FDA announcing a new plan to strengthen regulation of dietary supplements

Your multivitamins and brain-boosting pills may be suspect, and regulators are cracking down on the $40 billion industry

Erin Brodwin 

On Monday, Scott Gottlieb, the head of the Food and Drug Administration (FDA), announced a series of steps his agency would take in coming months to crack down on manufacturers that tout the ability of their formulas to do everything from increase energy to cure cancer. Of particular concern, he said in a statement, are pills that claim to treat Alzheimer's, a serious brain disease that hinders memory and has no cure. 

Read more, here....

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight

The use of dietary supplements, such as vitamins, minerals or herbs, has become a routine part of the American lifestyle. Three out of every four American consumers take a dietary supplement on a regular basis. For older Americans, the rate rises to four in five. And one in three children take supplements, either given to them by their parents or, commonly in teens, taking them on their own.

That’s why today we are announcing a new plan for policy advancements with the goal of implementing one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years.

I’ve personally benefited from the use of dietary supplements and, as a physician, recognize the benefits of certain supplements as a part of a comprehensive care plan. It’s clear to me that dietary supplements play an important role in our lives as we strive to stay healthy. It’s also clear that the U.S. Food and Drug Administration plays an important role in helping consumers make use of safe, high-quality dietary supplements while also protecting Americans from the potential dangers of products that don’t meet the agency’s standards for marketing.

In the 25 years since Congress passed the Dietary Supplement Health and Education Act (DSHEA), the law that transformed the FDA’s authority to regulate dietary supplements, the dietary supplement market has grown significantly. What was once a $4 billion industry comprised of about 4,000 unique products, is now an industry worth more than $40 billion, with more than 50,000 – and possibly as many as 80,000 or even more – different products available to consumers.

DSHEA imposes a number of requirements around the manufacture and labeling of dietary supplements. We know that most players in this industry act responsibly. But there are opportunities for bad actors to exploit the halo created by quality work of legitimate manufacturers to instead distribute and sell dangerous products that put consumers at risk. As the popularity of supplements has grown, so have the number of entities marketing potentially dangerous products or making unproven or misleading claims about the health benefits they may deliver.

Making healthy choices about diets can have a significant and positive impact on Americans’ health. To be able to make those choices with respect to dietary supplements, consumers need to have access to safe, well-manufactured, and appropriately labeled products. One of my top goals is ensuring that we achieve the right balance between preserving consumers’ access to lawful supplements, while still upholding our solemn obligation to protect the public from unsafe and unlawful products, and holding accountable those actors who are unable or unwilling to comply with the requirements of the law.

Today, we’re announcing new steps we intend to advance to achieve these twin goals. These steps include communicating to the public as soon as possible when there is a concern about a dietary supplement on the market, ensuring that our regulatory framework is flexible enough to adequately evaluate product safety while also promoting innovation, continuing to work closely with our industry partners, developing new enforcement strategies and continuing to engage in a public dialogue to get valuable feedback from dietary supplement stakeholders.

The opportunity to strengthen the framework that governs dietary supplements couldn’t come at a more pivotal time. On the one hand, advances in science and the growth and development in the dietary supplement industry carries with it many new opportunities for consumers to improve their health. At the same time, the growth in the number of adulterated and misbranded products – including those spiked with drug ingredients not declared on their labels, misleading claims, and other risks – creates new potential dangers.

Legitimate industry benefits from a framework that inspires the confidence of consumers and providers. Patients benefit from products that meet high standards for quality.

I’m concerned that changes in the supplement market may have outpaced the evolution of our own policies and our capacity to manage emerging risks. To continue to fulfill our public health obligations we need to modernize and strengthen our overall approach to these products. Toward these goals, the FDA is committing to new priorities when it comes to our oversight of dietary supplements at the same time that we carefully evaluate what more we can do to meet the challenge of effectively overseeing the dietary supplement market while still preserving the balance struck by DSHEA.

As part of our comprehensive efforts, today we sent 12 warning letters and five online advisory letters to companies whose products, many of which are marketed as dietary supplements, are being illegally marketed as unapproved new drugs because the products bear unproven claims to prevent, treat or cure Alzheimer’s disease, as well as a number of other serious diseases and health conditions, including diabetes and cancer. Products intended to treat Alzheimer’s disease must gain FDA approval before they are sold in order to help ensure they are safe and effective for their intended medical use. Dietary supplements can, when substantiated, claim a number of potential benefits to consumer health, but they cannot claim to prevent, treat or cure diseases like Alzheimer’s. Such claims can harm patients by discouraging them from seeking FDA-approved medical products that have been demonstrated to be safe and effective for these medical conditions. In recent years, we’ve also taken action against companies and dietary supplements making similar claims regarding treatment of serious conditions such as cancer and opioid addiction. These enforcement actions are just one part of our overall efforts to update our policy framework governing dietary supplements.

At the FDA, we have an obligation to ensure that we’re using the resources that we have as efficiently and effectively as we can, and as we engage in discussions about whether our existing resource levels are adequate, I take that obligation very seriously. That’s why I recently directed the establishment of a Dietary Supplement Working Group at the FDA, led out of my office and comprised of representatives from multiple centers and offices across the agency. I’ve tasked this group with taking a close look at our organizational structures, processes, procedures and practices in order to identify opportunities to modernize our oversight of dietary supplements.

Additionally, when the FDA created the Office of Dietary Supplement Programs (ODSP) three years ago, the agency recognized that keeping up with the evolving marketplace meant giving dietary supplement regulation more attention and making it a higher priority. One of the things that this office has done is to articulate the FDA’s strategic priorities on dietary supplements to ensure that we’re focusing our attention and using our resources in ways that make sense.

Our first priority for dietary supplements is ensuring safety. Above all else, the FDA’s duty is to protect consumers from harmful products. Our second priority is maintaining product integrity: we want to ensure that dietary supplements contain the ingredients that they’re labeled to contain, and nothing else, and that those products are consistently manufactured according to quality standards. Our third priority is informed decision-making. We want to foster an environment where consumers and health care professionals are able to make informed decisions before recommending, purchasing or using dietary supplements.

In the coming months, we’ll be providing additional details on the steps we are taking to continue moving our dietary supplement program forward to implement these priorities. Our new approach benefits consumers by balancing new policies to promote innovation and efficiency in the marketplace for dietary supplements with increased steps to protect the public from potential safety issues.

