FDA CDC News
FDA Advances Additional Activities to Prevent Drug Overdoses and Reduce Death
Addressing the drug overdose crisis and substance use disorder (SUD) is an issue of great concern for our nation and remains a top public health priority for the U.S. Food and Drug Administration. Upon returning to the FDA as Commissioner, I expressed my commitment to respond to all aspects of this ongoing crisis. As an agency focused on protecting public health, combatting this evolving emergency is an issue of particular urgency for us. Of note, a public health emergency, as a consequence of the opioid crisis, was declared by the U.S. Department of Health and Human Services in October 2017 and renewed on December 22, 2022.
In August 2022, I announced the FDA’s Overdose Prevention Framework – our expanded vision to undertake creative actions with an impact not only on preventing drug overdoses and reducing deaths from opioids and other substances, but also ameliorating the tremendous toll of addiction on American individuals and families. As part of that announcement, I shared that the agency would commission an independent external opioid-related activities review. That review was conducted by a team of subject matter experts affiliated with The Ohio State University who are familiar with the 2017 National Academies for Sciences, Engineering, and Medicine’s (NASEM) recommendations, a project initiated on my watch, and also related opioid prescribing issues. The review analyzed the FDA’s implementation of the NASEM recommendations along with key regulatory policies and decisions, including labeling.
Today, we are sharing that report, which provides lessons learned, recognizes the work already being done by the FDA, and makes the following three overarching recommendations outlined for the agency to take action:
- Continue efforts to comprehensively implement the recommendations in the 2017 NASEM Report, including evaluating scientifically-sound, inclusive study designs to inform a systems approach for regulatory decision-making that incorporates public health considerations.
- Consider seeking from Congress certain additional authorities regarding opioid analgesic approvals and review of the advertising and promotion for such products, as well as additional resources to implement such authorities to strengthen oversight of prescription opioid analgesics.
- Be as transparent as possible regarding decision-making for opioid analgesics, as increased transparency can encourage appropriate uses of prescription opioid analgesics, promote innovation in pain management and prevention of opioid use disorder, and enhance public trust.
We have reviewed these recommendations and while we are thoughtfully considering our actions to implement them, I am encouraged that the agency is already moving forward on multiple workstreams, while also adapting to the changing epidemiology of the ongoing public health emergency. New challenges confronting us include much more multidrug use and troubling distribution of powerful chemically-synthesized drugs.
While our response is centered on opioid regulation by the Center for Drug Evaluation and Research (CDER), all elements of the agency are involved as we work with digital applications of substance use disorder treatment, the inappropriate intermixing of prescription drugs—like certain veterinary medicines—in the illicit market, enforcement activities in the domain of the Office of Regulatory Affairs and the intersection of nicotine addiction with use of other addictive substances as the Center for Tobacco Products oversees tobacco products.
The activities outlined below are a sample of the broad and energetic effort across the agency to combat this emergency:
First, we’re taking steps to strengthen evidence generation within the agency and with multiple partner organizations in order to better inform our response to the opioid crisis. The FDA has invested significant resources to develop a data-driven, national-level simulation model of the opioids system, named SOURCE. We will continue to enhance systems modeling approaches, including SOURCE, to enable identification of evolving trends and gaps in our interventions.
Of particular interest is deepening our understanding of the long-term efficacy of opioid analgesics. To clarify the current state of this research and knowledge gap, we will hold an advisory committee meeting in April 2023. It will focus on clinical trial paradigms, including an enriched enrollment randomized withdrawal trial design to evaluate long term efficacy and the risk of opioid-induced hyperalgesia. This is part of a postmarketing requirement we issued to application holders of new drug applications for extended release and long-acting opioid analgesics. We appreciate the revised 2022 CDC Clinical Practice Guideline for Prescribing Opioids for Pain that once again pointed out the paucity of evidence on the potential benefits of long-term opioid use, raising questions for our consideration about the labeling of these drugs.
I had the opportunity to contribute to the planning in 2015-16 that eventually led to the NIH’s HEAL Initiative, which has multiple ongoing studies evaluating the clinical epidemiology, health services and interventions in clinical practice. As this extensive network conducts its work, we anticipate a steady stream of information that will inform our policies.
This information, along with other scientific evidence and insight, will aid our science-based evaluations of the benefit-risk assessment of opioid products, and help ensure that the benefit-risk assessment considers not only the outcomes of prescription opioids when used as prescribed but also the public health effects of inappropriate use.
