By: Andrea K. Avans

The U.S. regulatory system is often challenging to navigate. For companies manufacturing, importing, or selling products regulated by the FDA, USDA, or CBP, missteps can lead to seized shipments, significant fines, or operational disruptions.

That’s where Benjamin England steps in.

A 17-year FDA veteran turned legal strategist and business owner, England specializes in helping businesses navigate intense regulatory scrutiny. He’s the founder and CEO of FDAImports.com, an interdisciplinary regulatory consulting firm, and the owner of Benjamin L. England & Associates, a law practice focused on high-stakes federal compliance and enforcement defense.

But more than anything, England is a disruptor with a business-first mindset who happens to be a licensed attorney. In an industry often defined by caution and red tape, he’s gained recognition for challenging FDA interpretations, decoding complex enforcement patterns, and developing strategies that can provide his clients with a competitive advantage.

In short, he helps business decision-makers achieve what many consider highly difficult.

A Career Built Inside the Machine

England’s understanding of the regulatory system isn’t academic—it’s firsthand. He began his career as a microbiologist testing foods, cosmetics, and drugs before rising through the ranks of the U.S. Food and Drug Administration, eventually becoming Regulatory Counsel to the Associate Commissioner for Regulatory Affairs. He also served as a Special Agent in the FDA’s Office of Criminal Investigations, managing undercover operations and working with U.S. Attorneys’ Offices on federal cases.

In these roles, he learned how regulatory decisions are made—and how to assess when they may be flawed.

“I didn’t just enforce the law. I investigated it, prosecuted it, and helped shape the playbook companies are still judged by today,” England says.

That experience now enables him to guide clients through regulatory challenges, often helping them emerge with more efficient operations.

A New Kind of Regulatory Practice

In 2008, England founded FDAImports.com, a consulting firm that combines legal strategy, regulatory analysis, and business acumen in a distinctive way.

“Our clients aren’t just looking for advice,” he says. “They need actionable solutions. Quickly.”

FDAImports works with clients ranging from startups to multinational corporations, helping them manage:

• Premarket approvals and clearances for medical devices, drugs, and supplements
• Product labeling and claims compliance
• Customs seizures, import refusals, and CBP penalty cases
• FDA and USDA inspections, holds, detentions, refusals, and warning letters
• Litigation support, including expert witness services in complex federal cases

One area where England’s firm differentiates itself: integrated regulatory and legal representation. His companies offer both—providing clients with a unified approach to policy and litigation risks.

“That’s not just a service,” England says. “That’s how we approach problems.”

Clients Call Him When It Gets Real

While some consultants focus on routine compliance, England’s team often steps in during crises.

“I frequently work with companies facing product seizures, substantial financial losses, or public enforcement actions,” he says. “I help navigate chaos, identify the core issues, and guide them toward solutions.”

His firm has helped clients:

• Successfully challenge FDA import refusals
• Remove products from import alerts
• Facilitate the importation of drugs, devices, and biologics at various approval stages
• Defend against civil, regulatory, and criminal enforcement actions
• Prepare for and manage high-risk inspections, including Consent Decrees
• Restructure marketing strategies to meet regulatory requirements

England also emphasizes prevention, advising clients early in product development to minimize enforcement risks.

“If I can help a client avoid a warning letter,” he says, “that’s often more impactful than winning a court case later.”

Willing to Challenge the FDA

One notable aspect of England’s work is his readiness to sue the FDA—a step few in his field take.

“The FDA sometimes relies on guidance documents that aren’t legally binding,” England explains. “But they enforce them as though they are.”

In response, he’s taken legal action against the agency multiple times, with successful outcomes.

“I don’t just threaten to sue. I sue,” he says. “That tends to get their attention.”

His knowledge of FDA internal processes provides a strategic advantage. He understands where decisions are made and what documentation can influence a case.

His (slightly) tongue-in-cheek philosophy: “The government isn’t always right—and even when it is, the reasoning isn’t always sound.”

A Straight Talker in a Foggy Industry

England’s communication style sets him apart.

Whether writing, speaking, or advising, he avoids ambiguity. His tone is direct, informed, and sometimes laced with dry humor.

“You won’t catch me sugarcoating,” he says. “If something doesn’t make sense, I’ll say so.”

Clients value that candor, particularly when paired with practical advice.

“He’s the kind of person who tells you what you might not realize you need to hear,” says one former client. “And then he offers a path forward.”

When a client comes to me, they want to know what to do, not what the government thinks,” says England. “I ask if they want to know what I would recommend—and why? No CEO has ever said ‘no’ to that.”

What’s Next for Ben England?

With FDA, USDA, and CBP regulations constantly changing, England remains engaged in the conversation.

He’s publishing on LinkedIn, expanding his media presence, and speaking at industry events. He’s also advocating for regulatory reform, encouraging the FDA to improve transparency and accountability.

“This isn’t about opposing the FDA,” he says. “It’s about ensuring the system works fairly for everyone.”

In an era where regulation significantly impacts businesses, Benjamin England demonstrates that the right strategy, backed by expertise, can make a decisive difference.

To learn more about Benjamin England’s regulatory consulting and legal services, visit FDAImports.com or connect with him on LinkedIn.

Disclaimer: This article is for informational purposes only and does not constitute legal or regulatory advice. Readers should consult with qualified legal and regulatory professionals before making decisions based on the strategies or practices discussed in relation to FDA, USDA, or CBP regulations. 

Published by Stephanie M.