Today, I’m also announcing the first of several important steps to help advance our important policy goals. Among the steps that we’re considering or actively formulating, first are new ways to communicate more quickly when we have concerns that an ingredient is unlawful and potentially dangerous and should not be marketed in dietary supplements. We’re developing a new rapid-response tool to alert the public so consumers can avoid buying or using products with that ingredient, and to notify responsible industry participants to avoid making or selling them.

Second, we also need to ensure that our regulatory framework is flexible enough to adequately evaluate product safety while promoting innovation. The key to this effort will be important steps to foster the submission of new dietary ingredient (NDI) notifications. An effective NDI notification process represents the FDA’s only opportunity to evaluate the safety of a new ingredient before it becomes available to consumers and helps promote transparency and risk-based allocation of resources. We’re continuing to develop guidance for preparing NDI notifications to ensure FDA can thoroughly review the safety of these ingredients. In conjunction with this effort, we’re planning to update our compliance policy regarding NDIs.

We know these are important and timely issues and we’re also planning a public meeting this spring on the topic of responsible innovation in the dietary supplement industry. I expect the feedback received during this meeting will be essential as we move to modernize our approach toward NDIs. We’ll look to address other challenges that may act as barriers to dietary supplement innovation and safety including issues such as what the right incentives might be for establishing dietary supplement exclusivity, and the scope of permitted dietary ingredients. We invite all our stakeholders to share their views on how the FDA should strengthen the dietary supplement program for the future. So, please stay tuned for more information regarding registration and logistics.

Third, as with other commodities that the agency regulates, it’s critical that the FDA continue to work closely with our partners in industry to achieve our primary goal of protecting public health and safety. As the dietary supplement industry develops new products and ingredients, advances new delivery systems and innovates in other ways, the FDA must do more to leverage its existing resources and authorities to evaluate these products. This requires collaborative research and a shared understanding. I’m pleased to announce that we’ve recently created the Botanical Safety Consortium, a public-private partnership that will gather leading scientific minds from industry, academia and government to promote scientific advances in evaluating the safety of botanical ingredients and mixtures in dietary supplements. This group will look at novel ways to use cutting-edge toxicology tools, including alternatives to animal testing, to promote the goals of safety and effectiveness we share with consumers and other stakeholders.

Fourth, we’ll continue to take actions to protect public health – like those we took today for illegal Alzheimer’s disease products – and develop new enforcement strategies, as a key element of our approach to protecting consumers as the risks evolve. We’re already making our internal processes more efficient for taking enforcement action when products claiming to be supplements contain unlawful ingredients, including drug ingredients. For example, last April we took strong action to protect consumers from the dangers of dietary supplement products marketed in bulk and containing pure and highly concentrated caffeine. We warned consumers in November to not purchase Rhino male enhancement products because they were unapproved new drugs that contained sildenafil and/or tadalafil, which are among active ingredients in the FDA-approved prescription drugs Viagra and Cialis. During the same month, we issued warnings to companies for unlawfully marketing as dietary supplement products that contained a compound called tianeptine; these products were unapproved new drugs that bore unproven claims that the products could be used to treat opioid addiction. We’ve also been active with compliance and enforcement efforts against firms that have shown persistent inability to comply with the current good manufacturing practice requirements for dietary supplements, and taking action to protect the public against unsafe imports and recalled products.

Finally, we’ll engage a public dialogue around whether additional steps to modernize DSHEA are necessary. We’ve heard from stakeholders who want to open such a dialogue. While the FDA is committed to leveraging its existing resources and authorities to the fullest extent possible, we believe there may be value in a broader public conversation about whether certain changes to the law might be helpful. We believe there may be opportunities to modernize DSHEA for the future, while preserving the law’s essential balance. For example, some stakeholders have suggested that the statute should be amended to establish avenues for dietary supplement exclusivity and add a product listing requirement. A mandatory listing requirement could provide significant benefits by improving transparency in the marketplace and promoting risk-based regulation. It could also help facilitate efficient enforcement of the law and establish new mechanisms to identify bad actors who put the public at risk and undermine consumer confidence in the entire industry.

We’re interested in hearing other ideas our stakeholders may have, and not just those limited to changes to the law, so we can go about the task of regulating this space in a way that reflects where the industry is today, and continue to safeguard consumers’ ability to access safe, compliant dietary supplements for the next 25 years. For example, is it possible to design a product listing regime that helps us protect consumers and level the playing field for responsible industry participants by making it easier for us to take swift action against illegitimate and dangerous products, such as products that are tainted with drug ingredients? And is it possible to do this without disrupting the balance struck by DSHEA, and without imposing any significant new burdens on responsible firms? The answer to these questions may very well be yes. And if that’s the case, these are absolutely things that we should be talking about.

I’m confident that the efforts we’re announcing today, and the ones that we’ll continue to advance in the months and years to come, will help us achieve these goals on behalf of consumers. The steps outlined today highlight both where we are currently and where we look forward to moving toward. We are eager to continue our work with both our industry partners and dietary supplement consumers and will announce more upcoming ideas that we hope to roll out in the near future.

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.

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631065.htm

FDA - Possible Hepatitis A Contamination of Bauer’s Candies’ Modjeskas

Public Health Alert Concerning a Possible Hepatitis A Contamination of Bauer’s Candies’ Modjeskas

The FDA is alerting consumers to possible hepatitis A contamination of Bauer’s Candies Modjeskas, an individually wrapped marshmallow candy dipped in chocolate or caramel. We are advising consumers not to eat and to throw away any Bauer’s Candies Chocolate or Caramel Modjeskas, purchased after November 14, 2018 because a worker in the facility tested positive for hepatitis A.

These products are available at retail locations and can also be purchased through QVC and BauersCandy.com. We are currently working with Bauer’s Candies, located in Kentucky, on a voluntary recall of affected products. This posting will be updated with recall and retail information as it becomes available.