Next, the report suggests the agency should consider seeking additional authorities through Congress. We know that having fit for purpose regulatory authority is key to addressing opioid use, misuse and abuse. As referenced in the agency’s Overdose Prevention Framework, we are exploring the need for potential new authorities for opioid approval standards, including whether drug developers seeking approval for the marketing of new opioid analgesics should be required to demonstrate that their products offer material safety advantages over existing approved opioid analgesics.
For many years, the FDA has based decisions on whether to approve drugs, including opioids, on a framework for the assessment of the benefits and risks of a drug. That approach is the authority Congress mandated for us. When it comes to opioids, we also take into account public health factors such as the impact on family and others when reaching a decision on whether to approve a drug. Currently, the FDA lacks the statutory authority to require that drug developers seeking approval for the marketing of new opioid products demonstrate that their products offer material safety advantages (such as a reduction in abuse potential or a reduction in respiratory depression) over existing approved opioids. By enabling the FDA to refuse to approve new opioid analgesics that do not offer material safety advantages over already-approved opioids there is potential to, over time, improve the safety of opioid analgesics available to treat severe acute and chronic pain or drive research towards non-opioid alternatives to relieve pain. We stand ready to work with Congress on an improved regulatory tool for the agency.
As we examine the need for new authorities, we will continue to explore ways to use our current authorities, not only to regulate opioids more effectively, but also to improve the pipeline of non-addictive treatments for pain. While this has been a goal for many years now, the industry has been disappointingly unable to develop these much-needed alternatives.
Lastly, continuously working to earn and retain the public’s trust is not only important to our work, but also critical to our mission to protect public health. The report correctly highlights the importance of transparency in our decisions regarding opioid analgesics.
An area where we believe we can increase transparency is through further improvements of our advisory committee meetings. Our commitment to explore more effective use of our advisory committees to increase transparency regarding opioid analgesics will be a part of a broader internal effort to evaluate how to make the best use of all of our advisory committees and ensure agency decisions are informed by input from knowledgeable external advisors and the public and the decisions are shared publicly. Advisory committees play a crucial role in regulatory decision-making and publicly clarify the FDA’s expectations and the views of experts in the field while giving the public a chance for direct input. Although the airing of opinions at advisory committees, like democracy, can be messy, by improving transparency, better public understanding of the FDA’s decision-making process will lead to more confidence in it.
Within each of the overarching recommendations outlined are additional, more specific recommendations that we will continue to address and prioritize through our existing authorities and current activities within CDER and beyond.
I look forward to continuing to work across the agency to advance solutions that encourage appropriate prescribing, promote innovation in pain management, prioritize overdose prevention, reduce opioid and other substance use disorders, and champion effective treatment and support for those with SUD. We recognize that in the face of this ongoing emergency, we must continuously assess and improve our efforts and I appreciate the commitment of the FDA’s center directors and staff in this continuing effort while also dealing with other challenges that impact public health.
Related Information
- Food and Drug Administration Overdose Prevention Framework
- External Review of FDA Regulation of Opioid Analgesics
- FDA Continues Important Work on Substance Use and Overdose Prevention Efforts
- Timeline of Selected FDA Activities and Significant Events Addressing Substance Use and Overdose Prevention
Source: FDA
Author
Last Updated on May 6, 2026 by Daily News Staff
Second Nature Brands has issued a voluntary recall for certain 10-ounce pouches of SECOND NATURE KETO CRUNCH SMART MIX™ after discovering the product may contain undeclared cashews, pistachios, and cherries. For anyone with allergies or severe sensitivities—especially to tree nuts like cashews and pistachios—this is a serious safety issue.
The company says the affected product was distributed nationwide, both in retail stores and through online orders.
Why this matters
Undeclared allergens are one of the most urgent types of food safety alerts because consumers rely on labels to avoid ingredients that can trigger reactions. Second Nature Brands warns that people with allergies or severe sensitivity to cashews, pistachios, other tree nuts, or cherries could face serious or life-threatening allergic reactions if they consume the recalled product.
As of the announcement, no illnesses have been reported.
How to identify the recalled product
Check your pantry (and any recent online snack orders) for the following details:
- Product: SECOND NATURE KETO CRUNCH SMART MIX™
- Size: 10-ounce pouch
- UPC: 077034013405
- Best if used by date: 2/12/2027 (printed on the backside of the pouch)
Only pouches with the “Best if used by 2/12/2027” date are included. Other Best if used by dates are not affected, according to the company.
What happened
Second Nature Brands says the recall began after it was discovered that product containing cashews, pistachios, and cherries was placed into packaging that did not disclose those allergens. The company reports that a follow-up investigation indicates the issue was caused by a temporary breakdown in production and packaging processes.
The recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).
What consumers should do right now
If you have the affected product:
- Do not consume it.
- Keep the pouch (and take a photo of the UPC and Best if used by date if helpful).
- Contact Second Nature Brands for a full refund.
Contact information for refunds and questions
Second Nature Brands says consumers can reach them by phone or email:
- Phone: +1.800.651.7263
- Monday–Friday: 8:00 AM–8:00 PM ET
- Saturday–Sunday: 9:00 AM–5:00 PM ET
- Email: recall@secondnaturebrandsus.com
Health & fitness note: “Keto” doesn’t equal “risk-free”
Keto-friendly snacks can be convenient for people managing carbs, training schedules, or busy workdays—but this alert is a reminder that label accuracy is non-negotiable, especially for anyone balancing nutrition goals with medical dietary restrictions.
If you or someone in your household has a tree nut or cherry allergy, consider doing a quick sweep of:
- Snack drawers at home and work
- Gym bags and travel kits
- Recent bulk orders or subscription deliveries
Bottom line
If you have a 10-ounce pouch of SECOND NATURE KETO CRUNCH SMART MIX™ with UPC 077034013405 and Best if used by 2/12/2027, do not eat it. Contact Second Nature Brands for a refund and share the alert with anyone who may have purchased the product—especially those with tree nut or cherry allergies.
Source
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Health
Join the Fight Against ALS: Register and Make a Difference
Every year, doctors tell more than 5,000 Americans they have amyotrophic lateral sclerosis, better known as ALS. It is a life-changing diagnosis. In honor of ALS Awareness Month, learn more about the disease.
Join the Fight Against ALS: Register and Make a Difference
(Feature Impact) Every year, doctors tell more than 5,000 Americans they have amyotrophic lateral sclerosis, better known as ALS. It is a life-changing diagnosis.
Still, it’s hard to estimate the total number of ALS cases in the United States. No one knows what causes most cases of ALS, something the U.S. National ALS Registry is working to change.
In honor of ALS Awareness Month, learn more about the registry, how the information is used and how to enroll if you have ALS.
What is ALS?
ALS is a disease that affects the nerve cells that make muscles work in the body. This disease makes the nerve cells stop working and die. The nerves lose the ability to trigger specific muscles, which causes the muscles to become weak and leads to paralysis.
What is the registry?
“The National ALS Registry is a program of, by and for those living with ALS,” said Dr. Paul Mehta, principal investigator of the Registry. “The program collects, manages and analyzes data about people with ALS in the United States. It includes data and information provided by individuals who choose to register and complete the risk factor surveys.”
What is its purpose?
The main purpose is to gather information that can be used in the fight against ALS. The information is used to:
- Estimate the number of new cases of ALS diagnosed each year
- Estimate the number of people who have ALS at any given point in time
- Better understand who gets ALS and what factors affect the disease
- Enhance research that could improve care for people with ALS
How do researchers use the data?
Researchers can use the data to look for disease pattern changes over time and try to identify whether there are common risk factors among people with ALS. Since 2010, the registry has funded more than a dozen studies exploring potential ALS risk factors.
What does participation look like?
Individuals with ALS are encouraged to share their stories, enhancing ALS data and supporting research efforts. People living with ALS can help the National ALS Registry by completing up to 18 risk factor surveys, covering topics such as occupational history and environmental exposures, which help create a more complete picture of their ALS story.
How can someone join?
Anyone living with ALS can enroll. By joining and taking the risk factor surveys, individuals living with ALS can help future generations.
Get started at cdc.gov/als.
SOURCE:
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Lifestyle
Reclassification of marijuana opens doors for much‑needed medical research into the benefits and risks of the drug
The DOJ’s move to reclassify medical marijuana as Schedule III could unlock long-blocked cannabis research—while raising new questions about safety, regulation, and risk.
Carey S. Cadieux, Binghamton University, State University of New York
When the U.S. Department of Justice moved to reclassify medical marijuana to a Schedule III drug on April 23, 2026, it set the stage for a vast amount of medical research that has been hobbled for decades by its more restrictive Schedule I classification.
The Justice Department also called for an expedited federal rescheduling process, with proceedings expected to begin in late June 2026, but for now cannabis at the federal level remains a Schedule I drug.
I’m an associate professor of nursing and I edited a textbook for nurses about providing care with cannabis. Cannabis is the umbrella term for the plant genus that includes both marijuana and hemp – two varieties of the same plant distinguished primarily by their content of THC, one of the active components of cannabis.
