Production of 3D printed food is still in the research and development stage, but entrepreneurs and investors considered the potential regulatory implications for the industry at a workshop at the Inside 3D Printing, a conference and expo in New York City in April.
Claudia Lewis, Esq., a partner at Venable LLP who represents clients in matters related to FDA regulations, says the technology may be outpacing FDA’s regulations. The 3D printed food industry presents some novel questions that the FDA has not tackled in the past, she says. “The question will be whether new regulations need to be generated or whether the current laws in place, such as good manufacturing practices and the process for reviewing the safety of novel food ingredients are sufficient and should apply to the 3D printing industry.”
Innovations within the industry have demonstrated that 3D printers can turn out edible desserts, custom-designed pasta, pizza, pancakes, and hamburgers already loaded with condiments, according to a report in Business Insider. The technology is being touted for its potential to produce novelty items, such as special shapes or personalized messages within a food product, and for its ability to provide personalized food for people with special dietary needs, such as elderly patients, pregnant women, athletes, and people with diabetes.
“A lot of players in the 3D printed food industry may not understand how they are going to be regulated or what elements are going to be regulated,” says Heili Kim, Esq., an attorney in Venable’s Regulatory Group. “People who are not accustomed to the FDA space need to know that a food product is going to be regulated. They are not going to get to market unless they get some type of OK, whether it comes in the form of a notice or an approval, and they will need to comply with the agency’s requirements,” she says.
How the FDA decides to regulate the industry depends in large part on how the industry wants to categorize its products, Ms. Kim says. “The FDA can’t proactively regulate an industry until it knows what the industry wants to be.” For example, FDA regulations for beverages depend on whether the beverage is marketed as a dietary supplement or a conventional food. “At this point it would be beneficial for the FDA to understand more about the industry and for the industry to proactively consider how to approach the agency,” she says. Both attorneys spoke about FDA regulations at the Inside 3D Printing convention in New York.