At this time, the FDA and the Centers for Disease Control and Prevention (CDC) are not aware of any cases of hepatitis A related to consumption of these candies. Hepatitis A can have a long incubation period and can have serious health consequences for some people, especially those with other health problems. Although the risk of hepatitis A transmission from the candy is low, FDA recommends that consumers who ate candies purchased after November 14, 2018 and have not been vaccinated for hepatitis A consult with their healthcare professional to determine whether post exposure prophylaxis (PEP) is indicated. PEP may be recommended for unvaccinated people who have been exposed to hepatitis A virus (HAV) in the last 2 weeks; those with evidence of previous hepatitis A vaccination do not require PEP.

Hepatitis A is a contagious liver disease that results from infection with HAV. When symptoms occur, they can range in severity from a mild illness lasting a few weeks to a severe illness lasting several months. Hepatitis A is usually spread when a person ingests fecal matter — even in microscopic amounts — from an infected person; this can happen when an infected person prepares food without appropriate hand hygiene, even before that person shows symptoms of illness.

People infected with HAV may not have symptoms until 15 to 50 days after exposure. Symptoms may include fever, headache, fatigue, loss of appetite, nausea, vomiting, diarrhea, abdominal pain, yellowing of the skin or eyes (known as jaundice), dark urine, and pale stool. Young children may not show symptoms of HAV infection.

The FDA is recommending that anyone who ate Bauer’s Candies Chocolate or Caramel Modjeskas purchased after November 14, 2018, consult with their healthcare provider to determine whether PEP is indicated. Consumers and retailers should throw away and not consume any chocolate or caramel Modjeskas purchased after November 14, 2018.

https://www.fda.gov/Food/RecallsOutbreaksEmergencies/SafetyAlertsAdvisories/ucm627841.htm

More Raw Beef Recalled After Nationwide Salmonella Outbreak

NPR

More Raw Beef Recalled After Nationwide Salmonella Outbreak 

Amy Held
More than 2,500 tons of raw beef are being added to a recall in connection with a salmonella outbreak that federal officials say has sickened hundreds of people across 25 states. 

The Arizona-based JBS Tolleson processing plant initially recalled about 3,500 tons of potentially contaminated beef in October. JBS, the top global meatpacker that owns the plant, still maintains the move ensured all of the affected product had already been removed from store shelves

https://www.npr.org/2018/12/05/673702290/more-raw-beef-recalled-after-nationwide-salmonella-outbreak?utm_source=dlvr.it&utm_medium=twitter

FDA statement on the agency’s ongoing work to address the opioid crisis

FDA Statement 

Statement by FDA Commissioner Scott Gottlieb, M.D., on the agency’s ongoing work to forcefully address the opioid crisis

August 29, 2018

Over the past 17 months, we’ve set out to address the opioid crisis forcefully, using all the agency’s tools and authorities. These steps have been part of a comprehensive approach that the Secretary of Health and Human Services has outlined. Our efforts at the U.S. Food and Drug Administration are part of these broader efforts and cut across three broad areas.

First, we set out to cut the rate of new addiction. We did this in part by taking new steps to rationalize the prescribing of opioids, and amounts dispensed, as a way to reduce exposure to the drugs in the medical setting.

Second, we’ve stepped up enforcement of the marketing and sale of illicit opioids. One way that we’re doing this is by targeting online sites that enable the illegal sale of these drugs and their shipment through the mail.

Finally, we’ve undertaken new efforts to support novel product innovation. This includes innovation in treatments for opioid addiction, and efforts to promote their more widespread use. And it also includes steps to advance the development of non-addictive treatments for pain. We have great concern for the millions of Americans who live with chronic pain and for whom traditional treatment options have been exhausted.

I want to take this opportunity to provide an update on some of the work we are doing across each of these three areas and some of the new efforts we’re going to pursue. To pursue these goals, and many other commitments, in the last 17 months, we’ve taken a range of new steps.

We set out to extend our risk evaluation and mitigation strategy program to cover the immediate release formulations of opioid drugs, and we’ve updated our educational content for providers to include information on non-opioid alternatives. We also, for the first time, extended this training to non-physician prescribers.

And we’ve advanced a broad effort to develop evidence-based guidelines for opioid prescribing. We want to make sure that when opioids are used, the amount dispensed comports with the clinical reasons why these drugs are being used in the first place. No more 30-day prescriptions for a tooth extraction or an appendectomy.

We’ve also taken steps to protect children from unnecessary exposure to certain opioids in some common prescription cough and cold medicines.

We committed to look closely at the risks associated with the illicit use of these drugs as a factor in how we evaluate their pre- and post-market safety. We requested the market withdrawal of one drug – Opana ER – based on a consideration of risks that were manifest only when this drug was being misused and abused. We’ll soon release new guidance outlining how we make these considerations of risks associated with illicit use a clear factor in our pre- and post-market regulatory decisions.

We also took enforcement actions, including work in collaboration with the Federal Trade Commission targeting the proliferation of products on websites that marketed unapproved treatments for pain and addiction. With additional actions that we took yesterday, we’ve brought to 70 the number of web sites that we’ve targeted this summer for marketing unapproved opioid drugs. More enforcement actions are on the way. We also formed a broad collaboration with legitimate internet sites – including leading social media platforms – to target the sale of opioids in ways that are visible to the public, and in some ways that are not apparent.

We sharply expanded our oversight of drugs being shipped illegally through international mail facilities, growing by nearly a factor of 10 the number of packages that the FDA is able to open and inspect. We have also increased our special agents doing criminal work at the ports of entry as well as cybercrime, strategic intelligence and strategic analysis units – all of whom are critical to effective enforcement. And we launched major operations with other federal partners to target these shipments and get an accurate estimate of how many opioids are coming in illegally through the mail. We’ll soon announce the findings from this operation.

We expanded new pathways for the development of safe and effective treatments for addiction, lowering the barriers to innovation for treatments that meet our gold standard. New guidance we issued will expand the range of clinical endpoints that treatments for addiction can pursue, creating more opportunities for more efficient product development. And we undertook a broad campaign to promote Medication-Assisted Treatment (MAT), and address the inappropriate stigma that’s sometimes associated with replacement therapy.

We developed new regulatory guidance to promote abuse-deterrent formulations of opioid drugs, including a new path for the development of generic versions of drugs with these features. And we’ve launched an effort to evaluate whether the nomenclature that we use to describe these drugs inappropriately promotes a view that these formulations are somehow less addictive.

