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Slow-to-evolve FDA regulations could holdback 3D printing of food

By Elizabeth Crawford

15-Apr-2015
Last updated on 15-Apr-2015 at 12:28 GMT2015-04-15T12:28:45Z

Source: Natural Machines
Source: Natural Machines

Investing in 3D printing could open new markets and generate huge cost savings for food manufacturers and retailers, but first companies must overcome potential regulatory and legal hurdles, many of which are not yet identified, warn food and drug lawyers with the firm Venable in Washington, D.C.

The growth potential of 3D printing is “unlimited” for pioneers in the food industry, said Claudia Lewis, a food and drug lawyer with Venable in Washington, D.C. 

She explained to Food Navigator-USA that 3D printing could one day be used to create on demand customized food for people with special dietary needs, such as pregnant women, athletes or those who are managing health conditions, such as diabetes. It could enable food service providers to more easily substitute vegan or vegetarian options for animal proteins or create novelty items with personalized messages or shapes. It could even be used in specialized environments, such as outer space or schools without full kitchens.

The technology also could generate huge cost savings for food companies by eliminating the need for giant manufacturing facilities filled hundreds of workers operating multiple machines that prepare, package and transport food, added Heili Kim, a food and drug lawyer who works with Lewis at Venable in Washington, D.C. She explained firms could set up a 3D printer in a GMP-compliant building and print food with only four or five workers.

It also could cut costs for retailers and hospitals because they no longer would need to buy and store a large inventory of specialized food that could expire before it is used, Kim added. Rather, they could simply print it when they needed it.

Both women acknowledged that the technology for 3D printing food is not as fully developed as it is for medical devices, mechanics and art, and therefore cannot yet achieve these tasks. However, Kim noted, the technology is advancing exponentially and it is only a matter of time before it is efficient enough to be used on a personal and then a mass scale.

Regulatory challenges

Developing the technology, however, is only one part of bringing 3D printed food to market – the other part is ensuring the machines, processes and finished products meet FDA safety standards, which may not be advancing as quickly as the technology, Kim and Lewis said.

For example, they noted that many 3D foods are made with paste-like ingredients that need to have an adhesive-quality to them in order to stick to the previous layer and to dry or “cook” quickly enough for the finished product to hold its intended shape. FDA likely will require a safety evaluation of these ingredients, but currently how the agency will expect firms to meet this standard is unclear.

One option may be filing a notification with FDA that a 3D printing ingredient is General Recognized As Safe, Lewis said. However, agency scientists may not think that the research, data and other information submitted by a company in its GRAS dossier is sufficient for such a new technology.

The other current option for establishing the safety of a new ingredient could be through a food additive petition, however, this process can take years, which would fundamentally stall the advancement of 3D food printing, Lewis added.

Does 3D printing need unique GMPs?

An additional potential regulatory challenge is how FDA would oversee the safety of the 3D printing process, the women noted.

“The food GMPs are very broadly written and potentially are flexible enough to apply to 3D printing,” but the challenge is understanding how FDA will apply them and what the agency will deem as compliant, Kim said.

She noted that the food industry may consider requesting FDA to draft separate requirements for 3D printing so that the expectations are clear and tailored to the technology. The process of drafting a new set of GMPs or other document, such as a draft guidance, would be time-consuming, but anytime there is innovation in an FDA-regulated industry the agency has a learning curve that can slow down industry, she added.

The process would be “really about educating the agency about how the regulations apply or could be applied to 3D printing,” she said.

Firms working on 3D food printing can proactively address the regulation of the technology, process and final product by submitting comments to a general docket that the agency opened when it first began considering 3D printed medical devices, Lewis and Kim said.  While the docket is technically closed, firms can still submit comments to FDA, Kim said. 

However, because comments posted to the docket would be public, firms may want to meet privately with FDA to discuss 3D printing regulations and development in order to protect any trade secrets or advancements that they do not want to be a part of the public record, Kim added.

Adulteration and education

Adulteration is another risk that manufacturers working with 3D food printers will need to be aware of and protect against, Kim said. For example, she worries that just like fly-by-night suppliers currently dilute or spike some ingredients with lower quality and unwanted components, bad actors also could set up a 3D printer, print 30,000 loaves of bread made from a combination of a gluten material and papier-mâché and then tear down and move to a new location and new type of food without getting caught.

For this reason, supply chain management and quality control through analysis will be just as essential for 3D printed products as it is for conventional foods and ingredients.

In addition, consumers will need to be educated about 3D food printing and their fears and concerns addressed, Lewis said. If left unmanaged, she said, 3D printing could go down a similar path to genetically modified organisms with consumers calling for labeling and bans based on unsubstantiated safety questions and other concerns.

IP protection

Finally, players in the 3D space also will want to address early concerns about intellectual property rights and who owns which piece of the process, Lewis said.

She sees the potential for a lot of arguments surrounding who owns the physical printing technology, the recipe, the ingredients and how each piece is then used by a manufacturer to market a finished product to an end consumer.

Focusing on these challenges should not discourage stakeholders from investing in or exploring the potential of 3D printing of food, both women said. Rather, by “thinking ahead” to identify and address any challenges that arise during the 3D printing development process, stakeholders could reduce the time to market and maximize future returns on investment, Kim concluded. 

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