The White House Office of Management and Budget pulled six FDA guidances and rules from its review, a move prompted by President Joe Biden’s freeze on all regulations issued by the Trump administration that have not yet gone into effect. FDA also withdrew two final tobacco rules that were pushed out in the last days of the Trump administration.
Among other things, the regulations withdrawn by OMB would have laid out FDA’s cannabidiol enforcement policy, established a definition for the term “healthy,” reflected the new minimum age to purchase tobacco and explained FDA’s current policy for foods that are derived from plants.
OMB withdrew the regulations on Thursday (Jan. 21), changing the review status to “concluded” but clarifying that each rule had been withdrawn. An OMB spokesperson confirmed to Inside Health Policy that they were sent back to the agencies for review and reconsideration, per Biden’s regulatory freeze.
FDA’s CBD enforcement policy draft guidance, which had been under review at OMB since July, was withdrawn Thursday.
Stakeholders and lawmakers have been anticipating the guidance for two years, since the 2018 Farm Bill gave FDA authority over hemp-derived CBD. Representatives from the U.S. Hemp Roundtable and the National Industrial Hemp Council, both of which met with OMB to discuss the draft guide in late July, say the lack of regulatory clarity from FDA has led to uncertainty in the hemp and CBD industry.
OMB withdrew FDA’s proposed rule that would have defined the term “healthy” and laid out guidelines for making nutrient content claims. The rule had been under review since August 2019.
The Corn Refiners Association met with the White House in October 2019 to discuss the proposal. The group had previously called for FDA to deem high levels of sugar a disqualifier for use of “healthy” claims after a nationwide survey found a gap between the official meanings of “healthy” and “natural” and what consumers think those terms mean.
FDA’s final rule, “Prohibition of the Sale of Tobacco Products to Persons Younger Than 21 Years of Age,” also has been pulled back. The rule reflects that the new minimum age to purchase tobacco is 21 and increases the minimum age verification from 27 to “under the age of 30.”
The agency was required by law to publish the rule by June 17, 2020, though it did not send the rule to OMB until September. FDA’s fall 2020 unified agenda said the rule would be published in November.
OMB withdrew FDA’s proposed rule, “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” that would revise requirements for agricultural water.
FDA sent the rule to OMB for review in December. The agency’s spring 2020 unified agenda had slated the rule for a November 2020 release, but that was pushed back to December in the agency’s fall 2020 regulatory agenda.
FDA’s recent guidance, “Foods Derived from Plants Produced Using Genome Editing,” also has been withdrawn. It was sent to and withdrawn from OMB all on the same day, Thursday.
The guidance has not been previously published in any unified agenda, but the agency in 2017 did issue a request for comment on the use of genome editing to produce plants used for human or animal food.
In 2018, then-FDA Commissioner Scott Gottlieb and then-Deputy Commissioner Anna Abram unveiled a sweeping action plan to spur innovation in animal and plant biotechnology. Included on the list of actions the agency hoped to take was a draft guidance for industry that would explain FDA’s current regulatory policy for human and animal foods produced through modern molecular plant breeding techniques.
OMB withdrew an antimicrobial drug guidance that had not previously been published in the unified agenda but that had been under review by OMB since Dec. 4.
The guidance, “Recommendations for Drug Sponsors for Voluntarily Bringing Under Veterinary Oversight All Medically Important Antimicrobial Drugs Approved for Use in Animals that Continue to Be Available OTC,” was originally published by FDA as a draft in 2019 under a slightly different name.
In its draft version, FDA said that, once finalized, the guidance would provide information to sponsors of medically important antimicrobial new animal drug products who are interested in changing the approved marketing status of their products from over-the-counter to “by veterinary prescription,” consistent with FDA’s recommendation that the use of such drugs in animals be limited to uses that include veterinary oversight to mitigate development of antimicrobial resistance.
The agency received more than 7,000 comments on the draft between September 2019 and July 2020.
FDA also withdrew from the Federal Registertwo final tobacco rules that were pushed out in the last days of the Trump administration. One of the rules established application and recordkeeping requirements for premarket tobacco products, and the other set out format and content requirements for substantial equivalence reports.
Former FDA chief Stephen Hahn said on Tuesday (Jan. 19) that the rules marked an important milestone in FDA’s regulation of tobacco products. He and FDA tobacco product center director Mitch Zeller said the rules would create more transparency and efficiency around reviewing tobacco product applications.
The agency also had planned to withdraw its September 2011 PMTA draft guidance because the information outlined in the guidance is addressed in the final PMTA rule that was published on Tuesday. The withdrawal of that guidance has also been put on hold due to the regulatory freeze.
“The Food and Drug Administration withdrew this document while it was on public inspection. It will remain on public inspection until the close of business on January 27, 2021. A copy of the withdrawal request is available at the Office of the Federal Register,” FDA says in a note included in the Federal Register under each of the withdrawn regulations. — Beth Wang (bwang@iwpnews.com)