We launched an innovation challenge to spur the development of medical devices and mobile applications that can ultimately serve as alternatives to oral opioids to help combat the opioid crisis and prevent and treat opioid addiction. We also held two public meetings this year focused entirely on patients – one for Opioid Use Disorder and one for Chronic Pain. And we did many of these things under the direction of a new Opioid Policy Steering Committee that I formed when I arrived at the FDA, that brings together senior leaders from our programs. That Steering Committee has helped generate and oversee some of the new ideas that drive our strategy.

We appreciate the support that Congress has given us in the pursuit of these goals, with new resources as well as the new authorities that have passed the House and that the Senate is now considering that will help us in this fight. Along the way, as we’ve embraced these challenges, we’ve learned some hard lessons. I’ve learned some hard lessons. And one sticks with me above others. It’s this.

The reason that we find ourselves with a crisis of such proportion is that as a medical profession, we’ve been one step behind its sinister advance. Collectively, we didn’t take all the steps we could, when we could, to stop the advance of this crisis. We shunned hard decisions. As a profession, providers were too liberal in our use of these drugs well past the point where there were signs of trouble, and the beginning of a crisis of addiction.

I’m committed to making sure that we don’t perpetuate these mistakes of the past. And so, when we see this crisis taking new twists and turns, we’ve acted swiftly. For example, we’ve taken steps to address what we believe may be abuse of substances that contribute to the opioid crisis, like gabapentinoids and loperamide or kratom. And we’re increasing our vigilance around the risk of addiction, and acting more quickly to warn the public when we identify harmful trends and emerging risks.

I don’t want to look back ten years from now and wish there were more policies we had pursued, or more steps we had taken, to stop the advance of this crisis. We must all be able to say we did everything we could. That we acted as aggressively as needed. And that we succeeded.

So at the FDA, we’ve done all these things, and taken many other actions, with this promise in mind. We’re going to be taking many additional steps to continue to pursue these goals. That includes additional steps to foster innovation. Part of our approach is focused on developing non-opioid, and non-addictive alternatives for the treatment of pain. We know that many Americans suffer from chronic and episodic acute pain. For these people, sometimes opioids are the only drugs that work. To address these medical needs, we’re taking new steps to foster development of treatments for pain that don’t rely on opioids and don’t have their addictive features.

First, we intend to withdraw our existing, 2014 analgesic guidance document on developing new pain drugs. That guidance typically called for a large number of studies to get a general chronic pain indication and may have been difficult to implement because it was so broad. Instead, we’ve determined that a more focused approach would streamline drug development in specific areas.

To that end, we plan to issue at least four new guidance documents in place of this 2014 analgesic guidance document. We’ll issue these guidances in a series over the next six to twelve months. These new policies will create a more efficient path for new product innovation.

The new guidance documents will recommend the study of one or two populations for innovators who wish to pursue a more limited indication for the treatment of specific kinds of pain. This will broaden the range of new drug development opportunities that are available. Our new approach should also help more novel products for the treatment of pain come to market more efficiently.

Among the forthcoming guidance documents that we plan to issue is a guidance, which will be out soon, and will address drugs that can spare the use of opioids in the treatment of acute pain. This guidance document will set forth the FDA’s current thinking on how sponsors can demonstrate a clinically meaningful reduction in the use of opioid pain medications when used for acute pain.

In addition to this guidance, we also plan to issue a guidance to outline the information that the FDA will ask drug makers to provide to help assess the benefits and risks when new opioid pain drugs are put into development. This will include an updated framework for evaluating the risks associated with intentional or illicit misuse or abuse of drugs. As I noted, we’re explicitly considering the risks associated with illicit use as a factor in how we assess risks and benefits.

In a third guidance, we’ll outline a path for developing extended-release local anesthetics, which can serve as an alternative to the systemic use of oral opioid drugs. This guidance will address the clinical pharmacology, the proper evaluation of safety and efficacy, and the types of studies that may support approval of these products.

Finally, we also plan to issue a guidance document to assist sponsors with the development of new non-opioid pain medications for chronic pain that can provide therapeutic alternatives to the use of opioids.

These are just some of the new steps we’re taking to promote innovation for alternatives to opioid drugs for those who need treatment for acute and chronic pain. And today, I outlined just some of the overall steps we’re taking to address the crisis of addiction to opioids. We have many other actions underway. This is an all-of-the-above approach. Everything is on the table.

We needed to broaden our approach as this crisis continues to evolve. The epidemic is turning from one that was largely dominated by addiction formed in the medical setting, involving prescription drugs, to one that increasingly implicates the use of illicit drugs, including highly potent fentanyls. These drugs are obtained illegally, often through purchases made on-line, and in many cases shipped through the international mail.

A recent FDA analysis of commercially available data showed steep drops in dispensing of opioid analgesics in retail outpatient settings. In the first six months of 2018, the volume of opioid analgesics dispensed was 74.1 metric tons of oral morphine equivalent, down more than 16 percent from the first half of 2017, when the volume dispensed was 88.8 metric tons. Earlier declines were there, but smaller. The volumes of opioid analgesics dispensed in the first half of 2017 and 2016 were about 10.4 percent and 3.4 percent less than comparable values 12 months earlier. These trends seem to suggest that the policy efforts that we’ve taken are working as providers, payers and patients are collectively reducing some of their use of prescription opioid analgesic drugs.

But the public health impact from these reductions in prescription opioid use could be offset by the rising availability of illicit opioids, and principally fentanyl, that’s coming into America. The growing use of fentanyl is contributing to a rise in overdose deaths. It isn’t necessarily the case that more people are suddenly switching from prescription opioids to these illicit drugs. The idea of people switching to illicit drugs isn’t new as an addiction expands, and some people have a harder time maintaining a supply of prescription drugs from doctors. Many heroin users switched from prescription drugs. What’s new is that more people are now switching to highly potent drugs that are far deadlier. That’s driven largely by the growing availability of the illicit fentanyls.

At the FDA, we’re taking steps right now to accurately estimate the flow of these illicit drugs. But our current estimates are largely based on the fentanyl seized by our colleagues and partners at Customs and Border Protection (CBP). Based off of publicly available information, seizures of fentanyl by our CBP colleagues were reported as two pounds in fiscal year 2013, rising to 440 pounds in FY16, and 1,377 pounds in FY17. CBP reported 1,640 pounds seized during the first 10 months of fiscal year 2018. During these same periods, reported heroin seizures also increased, from 4,790 pounds in 2016, to 4,878 pounds in fiscal year 2017 and an estimated 5,472 pounds in fiscal year 2018 if we were to extrapolate seizures through July to the full fiscal year.

