FDA budget request outlines priorities in FSMA implementation, increased inspections

By Hank Schultz contact

- Last updated on GMT

FDA budget request outlines priorities in FSMA implementation, increased inspections

Related tags: Food and drug administration

The budget request from the White House for the Food and Drug Administration is part of President Obama’s overall budget that will not see the light of day.  Nevertheless, the massive document does include priorities that are likely to be addressed in FDA’s final funding picture, experts say.

Overall the White House has requested $4.9 billion for FDA for FY2016, which is $424 million, or 9% more than FY2015.  The lion’s share—$301 million—of that increase would go toward the food side, with a more modest increase for medical product safety.  This reflects the burden placed on the agency for the implementation of the Food Safety Modernization Act.

The specific numbers are of less import than the needs and priorities they address.  With the current political climate and party breakdown in Washington, the specifics of what the Administration wants exist in the realm of fiction.

“The President’s budget is dead on arrival and so is anything connected to it,”​ Daniel Fabricant PhD, CEO of the Natural Products Association told NutraIngredients-USA  “I think FDA will see a modest increase over what they saw last year.” 

“That doesn’t mean individual line items won’t play well,” ​said Steve Mister, president and CEO of the Council for Responsible Nutrition. “There is an appreciation even among Republicans that they are giving FDA more and more responsibility under FSMA. I think there is going to be an effort to find some way to fund the agency.  'Dead on arrival’ may too strong when it comes to the FDA portion of the White House’s budget.”

“I think everyone wants safe food and even the most conservative politicians understand that FDA is underfunded and they want to give them the tools to do their job,” ​Fabricant agreed.

Pace of inspections

The FDA budget request extends to 273 pages, little of which pertains directly to the dietary supplement industry. But a few sections outline priorities for the coming year.  For example, the document makes a point of outlining how many inspections were conducted by the agency in 2014—482. It also looked into 2,745 adverse event reports. 

The question is whether that pace is likely to continue, given the unsettled nature of the agency’s leadership. FDA Commissioner Margaret Hamburg’s impending departure was reported today, and the agency’s dietary supplements division is operating under interim leadership, with Cara Welch, PhD, having recently been tapped for a four-month stint. 

“I think the inspections go on because most of those come out of district offices. The inspections will go on whether there is permanent director or not. I’m thrilled that there have been more inspections and we think there should be even more,”​ Mister said. “I think the more critical issue is what they do when find problems, when they find 483 observations that are not addressed. That’s when you need strong leadership out of College Park to carry those cases forward."

FSMA implementation

A key part of the budget request relates to the implementation of FSMA, which has been called the most sweeping change to the US food safety system since the inception of the Food, Drug and Cosmetic Act itself in 1938. The White House mentioned FSMA specifically in its request.  Line items included an increase of $25 million for inspection and training upgrades, a $32 million hike earmarked toward a national food safety system, and $25.5 million more for import safety and implementation of the Foreign Supplier Verification Program.

The budget makes a specific request for technology to support increase border inspections, noted Loren Israelsen, president of the United Natural Products Alliance.

"There is a very interesting note regarding the Office of Regulatory Affairs implementing the use of hand-held analytical tools by investigators.  It appears this would include heavy metals and microbiological detection technologies.  Assuming FDA expands the use of these tools at the point of import, companies are advised to be highly vigilant in testing for heavy metals, herbicides, pesticides and micro-contamination from the point of export to avoid detention and rejection by FDA at the point of US import," ​he said.

Missing elements

Fabricant said that the budget request was interesting for what was not there as much as for what was included.  For example, he said the impending roll out of FSMA regulations will have a big impact on dietary supplement ingredient suppliers, a category of companies that were excluded from the last big regulatory push in the sector, the implementation of the Good Manufacturing Practice rules.

“I think one thing that was absent that I would have liked to have seen was an outreach to the ingredient suppliers on their  responsibilities will be under FSMA,” Fabricant said. “There has been virtually no engagement with the ingredients supply community in terms of what FSMA implementation will mean for them. This is one area where I think people really ought to have their head on a swivel,”​ Fabricant said.

And outside of the hand-held devices mention, Fabricant said he was surprised that the budget didn’t do more to address FDA’s yawning data and technology gaps.

“I didn’t seem much on the electronics and data end of spectrum. What about electronic data collection of adverse event reports? FDA needs a better way to use that data to set up enforcement targets.  FDA gets so much data and if they are not going to use it, that seems like a big waste,”​ he said.

Related topics: Regulation, GMPs, QA & QC, Adulteration

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