What does the freeze on new regulations and guidance documents mean for the food industry?

President Trump has issued a 10-to–1 Executive Order, which requires federal agencies to repeal 10 existing regulations or guidance documents for every new regulation or guidance document. This will impact agency agendas. It will focus attention on priorities. It will redirect agency actions going forward.

Although the intent of the Executive Order is deregulation, it will have other consequences. For instance, FDA guidance documents are not law but only explain the FDA interpretation of how to comply with the law. Fewer guidance documents means less guidance but not fewer requirements. Regulations are the law, but they also provide the specifics on how to comply with the broad language of the statute. For example, before the FDA wrote a regulation defining the use of “fresh” on food labels, the agency seized warehouses of products for false and misleading use of “fresh” on labels. The lack of a regulation defining “fresh” does not change the requirement that the use of “fresh” on labels cannot be false or misleading.

Seizures are one way for the agency to establish clarity of the requirements of the statute. Another way is through prosecution. Court decisions impose clarity about the requirements and set precedence. Direct enforcement avoids rule-making and issuance of guidance documents.

There certainly are bad regulations and old regulations that need revision. However, regulations have the advantage of giving manufacturers notice of each proposed new rule and an opportunity to comment. With seizures and prosecution, your opportunity to comment on the FDA’s interpretation of the law will be through pleadings to the court.