SSW preview: FSMA consultant warns of ‘blind spots’

Heather Fairman of DF Guardian Consulting Inc. stressed firms developing a new food or beverage product must not only understand what’s required of them based on FDA regulations in the Food Safety Modernization Act. They must be willing to execute and invest to meet the applicable rules.

Josh Long, Associate editorial director, Natural Products Insider

October 24, 2022

3 Min Read
FDA seafood inspection.jpg


That’s how regulatory consultant Heather Fairman described the  Food Safety Modernization Act (FSMA), a bill signed into law in January 2011 by President Barack Obama.

FSMA, which reflected the most sweeping modernization of food safety laws in generations, is still being implemented by FDA as the agency continues to publish an abundance of guidance documents and other materials.

Fairman, CEO and chief consulting officer, DF Guardian Consulting Inc., acknowledged the law and that accompanying regulations can be overwhelming to newcomers in the food and beverage market.

She will discuss food safety regulations during an education session from 9 to 11 a.m. Nov. 3 at Food ingredients North America, SupplySide West in Las Vegas, “Basics of food & beverage product development.” Moderated by Food & Beverage Insider Content Director Audarshia Townsend, the education session will feature Fairman and four other experts: Aimy Steadman, Beatbox Beverages LLC; Carlos Barroso, CJB and Associates; Lynn Dornblaser, Mintel Group Ltd.; and Sam Kressler, Stir Innovation.

In an interview, Fairman wondered why people appear “like a deer looking into the headlights” when she asks them about their FSMA program, especially considering it’s been over a decade since the law was signed.

FSMA is intended to ensure America’s food is traceable from “farm to fork” and ultimately safe for consumers. “But in between the farm and fork are your supply chain segments” responsible for meeting specific FSMA requirements, Fairman said.

Each FSMA rule is applicable to different aspects of industry, Fairman said, adding, “There’s no one-size-fits-all.”

While Fairman said she “nurtures” people’s ideas, she stressed firms developing a new food or beverage product must not only understand what’s required from a compliance standpoint—they must be willing to execute and invest to meet the applicable rules in FSMA.

“I understand the concept of getting to market first,” but cutting corners on compliance may result in adverse consequences such as the cost of a recall, Fairman cautioned. “We have a lot of new people who are excited about coming into the food and beverage and supplement industry because they know there’s no pre-approval. There’s no ‘this.’ There’s no ‘that.’ That’s what I call a blind spot.”

Fairman recalled meeting a raw material supplier new to the business who worked from his home and made a few million dollars. There was only one problem: FDA had detained raw materials he was importing from foreign countries.

“The guy tells me he’s a broker,” Fairman said. “He’s not. He’s on FDA’s FSVP [Foreign Supplier Verification Program] list, which he has absolutely no clue about. None. Zero.”

The raw material supplier, she said, tried to argue with her. Fairman didn’t take the bait.

“I let the documents tell the truth,” she said.

Fairman understands when people get excited about an idea for a new product. That, too, can lead to a blind spot, she warned.

“They’re all excited,” Fairman said. “They have the funding. They think they have enough. That’s another blind spot. Do I have enough to get to market? And the only way they’re going to know that is to sit down and compartmentalize everything. One of the biggest [questions] is, ‘What FSMA requirements am I subject to when I bring my idea to the table?’”

Fairman recalled working with the sales teams of a raw material company, helping the firm to achieve regulatory compliance after educating them.

“I was gentle but direct,” she reflected.

The result? Sales increased 20%, she said.

“Why? The salesmen had a foundation of credibility,” Fairman explained. “[They] could go out there and say, ‘Our products are compliant,’ and they were.”

Fairman concluded her remarks in the interview where she began them.

“Again, FSMA is daunting,” Fairman acknowledged. “FDA will be the first ones to tell you that. But just because it’s daunting doesn’t mean you evade it. And to evade it is really a detriment to your dream and to any company’s goals to have a sustained product … in the market.”

About the Author(s)

Josh Long

Associate editorial director, Natural Products Insider, Informa Markets Health and Nutrition

Josh Long has been a journalist since 1997, holds a J.D. from the University of Wyoming College of Law, and was admitted to practice law in Colorado in 2008. Josh is the legal and regulatory editor with Informa's Health and Nutrition Network, specializing on matters related to Natural Products Insider. Ping him with story ideas at [email protected].

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