FDA Issues Draft Guidance on the Safety and Regulatory Status of Nanotechnology in Food
On April 20, 2012, the U.S. Food and Drug Administration issued a Draft Guidance addressing the use of nanotechnology by manufacturers of food ingredients, manufacturers of food contact substances, and end users of ingredients or food contact substances. The draft guidance entitled, “Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and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Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives,” (“Draft Guidance”) is intended to describe the factors the food industry should consider when determining whether changes in manufacturing processes, including those involving nanotechnology, create a significant change that:
- Affects the identity of the food substance;
- Affects the safety of the use of the food substance;
- Affects the regulatory status of the use of the food substance; and
- Warrants a regulatory submission to FDA.
As described by FDA in its Draft Guidance, any manufacturing change, including those involving nanotechnology, have the potential to be significant.
FDA has not formally defined “nanotechnology.” The term most commonly is used to refer to “the intentional manipulation, manufacture or selection of materials that have at least one dimension in the size range of approximately 1 to 100 nanometers.” When considering whether an FDA-regulated product contains nanomaterials or otherwise involves the application of nanotechnology, FDA will ask:
- whether an engineered material or end product has at least one dimension in the nanoscale range (approximately 1 nm to 100 nm); or
- whether an engineered material or end product exhibits properties or phenomena, including physical or chemical properties or biological effects, that are attributable to its dimension(s), even if these dimensions fall outside the nanoscale range, up to one micrometer.
Considerations for Assessing the Impact of a Significant Manufacturing Process Change on the Safety and Regulatory Status of a Food Substance
Before a food substance can be legally marketed in the United States, it must satisfy a safety assessment, such as obtaining premarket approval or be “generally recognized as safe” or “GRAS.” Over time, the manufacturing process for a food substance may change. If the manufacturing process changes are significant, the food substance may no longer fall within the scope of a food additive regulation, a GRAS listing, an effective food contact notification, or an existing determination of GRAS status. The Draft Guidance provides the following list of examples that may be considered by the Agency as significant changes in manufacturing processes:
- A change in one or more starting materials;
- A change in the concentration of starting materials;
- A change in catalyst;
- A change in the source microorganism (including a change in strain) used for a food substance derived from fermentation of a microorganism; and
- A change in food manufacturing or ingredient technology, such as the use of emerging technologies that affect the particle size distribution of a food substance.
When determining if a significant change in a manufacturing process has occurred and whether that change requires a new authorization, it is important to determine if the change has altered the identity or intended use of the food substance. In the Appendix to the Draft Guidance, FDA provides three (3) specific examples of situations in which the FDA reconsidered the regulatory status of the use of a food substance and concluded that a significant change in the manufacturing process did not negatively impact safety.
Recommendations for Assessing the Effect of a Significant Manufacturing Process Change on the Safety and Regulatory Status of a Food Substance
The Draft Guidance provides specific steps for assessing the effect of a significant manufacturing process change on the safety and regulatory status of a food substance that is the subject of a food additive or color additive regulation in title 21 of the Code of Federal Regulation, affirmed or identified as GRAS, subject to an effective Food Contact Notification, or subject to an existing determination that a use of a food substance is GRAS. In the specific instance of nanotechnology, the Agency states, “[a]t present, for nanotechnology applications in food substances, there are questions related to the technical evidence of safety as well as the general recognition of that safety, [which] are likely to be sufficient to warrant formal premarket review and approval by FDA, rather than to satisfy criteria for GRAS status.”
Anyone can submit comments on the Draft Guidance at any time. However, in order to ensure that FDA considers comments on this Draft Guidance when developing the final guidance, electronic or written comments should be submitted within 90 days of the publication of the Notice of Availability in the Federal Register. Electronic comments should be submitted to http://www.regulations.gov. Written comments should be submitted to the Division of Dockets Management, (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.
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