All eyes on Dietary Supplement Master Files
The U.S. Food and Drug Administration’s Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) recently released an updated list of draft and final guidance topics that are a priority for the FDA Foods Program to complete during 2023. The list updates the guidance agenda released in February 2023 and focuses on Level 1 draft and final guidances.
At the top of the list is dietary supplement Master Files.
A Master File is an elective submission to FDA that contains data deemed proprietary by a company, such as an ingredient manufacturer. The Master File submission procedure is already used extensively in the drug industry. In general, Master Files would allow a party other than the holder of the Master File to reference material without seeing proprietary contents of the file.
The agency views Master Files as a tool to promote better compliance with New Dietary Ingredient (NDI) notification requirements. Ingredient manufacturers see the concept as a way to protect investments in technology and innovation.
“It’s a step in the right direction to see the master file concept getting some traction as it could incentivize companies to submit NDINs, especially if there’s some IP protection like there is for drug Master Files and actual enforcement – which clearly hasn’t been happening in the NDI space,” stated Rend Al-Mondhiry, Partner at Amin Talati Wasserman, LLP.
"However, there are still fundamental issues with the NDI framework that need to be solved before we get to Master Files, like when is an NDI notification even necessary, and will we ever see a list of grandfathered ingredients? At the ACI/CRN Legal Conference held last month, FDA stated it will be issuing separate NDI guidance documents in the ‘near term’ future, so I hope we’ll see more coming in terms of addressing these other critical issues
George Paraskevakos, Executive Director, International Probiotics Association (IPA), said that IPA has always been a proponent of Master Files.
“We always thought they were the way forward in the US, which allowed a proper way to assess an ingredient and in our case specifically probiotics, all the while maintaining confidentiality for intellectual property and innovation for the manufacturers.”
History
Paraskevakos told us that his ties to the Master File concept go back to 2009, when IPA reached out to Health Canada and engaged in discussions that took place over two years. These talks not only led to the development of Master Files for probiotic strains, but also the creation of the probiotic monograph. From there, IPA offered this Master File and pre-application approach of going to market to many other governments around the world where the model was adopted into legislating probiotics in several cases.
FDA first raised the concept of Master Files for dietary supplements in its 2016 revised NDI Guidance. The following year, FDA held a public stakeholder meeting where IPA requested FDA to look into adopting Master Files. Later in 2019, with the support of The International Food Additives Council (IFAC), IPA presented a way forward for probiotics, including a grandfathered list of probiotic species based on QPS list and again the master file approach.
Save a seat for IPA
“I strongly believe we need to be at the table if FDA were to start looking at the Master Files concept. This is very important as I draw example from our experience with the citizens petition that IPA filed back in 2016 to FDA, to try and amend regulations to have probiotics reported in CFU rather than mg on the SFP – as a result we were advised that regulations are difficult and lengthy process to change in the US, hence we not only got CFU but mg stayed as well. Understanding of the process and why it is needed is an important step to develop something which makes sense, but also can aid in making the FDA’s work more efficient in protecting the consumers,” said Paraskevakos.
Alignment is key
Lastly, Paraskevakos said it is important for all trade associations to put on a united front for regulators, who don’t want to be pulled in different directions.
“As example, our IPA EU office was a result of too many associations in the EU speaking for probiotics - where the EU commission requested we align as one voice for the probiotics category,” he said. “Regulators do not want to see trades running around in different directions, hence I hope we can align with other associations on this concept.