If we assume that the seizures effected by our colleagues at CBP represent some fraction of the overall illegal flows that are being smuggled into the U.S. through different routes and despite our best efforts; then we should worry that the public health impact of a decline in prescription opioid use in the medical setting could be offset by the rise in highly potent, illicit opioids like fentanyl. The FDA has garnered a strong partner with CBP in our efforts to combat these trends, whether it be our joint scientific or operational work. Our two teams are collaborating closely on solutions to this problem. We’re taking new steps to confront this dangerous turn.

We have additional enforcement operations underway. We’re taking new steps to promote innovation in the development of alternative treatments for pain that may not be as addictive as opioids. At the same time, we’re advancing new policies to rationalize the legal use of prescription opioid drugs in the medical setting. To address this goal we are also developing an approach on the use of blister packs for opioid drugs as a way to better control prescription dispensing and reduce exposure.

And we’re actively considering other new policy options, like novel steps to better manage the use of high-dose opioid formulations. More FDA action is on the way.

I made a commitment 17 months ago, when I first joined the FDA as the agency’s Commissioner, that we’d do everything in our scope to address this crisis. I’ve made this promise a cornerstone of my efforts at the agency, and a foundation of my obligation to Americans.

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.

FDA warned more online networks illegally marketing unapproved opioids; including tramadol

FDA News Release 

FDA takes action against 21 websites marketing unapproved opioids as part of agency’s effort to target illegal online sales

The U.S. Food and Drug Administration today announced it has warned four more online networks, operating a total of 21 websites, illegally marketing potentially dangerous, unapproved, and misbranded versions of opioid medications, including tramadol. The warning letters issued by the FDA to each of the networks state that they must immediately stop illegally selling these products to American consumers.

“The illegal online sale of opioids represents a serious risk to Americans and is helping to fuel the opioid crisis. Cutting off this flow of illicit internet traffic in opioids is critical, and we’ll continue to pursue all means of enforcement to hinder online drug dealers and curb this dangerous practice,” said FDA Commissioner Scott Gottlieb, M.D. “Today’s effort builds on previous actions against the illegal online sale of opioids, for a total of 13 warning letters to more than 70 websites just this summer. The FDA remains resolute in our promise to continue cracking down on these networks to protect the public health. We have more operations underway, and additional actions planned. We are also working closely with legitimate Internet stakeholders, including leading social media sites, in these public health efforts.”

Patients who buy prescription medicines, including opioids, from illegal online pharmacies may be putting their health at risk because the products, while being marketed as authentic, may be counterfeit, contaminated, expired, or otherwise unsafe. As noted in the warning letters, these websites offer for sale opioids that are misbranded and unapproved new drugs, including unapproved tramadol, in violation of the Federal Food, Drug, and Cosmetic Act. In addition to health risks, illegal online pharmacies can pose other risks to consumers, including credit card fraud, identity theft, and computer viruses.

The illegal sale of these products is particularly concerning considering that FDA-approved tramadol carries a boxed warning, the FDA’s most prominent warning, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. The boxed warning for tramadol addresses risks including addiction, abuse, misuse, life-threatening respiratory depression (breathing problems), and neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn babies). In addition, when taken with other central nervous system depressants, including alcohol, tramadol’s use may result in coma or death.

The networks receiving warning letters include:
CoinRX
MedInc.biz
PharmacyAffiliates.org
PharmaMedics

The FDA requested responses from each of the companies within 10 working days. The companies are directed to inform the agency of the specific actions taken to address the agency’s concerns. Companies who fail to correct the violations, as outlined in the warning letters, may be subject to legal enforcement action.

Opioid addiction is an immense public health crisis. Addressing it is one of the FDA’s highest priorities and supports the U.S. Department of Health and Human Services’ 5-Point Strategy To Combat the Opioid Crisis. One critical step to addressing this public health emergency is the adoption of a more proactive approach by internet stakeholders to crack down on internet traffic in illicit drugs. Illegal online pharmacies, drug dealers, and others continue to use the internet to further their illicit distribution of opioids, where the risk of detection and repercussions is significantly reduced.

The FDA has been active in combating the illegal online sales of opioids. In June, the agency announced a similar series of warning letters, and on June 27 the FDA hosted internet stakeholders and thought-leaders, government entities, academic researchers, and advocacy groups at an Online Opioid Summit to discuss ways to collaboratively take stronger action in combatting the opioid crisis by reducing the availability of illicit opioids online. Topics that were addressed during the summit included: research into the ease with which illicit opioids can be purchased online and industry approaches to addressing opioids marketed online, followed by a roundtable discussion to identify gaps and new solutions. The FDA continues to be engaged with the companies that participated in the Summit and will share more in the coming months.

The FDA remains committed to addressing the national crisis of opioid addiction on all fronts, with a significant focus on decreasing exposure to opioids and preventing new addiction; supporting the treatment of those with opioid use disorder; fostering the development of novel pain treatment therapies and opioids more resistant to abuse and misuse; and taking action against those who contribute to the illegal importation and sale of opioids. The agency will also continue to evaluate how opioids currently on the market are used, in both medical and illicit settings, and take regulatory action where needed.

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.

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm618658.htm

Toxin at heart of drug recall shows holes in medical safety net

August 22, 2018

Toxin at heart of drug recall shows holes in medical safety net 
Alexandra Harney, Ben Hirschler
SHANGHAI/LONDON (Reuters) - A toxin inadvertently produced in the manufacture of a widely prescribed medicine but not spotted for years raises questions about regulators’ ability to detect risks in a sprawling global drug supply chain increasingly reliant on factories in China.

