Note: This post doesn’t hold legal information. It has only general up-to-date details related to Kratom and the FDA. It’s important to do your research and consult someone with expertise in the legalities and use of drugs. Always check federal, local, and state laws to understand the consumption, buying, and sale of kratom.
Mitragyna Speciosa, commonly known as kratom, has gained significant popularity all around the world for its potential benefits, such as pain relief, mood enhancement, and assistance with opioid withdrawal symptoms. People like to consume kratom in various ways, such as capsules, powders, tablets, dried and crushed leaves, and extract forms.
Mitragynine and 7-hydroxymitragynine are two substances (alkaloids) that are the reason for controversies around kratom. Mitragynine produces stimulating effects in low doses and opioid-like effects at higher doses. The legal status of kratom has been a subject of intense debate, particularly the reason for the FDA evaluation.
In this article, we will learn the FDA’s stance on kratom, its concerns, and other things you must know about kratom’s legality.
What is the FDA’s Stance on Kratom?
The US Food & Drug Administration (FDA) has classified kratom as a “drug of concern” and labeled it as an herbal product that needs regulation and surveillance. However, nearly 2 million Americans are using (kratom) a substance that is banned in multiple states.
Read about kratom legality in detail here.
Here is a breakdown of the FDA’s key concerns and actions regarding kratom:
1. Safety Concerns
FDA has raised multiple concerns about this herb’s potential for addiction and abuse. They are also concerned about the side effects, which include nausea, dizziness, dehydration, and other respiratory issues. FDA has also questioned cases of salmonella contamination in Kratom.
2. Lack of FDA Approval
FDA has not approved Kratom, which means that it has not undergone the rigorous testing required for pharmaceuticals. The lack of approval makes it illegal to buy, sell, or consume kratom as a treatment for any health condition.
3. Opioid-Like Effects
FDA has raised concerns about active compounds present in Kratom: mitragynine and 7-hydroxymitragynine. The interaction of these alkaloids with opioid receptors in the human brain has fueled concerns about its potential for misuse and addiction.
4. Public Health Advisor
The FDA has also questioned multiple public health risks associated with Kratom, mainly for its contamination and addiction.
Is Kratom a Legal Substance?
The legality of kratom varies depending on your location. While it is legal at the federal level in the US, several states and municipalities have banned or restricted the buying, selling, or consumption of kratom.
1. Federal Level
Kratom is not classified as a controlled substance under Federal law of the United States, however, it is not approved by the FDA. The DEA (Drug Enforcement Administration) has considered scheduling kratom but has not done so as of now.
2. States and Local Level
Alabama, Arkansas, Indiana, Rhode Island, and Wisconsin have completely banned kratom. However, it is legal in some US states, and there is an age limit for consumption. For instance, in Florida, the sale of kratom to anyone under 21 is banned, as in Sarasota County.
3. International Regulations
Kratom is banned in several countries, including Australia, Denmark, and Thailand, while others have strict limitations in place.
FDA’s Role in Regulating Kratom Products

The FDA ensures the safety and efficiency of products available to consumers by regulating laws throughout the states. Here is how the agency’s action impacts kratom:
- FDA has prevented all unsafe and misbranded Kratom from entering the US market.
- They have also issued import alerts for checks and balances.
- FDA has also initiated recalls of products contaminated with salmonella or other harmful substances.
- The FDA has also taken strong action against companies and stores that make unproven health claims, such as its ability to treat critical diseases.
- They also monitor adverse events related to kratom and research them to understand the effects of this botanical herb better.
Can Kratom Help with Opioid Withdrawal Symptoms?

Kratom is widely known to alleviate opioid withdrawal symptoms as many users have reported positive experiences, however, the FDA has not approved kratom for this purpose and strictly condemns its use.
1. User Reports
Many consumers have claimed that this herb helps reduce withdrawal symptoms, such as pain, anxiety, and other cravings, making it easier to withdraw from opioids.
2. FDA’s Position
FDA’s stance on insufficient evidence to support kratom use for opioid withdrawal allows them to warn people of its potential for abuse and addiction.
3. Scientific Research
Some studies suggest that kratom’s alkaloids may have therapeutic properties, but more research is needed to confirm its safety and effectiveness.
What Does the Future Hold for Kratom?
1. Increased Regulation
The FDA may impose strict regulations on all products related to kratom and enforce mandatory testing, labeling requirements, or age restrictions.
2. Scheduling as a Controlled Substance
The DEA might classify kratom as a controlled substance, making it difficult to possess or distribute.
3. Approval for Medical Use
If sufficient research is conducted to prove the safety and efficacy of a drug, the FDA might approve it for specific uses, such as pain management.
4. Continued Legal Gray Area
Kratom may remain in a legal gray area, with varying regulations at the state and local levels.
What Can Consumers Do?
- Always choose reputable brands that sell high-quality, lab-tested products.
- Follow dosage guidelines and avoid overdose to minimize the risk of side effects.
- Stay informed with the latest FDA updates and regulatory laws.
Final Thoughts
The FDA’s opinion on kratom shows its commitment to protecting public health, but it also shows the lack of research on this beneficial herb. As a consumer, you should stay informed about current local and state laws, choose high-quality products, and use them responsibly.
If you have done proper research and are looking for kratom online, try Occurs Naturally ON7 tablets, which are available in 3 experiences (relief, energy, focus). You can get different potency levels in different pack sizes of 1,3, and 12 count. At Occurs Naturally, we source the highest botanical ingredients to ensure that our product is safe, effective, and ethically sourced. You can check the lab results for authenticity and transparency.
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