Author: stopgasstation

  • ‘Gas-Station Heroin’ Sold as Dietary Supplement Alarms Health Officials

    ‘Gas-Station Heroin’ Sold as Dietary Supplement Alarms Health Officials

    By Jan Hoffman – The New York Times –

    Tianeptine, found at convenience stores, at smoke shops and online, can mimic an opioid. It is among a growing class of substances that are difficult to control.

    The young father headed across the parking lot to join the other parents meeting their children’s new preschool teachers. After a few steps, he began sweating and twitching. As the sky reeled, he staggered back to the car, desperate to lie down in the back seat and breathe, hidden by tinted windows.

    “Did you take something?” his wife, Anne, shouted at him while dialing 911. Eric, 26, had completed rehab earlier in the summer.

    “The shot! The shot!” he groaned, just before he hit the ground and blacked out.

    In the emergency room of a nearby hospital in southern New Jersey, doctors tried to revive him with a defibrillator.

    “What’s he on?” they yelled at Anne.

    She showed them a shot-size bottle of the cherry-flavored elixir she had fished out of the car. It was labeled Neptune’s Fix. Eric had bought it at a local smoke shop.

    “What the hell is that?” a doctor asked.

    Neptune’s Fix features an ingredient called tianeptine — popularly known as gas-station heroin.

    Often sold as a dietary supplement and promoted by retailers as a mood booster and focus aid, tianeptine is among a growing, unregulated class of potentially addictive products available in gas stations, convenience stores and smoke shops and across the internet. They typically include synthetic pharmaceuticals and plant-derived substances.

    Some, like kratom and phenibut, can be addictive and, in rare cases, fatal. They often originate in other countries, including Indonesia and Russia, where they are commonly used, even prescribed, for mood management. But the Food and Drug Administration has not approved them as medicines in the United States.

    “Tianeptine is an emerging threat,” said Kaitlyn Brown, clinical managing director of America’s Poison Centers, which represents and collects data from 55 centers nationwide. “We have people who are able to get a substance that’s not well regulated, that has abuse potential and that, in high doses, can cause similar effects to opioids, leading to really harmful outcomes.”

    At least nine states have banned or severely restricted tianeptine, including Florida, Michigan and Ohio. In late November, the F.D.A. issued a nationwide alert about Neptune’s Fix specifically and tianeptine in general, telling people not to take it and warning that it had been associated with overdoses and deaths.

    Tianeptine, which also appears as a concentrated powder or an ingredient in products such as Tianaa, Zaza and Pegasus, “is illegally sold with claims to improve brain function and treat anxiety, depression, pain, opioid use disorder and other conditions,” the agency’s warning said.

    The F.D.A. loosely oversees dietary supplements, an expanding universe of some 50,000 products that includes minerals, vitamins and compounds like melatonin. But the agency does not evaluate supplements for safety or effectiveness; it can only forbid manufacturers to market them as medical treatments. It requires product labels making health claims to list ingredients and include boilerplate disclaimers, such as noting that the product has not been reviewed by the F.D.A. The agency does not review those labels before a product is released.

    Because the F.D.A.’s enforcement powers are limited by law, many products with tianeptine have long skirted labeling requirements. Although the F.D.A. has explicitly said, for example, that tianeptine does not qualify as a dietary supplement, the labels of some brands, like Tianaa, still make that claim.

    “There are now at least a dozen different products that are foreign drugs being openly marketed as dietary supplements right under the F.D.A.’s eyes, without them being able to stop the sales,” said Dr. Pieter Cohen, an associate professor at Harvard Medical School who studies the regulation of supplements.

    Tianeptine is a drug developed by French researchers in the 1960s as an antidepressant. It is approved in low doses for that use in many European, Asian and Latin American countries.

    But at higher doses, it also works much as an opioid does, delivering short-lived euphoria. In the United States, many people take tianeptine under the widespread, mistaken belief that it is a safe alternative to street opioids like fentanyl or heroin, or even a way to taper off using them. On social media sites like Reddit, its merits are hotly debated, with more than 5,000 people subscribing to a “Quitting Tianeptine” forum.

    “People develop a tolerance very quickly, and so they rapidly start advancing the dosing,” said Dawn Sollee, a clinical toxicologist and director of the Poison Control Center in Jacksonville, Fla. “They will set alarms to wake themselves every two hours to take tianeptine pills so they do not go into withdrawal. And then they have to keep taking more and more just to stay functional.”

    Expenses can mount swiftly, along with dangers. At a convenience store in Montclair, N.J., recently, 15 capsules of Tianaa Red cost $34. A bottle of Neptune’s Fix, which comes in lemon, tropical, cherry or chocolate-vanilla flavor, runs about $16. A salesman at a roadside smoke shop farther west said customers typically purchased 12-bottle boxes. A salesman at another roadside shop said that one customer bought 10 boxes each week — whether for resale or personal use, he did not know.

