Is kratom approved by the FDA?
FDA stands for Food and Drug Administration and is based in the united states of America. The association is involved in the promotion of the public health. It is responsible for the security and safety of the food supply, dietary supplements, cosmetics, and also regulating tobacco products.
The association has issued warnings to three distributors and marketers of the kratom’s products for selling kratom which is not approved. They are Colorado kratom spot of Irvine, Front Range kratom of Aurora and Revibe, Inc., of Kansas City. The kratom products have unproven benefits as FDA claims. Some of the benefits being claimed by the marketers and distributors include the following: –
- Relieving pain
- Preventing neuron damage as a result of strokes
- Treating Cancers
- Reducing the blood pressure
FDA suggests that there is no scientific proof, reliable enough to support the above-proclaimed benefits. FDA commissioner, Scott Gottlieb said that the association could not accept unscrupulous sellers to continue offering products with unattested claims that they can prevent opioid addiction. It was also suggested that kratom is an opiate analog, therefore associated with harmful side effects among the users.
The association agrees that it is free to review the data claiming that the active compounds in kratom can treat pain and addiction. The commissioner also suggested that the association will take up strict actions against distributors selling unsafe and unproved kratom products for the management of addiction and withdrawal syndromes. Instead, the approval process for more safe products to treat such conditions was to be made more efficient.
Currently, there are no approved uses of kratom by FDA. Consumers are, therefore, advised not use it. The association claims that kratom just like morphine activates the opioid’s receptors in the brain. Due to this, kratom put the consumers at the risk of developing the addiction, abuse, and dependence.
The FDA is evaluating all the available scientific studies and research. The association continues to insist that individuals should not consume products containing kratom or its psychoactive ingredients, such as 7-hydroxymitragynine and mitragynine. To formulate a kratom’s safety profile more studies need to be conducted, as the association suggests.
The companies that have blacklisted by the FDA use social media and websites to lure the buyers. Against the law, such companies make unproven claims that kratom can treat or even prevent diseases. Some of these unproven claims include the following: –
- Kratom leaves have blood pressure lowering property.
- Just like painkillers, kratom can relieve pain.
- That kratom is an effective anti-cancer agent.
- That for diabetic patients, kratom is useful in controlling the blood sugar.
- That kratom is effective in the treatment of arthritis, muscle pains, headaches, among others.
- Kratom is an antioxidant thus very useful in the reduction of the neuron damage.
- That kratom can be used in the management of ailments related to stroke.
The FDA claims that such claims can prevent the patients from seeking the approved therapies. This can pose health complications since kratom products have not been portrayed as being useful and safe for consumption. The products may not be effective, and the patient relying on it might develop serious complications or even die. By selling kratom products, these distributors are violating the Federal Food, Drug, and Cosmetic Act thus, a serious crime.
The priority of the FDA is to reduce the rate of addiction menace among the Americans. It is for this reason that it is terming kratom products illegal, as it has been shown to be a cause of addiction. Those affected may opt to use kratom to manage the addiction as claimed by the distributors. By so doing, their recovery path may delay.
They are also at higher risk of addiction as the FDA claims. According to the Substance Abuse and Mental Health Services Administration, the risk of death is reduced by 50% in patients who opt to consume the FDA-approved medication. It is for this reason that people should avoid using unapproved products such as kratom.
The FDA warning letter confirmed the various kratom products as illegal. The products include the following: –
- 1. Front Range Kratom
- Maeng Da White Vein Capsules
- Maeng Da Red Vein Powder
- Bali Green Vein Powder
- Bali White Vein Kratom Powder
- Maeng Da White Energizing Formula
- Liquid Kratom Red Maeng Da Enhanced Pain Formulation
- Kratom spot
- Red Thai Kratom Powder
- Kratom Extract 8x Kratom Powder
- Super Green Indo Kratom Capsules
- Ultra-Enhanced Malay Kratom Powder
- Green Malay Kratom Powder
- Borneo White Vein Kratom Powder
- 50x Black Diamond Extract
- Green Indo
- Red Borneo
- Green Sumatra
- Super Elephant
- White Sumatra
- Yellow Vietnam Kratom
The companies were to give to their responses to the FDA within fifteen days. In their responses, they were to outline the actions they had decided to take regarding the claims made by the FDA. The companies were supposed to correct the violation, failure to which, they were liable to legal actions.
The scientific name for Kratom is Mitragyna Speciosa, and this is what researchers typically refer to it as.
On March 26, 2018, FDA did testing on kratom products sold by Revibe. FDA concluded that the products were contaminated with salmonella. This led to the destruction of the Revibe’s products on April 19, 2018. FDA however, claims that it has not received any information as to whether Revibe recalled the products that had been distributed in the market.
The Federal Drug Association does not approve kratom products. Consumers are, therefore, advised not to consume such products, as this put them under the risk of harmful side effects. The FDA protects and promotes the health of the public. It also ensures the safety, security, and effectiveness of veterinary and human drugs, medical devices and vaccines. Therefore, the association is such an important one. Any adverse side effects associated with the use of kratom should be reported to the FDA. In the united states, it is illegal to distribute kratom products. Therefore, such companies selling kratom products are violating Federal Food, Drug, and Cosmetic Act. The FDA is urging people only consume FDA approved products as they are effective and safe. They are usually related with few and less severe side effects.