Last night, Reince Priebus, chief of staff for President Donald Trump, issued a memorandum announcing the new administration’s freeze on pending regulations.
In short, the freeze—which is likely to be temporary—will have little to no effect on the regulation of cigars by the U.S. Food & Drug Administration (FDA). Priebus’ memo applies largely to rules that are pending or have been recently published by the Office of the Federal Register, the government agency tasked with publishing official government policy.
Any rule that is pending review or had been published but has not taken effect, will be delayed for at least 60 days from their effective date. The deeming regulations were published in May of last year and went into effect on Aug. 8, 2016—making them far outside the window mentioned above.
However, the memorandum also covers guidance documents, a practice where an executive agency formally clarifies parts of a rule. In recent months, FDA has published numerous guidance documents to help provide clarity to some parts of the deeming rules, including announcing delays to certain deadlines.
This could affect FDA’s plans for the deeming regulations, though it should be noted that this particular regulatory freeze could at best just delay certain clarifications.
It’s also important to note that this step is not new. President Obama issued a similar measure in 2009. The purpose behind the regulatory freeze is to allow the new administration to review any pending or new rules before they go into effect. The regulatory freeze is likely to be temporary.
For cigar smokers, there’s not much victory in the actions taken. The move is one that was almost certain by any new administration and provides no specific relief.
The full text of the memorandum is as follows:
The President has asked me to communicate to each of you his plan for managing the Federal regulatory process at the outset of his Administration. In order to ensure that the President’s appointees or designees have the opportunity to review any new or pending regulations, I ask on behalf of the President that you immediately take the following steps:
1. Subject to any exceptions the Director or Acting Director of the Office of Management and Budget (the “OMB Director”) allows for emergency situations or other urgent circumstances relating to health, safety, financial, or national security matters, or otherwise, send no regulation to the Office of the Federal Register (the “OFR”) until a department or agency head appointed or designated by the President after noon on January 20, 2017, reviews and approves the regulation. The department or agency head may delegate this power of review and approval to any other person so appointed or designated by the President, consistent with applicable law.
2. With respect to regulations that have been sent to the OFR but not published in the Federal Register, immediately withdraw them from the OFR for review and approval as described in paragraph 1, subject to the exceptions described in paragraph 1. This withdrawal must be conducted consistent with OFR procedures.
3. With respect to regulations that have been published in the OFR but have not
taken effect, as permitted by applicable law, temporarily postpone their effective date for 60 days from the date of this memorandum, subject to the exceptions described in paragraph 1, for the purpose of reviewing questions of fact, law, and policy they
raise. Where appropriate and as permitted by applicable law, you should consider proposing for notice and comment a rule to delay the effective date for regulations beyond that 60-day period. In cases where the effective date has been delayed in order to review questions of fact, law, or policy, you should consider potentially proposing further notice-and-comment rulemaking. Following the delay in effective date:
(a) for those regulations that raise no substantial questions of law or policy, no further action needs to be taken; and
(b) for those regulations that raise substantial questions of law or policy, agencies should notify the OMB Director and take further appropriate action in consultation with the OMB Director.
4. Exclude from the actions requested in paragraphs 1 through 3 any regulations subject to statutory or judicial deadlines and identify such exclusions to the OMB Director as soon as possible.
5. Notify the OMB Director promptly of any regulations that, in your view, should be excluded from the directives in paragraphs 1 through 3 because those regulations affect critical health, safety, financial, or national security matters, or for some other reason. The OMB Director will review any such notifications and determine whether such exclusion is appropriate under the circumstances.
6. Continue in all circumstances to comply with any applicable Executive Orders concerning regulatory management.
As used in this memorandum, “regulation” has the meaning given to “regulatory action” in section 3(e) of Executive Order 12866, and also includes any “guidance document” as defined in section 3(g) thereof as it existed when Executive Order 13422 was in
effect. That is, the requirements of this memorandum apply to “any substantive action by an agency (normally published in the Federal Register) that promulgates or is expected to lead to the promulgation of a final rule or regulation, including notices of inquiry, advance notices of proposed rulemaking, and notices of proposed rulemaking,” and also covers any agency statement of general applicability and future effect “that sets forth a policy on a statutory, regulatory, or technical issue or an interpretation of a statutory or regulatory issue.”
This regulatory review will be implemented by the OMB Director. Communications regarding any matters pertaining to this review should be addressed to the OMB Director.
The OMB Director is authorized and directed to publish this memorandum in the Federal Register.