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ICYMI: Inside Sources Highlights Regenative Labs’ Fight Against Administrative Delays
Aug 17, 2026
Inside Sources | Andrea Ruth | August 12, 2026
Inside Sources recently highlighted Regenative Labs’ ongoing legal challenge against the U.S. Food and Drug Administration, bringing more national attention to the agency’s years-long delay in acting on the company’s applications for Certificates to Foreign Government (CFGs), which are required to export products to international markets.
As the article explains, Regenative Labs has repeatedly sought CFGs since 2023. Despite federal law requiring the FDA to act on such applications within 20 days, the agency has allowed the applications to remain unresolved, preventing the company from accessing foreign markets and growing its operation.
The article argues that the delay raises broader concerns about regulatory accountability and the impact of prolonged agency inaction on small businesses seeking to grow and create jobs.
“An agency can freeze a business without ever having to defend the freeze before a judge, as long as it never issues a final decision,” the author writes. “There’s no denial to appeal, no clock that ever runs out, no moment where the company gets its day in court, until the company drags the agency there itself. Which is precisely what Regenative just did, filing suit to force the FDA to act one way or the other.”
The piece notes that Regenative’s lawsuit seeks to compel the FDA to act on its pending applications and examines the implications of allowing agencies to delay decisions indefinitely despite statutory deadlines established by Congress.
“Companies that follow the rules ought to get a straight answer from the agency enforcing them. When the answer is silence for three years running, don’t be surprised when the company finally goes and gets one from a judge instead.”
This coverage underscores the importance of ensuring that small businesses receive fair and timely responses from the agencies charged with overseeing them.