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FDA Takes Steps to Advance the Development of Novel Therapies for Stimulant Use Disorders
Currently, there is no FDA-approved medication for stimulant use disorder.
Today, the U.S. Food and Drug Administration published a new draft guidance to assist sponsors in developing treatments for stimulant use disorders. The guidance, Stimulant Use Disorders: Developing Drugs for Treatment, when finalized, will be the first to provide the FDA’s current thinking on the overall development program and clinical trial design to develop drugs and biologics to support treatment of moderate to severe cocaine use disorder, methamphetamine use disorder and prescription stimulant use disorder.
“Currently there is no FDA-approved medication for stimulant use disorder. When finalized, we hope that the guidance will support the development of novel therapies that are critically needed to address treatment gaps,” said Marta Sokolowska, Ph.D., deputy center director for Substance Use and Behavioral Health in FDA’s Center for Drug Evaluation and Research. “The guidance is one of the actions within the agency’s Overdose Prevention Framework, which includes appropriate prescribing of prescription stimulants as well as development of evidence-based treatments for stimulant use disorder.”
Among other things, the draft guidance contains recommendations regarding clinical trial design related to evaluating stimulant use disorder treatments. Designing clinical studies to evaluate the safety and effectiveness of stimulant use disorder treatments presents a number of unique challenges—from selecting appropriate populations for studies to determining the most appropriate clinical endpoints—that require careful review. However, there are opportunities to improve clinical trial design and develop trials that are more person-centered, which may result in increased sensitivity to detect a treatment effect, with the potential for treatment effects to be linked to meaningful long-term outcomes.
The draft guidance also describes basic considerations throughout the drug development process including trial conduct, data collection, methods to assess treatment response, subject safety and new drug application requirements. For example, the guidance incorporates lessons learned about approaches that are unlikely to be successful and reflects current recommendations about approaches for treating stimulant use disorders and evaluating response to treatment.
Stimulant use disorder describes a range of symptoms associated with the use of stimulant drugs, including methamphetamine, cocaine, and amphetamines, but not including caffeine or nicotine. A diagnosis of stimulant use disorder is made when a clinician identifies a pattern of use of an amphetamine-type substance, cocaine, or other stimulant that leads to clinically significant impairment or distress, including an inability to reduce or control consumption, cravings to use a stimulant, continued use of a stimulant despite it causing negative consequences, and the need to use increased amounts of a stimulant to achieve the desired effect.
The agency has taken action to promote safe use and appropriate prescribing of prescription stimulants by requiring sponsors to update and standardize prescribing information for medications used to treat attention deficit/hyperactivity disorder (ADHD) and other disorders where stimulants are prescribed. Additionally, the FDA awarded the National Academies of Sciences, Engineering, and Medicine a grant to convene a workshop on the diagnosis and treatment of ADHD in adults. It has also funded several research projects to inform prevention of prescription stimulant misuse, addiction and overdose.
The FDA continues to encourage the development of treatments for stimulant use disorder and novel trial designs. Over the last several years, the agency has held workshops and public meetings with patients and patient advocates, researchers, industry and other stakeholder groups to better understand the stimulant use disorder landscape and inform the FDA’s understanding of the clinical context for drug review and regulatory decision making.
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Food and Beverage
Cinnamon, spice and ‘everything nice’ – why lead-tainted cinnamon products have turned up on shelves, and what questions consumers should ask
A Consumer Reports investigation revealed alarming lead levels in ground cinnamon, prompting concerns over safety, especially for children and pregnant women.
Katarzyna Kordas, University at Buffalo
Spices bring up feelings of comfort, cultural belonging and holidays. They can make our homes smell amazing and our food taste delicious. They can satisfy our cravings, expand our culinary horizons and help us eat things that we might normally dislike. Spices have health-enhancing properties and, in medicine, have been used to heal people since the ancient times.
Recently, however, spices have been getting a bad rep.
In September 2024, Consumer Reports, a nonprofit organization created to inform consumers about products sold in the U.S., investigated more than three dozen ground cinnamon products and found that 1 in 3 contained lead levels above 1 part per million, enough to trigger a recall in New York, one U.S. state that has published guidelines for heavy metals in spices.
The Food and Drug Administration issued three alerts throughout 2024, warning consumers about lead in certain brands of cinnamon products. Such notices rightfully put consumers on alert and have people wondering if the spice products they buy are safe – or not. https://www.youtube.com/embed/QxAwznMht8M?wmode=transparent&start=0 A Consumer Reports investigation of more than three dozen ground cinnamon products found that 1 in 3 contain lead levels above 1 part per million.
As an environmental epidemiologist with training in nutritional sciences, I have investigated the relationship between nutritional status, diets and heavy metal exposures in children.
There are several things consumers should be thinking about when it comes to lead – and other heavy metals – in cinnamon.
Why is lead found in cinnamon?
Most people are familiar with cinnamon in two forms – sticks and ground spice. Both come from the dried inner bark of the cinnamon tree, which is harvested after a few years of cultivation. For the U.S. market, cinnamon is largely imported from Indonesia, Vietnam, Sri Lanka, India and China.
