The Food and Drug Administration and the Federal Trade Commission have warned five companies for illegally selling copycat food products containing Delta-8 THC in violation of the Federal Food, Drug and Cosmetic Act (FD&C Act). The products could easily be mistaken for traditional foods like chips, candies and snacks from popular brands, the agencies said.
Companies that received warning letters were Hippy Mood, Levittown, Pennsylvania; Earthly Hemps, Cape Coral, Florida; Shamrockshrooms.com; Mary Jane’s Bakery Co. LLC, Miami, Florida; and Life Leaf Medical CBD Center, Murrells Inlet, South Carolina. The FDA also issued a warning letter independently to the company GrowGod LLC, San Bernadino, California, for the same FD&C Act violations. All six of those companies no longer have such products in stock, the agencies said.
“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.”
The companies have 15 working days to respond to the FDA on how they plan to address the violations, or they risk legal action.
Delta-8 is a substance found in the cannabis sativa plant, of which marijuana and hemp are two varieties, the agency said. Delta-8 THC products have not been evaluated or approved by the FDA for safe use and may be marketed in ways that put the public health at risk, the FDA said.
The FDA also warned consumers in June 2022 about consumption of food products containing Delta-8 THC. The agency said it received more than 300 adverse event reports from Jan. 1, 2021, through Dec. 31, 2023, related to children and adults who consumed edible products containing Delta-8.
In case you’ve missed it, this summer has seen Congress make some major progress on a key legislative priority of the Stop Gas Station Heroin coalition: closing the unregulated, intoxicating hemp loophole.
The hemp loophole refers to a legal gray area created by the 2018 Farm Bill that fuels the spread of Gas Station Heroin in American communities. More specifically, it has to do with intoxicating hemp products such as Delta-8, Delta-9, Delta-10, and HHC.
The government’s current definition of hemp permits the manufacture and distribution of products containing non-Delta-9 intoxicating cannabinoids — including Delta-8, Delta-10, and HHC — as long as their Delta-9 content remains below the statutory threshold.
The narrow standards of the 2018 Farm Bill have resulted in a regulatory loophole exploited by manufacturers and retailers of intoxicating, hemp-derived products sold in convenience stores, gas stations, and smoke shops across the country.
In other words, the legislation restores the original intent of the 2018 Farm Bill — which was never meant to create a loophole for synthetic THC — while protecting legitimate hemp farmers from rogue actors flooding the market with lab-made Gas Station Heroin.
If signed into law, the funding bill would mark the most consequential federal intervention in cannabinoid policy in years, preempting and superseding a growing patchwork of state laws by establishing a uniform federal prohibition on synthetically manipulated and intoxicating hemp derivatives.
We here at Stop Gas Station Heroin will be tracking the bill’s progress closely over the coming months, so stay tuned.
Officials in a Detroit metro community are concerned about the risks of widely available substances commonly referred to as “gas station heroin.”
The city of Warren might soon regulate the sale and possession of the substances.
Kratom comes from the leaves of a southeast Asian tree. It’s used primarily as a stimulant, in low doses.
But companies are also making a synthetic product called 7-OH that concentrates one of the chemicals in kratom. In high doses, 7-OH can cause similar sedative effects to opioids.
Dr. Mark Bicket is Co-Director of the Overdose Prevention Engagement Network, and Director of Pain and Opioid Research at the University of Michigan.
In an email to Michigan Public, Bicket said some people use the substances to manage pain, anxiety, or opioid withdrawal, but the FDA has not approved them for any medical use. Moreover, the agency found dangerous levels of heavy metals like lead and nickel in many kratom products sold in the U.S.
“The FDA considers both substances to have no proven benefits and serious potential risks. Kratom has been linked to serious health risks, including seizures and liver damage in adults and neonatal withdrawal syndrome in newborns.”
The Food and Drug Administration recently sent warning letters to companies that make 7-OH, saying it’s illegal to market drugs and food products that contain it.