China’s Zhejiang Huahai Pharmaceutical (600521.SS), which produces bulk ingredients for drugmakers, told its customers in late June it had found NDMA in its valsartan, an off-patent blood pressure drug originally developed by Novartis (NOVN.S). The discovery means that some of the 10 billion pills containing valsartan sold worldwide last year to prevent heart attacks and strokes had traces of N-nitrosodimethylamine (NDMA), classified as a probable human carcinogen. No one has been reported as sickened by the toxin, once used in the production of liquid rocket fuel... 

https://in.reuters.com/article/us-health-pharmaceuticals-china-insight/toxin-at-heart-of-drug-recall-shows-holes-in-medical-safety-net-idINKCN1L71D8

FDA: Hepatitis C Drug Labeling Updated to Include New Clinical Data

Pharmacy Times

FDA: Hepatitis C Drug Labeling Updated to Include New Clinical Data

The FDA has approved updates to the labeling for hepatitis C virus (HCV) drug glecaprevir and pibrentasvir (Mavyret) to include new data from 2 clinical studies, according to a press release.

Labeling revisions include updates to the dosing recommendations, as well as safety and efficacy outcomes data from the HCV/HIV-1 coinfection study (M14-730) and from the liver and renal transplant study (M13-596).

The Dosage and Administration section was updated to include dosing recommendations for 12 weeks in liver or kidney transplant recipients and a 16-week treatment duration in genotype 1-infected patients who are NS5A inhibitor-experienced without prior treatment with an NS3/4A protease inhibitor or in genotype (GT) 3-infected patients who are pegylated interferon, ribavirin, and sofosbuvir (PRS) treatment-experienced.

Additionally, the Adverse Reactions and Clinical Studies sections were updated to include safety and efficacy data from the trials for HCV/HIV-1 coinfected individuals and patients with liver or kidney transplant.

Continue to article: 

https://www.pharmacytimes.com/news/fda-hepatitis-c-drug-labeling-updated-to-include-new-clinical-data

Healio

FDA updates Mavyret label for new safety, efficacy data

The FDA recently approved safety and efficacy revisions to the Mavyret label based on data from a hepatitis C/HIV-1 collection study and a liver and renal transplant study.

Ongoing studies from the past year have shown Mavyret (glecaprevir/pibrentasvir, AbbVie) to be a pangenotypic treatment that is highly effective over an 8-week course for most patients.

According to the released revisions, the FDA recommends a 12-week course of glecaprevir/pibrentasvir for liver or kidney transplant recipients. 

The FDA also recommends a 16-week course for patients with genotype 1 and NS5A inhibitor-experienced without prior treatment with an NS3/4A protease inhibitor, and for patients with genotype 3 who are treatment-experienced with Sovaldi (sofosbuvir, Gilead Sciences) and ribavirin.

Continue reading:
https://www.healio.com/hepatology/hepatitis-c/news/online/%7B16476477-5087-4d86-b8e9-021cb73a828b%7D/fda-updates-mavyret-label-for-new-safety-efficacy-data

FDA Hepatitis Updates
FDA recently approved revisions to the MAVYRET™ (glecaprevir and pibrentasvir)
The FDA recently approved revisions to the MAVYRET™ (glecaprevir and pibrentasvir) tablets label to include safety and efficacy data from the HCV/HIV-1 coinfection study (M14-730) and from the liver and renal transplant study (M13-596). A summary of the major revisions includes the following:

Section 2: DOSAGE AND ADMINISTRATION was updated to include the following dosing recommendations.

2.3 Liver or Kidney Transplant Recipients

MAVYRET is recommended for 12 weeks in liver or kidney transplant recipients. A 16-week treatment duration is recommended in genotype 1-infected patients who are NS5A inhibitor- experienced without prior treatment with an NS3/4A protease inhibitor or in genotype 3-infected patients who are PRS treatment-experienced.

Section 6: ADVERSE REACTIONS was updated to include the following safety data.

Adverse Reactions in HCV/HIV-1 Co-infected Subjects

The safety of MAVYRET in subjects with HIV-1 co-infection with genotypes 1, 2, 3, 4 or 6 chronic HCV infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) was assessed in 153 subjects (EXPEDITION-2) who received MAVYRET for 8 or 12 weeks. Thirty- three subjects with HIV-1 coinfection also received 8 or 12 weeks of therapy in ENDURANCE- 1.

The overall safety profile in HCV/HIV-1 co-infected subjects (ENDURANCE-1 and EXPEDITION-2) was similar to that observed in HCV mono-infected subjects. Adverse reactions observed in greater than or equal to 5% of subjects receiving MAVYRET in EXPEDITION-2 for 8 or 12 weeks were fatigue (10%), nausea (8%), and headache (5%).

Adverse Reactions in Subjects with Liver or Kidney Transplant

The safety of MAVYRET was assessed in 100 post-liver or -kidney transplant recipients with genotypes 1, 2, 3, 4, or 6 chronic HCV infection without cirrhosis (MAGELLAN-2). The overall safety profile in transplant recipients was similar to that observed in subjects in the Phase 2 and 3 studies, without a history of transplantation. Adverse reactions observed in greater than or equal to 5% of subjects receiving MAVYRET for 12 weeks were headache (17%), fatigue (16%), nausea (8%) and pruritus (7%). In subjects treated with MAVYRET who reported an adverse reaction, 81% had adverse reactions of mild severity. Two percent of subjects experienced a serious adverse reaction, and no subjects permanently discontinued treatment due to adverse reactions.

Section 14: CLINICAL STUDIES was updated to include the following efficacy outcomes data.

14.7 Treatment-Naïve or PRS Treatment-Experienced Adults with HCV/HIV-1 Coinfection without Cirrhosis or with Compensated Cirrhosis

EXPEDITION-2 was an open-label study in 153 HCV/HIV-1-coinfected subjects. Subjects without cirrhosis received MAVYRET for 8 weeks and subjects with compensated cirrhosis received MAVYRET for 12 weeks. The study included subjects who were HCV treatment-naïve or treatment-experienced to combinations of (peg)interferon, ribavirin, and/or sofosbuvir, with the exception of GT3-infected subjects who were all treatment naïve.

Of the 153 subjects treated, the median age was 45 years (range: 23 to 74); 63% had HCV genotype 1, 7% had HCV genotype 2, 17% had HCV genotype 3, 11% had HCV genotype 4, 2% had HCV genotype 6; 11% had cirrhosis; 84% were male; and 16% were Black.
In EXPEDITION-2, the SVR12 rate in HCV/HIV-1 co-infected subjects was 98% (150/153). One subject experienced on-treatment virologic failure and no subjects relapsed.

