by Brian Shilhavy
Editor, Health Impact News

Angela C. Erickson and Thomas Berry of the Pacific Legal Foundation have just published a new report examining illegally issued regulations at the Department of Health and Human Services (HHS).

Their study found that:

Unconstitutional rulemaking procedures are rife at HHS, especially at the FDA.

They analyzed who were the people making these rules at HHS in what they claim is the largest study ever done on this subject.

[This] has never been studied before: a large expansion of rulemakers who are not democratically accountable.

These unaccountable rulemakers are not constitutionally authorized to issue final rules that have the force of law.

But, as this study shows, that hasn’t stopped them.

The basis for which they claim these rules are unconstitutional is what they call The Appointments Clause and the U.S. Supreme Court’s ruling on this issue 43 years ago.

The U.S. Constitution requires executive branch officials who exercise significant authority and discretion to be formally appointed in a manner the Appointments Clause specifies in Article II, Section 2.

All principal officers must be nominated by the President and confirmed by the Senate before they are appointed.

Inferior officers must undergo the same process unless Congress by law authorizes their appointment by the President or a department head.

The Framers specified these appointment rules to ensure that all high government officials who exercise significant power over us would be accountable to the people in a meaningful way.

The Supreme Court established 43 years ago that rulemaking was one of those significant powers that only democratically accountable officers appointed in this manner could exercise. Rightly so.

Permanent career staff in regulatory agencies have important jobs, but they are not democratically accountable to the people in this manner. They shouldn’t be issuing regulatory law that governs us. Their rules simply aren’t valid.

They claim that this is the largest study ever done on this topic, looking at 2,952 rules over a 16-year period.

Pacific Legal Foundation (PLF) analyzed the rulemaking practices of one executive department over several administrations. In a first-of-its-kind study, the researchers examined every regulation issued by the Department of Health and Human Services (HHS) from 2001 through 2017 (2,952 rules).

The study focused on who issued each final rule, the rulemaker’s authority, and the rule’s significance.

The study found that a majority of HHS regulations were illegally issued by low-level officials or career employees who had no authority to do so.

The Food and Drug Administration (FDA) was the most frequent and clear-cut violator. The FDA’s illegal rules were so numerous that they skewed the results for the rest of HHS.

PLF gave some examples of how these rules affect consumers and business owners, including how dairy farmers cannot call their milk “skim milk” unless they add synthetic vitamins to it.

In another example, dairy farmer Randy Sowers is required to call the milk produced by his cows “imitation skim milk” for the sole reason that he skims the fat off it and does not add synthetic vitamins.

He is not allowed to call it what it is, skim milk, because of a rule signed by an unelected public servant.

The results of their study found:

that a majority of HHS regulations were illegally issued by low-level officials or career employees who had no authority to do so. The Food and Drug Administration (FDA) was the most frequent and clear-cut violator.

The FDA’s illegal rules were so numerous that they skewed the results for the rest of HHS.

Among FDA final rules, 98% were issued by career employees who have no constitutional authority to do so.

Read the full report.