While a pause on federal health agencies is nothing new during presidential transitions, the Trump Administration’s 10-for-one Executive Order may impact some proposed rulings and brands should continue their compliance efforts for finalized rules, according to Jessica O’Connell, partner at law firm Covington and Burling.
Last month, the Trump Administration paused FDA’s communications with the public right after the agency released significant initiatives, including FDA’s final ruling on updating the nutrient claims for “healthy,” a proposal for front-of-pack labeling and de-authorizing Red Dye No. 3 in food.
While the pause arrived at a critical time in food safety and policy, a federal pause is a common occurrence during the transition of one administration to another, O’Connell said
“This is not something that is unique to the Trump Administration. It is something that has been done by the past few incoming – both Democratic and Republican – administrations,” O’Connell explained.
Federal pauses are implemented so an incoming administration can review newly issued plans to “make sure it is consistent with their policies and priorities across the board,” she said.
Historically, incoming administrations have rarely overturned significant regulatory actions from their predecessors. However, the Trump Administration in 2016 reversed regulations passed in the final days of the Obama Administration. The Biden Administration also issued a flurry of food-related regulations in its final weeks, giving the incoming Trump Administration even more to review, O’Connell explained.
How should companies prepare?
O’Connell advises food companies continue compliance efforts, especially for finalized rules. like the ban on Red Dye No. 3 and the voluntary updated “healthy” nutrient content claim, as these are unlikely to be reversed. While there is always a chance to influence policy from a freeze, businesses should not assume regulations will be rescinded, she added.
Robert Kennedy Jr.’s likely confirmation to head the Department of Health and Human Services suggests continued support for the Red No. 3 ban, given his past concerns about color additives, O’Connell said. The “healthy” claim rule may receive scrutiny, but is not expected to be overturned. Proposed rules like front-of-pack labeling offer more flexibility for the administration to modify or delay, she added.
Potential impact on FDA
Trump’s 10-for-one Executive Order, requiring agencies to repeal 10 existing regulations for every new one issued, could shape FDA’s regulatory approach moving forward, she added. Compared to Trump’s first administration where he issued a two-for-one executive order, the 10-for-one is significantly stricter and aimed at reducing regulatory burdens on businesses and promoting economic growth, O’Connell added.
The stricter 10-for-one executive order “is a deregulation initiative where it directs an agency that is promulgating a new requirement to identify at least 10 existing requirements to be repealed. The language, and it is quite broad, talks about a new rule, regulation or guidance. That is something agencies will have to be thinking in terms of setting regulatory priorities and agendas and thinking about what actions they might want to take and what documents they might want to issue,” O’Connell said.
With a stricter executive order, FDA may face challenges in pushing new regulations forward, explained O’Connell.
If fewer regulations are implemented, FDA may receive fewer resources. However, the agency also may seek alternative pathways to enforce standards outside of formal rulemaking, according to O’Connell.
“Agencies could look to consider whether they could impose requirements or take actions or set precedent through something that isn’t rulemaking, or isn’t a regulation or guidance,” she said.