Moving cannabis to a Schedule III drug ushers in the end of the cannabis prohibition era and the beginning of the regulation era, potentially creating promising opportunities around research and new therapeutics.
How are drugs regulated by ‘schedule’?
The Controlled Substances Act of 1970 categorizes all substances regulated under existing federal law into one of five schedules. The act regulates the manufacturing, importation, possession, use and distribution of substances on each schedule.
Several factors determine schedule placement, including the drug’s medical use, scientific evidence of its benefits and pharmacological effects, patterns and history of abuse, public health risk level, degree of physical or psychological addiction potential, and whether the drug can be used to make another controlled substance.
The Drug Enforcement Administration’s rescheduling of marijuana will move it from its current classification as a Schedule I drug, defined as having a high risk for abuse and no accepted medical use, to a Schedule III drug under the Controlled Substances Act. While still tightly regulated, Schedule III drugs are considered to have moderate to low risk for physical and psychological dependence and to have some medical benefits.
Other Schedule I drugs include heroin, psilocybin, LSD, peyote and MDMA, or ecstasy. These drugs cannot be dispensed or prescribed, with some exceptions. Current Schedule III drugs include ketamine, anabolic steroids, testosterone, products with less than 90 milligrams of codeine per dosage unit and some cannabinoids.
The move to reclassify medical marijuana products as Schedule III drugs applies only to those products certified by state-level medical cannabis programs. All other cannabis products remain a federal Schedule I drug, including those available from states’ recreational cannabis programs.
Impacts of cannabis reclassification
This legal order acknowledges that medical marijuana has some medical value and asserts that it has a lower potential for abuse than under the previous Schedule I classification.
The reclassification also ensures that state-registered medical cannabis patients continue to be permitted to purchase medical cannabis products without changes to their current certification or recommendation.
One of the challenges with this new law is that states have not standardized medical cannabis regulations, and each state will have its own quality and testing standards. In Maine, for instance, medical cannabis is not tested for molds, fungus, heavy metals or pesticides, while recreational cannabis is.
This means that the Schedule III medical cannabis in Maine could be contaminated, while the state’s testing of recreational cannabis makes it much safer to consume.
What are the implications for marijuana research?
For decades, researchers have struggled to conduct high-quality research studies due to their lack of access to the cannabis products that patients actually use and restrictions on their processes.
With the reclassification, researchers who are registered with the DEA to research cannabis will be able to obtain cannabis flower and plant material, as well as manufactured cannabis products, such as tinctures and edibles, directly from state-licensed businesses that are DEA-registered.
This means researchers will no longer need to rely on the federal DEA registry for access to cannabis products for research, which were often inferior in quality and variety in comparison to the everyday products medical cannabis patients typically have access to. Instead, they will be able to study cannabis products that patients use in daily life, such as vapes and various edible products.
This shift in access will now allow researchers to undertake the gold standard of research approaches: the randomized controlled trial.
Randomized controlled trials will help researchers like my colleagues determine how effective cannabis is in treating people with complex medical needs. This includes patients who experience nausea and pain while undergoing cancer treatments, multiple sclerosis patients with severe muscle spasm and stiffness, and chronic pain patients who strive to find relief without using opioids.
Might rescheduling send mixed signals?
Rescheduling may lead people to believe that cannabis is safe for all people to consume.
However, a growing body of research points to possible adverse effects from cannabis use, particularly in vulnerable groups, such as people who are pregnant, adolescents, people with preexisting mental health conditions such as schizophrenia or psychosis, and those with cardiac issues.
Cannabis can also lead to adverse drug interactions. Therefore, medical patients should use it with discretion and under the guidance of a healthcare professional.
For most medical cannabis patients, THC doses should start low and gradually be increased.
Rescheduling will be a big step toward helping researchers build a greatly needed solid body of evidence around both the benefits and potential harms of cannabis. But rescheduling should not be interpreted as a signal that cannabis is harmless.
Carey S. Cadieux, Associate Professor of Nursing, Binghamton University, State University of New York
This article is republished from The Conversation under a Creative Commons license. Read the original article.
Our Lifestyle section on STM Daily News is a hub of inspiration and practical information, offering a range of articles that touch on various aspects of daily life. From tips on family finances to guides for maintaining health and wellness, we strive to empower our readers with knowledge and resources to enhance their lifestyles. Whether you’re seeking outdoor activity ideas, fashion trends, or travel recommendations, our lifestyle section has got you covered. Visit us today at https://stmdailynews.com/category/lifestyle/ and embark on a journey of discovery and self-improvement.
