FDA CDC News

FDA Announces Preliminary Assessment that Certain Naloxone Products Have the Potential to be Safe and Effective for Over-the-Counter Use

FDA issued a Federal Register notice, Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use, that may help facilitate the development and approval of certain nonprescription naloxone drug products, including through the switch of certain naloxone drug products from prescription status to nonprescription status.

Published

2 years ago

November 15, 2022

Daily News Staff

Agency Continues to Encourage Sponsor Applications for Over-the-Counter Naloxone Products

Agency Continues to Encourage Sponsor Applications for Over-the-Counter Naloxone Products

Today, the U.S. Food and Drug Administration issued a Federal Register notice, Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use, that may help facilitate the development and approval of certain nonprescription naloxone drug products, including through the switch of certain naloxone drug products from prescription status to nonprescription status. Naloxone is a medicine that can help reduce opioid overdose deaths and when administered timely, usually within minutes of the first signs of an opioid overdose, can counter the overdose effects.

“Today’s action supports our efforts to combat the opioid overdose crisis by helping expand access to naloxone,” said FDA Commissioner Robert M. Califf, M.D. “The agency will keep overdose prevention and reduction in substance use disorders as a key priority and area of intense strategic focus for action as rapidly as possible.”

The Federal Register notice includes a preliminary assessment that certain naloxone drug products–up to 4 milligrams (mg) nasal spray and up to 2 mg autoinjector for intramuscular (IM) or subcutaneous (SC) use–may be approvable as safe and effective for nonprescription use. This preliminary assessment is intended to facilitate development and approval of nonprescription naloxone products; however, it is not a final determination that certain naloxone drug products are safe and effective for nonprescription use, and it does not mandate an immediately effective switch to nonprescription/over-the-counter (OTC) availability for naloxone.

To make its final determination, the FDA needs additional data, such as product-specific data on the nonprescription user interface design, including packaging and labeling. These data would usually be submitted to the agency in an application for a proposed nonprescription naloxone product.

By issuing this notice, the FDA is making application holders of certain prescription naloxone drug products aware of the preliminary assessment and the possibility that the agency may make a conclusive determination, through approval of a nonprescription naloxone drug product, that such products are safe and effective for use without a prescription.

The notice does not cover all naloxone products, as more data are needed on the safety and efficacy for nonprescription use of higher dose naloxone products and naloxone supplied in other presentations (including vials, ampules or syringes without integrated needles) before a preliminary assessment with respect to those products can be reached. The notice requests comments from the public on whether there is data to support safe and effective nonprescription use of higher dose naloxone products and on potential consequences of a switch from prescription to nonprescription status.

Over the last several years, the FDA has taken a number of steps to improve access to naloxone products. In September, the agency issued an immediately in effect guidance to clarify that certain Drug Supply Chain Security Act requirements do not apply to distribution of naloxone to harm reduction programs during the Opioid Public Health Emergency. Additional efforts include development of a model Drug Facts Label, which is required for OTC drug products, with easy-to-understand pictograms on how to use the drug to encourage manufacturers to pursue approval of OTC naloxone products; requiring drug manufacturers for all opioid pain relievers and medicines to treat opioid use disorder to add new recommendations about naloxone to their prescribing information; and extending the shelf life of naloxone nasal spray from 24 months to 36 months.

The FDA continues to make progress implementing the new FDA Overdose Prevention Framework – our vision to undertake impactful, creative actions to prevent drug overdoses and reduce deaths. The agency remains focused on responding to all facets of substance use, misuse, substance use disorders, overdose, and death in the U.S. through the four priorities of the framework, including: supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing; encouraging harm reduction through innovation and education; advancing development of evidence-based treatments for substance use disorders; and protecting the public from unapproved, diverted, or counterfeit drugs presenting overdose risks.

Related Information

Source: FDA

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Coca-Cola Recall Alert: Thousands of Cans Pulled From Shelves in Two States

Published

2 weeks ago

March 27, 2025

Hal Machina

selective focus photography of red coca-cola can lot on box — Photo by Craig Adderley on Pexels.com

In a significant recall notification, Coca-Cola has announced the withdrawal of over 10,000 cans of its popular beverage due to concerns over foreign object contamination. This announcement was initially made on March 6, and affected cans were sold in the states of Illinois and Wisconsin.

This week, the U.S. Food and Drug Administration (FDA) classified the risk level of this recall as Class 2. This designation indicates that consuming the affected Coca-Cola “may cause temporary or medically reversible adverse health consequences,” although the chances of serious health consequences are deemed to be remote.

Which Coca-Cola Products Were Recalled?