    Determining the number of cases of tianeptine abuse is challenging, because hospitals do not test for it. Reports to poison-control centers are voluntary, typically made by a worried relative, so officials say the numbers represent a drastic undercount.

    But case reports are increasing. In 2013, only four cases of tianeptine exposure were reported nationwide. In 2023, 391 cases were reported, according to America’s Poison Centers. New Jersey, which typically has one report a year, received 27 in 2023, with patients ranging in age from 20 to 69.

    “Some people apparently think it can help with chronic pain instead of having to use an opioid, which might explain the older demographic,” said Dr. Diane Calello, medical director of the New Jersey Poison Control Center.

    Similarly to many illicit drugs, tianeptine is often sloppily mixedwith unlabeled ingredients, such as potent synthetic cannabinoids. That is one reason overdose symptoms appear to range widely, poison-control medical directors said, including clamminess, nausea, low blood pressure and unconsciousness as well as seizures and severe stomach cramps.

    Sometimes naloxone, a drug that reverses opioid overdoses, can be effective in reviving patients, they said — and sometimes not. At least four deaths have been associated with tianeptine.

    About a year ago, Dr. Raymond Pomm, an addiction psychiatrist at Gateway Community Services in Jacksonville, saw his first tianeptine patient. To treat the patient’s withdrawal symptoms, he tried buprenorphine, a medication that dulls opioid cravings. He said he found that it helped patients to manage withdrawal from tianeptine and to maintain abstinence.

    Last summer, after Eric completed rehab for kratom, a potentially addictive herb from Southeast Asia that is readily available in convenience stores and smoke shops, doctors recommended medication for anxiety and depression. But Eric, a corporate salesman from a suburb in South Jersey, was determined to stay away from mood-altering prescriptions, to which he had been addicted in the past.

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  • FTC and FDA Send Second Set of Cease-and-Desist Letters to Companies Selling Products Containing Delta-8 THC in Packaging Designed to Look Like Children’s Snacks

    FTC and FDA Send Second Set of Cease-and-Desist Letters to Companies Selling Products Containing Delta-8 THC in Packaging Designed to Look Like Children’s Snacks

    Alert – FTC –

    Agencies call out firms for putting kids’ health at risk for the sake of profit

    For the second time in as many years, the Federal Trade Commission today sent cease-and-desist letters – jointly with the U.S. Food and Drug Administration (FDA) – to several companies currently marketing edibles containing Delta-8 tetrahydrocannabinol (THC) in packaging deceptively similar to many foods children eat such as Froot Loops and Chips Ahoy! chocolate chip cookies.

    “Companies that market and sell edible THC products that are easily mistaken for snacks and candy are not only acting illegally, but they are also putting the health of young children at risk,” said Samuel Levine, Director of the FTC’s Bureau of Consumer Protection. “Those that prioritize profits in front of children’s safety are at serious risk of legal action.”

    “Inadequate or confusing labeling can result in children or unsuspecting adults consuming products with strong resemblance to popular snacks and candies that contain delta-8 THC without realizing it,” said FDA Principal Deputy Commissioner Namandjé Bumpus, Ph.D. “As accidental ingestion and/or overconsumption of Delta-8 THC containing products could pose considerable health risks, the companies who sell these illegal products are demonstrating complete neglect for consumer safety. The FDA will continue to work to safeguard the health and safety of U.S. consumers by monitoring the marketplace and taking action when companies sell products that present a threat to public health.”

    The agencies sent letters to the following companies: 1) Hippy Mood (Levittown, Pennsylvania); 2) Life Leaf Medical CBD Center (Murrells Inlet, South Carolina); 3) Shamrockshrooms.com (online only); 4) Mary Janes Bakery Co. LLC and Miami Rave LLC (Miami, Florida); and 5) Earthly Hemps (Cape Coral, Florida).

    According to the letters, children can suffer serious health consequences from eating products containing cannabis, and they are at special risk of consuming edible THC products that appear similar to traditional foods because children are less likely to focus on or be able to understand text on the product labels.

    Image

    FTC-FDA THC cease and desist examples

    After reviewing online marketing for Delta-8 THC products sold by the companies, the FTC has determined that their advertising may violate the FTC Act’s prohibition against unfair or deceptive acts in the marketplace, including practices that present unwarranted health or safety risks. The letters stress that preventing practices that present such risks, particularly to young children, is one of the Commission’s highest priorities, and that imitating non-THC-containing food products that children consume is also misleading.

    The companies’ Delta-8 THC products mimic a range of food that appeal to children. Hippy Mood sells various Delta-8 THC cereal products with names like Berry Boss, Chocolate Balls, Cookie Cat Crunch, and Frutti Rocks that have colorful packages and other graphical elements causing them to resemble packaging for children’s cereal. For example, the Rainbow Rings Delta-8 Cereal package features a cartoon toucan on a red background and depicts ring-shaped cereal in multiple colors – all suggestive of the packaging for Kellogg’s Froot Loops cereal.

