US Marshals seize dietary supplements containing kratom
The U.S. Food and Drug Administration announced today that U.S. Marshals, at the agency’s request, seized nearly 90,000 bottles of dietary supplements labeled as containing kratom. The product, manufactured for and held by Dordoniz Natural Products LLC, located in South Beloit, Illinois, is marketed under the brand name RelaKzpro and worth more than $400,000.
“We have identified kratom as a botanical substance that could pose a risk to public health and have the potential for abuse,” said Melinda Plaisier, the FDA’s associate commissioner for regulatory affairs. “The FDA will continue to exercise our full authority under law to take action on these new dietary ingredients, especially if they ignore the notification requirements, as part of our commitment to protecting the health of the American people.”
Mitragyna speciosa, commonly known as kratom, is a botanical substance that grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. Serious concerns exist regarding the toxicity of kratom in multiple organ systems. Consumption of kratom can lead to a number of health impacts, including, among others, respiratory depression, vomiting, nervousness, weight loss and constipation. Kratom has been indicated to have both narcotic and stimulant-like effects and withdrawal symptoms may include hostility, aggression, excessive tearing, aching of muscles and bones and jerky limb movements.
In February 2014, the FDA issued an import alert that allows U.S. officials to detain imported dietary supplements and bulk dietary ingredients that are, or contain, kratom without physical examination.
In January 2016, the FDA administratively detained RelaKzpro under the Federal Food, Drug and Cosmetic Act (FD&C Act), as amended by the Food Safety Modernization Act (FSMA). Under its administrative detention authority, the FDA can detain a food or dietary supplement product if the agency has reason to believe the product is adulterated or misbranded. The agency can keep detained products out of the marketplace for a maximum of 30 days while it determines whether to take further enforcement action, such as seizure.
The U.S. Department of Justice, on behalf of the FDA, filed a complaint in the U.S. District Court for the Northern District of Illinois alleging, among other things, that kratom is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that it does not present a significant or unreasonable risk of illness or injury; therefore, dietary supplements containing kratom are adulterated under the FD&C Act.
The FDA is warning consumers not to use any products labeled as containing kratom. Health care professionals and consumers should report any adverse events related to products containing kratom to the FDA’s MedWatch program by:
- completing and submitting the report online at www.fda.gov/medwatch/report.htm; or
- downloading the form, completing it and then faxing it to 1-800-FDA-0178.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Filed under: General Problems
The FDA is the lap dog (if one want’s to refer to a Doberman as a lap dog) for Big Pharma. Kratom is an herb and as a natural product cannot be patented and made into a huge financial boon for Big Pharma. Big Pharma is a jealous master and will not countenance any competition. So Kratom is daemonized as a “public” safety threat (that is the catch-all excuse that the State uses for calling out some branch of the brute squad to solve any issue at gunpoint), the US Marshalls are called out and a private entity has their property stolen at gun point with no hope of any compensation. Big Pharma says, “Good Boy” and tosses the FDA a treat of some sort in terms of money of power and the day goes on. As Dr. Ibsen suggested, it should be studied.
As an aside, Common sense is the best indicator as to whether an herb is dangerous or not. If some Asian cultures have been using the herb medicinally for centuries, then it’s probably not that dangerous. if it were, they originating culture would have labeled it “Poison” and no one here would have ever known about it. There a few exceptions, e.g., Fox Glove, but for the most part, most of these herbs are not as dangerous as the State would have one believe. At the end of the day, it’s all very hypocritical on the part of the State. As proof that it is all about money and power and not public safety, I give you Big Tobacco. Now, I don’t smoke, but I also have no problem with people who choose to use Tobacco. It is dangerous, but that is their choice. The State permits it. Why? Because of the Dollar Sign Almighty. I can’t believe that Kratom is more dangerous. If the State could make a big enough buck on it, Kratom would be available.
Really, the only difference between organized crime and a government is the legitimacy that the people are give to one over the other based on the government being better at deceiving the people as to who the real enemy is.
It’s just because this particular herb is being used for chronic pain. Herbs like St. John’s Wort for depression, Melatonin for sleep or Turmeric for a cold the FDA doesn’t care. However since our government has (through the DEA) rerouted it’s war on drugs to a war on pain medication, specifically opioid medications, chronic pain patients have been left desperate to find their own pain relief. Many of these chronic pain patients have turned to Kratom, a legal herb that has not had one documented case of overdose or death and has been used for hundreds of years in Eastern medicine to treat their pain. If the government wants to completely ban opioid medications (and it’s looking like they do with the CDC about to hop on the bandwagon) then they really need to make some other viable, safe, legal options for pain control available.
Or, we could study it.
Nawww. Let’s just ban it.
Hell, in Indiana, they didn’t even give it a chance, they just lumped it in with their Spice chemicals ban. Banned it before it even hit the state. I find it ironic the FDA allows herbal products on the market without any actual clinical studies for efficacy (eg Saw Palmetto for male BPH/erectile issues) and yet old grandfathered prescription medications which we all know worked well such as thyroid, colchicine, quinine were pulled off and forced to go thru ANDA application processes, testing for efficacy before being allowed back on the market as new branded products (except thyroid products) but at astronomical prices. IMHO Iodinated glycerol was a much better expectorant then guaifenisin. I keep hearing they want to remove that too because in their belief, it is no better than drinking a crapload of water when you have a major congestion to thin the mucous…so one of these days, it’ll be bye bye Robitussion.