“Make America Healthy Again” is the slogan on which Robert F. Kennedy, Jr. ran his presidential campaign, and it came with him as he aligned himself with President-elect Trump. Signs point to Kennedy becoming the Secretary of Health and Human Services (HHS), which now gives him the opportunity to implement policies that can, indeed, make America healthier.
The problem is that the Food and Drug Administration (FDA), as with virtually all government, is burdened by multiple layers of bureaucracy. The U.S. has moved to a permissive form of government, where activities require the government to give its permission before projects can move forward. Consistent with this mindset, the FDA heavily regulates foods and medicines, which can cause change to be slow, expensive, and potentially impossible.
President-elect Trump understands the problem. A goal of the Trump administration is to “dismantle Government Bureaucracy, slash excess regulations, cut wasteful expenditures, and restructure Federal Agencies.” He recently created a Department of Government Efficiency to do just that.
One way that Kennedy wishes to make America healthy is to address highly processed foods. “We’re creating a diabetes problem in our kids by giving them food that’s poison.” These two goals these men have provide perfect opportunity to implement permitting reform.
To provide illustration, one may look to the process for modifying food standards, which are regulated by the FDA. As it stands, food standards govern cereal, canned drinks, margarine, sweeteners, food additives, etc. To change food, these regulations will need to be amended.
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For “any person” to petition the government to make modifications to food standards, part of the path toward change is to market test. The FDA can require that food undergo market testing before a party can petition to change food standards. The FDA recognizes that “before petitions to amend food standards can be submitted, appropriate investigations of potential advances in food technology may sometimes require tests in interstate markets….”
This market testing is allowed only if the party seeking the petition has obtained a permit. That permit requires a considerable amount of information, including the purpose, food label examples, and food samples.
For example, last year a permit was granted that allowed a cheese manufacturer to use olive oil as an anti-sticking agent. As it stands, lecithin is the approved anti-sticking agent. There are differences of opinion as to the healthiness of lecithin, but some suspect that it being derived from soy could have health concerns. While the author does not opine on this question, it is clear that some may see the benefit of using olive oil instead. This permit is the process for that change to happen.
The problem lies in the FDA’s gatekeeping function. “If the [FDA] concludes that the variation may be advantageous to consumers…a permit shall be issued….” But this is entirely subjective and full discretion is given to the FDA. Additionally, it gives no timetable for such a decision.
This can be improved by utilizing a different permitting approach. Permit by rule, which is used by at least 38 states and the federal Environmental Protection Agency, could streamline the process and provide near guarantees for the companies who wish to obtain the permit.
Permit by rule is simple. Government would create pre-set standards for any person who wishes to conduct the regulated activity. All would know what one must do to obtain the permit. That person would only have to certify that the standards are met and submit the certifications to the government. The government, in turn, would only have a short time period (perhaps 60 days) to object, otherwise the permit is automatically granted.
With permit by rule, the government’s main role is to enforce against bad actors. If a permittee is not living up to the standards expected, the government would enforce its authority to take the permit away.
But only bad actors would be impacted. Anyone living up to the standards would have very little involvement with the government. And the person would have incentive to comply since, if they were to lose their permit, their investments made would be lost.
It is recognized that Kennedy could amend food standards without private party involvement. But the market drives innovation, so streamlining this process would be helpful. The FDA has, more or less, already set the standards to do market testing for foods that do not comply with current food standards. It would be simple to implement permit by rule. The FDA should consider permit by rule here and anywhere else that permitting gets in the way of efficient change.
Curtis Schube is the Executive Director for Council to Modernize Governance, a think tank committed to making the administration of government more efficient, representative, and restrained. He is formerly a constitutional and administrative law attorney.
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