FDA’s Fabricant: ‘Unreasonable risk’ has nothing to do with efficacy
During a recent conference held by the United Natural Products Alliance (UNPA), FDA’s Daniel Fabricant, PhD, suggested that industry take another look at the ephedra rule and its application of "unreasonable risk".
“Some [people] have had a question on what unreasonable risk means as it pertains to dietary ingredients,” he said. “This information is covered in significant detail in the Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk from 2004.”
This led some within the industry to claim that this indicates that Food & Drug Administration (FDA) is looking to introduce efficacy in to what is essentially a safety issue.
“I don’t think that is the case,” he said. “The agency must determine unreasonable risk, and the ephedra ruling is an example of that. It doesn’t have to do with efficacy.”
Comment period
Dr Fabricant also responded to criticism about the 60-day extension to the comment period for the draft guidance. The announcement pushes the comment due date to December 2, 2011.
“We completed the draft guidance in 180 days, so 150 days should be sufficient time for comments,” said Dr Fabricant.
Suggestions that FDA was only accepting comments from select stakeholders were also dismissed by Dr Fabricant: “The comments are open to everyone. There is a formal comment period, and once that is closed then we’ll evaluate those comments. If people have comments after the fact, they can still submit them.”
Some comments have already been submitted, he added, all of which will be considered. He acknowledged a difficulty in weighing opposing comments from stakeholders, before adding, “We will look at the strength of the argument”.
Getting personal about personnel
Dietary supplement manufacturer Jarrow Formulas Inc (JFI) has questioned the appointment of Dr Fabricant, and the company’s president and chairman of the board Jarrow Rogovin recently sent FDA Commissioner Dr Margaret Hamburg a letter strenuously opposing the hiring.
Responding to questions from WholeFoods Magazine, Stephen King, FDA spokesperson, said: “As with all new FDA employees who come to the Agency from a position in a regulated industry, FDA requires that Dr Fabricant recuse himself from affairs involving certain individuals or organizations for whom he served as an officer, director, trustee, general partner, agent, attorney, consultant, contractor, or employee in the 12 months proceeding his hire.
“Therefore, absent specific authorization, Dr Fabricant would not participate in an official matter involving a specific party with whom he has had a covered relationship or represents a party to the matter.”
Dr Fabricant himself did not get drawn into a debate on the letter’s content, except to say: “The agency did its diligence”.
FOIA
Jarrow Formulas also recently submitted a 128-item Freedom of Information (FOIA) Request to the FDA with questions it deems ‘vital’ to any comments it seeks to file in response to the NDI draft guidance.
This FOIA request would have “no implications” for the current NDI comment process, said Dr Fabricant.
