Tag: kratom

FDA Commissioner Says Kratom Unsafe

Posted on by Patrick Morin

According to FDA’s Commissioner “anyone consuming kratom may be placing themselves at a significant risk of being exposed to salmonella.” This comes after a months long investigation by FDA and CDC into a salmonella outbreak that was traced to kratom products sold by various marketers and re-sellers. The FDA concluded that “anyone consuming kratom may be placing themselves at a significant risk of being exposed to salmonella.” To read the full press release, click here.

Kratom is not legally marketed in the United States as a drug or dietary supplement. Kratom is an considered an opioid by FDA. It is addictive and has been linked to many severe health consequences and several deaths. In a previous post, we noted FDA’s crackdown on kratom sellers believed to be sources of salmonella-tainted products.

Mitragyna speciosa, commonly known as kratom, is listed as a controlled substance in 16 countries. Two of those countries, Thailand and Malaysia, are among kratom’s native countries of origin. In addition, six states — Alabama, Arkansas, Indiana, Tennessee, Vermont and Wisconsin — have banned the substance; several more have legislation pending.

Morsel Law is actively investigating businesses involved in the sale, manufacturing and distribution of kratom in order to seek justice for were unjustly deceived and mislead. If you relied on false and misleading health claims about the benefits of kratom, you should contact our law firm. You may be entitled to compensation by filing a lawsuit and our attorneys can help!

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FDA Issues Additional Warnings to Kratom Sellers

Posted on by Patrick Morin

Last week the FDA issued a statement continuing to warn consumers not to use products containing kratom. FDA Commissioner Dr. Scott Gottlieb stated “[d]espite our warnings that no kratom product is safe, we continue to find companies selling kratom and doing so with deceptive medical claims for which there’s no reliable scientific proof to support their use.” A major concern for the agency is that sellers continue to make claims that kratom can cure opioid addiction. Gottlieb noted that “we cannot allow unscrupulous vendors to take advantage of consumers by selling products with [these] unsubstantiated claims.”

As part of their crackdown on kratom, the FDA issued Warning Letters to three marketers and distributors — Front Range Kratom of Aurora, Colo., Kratom Spot of Irvine, Calif., and Revibe Inc. of Kansas City, Mo. The letters referenced more than 65 kratom products, including Maeng Da Red Vein Powder, Red Thai Kratom Powder, 50X Black Diamond Extract, Super Elephant, White Sumatra and Borneo White Vein Kratom Powder.

As we mentioned in an earlier article, the FDA issued a health advisory that warned consumers not to use the botanical substance kratom, which the agency said “affects the same opioid brain receptors as morphine” and “appears to have properties that expose users to the risks of addiction, abuse and dependence.”

Mitragyna speciosa, commonly known as kratom, is listed as a controlled substance in 16 countries. Two of those countries, Thailand and Malaysia, are among kratom’s native countries of origin. In addition, six states — Alabama, Arkansas, Indiana, Tennessee, Vermont and Wisconsin — have banned the substance; several more have legislation pending.

Morsel Law is actively investigating businesses involved in the sale, manufacturing and distribution of kratom in order to seek justice for were unjustly deceived and mislead. If you relied on false and misleading health claims about the benefits of kratom, you should contact our law firm. You may be entitled to compensation by filing a lawsuit and our attorneys can help!

FREE CONSULTATION

If you poke an alligator with a stick, expect to get bitten!

Posted on by Patrick Morin

Now I know it can be frustrating when someone says “no,” but even my grade school-aged children know better than to respond “well, I’m going to do it anyway.” This is even more so when the person saying no is in a position of authority (i.e., dad). However, not all of us remember the lessons of our childhood and because of that some pay for the consequences of their actions. As such, I expect some FDA enforcement actions will be forthcoming soon.

Two days ago the FDA notified Industrial Chemicals, LLC (and it’s related company INI Botanicals) that it must advise the FDA on its intention to launch its product Mitrasafe, a product containing an extract of mitragynine (i.e., kratom). If that wasn’t enough, FDA Commissioner Scott Gottlieb, M.D. issued a press release noting that Industrial Chemicals’ “claims are unproven and dangerous” and the FDA intends “to take appropriate steps to protect the public health against kratom products that try to circumvent the law.” My interpretation…you just poked the gator, now get ready for its bite!

