PFC Review Board Member, Jim Tozzi’s Role in Stopping the DEA from Classifying Drug in Schedule 1 Status PFC Review Board Member Jim Tozzi’s Role in Stopping the DEA from Classifying Drug in Schedule 1 Status
November 29, 2016 | Allayne Sherer
Until a few months ago, few people in the US had ever heard of kratom, a tropical evergreen tree in the coffee family has been known to be used for medicinal purposes. That was until the Drug Enforcement Administration (DEA) tried place kratom in Schedule I of the controlled substances list through an emergency process. This action brought criticism from thousands of people including Senator Orrin Hatch and Senator Corey Booker. While kratom does possess opiate-like qualities, it also has been shown to treat opioid addiction and mitigate symptoms of pain, diarrhea, depression, and anxiety.
However, it looked like the fate of the medicinal herb was sealed until the Center for Regulatory Effectiveness (CRE) got involved. Jim Tozzi, head of the CRE, author of the Data Quality Act (DQA, also known as the Information Quality Act), and PFC Review Board member remarked on CRE’s involvement “when 100,000 members of the public express outrage with a regulatory decision, it deserves a second look.”
And that is exactly what they did. The CRE, in conjunction with several other lobbying firms, educated federal agencies on the health qualities of kratom, and the downsides of issuing a premature ban. On September 12, 2016 the CRE sent a letter to the DEA with the recommendation that the DEA extend the decision to classify kraton as Schedule I, and that they conduct an interagency peer review of DEA’s science which lead to a Schedule I listing of kratom as required by the HISA requirements of the Data Quality Act.
In its conclusion, the CRE reminded the DEA that in order to sustain its claim that kratom is a threat to public health, it would have to overcome the work of three renowned governmental research organizations. Canada, where kratom is legal, has never believed it to be an imminent threat to public health. The US Department of Agriculture also conducted its own study of kratom, and did not note any "imminent hazards." The National Institute of Health, not only sponsored a study of kratom, but never once suggested that it could have the potential to poses a threat to public health. Most importantly, the DEA also failed to disclose any analysis of how a ban on kratom in the United States could affect crime since kratom is a legal product in Canada.
In its sudden rush to ban kratom, the DEA also violated several fundamental statutes including the Data Quality Act, Executive Order 12866, and the Office of Management and Budget’s (OMB) Peer Review guidelines. So in an unprecedented act, with help from Jim Tozzi and his team, the DEA withdrew their notice to classify kratom as a Schedule 1 drug. This is something that has never been done before, and the first time in DEA history that an organization was able to stop an order to place a substance in Schedule 1.
“This is an unprecedented action. It’s never happened before,” DEA spokesman Russ Bayer told The Guardian . “We’ve never withdrawn a notice to temporarily schedule any substance but we want to move through this process in a transparent manner.”
We at Americans for Safe Access, want to personally thank Jim Tozzi, and the CRE for this insurmountable achievement that has impacted the health of thousands of Americans.
For more information about kratom, please check out the following articles by ASA Senior Scientist, Jahan Marcu, Ph.D.: