The paper titled, “Probiotics, Finding the Right Regulatory Balance,” was written by a group of academics led by Maryland law professor Diane Hoffman who is the head of the law school’s Law and Health Care Program. The project, funded by the National Institutes of Health, resulted in a short commentary in Science magazine and a 110-page white paper.
The article’s basic premise is that the Human Genome Project will give rise to ever more applications for probiotics, and that the current system the the Food and Drug Administration and Federal Trade Commission use to regulate the research and commercialization of the organisms is not up to the task.
The title of the paper sums up the crux of the matter, Hoffman said. It’s as hard to find the right balance on the regulatory front as it is to define what “balance” means when discussing the performance of the human gut.
“We were seeking sometbing that is flexible enough to not discourage research,” Hoffman told FoodNavigator-USA.
Streamlined IND process
The authors propose an abbreviated Investigational New Drug application process for probiotics studies that are aimed at disease end points and a monograph system to apply to probiotics that will be marketed as foods and dietary supplements. The goal, the commentary says, is to find a system that: “adequately addresses issues of safety and effectiveness; provides sufficient information to consumers to make informed choices; and sufficiently allows for, or at least does not discourage, research on potential therapeutic benefits.”
Adopting the streamlined application approach could help boost research, the authors said. All too often under the current regime, company scientists and academics have hit a brick wall when seeking to conduct probiotics research. Under the authors’ proposal, a researcher could bypass the lengthy and expensive phase 1 toxicological studies that are now part of the IND process for organisms that have long been in the food supply or that have GRAS status.
Barriers to research
Duffy Mackay, vice president of scientific and regulatory affairs for the Council for Responsible Nutrition, said the constriction of research is a real problem. He relayed the true story of a researcher who wanted to study a frozen yogurt that had long been served in a college cafeteria. Anecdotal evidence suggested that the students who regularly consumed the food had fewer cold and flu symptoms. When the researcher submitted his plan to test this hypothesis, he was told by FDA he’d need to file an IND application.
“So he went to fill out the form and the form is completely based on drugs. What is your molecule, what is the active constituent, where are your safety studies? Then FDA said, wow, you are using live bugs, so we are going to send this over to the Center for Biologics.All those people deal with is vaccines, and attenuated vaccines for serious diseases. And they said, you are putting live bugs into people’s bodies so we need all kinds of safety data," MacKay said.
“The researcher said, all I want to do is to study yogurt. FDA shouldn’t be making it that hard for me,” he said.
“Somehow FDA has to reconcile that they have build multiple decades of regulation around drugs and it’s not fit for purpose for a lot of nutrition, bioactives and probiotics. If there is a food that keeps us healthy we should be able to research that without barriers to entry,” MacKay said. “The flip side is that there also need to be check and balances on claims,” MacKay said.
Providing those checks and balances is what a modified mongraph system would provide, the authors say. A monograph could specify approved evidence-based claims, which presumably would reduce the frequency of unsupport claims in the marketplace, and might even allow some products to make drug-type claims without going through the IND process.
“We thought that would make a lot of sense,” Hoffman said. “In same ways it would allow products that want to make health claims (as opposed to structure/function claims) or even drug claims.”
But changing the course of FDA regulation is a daunting task, and in that light the ideas put forth in the paper must be seen as a starting point for discussion, observers said.
“It’s interesting to see people grappling with the question of what level of substantiation is necessary before a claim can be made for a dietary supplement or a food. I think that’s a perennial issue,” said Jason Sapsin, a former FDA counsel and now an attorney with the firm Fox Rothschild. “The first thing that comes to mind is whether that is practical given FDA’s resources at the moment.”
Even Hoffman said the paper is meant as a way to get the discussion ball rolling.
“We hope that this will provoke additional discussion about these ideas and maybe prompt FDA to invoke a similar kind of body to what we brought together,” she said.