By: Lucas M. Rhodes
In the labyrinth of federal regulation, where food, drugs, cosmetics, and medical devices are constantly scrutinized, few individuals have the expertise—or the nerve—to challenge the system from both the inside and out.
Meet Benjamin England, a former FDA Regulatory Counsel, Special Agent, and criminal investigator who now leads a legal and consulting firm that supports companies navigating the complexities of U.S. regulation.
With over 17 years working inside the U.S. Food and Drug Administration and nearly 20 years building his own practice—FDAImports.com—Ben England has become a widely recognized advisor and strategist for companies seeking to stay compliant, manage enforcement risks, and expand into the U.S. market.
But his story didn’t begin in a courtroom or a boardroom. It started in lab coats and fieldwork.
From Inside the FDA to Working Across the Aisle
“I might have once been your worst nightmare,” England jokes, “a scientist with a gun.”
That’s not an exaggeration. England spent years as a Special Agent in the FDA’s Office of Criminal Investigations, conducting undercover operations, executing search warrants, and supporting federal cases against violators. He later moved into senior legal roles, advising the Associate Commissioner for Regulatory Affairs and contributing to interagency policy efforts—work that involved shaping how the FDA collaborated with Customs and Border Protection (CBP), the U.S. Department of Agriculture (USDA), and other federal and state entities.
Since then, he’s transitioned from regulator to consultant and legal advocate.
“I know what the FDA looks for during enforcement,” England says. “And I understand how to engage with them—and, when necessary, challenge their decisions through legal means.”
He has represented clients in litigation against the FDA—and reports success in multiple cases.
“Sometimes the only way to get the FDA’s attention is through legal action,” he notes.
Building a Modern Framework for FDA and CBP Compliance
In 2008, England launched FDAImports.com, a regulatory consulting firm that today represents clients from over 100 countries. Through his affiliated law firm, Benjamin L. England & Associates, and partner firm Olsson Frank Weeda, he helps clients bring FDA-regulated products into the U.S., including foods, supplements, cosmetics, pet products, medical devices, and more.
The firm offers services such as:
- FDA inspection and enforcement response support
- CBP seizure and penalty mitigation
- Labeling and marketing compliance
- USDA and wildlife permitting (including pet food and bottled water)
- Regulatory strategy and expert witness support
His model is built on direct regulatory experience and procedural insight. “We’ve designed an approach we believe aligns with both the letter and the intent of federal law,” England explains. “Because we’ve seen how things can break down in practice.”
A Strategic Partner When the FDA Comes Knocking
England’s clients include early-stage businesses, global importers, and large manufacturers. One common thread: they often reach out when a regulatory crisis is already in motion.
“By the time I get the call, things are already complicated,” he says. “My role is to help manage the fallout and clarify next steps.”
More recently, companies have started to seek guidance earlier—during product development, marketing reviews, and pre-launch regulatory planning.
“Proactive compliance doesn’t mean over-regulation,” he says. “It can lead to more efficient operations and reduced enforcement risk.”
A Constructive Voice on Regulatory Reform
Ben England has publicly expressed concern over how the FDA applies guidance documents. He argues that these documents, while non-binding, are often treated as enforceable rules—raising questions about due process.
“In my view, applying guidance as de facto law can create unnecessary uncertainty for businesses,” he explains. “And that uncertainty can have real consequences.”
His position reflects growing debate in regulatory circles about the agency’s balance between flexibility and formal rulemaking.
Practical Insights, Not Just Commentary
England shares his perspective through articles, podcasts, whitepapers, and LinkedIn commentary. He positions himself not as a critic, but as a pragmatic advisor who draws from experience.
“I don’t just tell people what sounds good,” he says. “I focus on what I would do if I were in their position.”
Learn More
To explore Benjamin England’s work or regulatory consulting services, visit FDAImports.com or connect with him on LinkedIn.
Disclaimer: The information presented in this article reflects the professional background, insights, and personal experiences of Benjamin England and is intended for general informational purposes only. It does not constitute legal advice, nor should it be relied upon as a substitute for consultation with qualified legal counsel. Regulatory requirements can vary by jurisdiction, product category, and specific circumstances. For advice tailored to your unique compliance or legal situation, please consult a licensed attorney or regulatory expert.
Published by Stephanie M.
