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FDA on Nanotechnology: Size Matters

FDA on Nanotechnology: Size Matters

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Nanomaterials may be minute in size, but they have become a big part of emerging technologies in food manufacturing, generating media and consumer interest as well as new regulatory guidance. On June 26, 2014, the US Food and Drug Administration (FDA) issued final guidance documents addressing the use of nanotechnology in food and in cosmetics. For food, the guidance focused on 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. The Agency has now also released a Draft Guidance for Industry Use of Nanomaterials in Food for Animals.

The foods guidance alerts manufacturers to the potential impact of any significant manufacturing process change – including nanotechnology – on the safety and regulatory status of a food; it also describes considerations for determining whether such a change affects the identity, safety, or regulatory status of a food already on the market, necessitating a regulatory submission to FDA. Perhaps of greatest interest is FDA’s statement that just because an ingredient has Generally Recognized as Safe (GRAS) status, if the safety of the nano-sized version is questioned, this could warrant the exclusion of the nano-scale ingredient from the GRAS list. This begs the question: Can anyone raise the “safety flag” and prompt extensive studies on a particular ingredient? Will nano-scale ingredients be guilty until proven innocent? And do we have the technologies and methodologies in place to make this judgment?

The draft guidance for animal food also suggests somewhat of a shift in FDA’s previous stance that size doesn’t necessarily matter, rather the Agency stated that it “considers food manufacturing processes that involve nanotechnology in the same manner as any other food manufacturing technology.” In the new document, FDA states, “Because the application of nanotechnology may result in new or different physicochemical properties, specific data should be used as evidence to show that the use of the nanomaterial version of the animal food ingredient is safe for its intended use, even if it shares the same chemical composition as a larger-scaled animal food ingredient that is determined to be GRAS for that intended use or is a food additive approved for that intended use.” The guidance explicitly states that an evaluation of the safety of nano-scale ingredients cannot rely entirely on the data and information used to establish the safety of the larger-sized counterpart. The guidance on the safety and regulatory status of food ingredients suggests that if a nanotechnology is being applied to manufacture a nano-sized food ingredient that the manufacturer consult with the FDA. To us, this implies that if you are developing ingredients in the nano-range, you will need the okay from the regulators, whether that’s based on meeting with them or by going through a more formal approval process.

Why the focus on this tiny technology? What are the current uses, risks and concerns?

Nanotechnology is defined by the National Nanotechnology Initiative (NNI) as the understanding and control or manipulation of matter at the nanoscale. Nanoscale is particle sizes between 1 and 100 nanometers – one-billionth of a meter. One concern is that nano is not completely understood from a public health risk perspective. Involving diverse fields (e.g., physics, chemistry, biology, material science and engineering), nanoscale materials may exhibit different physical and chemical properties compared with the same substances at normal scale. Thus, as FDA states in the guidance, “nano-engineered food substances can have substantially altered bioavailability and may, therefore, raise new safety issues that have not been seen in their traditionally manufactured counterparts.” With all this, the considerations of and questions around nanotechnology and food safety are similar to those raised when considering GMO safety, with the primary question being what the human and environmental impact may be.

Current nanotechnology applications tend to focus primarily on the use of nanoparticles in packaging to increase the shelf life of the food and/or add antimicrobials. Of concern, and current research, is whether those nanoparticles can leach into the packaged food and have an impact on that food. One of the most common applications of the use of nanotechnology in food itself (as well as in dietary supplements and packaging) is that of titanium dioxide (TiO2), which is used as a whitening agent, to make food colorings more opaque, and/or to keep ingredients from caking. Other nanoparticles are used to control the absorption of nutrients and keep food fresher longer.

Research published in the Journal of Biomedical Nanotechnology (2011) compared the effects of TiO2 nanoparticles in peripheral blood lymphocytes from patients with respiratory diseases with those in healthy individuals. The results showed genotoxic effects in both groups. Additionally, nonporous titania (NP TiO2), which appeared stable for weeks when dispersed in water, grew in size and sedimentation when transferred or directly dispersed in the cell culture medium (DMEM). Research has also been conducted on the use of TiO2 in sun creams. According to an article in The Guardian, Jonathan Powell, head of biomineral research at the Medical Research Council’s Human Nutrition Research Centre in Cambridge, UK, found that if the TiO2 nanoparticles get inside the body, they can accumulate in parts of the small intestine used by the immune system. “Although the health implications of this accumulation are not understood, Powell thinks that manufacturers should steer clear of using nanoparticle additives that do not have a clear benefit,” the article states.

Additionally, a report, published in the journal ACS Sustainable Chemistry & Engineering, suggests that nanomaterials in food and drinks could interfere with digestive cells and lead to the release of the potentially harmful substances to the environment. The effects of eight commercial drinks containing nano-size metal or metal-like particles on human intestinal cells were tested in the lab. As explained, “The drinks changed the normal organization and decreased the number of microvilli, finger-like projections on the cells that help digest food. In humans … these materials could lead to poor digestion or diarrhea.” Additionally, sewage waste containing these particles suggests that much of the nanomaterials are likely making their way back into surface water.

Nanotechnology does provide certain benefits to foods and their production. In addition to the packaging and shelf-life benefits described above, there is some work being done on nanosensors to detect pathogens, pesticides, and other contaminates on food and sensors are already being used on packaging to detect and display a warning of food spoilage. However, it is primarily because of all the unknowns that consumer groups, such as Friends of the Earth (FoE), are arguing for mandatory labeling of products (including foods, cosmetics, and sunscreens) that use nanomaterials as well as for stronger regulation “with a precautionary approach that puts people’s health before corporate profits.”

As aforementioned, the foods guidance encourages industry to consult with FDA early in the product development process to address questions related to the safety, effectiveness, or other attributes of nanotechnology products, or to address questions about regulatory status of the products. FDA notes that it has not yet received any food or color additive petitions or GRAS notifications that are specific to materials exclusively in the nano range. The guidance suggests that if the functionality or safety of the nano-scale ingredient differs from its conventional counterpart, it will need to go through the appropriate regulatory channels.

The draft animal food guidance has somewhat stronger language, stating that even if a company believes that a nano-scale animal food ingredient meets the criteria for GRAS, the firm should still consult with the Agency. This document seems to suggest that a Food Additive Petition will likely be needed, and it outlines the factors that need to be addressed in such a petition.

While FDA is moving forward on the regulatory aspects of nanotechnology, there are still many questions to be researched and resolved, not the least of which is whether we have the right tools in the tool box. Do we even have methods available to truly assess the risk? And at the end of the day, how do the risks compare to the benefits? And how do the risks of nano-sized ingredients—whether for human or animal food- compare to other types of food safety risks?

About the Author

Dr. David Acheson is the Founder and CEO of The Acheson Group (TAG).  Headquartered in Chicago, TAG is a renowned consultancy that brings a unique suite of services that provides the food and beverage companies with deep industry expertise and a global perspective focused on assessing and managing operational risk, reputational risk and regulatory risk.  XL Group partners with Dr. Acheson and his team to bring its clients consultation on food safety issues and assistance in the event of a product recall. 

View other recent blogs by Dr. Acheson and his team including:

Should We Modernize Poultry Production?

Traceability Recordkeeping Flows Downstream to Retail

Battling the Goliath of Miscommunication: Industry Fights Back

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