HEALTH

FDA cracks down on kratom

BY Michael Johnsen

The FDA on Wednesday announced the voluntary destruction and recall of a large volume of kratom-containing products marketed as dietary supplements that were manufactured and distributed under the brand names Botany Bay, Enhance Your Life and Divinity by Divinity Products Distribution of Grain Valley, Missouri.

In cooperation with the FDA, the company has also agreed to stop selling all products containing kratom. Based on the scientific evidence of the serious risks associated with the use of kratom, in the interest of public health, the FDA encourages all companies currently involved in the sale of products containing kratom intended for human consumption to take similar steps to take their products off the market and submit any necessary evidence, as appropriate, to the FDA to evaluate them based on the applicable regulatory pathway.

“The extensive scientific data we’ve evaluated about kratom provides conclusive evidence that compounds contained in kratom are opioids and are expected to have similar addictive effects as well as risks of abuse, overdose and, in some cases, death. At the same time, there’s no evidence to indicate that kratom is safe or effective for any medical use,” FDA Commissioner Scott Gottlieb said. “To protect the public health, we’ll continue to affirm the risks associated with kratom, warn consumers against its use and take aggressive enforcement action against kratom-containing products. We appreciate the cooperation of companies currently marketing any kratom product for human consumption to take swift action to remove these products from circulation to protect the public.”

When intended for use as or in a dietary supplement, the FDA considers kratom to be a new dietary ingredient. Generally, any dietary supplement containing kratom would need to be the subject of a New Dietary Ingredient Notification demonstrating that the product will reasonably be expected to be safe. To date, the FDA is not aware of any evidence of safety establishing that kratom (or any compounds derived from kratom) will reasonably be expected to be safe as a dietary ingredient. Additionally, kratom should not be used to treat any medical conditions, nor should it be used as an alternative to prescription opioids.

There are currently no FDA-approved therapeutic uses of kratom and importantly, the FDA has evidence to show that there are significant safety issues associated with its use. Before it can be legally marketed for therapeutic uses in the U.S., kratom’s risks and benefits must be evaluated as part of the regulatory process for drugs established by Congress.

“We know that some patients are using kratom because they believe it can help treat their opioid dependency, but there’s no reliable evidence to support kratom’s effectiveness for this use; and we’re deeply committed to making sure patients have access to safe, effective treatment options,” Gottlieb said. “There are three FDA-approved products that are safe and effective for the treatment of opioid use disorder and we encourage patients to seek advice from their health care professional and pursue treatment for addiction. Additionally, the FDA is taking new steps to bring new, safe and effective, FDA-approved therapies to the market for treatment of opioid use disorder. We understand that patients suffering from opioid addiction need access to effective treatment options. Creating an efficient pathway for the development of these treatments is a very high priority of mine.”

The FDA recommends that consumers not use these or any kratom products and dispose of any products currently in their possession.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?
HEALTH

Migraine pain — it’s big, it’s real and it’s underappreciated

BY Michael Johnsen

People diagnosed with migraine experience on average only 15.4 completely pain-free days over the previous 30 days, Eli Lilly reported Tuesday as part of its recently published Migraine Impact Report. The report also highlighted the impact of migraine on a person’s day-to-day-life, with respondents noting the symptoms of their migraine prevented them from doing what they wanted to do for one week (6.9 days) over the previous 30 days.

“As a practicing neurologist, I saw firsthand both the burden faced by people living with this often disabling, neurological disease, and the feeling that people must ‘power through’ their lives because those around them may not understand just how all-encompassing migraine can be,” Sheena Aurora, medical fellow, Eli Lilly and Company, said.

Notably, the worst migraine pain ranked higher than that of childbirth among those surveyed who had experienced both. Respondents diagnosed with migraine on average rated the worst migraine pain similarly to that of the “most painful thing I have ever experienced” and higher than both the pain associated with kidney stones and broken bones.

People who do not have migraine often underestimate the pain and average duration of migraine. Nearly all respondents diagnosed with migraine (91%) agreed those who do not suffer from migraine do not understand the severity of the disease. And 62% of those surveyed who were diagnosed with migraine agreed they try to hide the true impact of migraine from those at work or at school.

On average, respondents diagnosed with migraine estimated the length of a migraine as 10.3 hours longer than those respondents who do not have migraine (an average score of 31 hours per migraine compared to an average score of 20.7 hours per migraine, respectively).

Among those diagnosed with migraine, 82% of survey respondents agreed it is stressful to have an unpredictable disease like migraine. Respondents diagnosed with migraine missed an average of 7.4 important events in the previous year due to migraine, such as birthdays, graduations or holiday gatherings. Nearly three-quarters of respondents diagnosed with migraine (70%) agreed with the statement, “I’ve avoided making plans because of migraine.”

“Results from the Migraine Impact Report support what physicians who care for patients with migraine have known for many years. The results also demonstrate the severity of this disease and the pervasive impact migraine has on an individual’s personal, family and professional life,” Timothy Smith, vice president, National Headache Foundation, said. “These findings shine a spotlight on the serious need for additional treatment options for the more than 36 million Americans battling with migraine, many of whom lack a treatment option that addresses their symptoms and allows them to function in their day-to-day lives or which is tolerable for them.”

Respondents included 1,018 U.S. adults, including 518 people who have been diagnosed with migraine by a healthcare provider, 200 people who know someone with migraine and 300 community members who do not know someone with migraine.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?
HEALTH

Optimum Nutrition brings plant-based protein to market

Optimum Nutrition on Tuesday expanded its Gold Standard protein line with the brand’s first plant-based protein powder. ON Gold Standard 100% Plant has a multisource blend of plant-based protein that delivers a complete profile of essential amino acids without any artificial flavors, colors or sweeteners.

“As a global leader in protein, we worked to develop a premium offering to serve the growing population that prefers plant-based protein sources as part of their personal diet plans. It was our goal to develop a plant-based protein option that represents the level of quality, nutritional value, texture and great taste that is so closely associated with the ON Gold Standard brand,” Stuart Heflin, director of North American marketing for ON, said.

A recent Nielsen global survey revealed that 23% of consumers want more plant-based protein options on the market. The survey also found that 39% of Americans are trying to incorporate more plant-based foods into their diets, and that preference for plant-based options is not limited to only those who practice a strictly vegetarian or vegan diet. Among the reasons for the interest in a plant-based diet, people cite improved overall health, weight management, a desire to eat clean or personal convictions.

“Whatever their reasons for choosing a plant-based protein, consumers should not have to compromise on taste and texture,” Heflin said. “We heard the common concerns about plant proteins – including aftertaste or chalky texture – and innovated to eliminate them. We created ON Gold Standard 100% Plant to taste great and mix easily, and we believe people will be very excited about the result.”

Optimum Nutrition Gold Standard 100% Plant is made from a blend of organic pea, organic rice and organic sacha inchi proteins, delivering 24 grams of complete protein per serving. It includes a gluten-free complex of ancient grains including amaranth, quinoa, buckwheat, millet and chia as well as organic pomegranate powder. In addition to supporting muscle recovery, ON Gold Standard 100% Plant also contains 100% of the Daily Value for vitamin C and is a source of vitamin B12.

ON Gold Standard 100% Plant is available in three flavors – chocolate, vanilla and mixed berry.

Consumers can find ON Gold Standard 100% Plant online or at nutrition retailers nationwide at a suggested retail price of $39.99.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?