Does the FDA regulate kratom?

Kratom has had some naysayers in the United States, the Food and Drug Administration (FDA) being one of them. Since kratom is available as a dietary supplement in the market, FDA is one of the key regulators for the kratom industry.

In the past, various quality concerns and malpractices have caught the attention of regulatory bodies and authorities. In this blog, we discuss the role of the U.S. Food and Drug Administration (FDA) in regulating kratom and its recent activities.

However, as a disclaimer, we’d like to state that our purpose is to inform amid misinformation and false narratives. The information provided should not be taken as medical advice.

What is the FDA?

According to the FDA, their mission is “to protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.”

The FDA’s key responsibility is to ensure consumer safety. Many believe that the Food and Drug Administration led a campaign to try and ban kratom. But the recent string of victories in state houses across America now hints towards stronger advocacy and sensible regulation for the first time in years.

FDA’s Stance on Kratom

The federal agency reiterates the need for further research on kratom, citing concerns regarding consumer safety and thus not approving any medicinal uses.

This position is not any different from other dietary ingredients, botanical supplements, or dietary supplements. In 1994, the FDA’s overregulation of dietary supplements forced the introduction of the Dietary Supplement Health and Education Act (DHEA).

Unlike the FDA’s claim, kratom is not an opioid by plant genetics, chemical structure, or legal definition. Many people use kratom to replace coffee, as the benefits are similar. Kratom increases alertness, mental focus, and overall energy levels without caffeine.

The FDA’s recommendations for scheduling were rejected by the Drug Enforcement Administration (DEA), the U.S. Department of Health and Human Services (HHS), and the Expert Committee on Drug Dependence (ECDD) for the U.N. Commission on Narcotic Drugs. 

To learn more about why FDA’s claims are controversial, read Protect Kratom’s comprehensive fact-based clarifications. Also, leading public health officials and scientists are now opposing FDA’s stance on kratom’s potential for overuse and usage safety after reviewing the current evidence and data on kratom. 

More than $30 million is spent on kratom research studies by the National Institute on Drug Abuse (NIDA). Find out more about the current research and whether kratom is safe.

Is Kratom FDA Approved?

Unlike drugs, dietary supplements do not need FDA approval. Because kratom is no exception, kratom vendors can market kratom supplements to consumers. However, the concern for safety in terms of quality is valid. 

We want to emphasize that all our products undergo strict quality control procedures to ensure our kratom is safe to consume. We follow the American Kratom Association’s GMP Standards Program – a continuously improved and commonly accepted Good Manufacturing Practices (GMP) for Dietary Supplements.

The GMP Standards Program requires every approved kratom vendor to successfully demonstrate that their kratom products are safe, high-quality, and adequately labeled for consumers to make an informed purchasing decision.

Kratom vendors like Super Speciosa that qualify and maintain the high standards of this program are listed as an AKA Qualified Vendor, and their products bear the “AKA GMP Qualified” seal on their packaging.

FDA’s most significant concern has been the risk of overuse and self-medication by consumers. We’d also strongly advise against any self-medication or heavy use of kratom.

Kratom supplements are not made to help with opioid withdrawal symptoms or to manage opioid addiction or cravings. FDA-approved addiction treatment or mental health therapy is the preferred solution.

Current research and science continue to favor that kratom could improve people’s lives, as many stories tell now.

FDA Actions on Kratom

2012 – the Food and Drug Administration (FDA) flagged kratom as an unapproved drug and issued an import alert.

2014 – the FDA issued a second import alert and banned kratom imports due to contamination reports.

2016 – the Drug Enforcement Administration (DEA) withdrew its intent to classify kratom as a Schedule I drug under the Controlled Substances Act within a month.

As it stands, kratom is still legal at the federal level but has no approved medical use.

The Legal Status of Kratom

Kratom is not legal everywhere in the United States of America. It is a scheduled and controlled substance in some states, cities, and counties. Super Speciosa doesn’t ship to any address where kratom is illegal.

The AKA has helped 11 states regulate kratom as a food ingredient, with some states opting for a more in-depth version that includes laws against shoddy manufacturing standards. 

In the six states that have scheduled kratom, the AKA has worked with five to advance discussions and policy proposals to reverse the bans. 

States where kratom is illegal: Alabama, Arkansas, Indiana, Rhode Island, Vermont, and Wisconsin. 

Cities and counties where kratom is currently illegal: Sarasota County, FL; Union County, MS; San Diego, CA; Jerseyville, IL; Oceanside, CA; and Ontario, OR.

On the federal level, the AKA worked with lawmakers on both sides of the aisle to introduce “groundbreaking” legislation in the form of a proposed “Federal Clarity for Kratom Consumers Act.” 

The AKA has also organized the American Kratom Protectors, a national grassroots organization that kratom enthusiasts can join to support kratom advocacy and share their positive kratom experiences with the local gov and public office holders.

Check kratom legality in your state or read our news section to catch the latest on kratom legality and more.

Frequently Asked Questions (FAQs) on Kratom Regulation

What is Kratom?

Kratom is a botanical and has seen a growing consumer market as an herbal supplement by natural wellness enthusiasts. Mitragyna speciosa, as the scientific community knows it, is a tropical tree grown in the wild rainforests of Southeast Asia. The tree is mainly grown in Malaysia, Thailand, and Indonesia.

Unlike traditional chewed fresh kratom leaf, kratom available in the market is usually dried or aged in various ways, producing different alkaloid profiles and strains such as Maeng Da, Bali Kratom, Green Malay, Red Borneo, and White Thai.

Does the FDA consider kratom a controlled substance?

While kratom is not currently classified as a federally controlled substance, the FDA has expressed concerns about its safety, addictive potential, and lack of approved medical use.

Can the FDA ban or schedule kratom?

Unlike drugs, dietary supplements do not need FDA approval. The FDA can recommend scheduling certain substances under the Controlled Substances Act (CSA). However, as of now, kratom is not classified as a federally controlled substance. While the FDA has expressed concerns about kratom’s safety and potential for abuse, it has not succeeded in banning or scheduling kratom.

Can kratom be marketed as a dietary supplement?

Under the Kratom Consumer Protection Act, kratom products can be marketed as dietary supplements if they comply with necessary labeling and other requirements.

What are the potential side effects of kratom?

Potential side effects of heavy use of kratom are nausea, vomiting, constipation, stomach upset, and either drowsiness/dizziness or irritability/agitation. 

Are there any FDA-approved kratom products?

Unlike drugs, dietary supplements do not need the U.S. Food and Drug Administration’s approval. Because kratom is no exception, kratom vendors can market kratom supplements to consumers. However, the concern for safety in terms of quality is valid.

We want to emphasize that all our products undergo strict quality control procedures to ensure our kratom is safe to consume. We follow the American Kratom Association’s GMP Standards Program – a continuously improved quality standard for Dietary Supplements.

Can the FDA enforce regulations on kratom vendors?

The FDA can enforce regulations or legal action on kratom vendors if they market their kratom products under false medical claims.

What is GMP Standards Program?

The GMP Standards Program requires every approved kratom vendor to successfully demonstrate that their kratom products are safe, high-quality, and adequately labeled for consumers to make an informed purchasing decision.

Is kratom legal in my state/county?

States where kratom is illegal: Alabama, Arkansas, Indiana, Rhode Island, Vermont, and Wisconsin. 

Cities and counties where kratom is currently illegal: Sarasota County, FL; Union County, MS; San Diego, CA; Jerseyville, IL; Oceanside, CA; and Ontario, OR. Check kratom legality in your state or read our news section to catch the latest on kratom legality and more.