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Scientists Response to FDA

Dear Health and Human Services and Drug Enforcement Administration:


We are writing to comment on the recently released October 17, 2017 letter “Basis for the recommendations to control mitragynine and 7-hydroxymitragynine in Schedule I of the Controlled Substances Act” (hereafter, “8-Factor Analysis” or “8-FA”) developed by the Food and Drug Administration (FDA), from the United States Department of Health and Human Services (DHHS) to the United States Drug Enforcement Administration (DEA) recommending the placement of mitragynine and 7-OH-mitragynine, the active alkaloids found in kratom, into Schedule I of the Controlled Substances Act.


The cover letter is dated October 17, 2017. The letter and the 8-FA were made public by STAT News following their delivery from DHHS pursuant to a Freedom of Information Act request by STAT News (see https://www.statnews.com/2018/11/09/hhs-recommended-dea-ban-kratom-documents-show/). STAT News made the documents public at https://www.documentcloud.org/documents/5031552-HHS-kratom-letter.html.


Unfortunately, the disclosure omitted many pages of its 8-FA and the FDA has thus far declined to provide the full document stating as follows: “This document was inadvertently disclosed and should have been withheld as it is part of a pre-decisional, deliberative process rightfully protected by the Freedom of Information Act and implementing regulations,” said HHS spokesperson Caitlin Oakley. “That deliberative process is still ongoing, and therefore we have nothing further to add.” From STAT News at https://www.statnews.com/2018/11/09/hhsrecommended-dea-ban-kratom-documents-show/.


Nonetheless, what was disclosed provided the basis for evaluating its accuracy and determining if FDA’s approach met the standards of a reliable and valid decision-guiding document. It is possible that a review of the complete document would alter some of our specific comments, and therefore, we urge complete disclosure of the document. Whether its release was intended or not, its findings and recommendations are now public and full disclosure would prevent misinterpretation of FDA’s full evaluation due to omissions in the disclosure.


Based on our analysis of FDA’s 8 FA, and with reference to the requirements of the Controlled Substances Act, we have major concerns about its conclusions, the actions that could be based upon it, and the implications for public health. We come to the following main conclusions and recommendations.


Main Conclusions


1. FDA’s 8-Factor Analysis does not constitute a reliable and valid scheduling decision guiding document.


2. FDA clearly did not involve NIDA or kratom science experts, as revealed by its major deficiencies.


3. The FDA analysis is incomplete, omitting key data sources routinely relied upon for identifying trends in abuse (e.g., the major federal surveys) and key scientific studies, AND is out-of-date as it does not refer to critical studies including those by NIDA (Yue et al., 2018) and Hemby et al., 2018.


4. The evidence is sufficient to conclude that placement of kratom in Schedule I or any other approach that would ban kratom, would lead many kratom consumers to seek black market kratom and some to relapse to opioids and thus pose a serious risk of death.


Main Recommendations


1. DEA should ask FDA to reexamine the abuse potential of kratom and potential alternative regulatory approaches to kratom with involvement of NIDA and kratom experts, and stakeholders that have additional data and will be affected, namely kratom vendors and kratom consumers. This should be done transparently and include public meetings.


2. Federal agencies should conduct a nationally representative survey to better understand how many people use kratom, use it in place of opioids and would be put at risk of relapse to opioids if kratom was banned, where they live geographically, and other information critical to understanding the nature and magnitude of a ban, as well as regulatory alternatives to a ban.


3. We recommend that FDA propose a regulatory framework that will ensure that safely manufactured kratom products remain continuously available to consumers in natural leaf forms and manufactured extractions that are widely Page 3 – Comment on FDA Kratom CSA 8-Factor Analysis used by consumers, with regulations to ensure quality and appropriate standards for contents, labeling, and marketing. With an advance notice of proposed rulemaking (ANPR), the FDA could solicit comments, and perhaps plan a public hearing to obtain input from key stakeholders including consumers, vendors, experts, and kratom advocacy organizations.


The leading kratom consumer advocacy group in the United States, the American Kratom Association, has issued a Statement of Principles on Regulating Kratom (at: https://www.americankratom.org/abou-aka/statement-of-principles.html) and a voluntary Good Manufacturing Processes (GMP) Standards Program (at: https://www.americankratom.org/index.php/component/sppagebuilder/91-akagmp-certification-program) that may be useful as both have been developed with consideration given to consumers, vendors and with expert input. The implementation of these standards by the FDA, as dietary ingredients/supplements are currently regulated, will offer consumers a safer supply chain for kratom products and help educate consumers on avoiding kratom products that are adulterated or misbranded.


Read the full article here: https://www.americankratom.org/images/file/Scientists-Response-to-FDA-Kratom-8FA--28-Nov-2018-FINAL.pdf




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