US FDA Lacks Oversight on Nano Food Additives

The GAO report examines the extent to which

• FDA’s oversight of new GRAS determinations helps ensure the safety of these substances,
• FDA ensures the continued safety of current GRAS substances as new scientific information emerges, and
• FDA’s approach to regulating engineered nanomaterials in GRAS substances helps ensure the safety of the food supply.

"Currently, companies may determine a substance is GRAS without FDA's approval or knowledge," said the report. As GAO notes, there are have been instances where additives initially deemed GRAS were later banned for safety reasons.

In 1986, FDA banned the use of sulfites on fruits and vegetables intended to be served raw and added labeling requirements for food containing the additive because of potentially severe allergic reactions. Sulfites had been considered GRAS since 1959.

Despite a slew of concerns from consumer groups over the safety over certain GRAS additives, the GAO found that FDA has not reconsidered the safety of any substances in the category since the 1980s.

"FDA is not systematically ensuring the continued safety of current GRAS substances," according to the summary of findings. This lack of oversight goes against FDA regulations, which require the agency to reconsider the GRAS status of a substance as new scientific information emerges.

Not only is the agency not reviewing the safety of GRAS additives, but it has not responded to a series of petitions from consumer groups over certain substances.

Individuals and consumer groups submitted 11 petitions between 2004 and 2008, expressing concerns on salt, partially hydrogendated oils, and other substances, and FDA has only definitively responded to one.

The report also expressed concerns about the FDA's lack of information and oversight on nanomaterials in GRAS substances. While the report acknowledged certain nanomaterials could enhance food safety, there are also potential public health risks and "uncertainties remain about how to determine their safety in food."

"FDA encourages, but does not require, companies considering using engineered nanomaterials in food to consult with the agency regarding whether such substances might be GRAS."

Under the current voluntary notification scheme, companies are not required to identify nanomaterials in GRAS substances.

According to GAO, "FDA has no way of knowing the full extent to which engineered nanomaterials have entered the U.S. food supply."

The report also points out that in Canada and the European Union, any food ingredient that incoporporates engineered nanomaterials must clear regulatory hurdles before being approved for the marketplace.

The European Union (which regulates food on behalf of its 27 member countries) - do not have a GRAS exemption that would allow companies to market a food ingredient containing engineered nanomaterials without first notifying and obtaining approval from regulators. All novel foods and food additives they oversee are subject to regulatory review before they are introduced into the market.

The European Union has also taken a step to more directly regulate engineered nanomaterials in food. The European Parliament and the Council of the European Union, the European Union’s legislative bodies, recently revised their regulations on food additives. These revised regulations include language clarifying that when there is a change in the particle size of a food additive that has previously been approved, for example through nanotechnology, premarket approval for the altered food additive is required. These regulations took effect in January 2010. The same rules would apply to food contact materials produced through nanotechnology.

The full report is available here.

Source: SafeNano | GAO Report