So how did this situation come about? The FDA previously denied Industrial Chemicals’ request for Mitrasafe to qualify as a new dietary ingredient and notified them that the FDA considers the product an unapproved drug. However, Industrial Chemicals apparently didn’t like the answer they received and instead issued a press release stating that Mitrasafe is “a New Dietary Ingredient that has complied with notification and safety requirements.” In fact, their website is still up and running, advertising the product available for sale starting February 28th.

This is a pretty brazen statement since Industrial Chemicals is opening themselves up not only to FDA enforcement, but also false advertising claims enforced by the Federal Trade Commission. In fact, last month the FDA and FTC jointly issued warning letters to 11 marketers and distributors of opioid cessation products making drug claims similar to Mitrasafe. Industrial Chemicals’ actions may have even possibly exposed themselves to consumer lawsuits for unfair and deceptive advertising.

While Industrial Chemicals is now represented by an attorney (see letter from FDA mentioned above), it is unclear if they are being provided sound advice or if they are just ignoring counsel’s advice. But either way, I don’t expect things to end well for them.

When you’ve spent considerable time, effort and money on a idea or product, it can be hard to handle rejection. But just because a regulator stops you forward progress, it doesn’t mean the end. This being said, there are right and wrong ways to go about overcoming obstacles. In my experience, taunting a 5,000 lbs alligator (i.e., flagrantly disobeying an order) never works out favorably in the long run.

If you have questions about kratom or dietary supplements containing kratom, please contact us here at Morsel Law.

 

FDA Issues Health Advisory for Kratom

Posted on by Patrick Morin

The U.S. Food and Drug Administration (FDA) issued a public health advisory that warned consumers not to use the botanical substance kratom, which the agency said “affects the same opioid brain receptors as morphine” and “appears to have properties that expose users to the risks of addiction, abuse and dependence.” In addition to being used to treat pain, anxiety and depression, FDA Commissioner Dr. Scott Gottlieb noted, kratom is “taken recreationally by users for its euphoric effects” — in part because the substance “has similar effects to narcotics like opioids” — and carries “similar risks of abuse, addiction and, in some cases, death.”

Gottlieb also said, it was “very troubling to the FDA that patients believe they can use kratom to treat opioid withdrawal symptoms,” despite the fact that “there is no reliable evidence to support the use of kratom as a treatment for opioid use disorder.” Gottlieb stressed that there are “clear data on the increasing harms associated with kratom,” including a tenfold increase in the number of calls to poison control centers regarding kratom.”

In addition, the FDA has received reports of 44 deaths associated with the use of products containing kratom, and use of the products has been associated with seizures, liver damage, withdrawal symptoms and other serious side effects. Gottlieb stressed, “there are currently no FDA-approved, therapeutic uses of kratom.”

The FDA public health advisory warns consumers not to use any products labeled as containing kratom or its psychoactive compounds, mitragynine and 7-hydroxymitragynine.

This isn’t the first time the FDA has taken action to prevent kratom from distributed and sold to consumers. The FDA issued an Import Alert in 2012 for kratom as an unapproved drug and an Import Alert in 2014 for kratom containing dietary supplements. The FDA has worked with U.S. Marshals Service to seize kratom products from several U.S.-based businesses, including 25,000 pounds of raw kratom, 90,000 bottles of dietary supplements containing kratom, and 100 cases of products containing kratom.

Kratom is listed as a controlled substance in 16 countries. Two of those countries, Thailand and Malaysia, are among kratom’s native countries of origin. The botanical also is sourced from Indonesia and Papua New Guinea. In addition, six states — Alabama, Arkansas, Indiana, Tennessee, Vermont and Wisconsin — have banned the substance; several more have legislation pending.

If you have questions about kratom or dietary supplements containing kratom, please contact us here at Morsel Law.