Nanotechnology in Food Products Workshop Summary (2009) / Chapter Skim
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3 Safety and Efficacy of Nanomaterials in Food Products
3 Safety and Efficacy of Nanomaterials in Food Products
Pages 55-84
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From page 55... ...
He emphasized that in addition to thinking about the nanosized materials themselves, it is important to consider all of the "things that come along with the nanotechnology." As examples, he pointed to the biocompatible surfactants often added to nanoparticles as a way to prevent clumping and the metals that are sometimes used during the synthesis of carbon nanotubes: both of these added substances raise potential toxicity issues. It is also important to consider how nanomaterials behave not just in the context of the food matrix (which Aguilera had previously addressed)
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From page 56... ...
In fact, the Food Additive Amendment (FAA) of 1958, which was enacted in response to a post-WWII public health scenario created by the sudden availability of thousands of new synthetic chemicals, was designed to address the very same types of safety issues presented by the use in food of nanomaterials with novel properties.
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From page 57... ...
. 3 For example, when carbon nanotubes are taken out of pristine deionized water and placed in solution, they tend to agglomerate very quickly because of the forces that predominate at these smaller sizes.
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From page 58... ...
Also in addition to considering the toxicity of all of the various added substances required to deploy a nanotechnology application appropriately, one must consider what happens to the nanomaterial in the biological context. Philbert pointed to some very interesting studies coming out of Dublin 4 that show how durable carbonaceous materials, when introduced into a high protein environment such as the inside of a cell, can cause abnormal protein fibrillation.
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From page 59... ...
And finally, in health care, nanotechnology is being used to develop targeted delivery of therapeutics; Philbert pointed to the work of Donald Tomalia 5 as one example of an application; targeting therapeutics to cancer cells. One needs to be very careful, Philbert said, about the claims being made about nanotechnology, as these claims very quickly go "from the sublime to the ridiculous." As just one example, there are "plans afoot" to add a nano-structured robot to the back of a spermatozoon, raising questions about the ethical implication of "subverting normal biological processes and achieving something that nature never intended to occur." Moreover, not all that claims to be nanotechnology is truly "nano." There are now more than 800 self-identified nanotechnology products on the market.
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From page 60... ...
The potential health risks extend beyond exposure to the nanomaterial itself and include exposure to the final engineered products as well. He said, "I urge all of us to think more broadly about the implication of the inclusion into materials, not just the hazard associated with limited exposure to material." Current Knowledge of Nanoscale Material Toxicity Knowledge about physical properties of other materials can be used to predict how nanoparticles will behave and whether they will be toxic in the human body.
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From page 61... ...
2004. Pulmonary toxicity of single-wall carbon nanotubes in mice 7 and 90 days after intratracheal instillation.
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From page 62... ...
2006. Sorting carbon nanotubes by electronic structure using density differentiation.
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From page 63... ...
2006. Coating single-walled carbon nanotubes with phospholipids.
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From page 64... ...
64 NANOTECHNOLOGY IN FOOD PRODUCTS with mechanisms that promote a healthy flora. 10 Philbert stated that since "not all guts are ‘normal,' it would be foolish for us to assume that all interactions of nanomaterials in food are going to be utterly predictable." Not only is there wide variation in gut microflora, but also there is wide variation in the "tone" of the epithelium of the gut, with the morphology of the gut lining changing with microfloral composition.
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From page 65... ...
She remarked that the focus of her presentation would be the scope of FDA's authority and oversight over foods, food ingredients, and nutrients and that she would be providing an overview of the regulatory framework currently in place. Tarantino recommended the FDA Nanotechnology Task Force Report, which was issued in July 2007 as a source of information about the state of the science of biological interactions among nanomaterials (at that time -- if the report were written today, its synopsis of the state of the science would be slightly different)
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From page 66... ...
Tarantino identified three categories of food items that she said were "somewhat arbitrary," but the categorization makes it a little easier to understand the spectrum of FDA oversight: 1. Dietary ingredients in dietary supplements 2.
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From page 67... ...
Food and Color Additives As with food contact substances, food additives (which include emulsifiers, sweeteners, etc.) and color additives also require approval before marketing.
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From page 68... ...
Dietary Ingredients in Dietary Supplements Dietary ingredients in dietary supplements are exempt from the definition of food additive and do not require pre–market approval. Tarantino defined a dietary ingredient as "essentially the thing you take the dietary supplement for." Other dietary supplement additives (e.g., color additives or added sweeteners)
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From page 69... ...
