of these products?
- 2. What assessment tools are available (including test methods and standards) for evaluating the characteristics of nanoscale materials that may affect the safety, effectiveness, and quality of FDA-regulated products?
- 	• How reliable are these tools?
- 	• How widely available are these tools?
- 	• Are these tools practical for regulatory use or do they have aspects that render them impractical?
- 	• What additional tools should FDA and industry consider developing to evaluate the characteristics of nanoscale materials?

## General Questions

- 3. Are there unique features of the manufacturing process for products containing nanoscale materials? If so, how should these features be evaluated?
- 	• Is the manufacturing process for nanoscale materials different from that of conventional materials? If so, how?
- 	• What parameters are critical when manufacturing products containing nanoscale materials?
- 	• What unique challenges are there for ‘‘scale-up’’ of manufacturing for products using nanoscale materials?
- 	• How do potentially unique features of nanoscale materials, such as particle size, shape, and surface charge, affect what should be considered in the development of controls, standards, and specifications for manufacturing?

## General Questions

- 4. Are there particular aspects of product formulation, processing, or storage that can affect the quality, safety, or effectiveness of products containing nanoscale materials, including as excipients?
- 5. What has been your experience with products containing nanoscale materials? Have you avoided these products due to specific concerns about aspects of development, characterization, or manufacturing?
- 6. What additional questions focusing on characterization (including stability) and manufacturing aspects of products containing nanoscale materials should be addressed in this forum or otherwise brought to the attention of FDA?

## Ingredient/Packaging Specific Questions

- 1.) Can you identify specific classes of food ingredients or packaging components derived from or incorporating nanotechnology that you would identify as raising or not raising unique safety concerns and why?
- Task Force report
- Focus questions and resources where needed

## Ingredient/Packaging Specific Questions

- 2.) In your experience, what analytical methods and tools have proven to be of the most use to you in characterizing nanoscale materials?  Looking to the future, can you suggest methods that might be developed or refined to augment those methods currently used?
- Specifications and controls relate to technical effect
- Need to connect technical effect with possible human health effect

## Ingredient/Packaging Specific Questions

- 3.) What physical characteristics of food-related nanoscale materials are of greatest concern regarding the safety of dietary consumption?
- Need to leverage our knowledge base in order to focus scarce review resources to best protect public health

## Ingredient/Packaging Specific Questions

- 4.) Nanoscale food ingredients and food packaging may behave differently than macroscale materials.  For example, nanoscale materials may agglomerate in food, interact with other components of the food matrix, and interact in the human body following ingestion.  What methods are you using to characterize nanoscale materials in the food matrix and in the human body following ingestion?
- Concern is always for what the consumer is exposed to and how that substance relates to our knowledge base of safety information.

## Ingredient/Packaging Specific Questions

- 5.) Are the current FDA *Redbook * toxicological endpoints and array of toxicity tests used for assessing the safety of macroscale food ingredients and packaging components sufficient to describe the toxicity of their nanoscale counterparts, or must new endpoints and assays be considered?
- 	Are you aware of any other toxicity tests not presently in wide use that may be more suitable?

## Ingredient/Packaging Specific Questions

- 5.)Are there toxicity tests that could be used to bridge data on macroscale ingredients to their nanoscale counterparts?
- FDA maintains the option to always request additional or unique data to support safety
- Thoughtful planning should precede testing to demonstrate safety and testing strategy should include an element of continual monitoring to ensure that questions are completely addressed

## Ingredient/Packaging Specific Questions

- 6.) Is nanotechnology applied to food ingredient and food packaging production primarily to create new effects for such compounds or to enhance existing effects?
- 	What are the perceived impacts on regulatory status or good manufacturing practice in each of these scenarios?
- Decisions regarding the regulatory status of a substance should be made with due care.

## Ingredient/Packaging Specific Questions

- 7.) How can FDA better communicate issues of regulatory status and safety of food ingredients and packaging components derived from nanotechnology to the public and industry?
- Where is there a need for guidance versus other routes of communication.

## Contact Information

**Meeting materials:**
- 	For all meeting materials or any additional information please contact **nanotech@fda.hhs.gov** or call **301-827-3360**.
**Any Comments are due by Friday, October 24, 2008.**
**Send Comments To:**
- 	Division of Dockets Management (HFA-305)Food and Drug Administration5630 Fishers Lane, Room 1061Rockville, Maryland 20852 **http://www.regulations.gov**