The FDA recently issued a final guidance titled, "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." Although broader in scope, this guidance covers the use of nanotechnology in the manufacture of food ingredients, including color additives and food contact substances, i.e., packaging.
The basic message of this draft guidance is that food or packaging manufacturers who incorporate nanoscale ingredients into their products should be prepared to prove the resulting products are safe and appropriate tests were used to validate their safety.
The guidance includes a review of the statutory and regulatory
provisions governing food, food additives, and food contact
substances. Food is considered adulterated if it includes a
poisonous or deleterious substance or an unsafe food or color
additive. In this context, "unsafe" means "not
pre-approved by the FDA" unless the additive is generally
recognized as safe (GRAS) by experts in the field. In general,
color additives must also be pre-approved and there is no GRAS
exception for color additives. The FDA's approval of food
products assumes that they are manufactured according to good
manufacturing practices (GMP).
The guidance next describes the FDA's process for assessing
the safety of a food substance. In connection with the
manufacturing process, the guidance notes that the manufacturing
process can affect the identity of the food, the conditions of its
use and the level of impurities it contains. The guidance then
states:
As with any other manufacturing technologies applied to food,
nanotechnology and other emerging technologies may introduce issues
that warrant additional or different evaluation during a safety
assessment of a food substance. For example, so-called
nano-engineered food substances can have significantly altered
bioavailability and may, therefore, raise new safety issues that
have not been seen in their traditionally manufactured
counterparts. . . . When a food substance is manufactured to
include a particle size distribution shifted more fully into the
nanometer range, safety assessments should be based on data
relevant to the nanometer version of the food substance. Where
nano-engineered food substances have new properties, additional or
different testing methods may be necessary to determine the safety
of the food substance...Thus, as with any studies to support the
safety of food substances, studies to establish the safety of food
substances manufactured using nanotechnology should have been
appropriately validated for these materials.
For food or color additives that have been approved by regulation,
foods that have been identified as GRAS, or food contact substances
that have been approved via a food contact notification to FDA,
when there is a significant change to the manufacturing process,
including the incorporation of nanoscale ingredients, the guidance
recommends that the manufacturer take several steps:
- Determine what changes have been made to the food substance, including its physicochemical structure and properties, purity and impurities
- Conduct a safety assessment for the food substance, including the factors set forth above, bioavailability, and toxicity
- Consider whether the substance is within a relevant regulation, GRAS determination, or food contact notification
- Consult with FDA about your conclusions
- Make a regulatory submission if warranted
The guidance states the FDA's view that it is unlikely
nanotechnology applications in food substances will qualify as
GRAS, so formal premarket review and approval will be
necessary.
In short, manufacturers of foods, food or color additives, and
food contact substances who plan to incorporate nanoscale materials
into their products will have to consider conducting safety testing
of their products, according to tests that are validated for use
with nanoscale materials, and obtain the FDA's approval prior
to marketing the products, or risk FDA enforcement action.
As always, it is important to recall the FDA guidance documents do
not have the force of law, but rather simply represent the
FDA's current thinking on a topic.
A pdf copy of the guidance is available here.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.