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Study: Almost all FDA rules unconstitutional


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Ninety-eight percent of the rules issued recently by the U.S. Food and Drug Administration were unconstitutional because the bureaucrats who created them lacked authority, a new study finds.

The Pacific Legal Foundation, which conducted the research, also found that nearly three-fourths of the rules from the Health and Human Services Department, 71 percent, are unconstitutional, based on who finalized and issued them.

The majority of unconstitutional rules were from the FDA.

“Among substantive final rules considered to have a significant regulatory impact by the Office of Management and Budget, 80 from the FDA were unconstitutional – 93% of all substantive and significant HHS rules,” the study found.

The study looked at 2,952 rules from HHS over a 17-year period from 2001 through 2017.

Most came from those “low-level officials and career employees who lack constitutional authority.”

“Such rules are unconstitutional,” the report said. “The Constitution requires that significant government decisions must be made solely by ‘principal officers’ appointed by the president after Senate confirmation. Issuing a regulation with the force of law is one of those actions that only principal officers can perform.”

Report co-author Thomas Berry, an attorney at Pacific Legal Foundation, argued that in a democracy, “those who make the rules need to be accountable to the people.”

“That’s why the Framers included the Appointments Clause in the Constitution,” he said. “Only properly appointed officers in the executive branch may issue regulations that are binding on the public. This preserves democratic accountability for significant executive branch actions.”

One example is the “deeming rule,” which classifies tobacco-free vaping products as tobacco products. “The rule prohibits Steve Green, a California vape shop owner, from telling his customers his story about using vaping to stop smoking and recover from early signs of emphysema,” PLF’s report said.

“Among the hundreds of illegal FDA rules, 25 rules were classified as significant because they had an impact on the American economy of at least $100 million or had other significant economic impacts,” said Angela Erickson, PLF’s strategic research director and study co-author.

“Congress and the White House should ensure that this practice ends and agencies comply with the law.”

Another example is that because of the FDA, “dairy farmers such as Randy Sowers of Frederick County, Maryland, cannot call their skim milk ‘skim milk’ without first adding artificial vitamins,” PLF’s report said.

“Congress needs to ensure that rulemaking under statutes it enacts is exercised solely by democratically accountable officers – principal officers nominated by the president and confirmed by the U.S. Senate. It can do so by using confirmation hearings, appropriations bills, and regulatory reform legislation. Congress also needs to expressly prohibit delegations of rulemaking authority from Senate-confirmed officials to career bureaucrats.”

The president also could help, the report said.

“The president can act on his own. With a stroke of his pen, he can and should order his senior appointees to take personal responsibility for regulations issued during his administration.”

One of President Trump’s goals in office was to eliminate unnecessary federal rules, and he has exceeded expectations.

“The current administration made a serious commitment to reduce the regulatory burden, and numerous members of Congress from both parties share this goal. For these reform-minded leaders, ending the unconstitutional practice of delegating authority for issuing final rules should be a top priority,” the report said.

“The growing thicket of red tape created by countless federal regulations stifles American economic growth, wages, and job creation,” PLF said. “It raises prices, limits consumer choice, and restricts individual liberty. The toll on economic growth alone is significant. From 1980 through 2012, regulations cost Americans $4 trillion in economic growth – $13,000 per person.”


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