The facts are clear, twelve world-recognized Kratom experts that have come together to conclude Kratom is in fact safe.
FDA clearly did not involve NIDA or kratom science experts, as revealed by its major deficiencies.
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relied upon for identifying trends in abuse (e.g., the major federal surveys) and key scientific studies, AND is out-of-date as it does not refer to critical studies including those by NIDA (Yue et al., 2018) and Hemby et al., 2018.
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.
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.
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 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.