Yahoo Finance | Eric Boehm | July 17, 2026
Yahoo Finance recently highlighted Regenative Labs’ lawsuit against the U.S. Food and Drug Administration, drawing awareness around the company’s effort to obtain Certificates to Foreign Governments (CFGs), which are required to export certain products abroad.
As the article explains, Regenative Labs has been waiting nearly three years for the FDA to act on
its applications despite continuing to lawfully market its products in the United States. The
report notes that federal law calls for the FDA to review CFG applications within 20 days, yet
Regenative’s most recent application has remained pending for more than 10 months.
The article also explores the broader policy questions raised by the lawsuit.
At its core, the question raised by the new lawsuit is a bit simpler than it might at first seem:
Can the FDA arbitrarily refuse to let an American company operate overseas because it might
someday change how it regulates that company’s products?While Regenative Labs is obviously hoping for a legal result, the new lawsuit might be best
understood as an attempt to push this issue in front of the Trump administration, which now has
an opportunity to fix a mess created during the Biden administration. It also presents the Trump
FDA with a chance to provide some much-needed regulatory certainty to an American small business
that’s trying to expand.
The article concludes that the case extends beyond a single company, noting the lawsuit presents an
opportunity for the FDA to provide greater regulatory certainty for American innovators.
Regardless of what happens from here, it’s obvious that the FDA’s handling of Regenative Labs’
application has been unacceptable. American businesses shouldn’t face endless waits while
regulators try to decide what rules they might apply tomorrow.