Regulatory approval tips

Gaining novel food regulatory approval is one of the main barriers behind getting many innovative foods, including cultivated meat and precision fermented products, to market. The process takes time and requires care and attention to detail from both applicants and regulators. But there are ways to increase the likelihood that your product will be approved, and the speed of approval time. Perhaps the hardest part of applying for regulatory approval is deciding when the right time is to do so, explained Andrew Janis, general counsel of cultivated meat company Vow, at Future Food-Tech London. Deciding when a novel food “is good enough . . . is viable enough, that we can bring it through the process” is the biggest decision any applicant will make. “It never feels ready,” he admits, but the decision must be made. There’s a lot of information gathering involved in the regulatory process, explains Vow’s Janis. Firstly, the company must choose the right regulatory authority. “What does regulator A care about, what are they gonna focus on? What does regulator B, what does regulator C?” As well as thinking about the concerns of the regulators themselves, companies must consider the geographies in which they’re located, balancing the potential length of the application process with the number of consumers they will be gaining access to. While all markets have the potential to change, you should be sure that there is interest in the sector in which you’re applying from the regulator itself. “If you’re interested in a country that has never mentioned cultivated meat before, has a regulator that doesn’t seem to care about it, if you just show up and put a 400 page dossier in their basket, it’s probably going to sit there for many years and not get a lot of love,” Vow’s Janis pointed out. In Vow’s experience, some regulators are more hands-on than others, reading documents and providing direct advice. The application dossier will be the regulator’s main source of information about a product. The more the regulator has to go back and ask for more information, the more the process will be delayed, pointed out Thomas Vincent, deputy director of innovation at the UK’s Food Standards Agency (FSA) at Future Food-Tech. While the FSA releases guidance for new applicants, it is often difficult to match this to truly new sectors. However, in order to make the process easier for applicants, the FSA has released a guidance hub, which will collect its guidance by sector. During the approval process, the regulator will often request more information about the product being examined. Responding quickly to these requests will likely help the process go smoother, explains Janis. In short, it’s better to over communicate than under communicate. In Vow’s case, it would respond within the day, suggesting solutions to the problems identified by the regulator as quickly as possible. “By pushing and telling the regulator where you are very quickly”, you’ll avoid a situation where, for a month, “you’ve been doing something that’s not fit for purpose.” Rather than just wait, he said, take ownership.