The recall impacts a total of 864 packs of 12 cans of Coca-Cola, amounting to 10,368 cans in total. The specific details of the recalled products are as follows:

Product Description: Coca-Cola Original Taste, 12 Fl Oz
Can UPC: 0 49000-00634 6
12-Can Pack UPC: 0 49000-02890 4
Date Code: SEP2925MDA
Time Stamp: 1100-1253

Which States Are Affected?

The recall specifically concerns Coca-Cola cans distributed in the following states:

Illinois
Wisconsin

Why Were the Coca-Cola Cans Recalled?

The FDA has reported that these Coca-Cola cans were recalled due to contamination with a foreign object, in this case, plastic. Such contaminants can inadvertently enter food and beverage products at various stages during the production process, posing a safety risk if ingested. It is important to note that the FDA report did not indicate any associated injuries related to this specific recall

If you have purchased Coca-Cola cans with the above UPC codes in Illinois or Wisconsin, it is recommended that you refrain from consuming the affected products. Instead, please return them to the store where you purchased them for a full refund or exchange. Staying informed about product recalls is crucial to consumer safety, and it is always advisable to check for the latest updates from the FDA and Coca-Cola regarding product safety issues. For any additional questions, feel free to reach out to Coca-Cola directly or visit the FDA’s website. Stay safe!

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FDA CDC News

Alert: Kroger Issues Food Recalls Affecting Multiple States

Published

2 months ago

February 7, 2025

Hal Machina

Senior woman with tablet computer in the store.

As of early February 2025, Kroger has announced a series of food recalls affecting customers across at least 15 states, as well as several subsidiary stores nationwide. The recalls, initiated due to safety concerns, include a variety of products that consumers should be aware of.

Twelve Hummus Tubs from King Harvest

Kroger subsidiary stores Fred Meyer and QFC, located in Alaska, Idaho, Oregon, and Washington, have recalled the following King Harvest hummus tubs, each weighing 10 oz:

King Harvest Lemon Hummus
King Harvest Classic Hummus
King Harvest Roasted Garlic Hummus
King Harvest Toasted Onion Hummus
King Harvest Chipotle Hummus
King Harvest Spinach Hummus
King Harvest Black Olive Hummus
King Harvest Sesame Hummus
King Harvest Jalapeño Hummus
King Harvest Balsamic Hummus
King Harvest Sun Dried Tomato Hummus
King Harvest Roasted Pepper Hummus

These products were recalled on February 5, 2025, due to a defect in their plastic tubs that may lead to the presence of plastic foreign objects within the containers. Kroger has advised customers, “Customers who purchased any of the item(s) below should not eat the product.” It remains unclear whether this recall is connected to a previous incident from September 2024 involving similar concerns.

DJs Boudain Products in Texas and Louisiana

Kroger stores in Texas and Louisiana have also issued a recall for the following DJs Boudain products:

DJs Boudain Hot Jalapeño Boudain, 12 oz
DJs Boudain Boudain Sausage, 24 oz
DJs Boudain Boudain Sausage, 16 oz

These items were recalled on February 1, 2025, due to potential contamination with pieces of a pen. This recall is part of a broader action directed by the U.S. Department of Agriculture (USDA), which called for around 17,720 pounds of boudain sausage link products to be removed from stores across Louisiana, Mississippi, and Texas.

Gerber Products for Teething Children

In addition, two Gerber products intended for teething children were recalled from Kroger stores across multiple states, including Ohio, Virginia, Michigan, Indiana, Illinois, Missouri, Kentucky, Tennessee, Alabama, North Carolina, West Virginia, Texas, and Louisiana. The affected products are:

Gerber Soothe N Chew Teething Sticks Banana, 3.2 oz
Gerber Soothe N Chew Teething Sticks Strawberry Apple, 3.2 oz

These products were removed from shelves due to potential choking hazards. Kroger has assured customers that those who purchased these items can return them for a full refund. This recall is part of a nationwide action announced by the Food and Drug Administration (FDA). Gerber has expressed regret over the situation, stating, “The recall was initiated after receiving consumer complaints of choking incidents. To date, one emergency room visit has been reported to the firm…We sincerely apologize for any concern or inconvenience this action represents to parents, caregivers, and retail customers.”

Conclusion

Customers who have purchased any of the recalled products are urged to refrain from consuming them and to return the items for a refund. It is always advisable to stay informed about food recalls to ensure the safety of you and your family. For more updates on recalls and food safety, keep an eye on announcements from Kroger and the relevant health authorities. Stay safe!

