FDA Compliance
Kratom usage is not approved by the FDA. Its potential as a medical treatment and dietary supplement is still under review. The FDA warns US citizens to avoid consuming non-approved substances. Any claims, anecdotes, or references made by Ancient City Alchemy regarding the beneficial effects of Kratom on any disease, or symptom of disease, or condition associated with a natural state or process are unsubstantiated. Claims or anecdotes made by Ancient City Alchemy regarding the usage of Kratom as a therapeutic substance are unsubstantiated.
FTC Compliance
Any claims or anecdotes made by Ancient City Alchemy regarding the effects of Kratom on disease or symptoms of disease, or as a therapeutic substance are unsubstantiated. Kratom is not a drug or dietary supplement. Kratom’s importation, sale, and consumption is regulated in a number of US states. Potential customers of Ancient City Alchemy are encouraged to learn and observe their locality’s specific legality & regulation for Kratom before purchasing. Ancient City Alchemy observes the FTC’s regulations for the sale of Kratom.
Useful Links & Documents
- Regulation of the sale and importation of Kratom by state
- General Marketing Guidelines (Federal Trade Commission)
- Manual of Compliance Guides (Federal Drug Administration)
Further Notes
The Federal Drug Administration prohibits the following statements to be made in reference to un-approved substances:
• Claims an effect on a disease or class of diseases
• Claims an effect on characteristic signs or symptoms of disease using scientific or lay terminology
• Claims an effect on a condition associated with a natural state or process
• It is an implied disease claim because of the product name, formulation, use of pictures, or other factors
• Claims that a product belongs to a class of products that is intended to diagnose, mitigate, treat, cure, or prevent a disease
• Claims to be a substitute for a product that is a therapy for a disease
• Claims to augment a therapy or drug intended to diagnose, mitigate, treat, cure, or prevent a disease
• Has a role in the body’s response to a disease or to a vector of disease
• Claims to treat, prevent, or mitigate adverse events associated with a therapy for a disease
• Otherwise suggests an effect on a disease or diseases
Kratom is a botanical that qualifies as a dietary ingredient under section 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(ff)(1)]. When marketed as a dietary ingredient, FDA also considers kratom to be a new dietary ingredient under section 413(d) of the Act [21 U.S.C. 350b(d)] because, to the best of the agency’s knowledge, there is no information demonstrating that this substance was marketed as a dietary ingredient in the United States before October 15, 1994.
Furthermore, based on FDA’s review of the publicly available information regarding kratom, there does not appear to be a history of use or other evidence of safety establishing that kratom will reasonably be expected to be safe as a dietary ingredient. In fact, the scientific literature disclosed serious concerns regarding the toxicity of kratom in multiple organ systems. Consumption of kratom can lead to a number of health impacts, including respiratory depression, nervousness, agitation, aggression, sleeplessness, hallucinations, delusions, tremors, loss of libido, constipation, skin hyperpigmentation, nausea, vomiting, and severe withdrawal signs and symptoms. In the absence of a history of use or other evidence of safety establishing that kratom will reasonably be expected to be safe as a dietary ingredient, kratom and kratom-containing dietary supplements and bulk dietary ingredients are adulterated under section 402(f)(1)(B) of the Act [21 U.S.C. 342(f)(1)(B)], because they contain a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