    Life Leaf Medical CBD Center sells a Delta-8 THC product that strongly resembles Nerds Rope candy, with both products comprising multi-colored crunchy candies attached to a gummy rope. The company’s packaging features a brightly colored background, the blue and white Nerds logo, and what appears to be the Nerds mascot — a cartoon anthropomorphic Nerds candy with two eyes, a prominent round nose, and two legs.

    Mary Janes Bakery Co. LLC and Miami Rave LLC sell Trips Ahoy chocolate chip cookies, which are in packaging that closely resembles that for Nabisco Chips Ahoy cookies, including the use of a blue background, the depiction of a chocolate chip cookie with a bite taken out on the left side displayed underneath the word “ORIGINAL” in all caps in a white font that mimics handwriting, and the use of a similar color scheme and font for the “Trips Ahoy!” logo as that used for Chips Ahoy! logo. The packaging for other products sold on the companies’ sites, including Stoney Patch Sour Watermelon Slices, Stoney Ranchers Hard Candy, Dank Ropes, and Flaming Hot Weedos, contain color schemes and graphical elements resembling Sour Patch Kids Watermelon Candy, Jolly Rancher hard candy, Nerds Rope, and Flamin’ Hot Cheetos.

    In the letters, the FTC demands the companies immediately stop marketing edible Delta-8 THC products that imitate conventional foods using advertising or packaging that is likely to appeal to young children. The FTC also strongly urges the sellers to review all of their marketing and product packaging for similar edible THC products and to take swift action and steps to protect consumers, especially young children, from these products. Finally, the FTC has asked each company to contact agency staff within 15 days to detail the specific actions it has taken to address the Commission’s concerns.

    In July 2023, the agencies sent joint warning letters to six companies that were marketing edible products containing Delta-8 THC in packaging almost identical to many snacks and candy children eat, including Doritos, Cheetos, and Nerds. The letters sent today follow up on that effort and put additional companies on notice that selling such products may violate the FTC Act and lead to enforcement action.

    The primary staff attorney on this matter is Christine DeLorme in the FTC’s Bureau of Consumer Protection.         

    The Federal Trade Commission works to promote competition and protect and educate consumers. The FTC will never demand money, make threats, tell you to transfer money, or promise you a prize. Learn more about consumer topics at consumer.ftc.gov, or report fraud, scams, and bad business practices at ReportFraud.ftc.gov. Follow the FTC on social media, read consumer alerts and the business blog, and sign up to get the latest FTC news and alerts.

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  • NDEWS ALERT: Web Monitoring Team: Reddit online mentions of 7-OH

    NDEWS ALERT: Web Monitoring Team: Reddit online mentions of 7-OH

    Alert – NDEWS –

    What is 7-OH? 7-hydroxymitragynine or 7-OH is an opioid-receptor binding alkaloid that occurs naturally in trace amounts in kratom leaves
     
    What was found? Dr. Christopher McCurdy, an internationally recognized kratom expert, alerted the NDEWS team to the presence of synthetically created 7-OH pharmaceuticals being marketed as kratom products. In response, the NDEWS team analyzed Reddit to find mentions of 7-OH. Analysis of online discussions indicates a recent increase in interest and discussion. Discussion remained relatively stable until November 2023 when an upward trend started to emerge. Since March 2024, there has been a strong upward trend with an over 300% increase in discussion. This sudden surge in interest raises concerns about the potential for increased misuse of this potent compound.

    Expert Insight: “These new products are not kratom and are synthetically produced to generate high levels of 7-hydroxymitragynine. 7-Hydroxymitragynine is a highly selective opioid that does not behave like the naturally occurring alkaloids in the plant. It is essentially an unregulated synthetic opioid that is untested in humans and creates a significant risk to public health.” -Dr. Christopher McCurdy
     
    How is it being discussed? Reddit users report that 7-OH provides subjective effects similar to prescription opioids. Some Reddit users report developing a dependence within just two weeks of use, as well as severe and long-lasting withdrawal symptoms. Users report that single doses can be highly potent. There are also concerns about the safety and purity of 7-OH tablets, as they may be cut with other substances. Many discussants report that they purchased 7-OH for chronic pain management.
     
    Drug Terms: 7-hydroxymitragynine, 7-OH, 7HMZ, 7(omega)MZ
     
    Methodological Note: Data was collected and analyzed by the NDEWS Web Monitoring Team, led by Dr. Elan Barenholtz and NIDA T32 predoctoral fellow Daniel Van Zant of the Machine Perception and Cognitive Robotics (MPCR) Lab at Florida Atlantic University. Metrics are based on post counts derived from algorithmic monitoring of all subreddits on Reddit. No personally identifiable or post-specific information is incorporated into this monitoring process. Due to modifications in our data collection protocols, the NDEWS Web Monitoring Team is currently unable to collect data for substances that generate high volumes of posts (e.g. xylazine or psilocybin). This temporary restriction, which is anticipated to persist until early June, reflects recent revisions to Reddit’s Terms of Service on data gathering. For more methodological details:

     See Original Publication