Read the article in Newsweek: https://www.newsweek.com/kroger-food-recalls-issued-15-states-full-list-products-impacted-2027160

https://stmdailynews.com/

Author

Hal Machina

Hal Machina is a passionate writer, blogger, and self-proclaimed journalist who explores the intersection of science, tech, and futurism. Join him on a journey into innovative ideas and groundbreaking discoveries! View all posts journalist

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health and wellness

A Bold Move Towards a Healthier Future: FDA’s Proposed Nicotine Regulation

On January 15, 2025, the FDA proposed regulating nicotine levels in cigarettes to minimize addiction, aiming to prevent millions from smoking. This significant public health initiative promotes fewer smoking-related diseases and economic benefits.

Published

2 months ago

January 27, 2025

Charles Elliot

close up photo of cigarette ashes. nicotine — Photo by Basil MK on Pexels.com

On January 15, 2025, the U.S. Food and Drug Administration (FDA) made headlines with a groundbreaking proposal that could revolutionize the landscape of tobacco products. The agency announced a plan to limit the nicotine content in cigarettes and certain combusted tobacco products to levels that will make them minimally or nonaddictive. This significant step is geared towards preventing future generations from falling victim to the perils of tobacco addiction and smoking-related diseases.

A Bold Move Towards a Healthier Future: FDA’s Proposed Nicotine Regulation

A Step Long in the Making

The journey to this proposal began in 2018 when the FDA first expressed intentions to regulate nicotine levels in tobacco products. Now, as we stand on the brink of potentially transformative change, it’s clear that the FDA’s vision is not only ambitious but also rooted in a wealth of scientific evidence. The proposed nicotine cap, set at a mere 0.7 milligrams per gram of tobacco, is poised to dismantle the addictive potential of cigarettes, thus reducing the likelihood of new smokers picking up the habit.

Saving Lives and Reducing Costs

The impact of this regulation could be enormous. According to the FDA’s research, by the year 2100, this new nicotine standard has the potential to prevent around 48 million young people from starting to smoke. Additionally, it could encourage over 12.9 million current smokers to quit within the first year of the regulation’s enactment—numbers that elevate to an astonishing 19.5 million after five years. Ultimately, the FDA estimates that over the coming decades, we could see 1.8 million lives saved, climbing even higher to 4.3 million by the end of the century.

The financial implications are just as compelling. With an estimated annual benefit of over $1.1 trillion—not to mention the reduction in healthcare costs, lost productivity, and the avoidance of tobacco-related diseases—the proposal is not only a public health victory but also an economic one.

A Public Health Perspective

Cigarettes remain the deadliest consumer product in history, accounting for nearly half a million preventable deaths each year in the U.S. alone. The FDA Commissioner Robert M. Califf, M.D., expressed a clear commitment to making significant progress in combating this public health crisis. “Today’s proposal envisions a future where it would be less likely for young people to use cigarettes and more individuals who currently smoke could quit or switch to less harmful products,” he stated.

The focus on addiction prevention and smoking cessation aligns with a broader goal: to create a healthier society where smoking-related diseases are no longer a pervasive threat. The proposed rule does not impose a ban on tobacco products but instead aims to create a safer environment by altering the products themselves. This is a crucial distinction as it allows for a path that encourages adult smokers to transition to less harmful alternatives without criminalizing their existing choices.

Why Public Engagement Matters

With the proposal open for public comment from January 16 to September 15, 2025, the FDA is keen on gathering input from diverse stakeholders, ensuring that a myriad of perspectives is considered. This effort to foster public dialogue is essential as it demonstrates a collaborative approach to policymaking, inviting the voices of health advocates, smokers wishing to quit, and the general public into the conversation.

The FDA is also reaching out to its Tobacco Products Scientific Advisory Committee to explore further implications of this proposal, underlining the importance of scientific scrutiny in shaping effective tobacco regulations.

Looking Ahead

As we await the final decision on this transformative proposal, the message is clear: reducing nicotine levels in combusted tobacco products could redefine smoking norms in America. The FDA’s intent to prioritize public health and encourage cessation underscores a commitment to safeguarding future generations.

While no tobacco product is completely safe and the best choice for individual health is to avoid all forms of tobacco, the proposed regulations represent a critical stride towards mitigating the risks associated with smoking. With collective efforts and robust community engagement, a healthier future is not only possible, but within reach.

Join the Conversation

Are you interested in contributing to this historic movement? The FDA encourages public input, and your voice matters! Take part in this important conversation in shaping the future of tobacco regulation. Together, we can help create a society where smoking-related deaths are significantly reduced, and a healthier lifestyle becomes the norm.

Stay engaged, stay informed, and let’s pave the way for a smoke-free future!