14.8 Treatment-Naïve or PRS Treatment-Experienced Adults with Liver or Kidney Transplant without Cirrhosis

MAGELLAN-2 was a single-arm, open-label study in 100 post-liver or -kidney transplant HCV GT 1, 2, 3, 4, or 6 infected subjects without cirrhosis who received MAVYRET for 12 weeks. The study included subjects who were HCV treatment-naïve or treatment-experienced to combinations of (peg)interferon, ribavirin, and/or sofosbuvir, with the exception of GT3-infected subjects who were all treatment-naïve.

Of the 100 subjects treated, the median age was 60 years (range: 39 to 78); 57% had HCV genotype 1, 13% had HCV genotype 2, 24% had HCV genotype 3, 4% had HCV genotype 4, 2% had HCV genotype 6; 75% were male; 8% were Black; 80% of subjects were post-liver transplant and 20% were post-kidney transplant. Immunosuppressants allowed for co- administration were cyclosporine ≤100 mg, tacrolimus, sirolimus, everolimus, azathioprine, mycophenolic acid, prednisone, and prednisolone.

The overall SVR12 rate in post-transplant subjects was 98% (98/100). There was one relapse and no on-treatment virologic failures.
The updated label will soon be available at drugs@fda or DailyMed
Mavyret - FDA Approval Date(s) and History, Letters, Labels, Reviews

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration

Elizabeth Thompson
Division of Antiviral Products
Food and Drug Administration

Michael Stanfield Jr.
Division of Antiviral Products
Food and Drug Administration

FDA Recall: Opioid Antidote Naloxone

FDA: Opioid Antidote Naloxone Recalled
TUESDAY, June 5, 2018 (HealthDay News) -- A recall of the opioid overdose antidote Naloxone was announced Monday. The U.S. Food and Drug Administration said the recall was triggered by the possibility of "loose particulate matter on the syringe plunger" that could pose a number of health risks, CNN reported.

Those risks include "local irritation, allergic reactions," and a range of cardiovascular issues, including blood clots, according to the FDA. The agency has not received any reports of patient harm from the recalled Naloxone, made by Hospira.

Continue reading....

FDA 

Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter

Hospira, Inc., a Pfizer company, is voluntarily recalling lots 72680LL and 76510LL of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system (NDC 0409-1782-69), to the hospital/institution level due to the potential presence of embedded and loose particulate matter on the syringe plunger.

In the event that impacted product is administered to a patient, the patient has a low likelihood of experiencing adverse events ranging from local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity. The risk is reduced by the possibility of detection, as the labeling contains a clear statement directing visual inspection of the product for particulate matter and discoloration prior to administration. To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for these lots.

Naloxone Hydrochloride, an opioid antagonist, is indicated for the complete or partial reversal of opioid depression. It is also indicated for the diagnosis of known or suspected opioid overdosage, and as an adjunctive agent for the management of septic shock. It is available as a sterile solution for intravenous (IV), intramuscular (IM), and subcutaneous (SC) administration. Naloxone is supplied in a Carpuject single-use cartridge with a 1 mL fill for use with the Carpuject syringe system.
The NDC, Lot Number, Expiration Date, Strength and Configuration details for Naloxone Hydrochloride Carpuject Injection is indicated below. Product lots were distributed nationwide to wholesalers/distributors/hospitals in the United States, Puerto Rico, and Guam from February 2017 to February 2018.

NDC	Number	Date	Strength	Configuration/Count
0409-1782-03 (Single Unit) 0409-1782-69 (Box/Carton)	72680LL	1DEC2018	0.4 mg/mL 1 mL in 2.5mL	10-1 mL Single Use Carpuject&trad; (Sterile Cartridge Unit with Luer Lock) per box/carton; 100 boxes/cartons per case (1000)
	76510LL	1APR2019	0.4 mg/mL, 1 ml in 2.5 mL

Hospira, Inc., places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Hospira, Inc. has notified wholesalers/ distributors/hospitals to arrange for return of any recalled product.

Distributors or retailers with an existing inventory of the lots, which are being recalled, should stop use and distribution and quarantine immediately. Inform Healthcare Professionals in your organization of this recall. If you have further distributed the recalled product, to the wholesale or retail level, please notify any accounts or additional locations which may have received the recalled product from you. For additional assistance, call Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.

Healthcare Professionals with questions regarding this recall can contact Pfizer using the below information.

Contact	Contact Information	Areas of Support
Pfizer Medical Information	1-800-438-1985, option 3 (8am to 7pm ET Monday through Friday)	Medical Inquiries
Pfizer Safety	1-800-438-1985, option 1 (24 Hours a day 7 days per week)	To report adver Events or product complaints

Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Adverse events or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: download form www.fda.gov/MedWatch/getforms.htm or call 1-800-FDA-1088 to request form, then complete and return address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Hepatitis C Virus Infection Treatments to Be Discontinued:Technivie, Viekira XR and Simeprevir

In Case You Missed It

FDA Website:
https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm?panels=0&#tabs-4

Also discontinued:
Janssen Pharmaceuticals (New 05/23/2018)
Simeprevir Capsules
Status: Discontinuation

Viekira XR
Abbvie (New 05/22/2018)
Dasabuvir Sodium; Ombitasvir; Paritaprevir; Ritonavir (Viekira XR) Tablets
Status: Discontinuation
Estimated product availability until January 1, 2019.
The product discontinuation is voluntary and not related to product quality, safety or efficacy.

Technivie
Abbvie (New 05/22/2018)
Ombitasvir; Paritaprevir; Ritonavir (Technivie) Tablets
Status: Discontinuation
Estimated product availability until January 1, 2019. The product discontinuation is voluntary and not related to product quality, safety or efficacy.