Warren’s City Council has asked the city’s attorney to draft an ordinance that could regulate kratom sales and possession. Such regulations have been adopted in 16 states, not including Michigan.
Research Conducted on Dogs Shows Serious Adverse Effects at Doses Far Lower Than Commonly Sold Amounts.
WASHINGTON, D.C. — The Stop Gas Station Heroin coalition is sounding the alarm after reviewing a new animal study commissioned by CBD American Shaman, a Missouri-based company that sells “7” products in stores across the country.
The study, which tested the effects of increasing doses of two lab-made substances — “7” (7-hydroxymitragynine) and “Pseudo” (mitragynine pseudoindoxyl) — was funded to support the company’s bid for FDA drug approval. But the research methods and results raise serious red flags for consumers of Gas Station Heroin.
Second, the study suggests these drugs may be far more dangerous than their labels imply: CBD American Shaman tells consumers that 7.5 milligrams, or half a tablet, is a safe serving. But based on the study’s own data, that amount may be more than 25 times higher than what would be considered safe for human consumption.
Using standard FDA methods to translate the effects seen in dogs to humans, Stop Gas Station Heroin estimates that just 0.3 milligrams could cross the threshold for risk. Yet many consumers of these products are unknowingly ingesting significantly greater amounts. Moreover, the study points to clear risks of addiction and dependency with misuse.
“These are not natural products. They are chemically altered, unapproved pharmaceutical drugs being marketed as herbal remedies,” said Matthew Lowe, Executive Director of Stop Gas Station Heroin. “You can’t just slap a ‘dietary supplement’ label on a drug and skip the safety trials.”
CBD American Shaman and other purveyors of Gas Station Heroin have marketed “7” and “Pseudo” products as supplements formulated to cure, treat, and mitigate disease — namely, chronic pain and opioid use disorder — even though the products have never been approved by the FDA for any medical use.
If companies like CBD American Shaman want to sell these substances legally, they must demonstrate the drugs’ safety and effectiveness through a rigorous series of clinical trials and submit the results to the FDA as part of the New Drug Approval process. Until then, Stop Gas Station Heroin is calling for the immediate removal of these synthetic street drugs from store shelves.
President Donald Trump hosted congressional leaders and families affected by the fentanyl epidemic on Wednesday for a signing ceremony on bipartisan legislation that will strengthen prison sentences for fentanyl traffickers.
The Halt All Lethal Trafficking of Fentanyl Act, which recently passed both the Senate and the House with bipartisan support, represents a key priority for the president who has claimed the illicit flow of fentanyl is one of the underlying reasons for his tariff threats against Canada, Mexico and China.
The bill will place all fentanyl-related substances, specifically, copycat versions of the drug, on the US Drug Enforcement Administration’s list of most dangerous drugs, classifying them as Schedule I under the Controlled Substances Act.
The Trump administration argues the move will limit the incentive for cartels to create new synthetic, fentanyl-like drugs to evade the reach of the Controlled Substances Act.
“Under the HALT Fentanyl Act, anyone who possesses, imports, distributes, or manufactures any illicit FRS (fentanyl-related substances) will be subject to criminal prosecution in the same manner as any other Schedule I controlled substance,” a White House document on the legislation obtained by CNN reads.
“First, we close the loopholes criminals use to skirt around the law. Second, we make it easier for law enforcement to prosecute those criminals,” the document says.
While the legislation has received strong bipartisan support, some critics argue the bill could lead to harsh penalties for millions of people struggling with drug addiction, especially Black Americans.
The White House event prominently featured families who have lost loved ones due to fentanyl use, including activist Anne Funder, who lost her eldest son — 15-year-old Weston — to fentanyl poisoning. Funder was also a speaker at the Republican National Convention in Milwaukee last year, where she called on the government to do more to deal with the fentanyl crisis in the US.