One way that lead could accumulate in cinnamon tree bark is when trees are cultivated in contaminated soil. Lead can also be introduced in cinnamon products during processing, such as grinding.
When ground cinnamon is prepared, some producers may add lead compounds intentionally to enhance the weight or color of the product and, thus, fetch a higher sale price. This is known as “food adulteration,” and products with known or suspected adulteration are refused entry into the U.S.
However, in the fall of 2023, approximately 600 cases of elevated blood lead levels in the U.S., defined as levels equal to or above 3.5 micrograms per deciliter – mostly among children – were linked to the consumption of certain brands of cinnamon apple sauce. The levels of lead in cinnamon used to manufacture those products ranged from 2,270 to 5,110 parts per million, indicating food adulteration. The manufacturing plant was investigated by the FDA.
More broadly, spices purchased from vendors in the U.S. have lower lead levels than those sold abroad.
There is some evidence that cinnamon sticks have lower lead levels than ground spice. Lead levels in ground cinnamon sold in the U.S. and analyzed by Consumer Reports ranged from 0.02 to 3.52 parts per million. These levels were at least 1,500 times lower than in the adulterated cinnamon.
There are no federal guidelines for lead or other heavy metals in spices. New York state has proposed even stricter guidelines than its current level of 1 part per million, which would allow the New York Department of Agriculture and Markets to remove products from commerce if lead levels exceed 0.21 parts per million.
What does it mean that ‘the dose makes the poison’?
The current FDA guideline on daily intake of lead from diets overall is to limit lead intake to 2.2 micrograms per day for children. For women of reproductive age, this value is 8.8 micrograms.
The lead dose we are exposed to from foods depends on the level of lead in the food and how much of that food we eat. Higher doses mean more potential harm. The frequency with which we consume foods – meaning daily versus occasionally – also matters.
For spices like cinnamon, the amount and frequency of consumption depends on cultural traditions and personal preference. For many, cinnamon is a seasonal spice; others use it year-round in savory dishes or sauces.
Cinnamon is beloved in baked goods. Take a cinnamon roll recipe calling for 1.5 tablespoons (slightly less than 12 grams) of the spice. If a recipe yields 12 rolls, each will have around 1 gram of cinnamon. In the Consumer Reports investigation, some cinnamon products were classified as “okay to use” or “best to use.”
The highest value of lead in cinnamon products in the “okay to use” category was 0.87 parts per million, and in the “best to use” category, it was 0.15 parts per million. A child would have to consume 2.5 or more rolls made with the “okay to use” cinnamon to exceed the FDA guideline on limiting lead intake from foods to 2.2 micrograms per day, assuming that no other food contained lead. To exceed this guideline with “best to use” cinnamon, a child would have to eat 15 or more rolls.
Can cinnamon contribute to elevated blood lead levels?
Because of lead’s effects on development in early life, the greatest concern is for exposure in young children and pregnant women. Lead is absorbed in the small intestine, where it can latch onto cellular receptors that evolved to carry iron and other metals.
The impact of a contaminated spice on a person’s blood lead level depends on the dose of exposure and the proportion of lead available for intestinal absorption. For several spices, the proportion of available lead was 49%, which means that about half of the lead that is ingested will be absorbed.
Lead absorption is higher after a fast of three hours or more, and skipping breakfast may contribute to higher blood lead levels in children.
People who have nutritional deficiencies, such as iron deficiency, also tend to absorb more lead and have higher blood lead levels. This is because our bodies compensate for the deficiency by producing more receptors to capture iron from foods. Lead takes advantage of the additional receptors to enter the body. Young children and pregnant women are at higher risk for developing iron deficiency, so there is good reason for vigilance about lead in the foods they consume.
Studies show that among children with lead poisoning in the U.S., contaminated spices were one of several sources of lead exposure. Studies that estimate blood lead levels from statistical models suggest that consuming 5 micrograms of lead or more from spices daily could substantially contribute to elevated blood lead levels.
For occasional or seasonal consumption, or lower levels of contamination, more research is needed to understand how lead in spices would affect lead levels in the blood.
For people who have other sources of lead in their homes, jobs or hobbies, additional lead from foods or spices may matter more because it adds to the cumulative dose from multiple exposure sources.
How to test for elevated blood lead levels
The Centers for Disease Control and Prevention recommends that children at risk for lead exposure get a blood lead test at 1 and 2 years of age. Older children can also get tested. Finger-prick screening tests are often available in pediatric offices, but results may need to be confirmed in venous blood if the screening result was elevated.
Adults in the U.S. are not routinely tested for lead exposure, but concerned couples who plan on having children should talk to their health care providers.
What to consider when using or buying cinnamon or other spices
If the product is on an FDA Alert or the Consumer Reports “don’t use” list, discard it.
Other questions to consider are:
- Does your household use spices frequently and in large amounts?
- Do young children or pregnant women in your household consume spices?
- Do you typically consume spices on breakfast foods or beverages?
