FDA nanotechnology draft guidance represents ‘marginal progress’ – petition group

By Mark Astley

- Last updated on GMT

Related tags: Food and drug administration, Regulation

FDA nanotechnology draft guidance represents ‘marginal progress’ – petition group
US Food and Drug Administration (FDA) draft guidance on the use of nanotechnology in food and food contact substances represents only “marginal progress” towards regulation of the technology, a petition group has claimed.

In response to the FDA guidance, the Center for Food Safety (CFS), Friends of the Earth (FoE), the Institute for Agriculture and Trade Policy (LATP) and the International Center for Technology Assessment (ICTA) have called for the introduction of further regulations to cover the food sector’s use of the technology.

The FDA document pinpointed factors that should be considered when trying to determine whether changes in manufacturing process, such as the intentional reduction in particle size to the nanoscale, can affect the safety of food.

Once finalised, Draft Guidance for Industry: Assessment the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food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 Colour Additives​ will represent the FDA’s current thinking on the topic.

The Center for Food Safety (CFS), which campaigns against harmful food production technology, has urged the FDA to issue more than just voluntary guidance on the issue.

“Marginal progress”

The campaigners, which are all currently working on nanotechnology oversight, have called on the FDA to further the so-far “marginal progress toward regulation of products made with this new technology.”

The draft guidance followed a lawsuit filed in December 2011 by the group, regarding the FDA’s failure to respond to their 2006 petition. The FDA responded to the groups’ lawsuit in April 2012.

“In its formal response to the groups’ lawsuit, FDA acknowledged that there are differences between nanomaterials and their bulk counterparts, and the nanomaterials have potential new risks and may require new testing,” ​said the group’s statement.

“However, the agency declined to enact mandatory regulations at this time.”

“Despite already being commercially available, nanomaterials in sunscreens, cosmetics, foods and food contact substances are unlabelled and largely untested and largely untested for their human health effects,” ​added the statement.

Existing research has flagged-up several potential nanotechnology-related health risks, including the dangers surrounding the ability of nanomaterials to enter the bloodstream through skin contact, ingestion and inhalation.

Mandatory regulations

While agreeing that the FDA stance on nanotechnology “has improved”​, CFS attorney George Kimbrell called on the Agency to implement more than just voluntary guidance.

“As these new responses show, the agency is no longer ignoring the scientific consensus that these nanomaterials have the capacity to be fundamentally different, and can create new and novel risks, necessitating new testing,” ​said Kimbrell.

“Unfortunately, the agency has thus far only taken a voluntary rather than mandatory regulatory approach, despite the failure of voluntary approaches to elicit industry cooperation to regulate nanomaterials.”

“Much more than voluntary guidance is needed, and we will remain vigilant in our efforts to drag the agency towards responsible regulation,” ​he added.

Related topics: Regulation, Food safety

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