Gregory Swan, whose son Drew died of fentanyl poisoning, also spoke. In the years following his son’s death, Swan started a group known as Fentanyl Fathers, in which parents tell their story to high schools across America.
Jacqueline Siegel, the founder of Victoria’s Voice, an organization born from the loss of her 18-year-old daughter Victoria to a drug overdose in 2015, spoke too.
House Speaker Mike Johnson attended the ceremony, as did GOP Sens. Chuck Grassley, chairman of the Senate Judiciary Committee, and Bill Cassidy — who introduced the legislation with Democratic Sen. Martin Heinrich.
Several organizations that have backed the legislation were also expected to join the president for the ceremony, White House officials said ahead of time, including the Fraternal Order of Police and anti-immigration groups the Center for Immigration Studies and Federation for American Immigration Reform, among other drug, immigration and law enforcement groups.
Agency Enforcement Targets Lab-Made Analogs, Protecting Consumers From Unapproved New Drugs
WASHINGTON, D.C.— The Stop Gas Station Heroin coalition today commended the U.S. Food and Drug Administration (FDA) for issuing warning letters to companies marketing 7, a dangerous semi-synthetic alkaloid often disguised as a natural dietary supplement.
This action marks a critical step toward curbing the spread of Gas Station Heroin — a term used to describe a range of often imported lab-made substances that include tianeptine, nitrous oxide, semi-synthetic and synthetic alkaloid products, and intoxicating hemp products.
7-hydroxymitragynine (7OH) is only naturally present in trace amounts in dried kratom leaves. Bad actors synthetically mass produce high-concentration, ultra-potent 7OH isolates in tablets, capsules, powders, and gummies. These chemically manipulated products are misleadingly marketed as natural dietary supplements or food. In reality, they act like prescription opioids and not botanicals, posing serious health risks such as respiratory depression, addiction, and overdose.
The FDA’s warning letters underscore what scientists and public health experts have long known: Gas Station Heroin products are not supplements. They are unapproved, mislabeled street drugs designed to mimic the effects of opioids and other narcotics.
As the FDA notes, Gas Station Heroin products are often aggressively advertised online and in retail locations with deceptive claims about their safety and effectiveness, particularly to individuals seeking to get high or prescription alternatives for pain relief, anxiety, or opioid withdrawal.
Stop Gas Station Heroin applauds the FDA for using its enforcement authority to hold these illicit companies accountable and to protect American consumers from the growing threat posed by synthetic drugs.
Wisconsin has no age restriction on the sale of hemp products, but after an incident from August of 2024 in which two children were hospitalized after being sold “THC gummies,” city officials have found a way to crack down on the sale of hemp-derived THC products.
Common Council members backed a proposal July 15 to restrict the purchasing of hemp-derived products to anyone under 21 years old.
Those include products with names such as delta-8 and delta-10 — chemical cousins to marijuana. The legislation does not apply to “any non-intoxicating cannabinoids,” including CBD.
To hold establishments accountable, anyone violating the ordinance would receive a citation ranging from $400 to $1,000. They could also be prosecuted for the offense.
An investigation last year by the Milwaukee Journal Sentinel, The Examination and AL.com found the products are causing a sharp rise in reports of children and adults getting sick. Those findings are alarming doctors and public health researchers.
Such products can be traced to Congress’ legalization of the sale of hemp and products extracted from it in the 2018 Farm Bill. Hemp is a type of cannabis plant with low levels of the psychoactive compound that gets people high, known as delta-9 THC.
A city committee voted unanimously to support the legislation earlier this month, and now that Common Council backed the potential ordinance, Mayor Cavalier Johnson would need to sign off before it can be enacted.