If the answer to any of these questions is yes, then buy good-quality products, from large, reputable sellers. Think about using cinnamon sticks if possible.
And continue to enjoy spices!
Katarzyna Kordas, Associate Professor of Epidemiology and Environmental Health, University at Buffalo
This article is republished from The Conversation under a Creative Commons license. Read the original article.
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In early November, the U.S. Food and Drug Administration (FDA) announced a Class II recall concerning Hannaford Seafood Salads, affecting over 1,600 units across five states: Maine, New Hampshire, Vermont, Massachusetts, and New York. The recall, initiated on October 31, was due to a mislabeling incident that poses a significant risk to consumers with soy allergies.
Understanding the Class II Risk Level
The FDA has classified this recall as a Class II risk, indicating that exposure to the affected products may cause “temporary or medically reversible adverse health consequences.” However, the risk of experiencing serious health consequences remains “remote.” Despite this classification, consumers with an allergy or severe sensitivity to soy must take this recall seriously, as they could face life-threatening allergic reactions if they consume the mislabeled salads.
What Happened?
The problem arose when the printer responsible for the salad labels provided Elevation Foods, the manufacturer of the salads, with labels that did not accurately reflect the current product formulation. Instead of the correct labels, the printer mistakenly issued labels meant for an upcoming formulation change. As a result, the affected salads may contain undeclared hydrolyzed soy protein, a known allergen that must be clearly stated on product labels to protect consumer safety.
Product Details
The implicated Hannaford Seafood Salads were distributed between October 25 and 29, and they feature use-by dates of November 13 and 14. Consumers can find these dates printed on the lid of the containers. Following the recall announcement, all affected products were promptly removed from store shelves.
Health Risks Associated with Soy Allergies
For individuals with soy allergies, the immune system mistakenly identifies soy proteins as harmful invaders, leading to a range of symptoms that can vary in severity. Common reactions include stomach issues, coughing, itching, wheezing, vomiting, hives, and difficulty breathing. In severe cases, these reactions can escalate to life-threatening conditions, such as anaphylaxis.
To mitigate risks, those with soy allergies are advised to carry an epinephrine injection (Epi-Pen) to counteract severe allergic reactions swiftly.
What Should Consumers Do?
Customers who purchased Hannaford Seafood Salads before the recall are urged not to consume the products. Instead, they can return them to the store where they made the purchase for a full refund. Elevation Foods has not reported any known cases of illness related to these salads, but consumer safety remains a top priority.
Conclusion
This seafood salad recall serves as a crucial reminder about the importance of accurate labeling, especially when it comes to potential allergens. Consumers should remain vigilant and informed about the products they purchase, particularly if they have food allergies. Stay safe and always check your labels!
Related Links:
https://www.newsweek.com/seafood-salad-recall-update-fda-risk-level-hannaford-1992294
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Dog Treat Recall
In a recent announcement that has concerned dog owners across the Southeastern, Midwestern, and Mid-Atlantic regions of the United States, the FDA has reported a recall of “Hollywood Feed Carolina Made Chicken Chips” dog treats manufactured by Carolina Prime Pet, Inc. of Lenoir, North Carolina. This recall, affecting approximately 400 bags of these popular dog treats, is attributed to the potential risk of Salmonella contamination.
Why Is This Recall Important?
While there have been no reported illnesses linked to the consumption of these chicken chips, the safety of pets—and by extension, their human companions—is paramount. Salmonella, a bacteria that can cause severe gastrointestinal distress in animals and humans alike, can be particularly dangerous for pets, leading to symptoms such as vomiting, diarrhea, and lethargy. For individuals, Salmonella can also result in serious health complications, especially in young children, elderly adults, or those with weakened immune systems.
Details of the Recall
The recall specifically pertains to 16-ounce bags of “Hollywood Feed Carolina Made Chicken Chips” that carry the lot number 20051324L2 and an expiration date of 11/13/25. Consumers can easily identify the affected product by checking the back of the packaging, which features a distinctive purple-and-black design. The recall extends to retail locations across 19 states, including:
- Alabama
- Arkansas
- Florida
- Georgia
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Michigan
- Mississippi
- Missouri
- North Carolina
- Ohio
- Oklahoma
- Pennsylvania
- South Carolina
- Tennessee
- Texas
For those who purchased the treats online, they were also available on the company’s website at www.hollywoodfeed.com.
What Should Consumers Do?
Carolina Prime Pet, Inc. has advised consumers to check their homes for the affected product. If your dog treats match the recalled lot number and expiration date, it is crucial not to feed them to your pet. Instead, return the products to the place of purchase for a full refund. For those who have questions or need more information, the company encourages contacting their customer service.
Final Thoughts
As pet owners, it is our responsibility to stay informed about the products we give our furry friends. The safety of our pets is essential, and recalls like these serve as a reminder to always check product packaging and stay updated on food safety announcements. If you have any concerns about your pet’s health or have noticed any unusual symptoms after consuming potentially contaminated food, it is advisable to consult with a veterinarian immediately.
Stay alert, stay informed, and together we can ensure the safety and well-being of our beloved pets.
Related links:
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