This wide range of regulatory authorities over food serves as a "pretty adaptable system," Tarantino said, and nano-sized product ingredients, or nanomaterials, are really just a "special case of something that we have been doing all along." Consider, for example, a food additive regulation for a particular emulsifier. The regulation would include specification for all contaminants anticipated when the regulation was written (i.e., specification for the maximum amount of contaminant allowed)
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From page 70... ...
For each case, the participants considered what kinds of testing would be necessary, what kinds of things would be considered during the approval process, and generally what the approval process would encompass. The exercise resulted in a report, Assuring the Safety of Nanomaterials in Food Packaging: The Regulatory Process and Key Issues, which is published on the Wilson website.13 Tarantino said it was a very useful exercise -- it was a training of sorts for FDA reviewers, and it gave developers of these types of products a chance to talk about some of the issues with both FDA and EPA regulators.
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From page 71... ...
But many practical questions still remain unanswered and those are where the discussions with FDA really need to take place, for example with respect to what these materials do in the gut and what effects they may have in the context of a complex food matrix. While there is no complete written guidance available yet, Tarantino said that the FDA has updated its guidance for food contact substances to include some language about particle size.
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From page 72... ...
Whether FDA's statutory authorities provide sufficient tools to evaluate and regulate the safety of nanomaterials with novel properties when used in food, food packaging, and dietary sup plements.
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From page 73... ...
The answer to the second question is, again, a "big yes" with respect to foods, food packaging, and color additives. But, again, with respect to dietary supplements, the current system is not as comprehensive, but nonetheless does exist.
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From page 74... ...
Synthetic food ingredients were being manufactured very suddenly, and the FDA was confronted with literally thousands of new ingredients whose safety had never been reviewed. The FAA was designed to address a public health scenario with the following: • Potentially thousands of novel substances to be added to food • Only a few such substances specifically tested/reviewed for safety • An existing regulatory system hampered by limited re sources • Public/private sector concerns about under/over regulation What makes the FAA so vibrant and effective?
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From page 75... ...
Degnan characterized the GRAS concept as "the grease, … the element that allows the FAA to work, and it's been that way since the inception of FDA's regulation of food additives in 1958." The GRAS provision allows the FDA to prioritize its limited resources and examine only those new and novel substances that demand its attention. And, it provides a flexible way to address food safety concerns in an efficient manner.
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From page 76... ...
As Tarantino had stated earlier, dietary ingredients in dietary supplements qualify as an exemption to the definition of a "food additive," and thus are not subject to a pre–market approval process. The regulation process for dietary supplements is a post–market approval process, and the only way the FDA can take a dietary supplement off the market is to show that the supplement presents a "significant or unreasonable risk of illness or injury." This is a difficult burden of proof for FDA to meet.
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From page 77... ...
• What criteria will FDA apply in the "notification" process for evaluating safety of dietary ingredients nanomaterials with novel properties? For other food substances (i.e., food and color additives and GRAS nanomaterials)
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From page 78... ...
While FDA needs to take a leadership role, the ulti mate responsibility is still always going to fall on industry. As a "postscript" to the topic of FDA's regulation of nanotechnology in the context of food and dietary ingredients, Degnan facetiously commented that the Food, Drug, and Cosmetic Act is "misbranded," in light of the fact that the Act provides FDA authority to regulate far more than just food, drugs, and cosmetics.
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From page 79... ...
Other topics of discussion included how to encourage early industry consultation with the FDA (and other regulatory agencies) ; when to expect written guidance on nanomaterials in food from the FDA; and the difference between foods with targeted delivery capacities and drugs.
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From page 80... ...
" Bruner asked. Degnan responded, "No." He pointed to work sponsored by the International Life Sciences Institute in the late 1980s and early 1990s on transgenic food safety and conducted by an organization called the International Food Biotechnology Council (IFBC)
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From page 81... ...
He said, "I think the days of developing a chemical and then looking at the toxicity are over" and that "involving the toxicologists and the biologists from the outset is the only way to do this." Tarantino added that toxicologists and biologists from the FDA should be involved from the outset. She reiterated, "Come in before you do all the studies and talk to us, rather than at the end, and we'll be less likely to reject them." Early Consultation with the FDA Tarantino's last comment prompted workshop attendee Bill Jordan of the U.S.
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From page 82... ...
He asked if there was any way that the FDA could regulate this type of activity. Tarantino said that part of the answer depends on whether these foods are being advertised as dietary supplements and whether the FDA can take action; and another part depends on what sort of claims are being made and whether those claims are supported (i.e., if not, then the FDA can take action)
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From page 83... ...
A manufacturer can lawfully make claims about nutrients, and there is a rubric for dealing with those claims. Only if that nutrient delivery is used for a therapeutic purpose does one enter "drug territory."
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