Article:

MPR > News > Two Hepatitis C Virus Infection Treatments to Be Discontinued
Da Hee Han, PharmD
May 24, 2018
Two Hepatitis C Virus Infection Treatments to Be Discontinued
Two hepatitis C virus (HCV) combination treatments, Technivie (ombitasvir, paritaprevir, ritonavir) and Viekira XR (dasabuvir sodium, ombitasvir, paritaprevir, ritonavir), have been discontinued by AbbVie, according to the Food and Drug Administration (FDA). The discontinuation is voluntary and is not related to product quality, safety or efficacy.
Read the article: https://www.empr.com/news/technivie-viekira-xr-discontinued-hepatitis-c-virus-treatments/article/768368/

FDA warns companies selling illegal, unapproved kratom products marketed for opioid cessation, pain treatment and other medical uses

FDA Press Release

The U.S. Food and Drug Administration has issued warning letters to three marketers and distributors of kratom products – Front Range Kratom of Aurora, Colorado; Kratom Spot of Irvine, California and Revibe, Inc., of Kansas City, Missouri – for illegally selling unapproved kratom-containing drug products with unproven claims about their ability to help in the treatment of opioid addiction and withdrawal. The companies also make claims about treating pain, as well as other medical conditions like lowering blood pressure, treating cancer and reducing neuron damage caused by strokes.

“Despite 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,” said FDA Commissioner Scott Gottlieb, M.D. “As we work to combat the opioid epidemic, we cannot allow unscrupulous vendors to take advantage of consumers by selling products with unsubstantiated claims that they can treat opioid addiction. Far from treating addiction, we’ve determined that kratom is an opioid analogue that may actually contribute to the opioid epidemic and puts patients at risk of serious side effects. If people believe that the active ingredients in kratom have drug-like effects that can treat pain or addiction, then the FDA is open to reviewing that data under our new drug approval process. In the meantime, I promised earlier this year that the FDA would step up our actions against unapproved and unsafe products that are being deceptively marketed for the treatment of opioid addiction and withdrawal symptoms. At the same time, we also promised to make the approval process more efficient for novel, safe and effective medical treatments aimed at the treatment of addiction; and to help more people suffering from addiction get access to approved therapies. In fulfilling these commitments, we’ll continue to take enforcement actions against unscrupulous products to protect the public health.”

The FDA continues to warn consumers not to use Mitragyna speciosa, commonly known as kratom, a plant which grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. The FDA is concerned that kratom, which affects the same opioid brain receptors as morphine, appears to have properties that expose users to the risks of addiction, abuse and dependence. There are no FDA-approved uses for kratom, and the agency has received concerning reports about the safety of kratom.

The FDA is actively evaluating all available scientific information on this issue and continues to warn consumers not to use any products labeled as containing the botanical substance kratom or its psychoactive compounds, mitragynine and 7-hydroxymitragynine. The FDA encourages more research to better understand kratom’s safety profile, including the use of kratom combined with other drugs.

The companies receiving warning letters use websites where they take orders for kratom products or they use social media to make unproven claims about the ability of their kratom drug products to cure, treat, or prevent a disease, which is against the law. Examples of claims being made by these companies include:

• “Along with helping drug addiction, the health benefits of kratom leaves include their ability to lower blood pressure, relieve pain, boost metabolism, increase sexual energy, improve the immune system, prevent diabetes, ease anxiety, eliminate stress, and induce healthy sleep.”
• “The mood elevation qualities of kratom reduces opiate withdrawal effects.”
• “Kratom, like any other pain killer, relieves temporary or even chronic pain.”
• “This plant can relieve headaches, vascular pain, arthritic pain, muscle pain among others.”
• “Kratom can be used as a remedy for stroke-related ailments and condition as it is a powerful antioxidant that works to reduce neuron damage.”
• “It can . . . help in lowering blood pressure.”
• “Kratom is also said to have elements that control blood sugar level in the body for diabetic patients.”
• “It is said, that kratom is very effective against cancer.”

Health fraud scams like these can pose serious health risks. These products have not been demonstrated to be safe or effective and may keep some patients from seeking appropriate, FDA-approved therapies. Selling these unapproved products with claims that they can treat opioid addiction and withdrawal and treat other serious medical conditions is a violation of the Federal Food, Drug, and Cosmetic Act.

Reducing the number of Americans who are addicted to opioids and cutting the rate of new addiction is one of the FDA’s highest priorities. This work includes promoting more widespread innovation and access to opioid addiction treatments for the more than 2 million of Americans with an opioid use disorder. The FDA is taking new steps to make safe and effective medication assisted treatments (MAT) available to those who suffer from opioid use disorder and to reduce the stigma that is sometimes associated with use of these therapies. Using products with unsubstantiated claims may prevent those addicted to opioids from seeking treatments that have been demonstrated to be safe and effective. Reliance on products with unsubstantiated claims may delay their path to recovery and put them at greater risk of addiction, overdose and death. In fact, patients receiving FDA-approved medication-assisted treatment cut their risk of death in half, according to the Substance Abuse and Mental Health Services Administration.

The warning letters included more than 65 kratom products. Some of these products include:

Front Range Kratom:

• “Maeng Da Red Vein Powder”
• “Maeng Da White Vein Capsules”
• “Liquid Kratom Red Maeng Da Enhanced Pain Formulation”
• “Bali White Vein Kratom Powder”
• “Bali Green Vein Powder”
• “Maeng Da White Energizing Formula”

Kratom Spot:

• “Red Thai Kratom Powder”
• “Indo White Vein Kratom Powder”
• “Borneo White Vein Kratom Powder”
• “Green Malay Kratom Powder”
• “Super Green Indo Kratom Capsules”
• “Ultra Enhanced Malay Kratom Powder”
• “Kratom Extract 8x Kratom Powder”

Revibe:

• “50x Black Diamond Extract”
• “Green Horn Kratom”
• “Green Indo”
• “Green Sumatra,” “Lucky 7”
• “Red Borneo”
• “Super Elephant”
• “White Sumatra”
• “Yellow Vietnam Kratom”

The FDA requested responses from each of the companies within 15 working days. The companies are directed to inform the agency of the specific actions taken to address each of the agency’s concerns. The warning letters also state that failure to correct violations may result in law enforcement action such as seizure or injunction.

Previous FDA testing also confirmed salmonella contamination in kratom products distributed by Revibe. On March 26, 2018, the FDA contacted Revibe regarding a recall of all Revibe kratom containing products that may be contaminated with salmonella. On April 3, 2018, the agency oversaw the destruction of products at Revibe’s facility, but, as of April 19, 2018, the company has not provided the FDA information to confirm that they have recalled the products it distributed. The FDA reminds consumers of the risks and urges them not to use these or any other kratom products.

Health care professionals and consumers are encouraged to report any adverse events related to these products to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed form can be submitted online or via fax to 800-FDA-0178.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, 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.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608447.htm