Alkaloid known as 7-OH is not a lawful dietary supplement, food additive, or ingredient in any approved drug
The U.S. Food and Drug Administration today announced seven recent warning letters sent to companies for illegally marketing products containing 7-hydroxymitragynine, also known as 7-OH.1 This action reflects the Agency’s growing concern around novel potent opioid products being marketed to U.S. consumers and sold online and in smoke shops, gas stations, and corner stores. While 7-OH occurs naturally in trace amounts in kratom, the Agency’s letters focus on concentrated 7-OH products such as tablets, gummies, drink mixes, and shots, which may be dangerous.
7-OH is not lawful in dietary supplements and cannot be lawfully added to conventional foods. Additionally, there are no FDA-approved drugs containing 7-OH, and it is illegal to market any drugs containing 7-OH. Consumers who use 7-OH products are exposing themselves to products that have not been proven safe or effective for any use.
. These letters specifically focus on products containing 7-OH as an added ingredient or enhanced levels of 7-OH. Some products are adulterated conventional foods or dietary supplements because 7-OH does not meet the relevant safety standard. Others are unapproved new drugs with unproven claims such as relieving pain and managing anxiety.
Gas Station Heroin refers to a range of foreign lab-made synthetic substances that include tianeptine, nitrous oxide, semi-synthetic and synthetic alkaloid products, and intoxicating hemp products such as Delta-8, Delta-9, Delta-10, and HHC. At issue here is this latter category of intoxicating hemp and its legal definition.
Critically, the Senate funding bill would decrease the Delta-9-THC limit for hemp-derived products to zero. The government’s current definition of hemp permits the manufacture and distribution of products containing non-Delta-9 intoxicating cannabinoids — including Delta-8, Delta-10, and HHC — as long as their Delta-9 content remains below the statutory threshold.
The narrow standards of the 2018 Farm Bill have resulted in a regulatory loophole exploited by manufacturers and retailers of intoxicating, hemp-derived products sold in convenience stores, gas stations, and smoke shops across the country.
These chemically altered, highly concentrated products are concocted with imported extracts from overseas labs and rake in significant revenue for the international Gas Station Heroin syndicate, a multi-billion-dollar enterprise exploiting legal loopholes to drive addiction and profit while endangering Americans.
The Senate funding bill restores the original intent of the 2018 Farm Bill, which was never meant to create a loophole for synthetic THC, while protecting legitimate hemp farmers from rogue actors flooding the market with lab-made Gas Station Heroin.
Moreover, the bill would mark the most consequential federal intervention in cannabinoid policy in years, preempting and superseding a growing patchwork of state laws by establishing a uniform federal prohibition on synthetically manipulated and intoxicating hemp derivatives.
This important legislation underscores that natural botanicals are not the same as harmful synthetic substances. Although whole plant products have been used safely for centuries, bad actors are now isolating basic compounds from plants and chemically altering them in labs to create hyper-potent drugs that are poisoning consumers.
Stop Gas Station Heroin applauds Chair of the Senate Appropriations Committee Susan Collins, Chair of the Appropriations Agriculture Subcommittee John Hoeven, and Senator Mitch McConnell for their leadership in combating the Gas Station Heroin crisis by seeking to close the hemp loophole.
St. Louis lawmakers say intoxicating hemp seltzers and edibles pose a health risk because they’re unregulated.
When St. Louis Alderman Shane Cohn filed legislation last year to regulate intoxicating hemp products, he didn’t hear much about it from local residents or leaders of the fast-growing industry.
“I did not get one call, email, etc., when I introduced this last session,” Cohn said, a Democrat who represents a southern portion of St. Louis city. “And then all of a sudden, it’s like everyone is coming out of the woodwork — and I haven’t even requested a hearing on this yet.”
His bill would prohibit hemp-derived THC beverages and edibles from being sold outside of marijuana dispensaries, which would effectively ban them. Intoxicating hemp products, sometimes labeled as “Delta-8,” have largely been unregulated in Missouri since 2018, when Congress passed a Farm Bill that legalized hemp.
This year, Cohn has gotten calls from “every single media outlet,” he said, along with hemp beverage distributors, hemp edible companies and lobbyists.
His bill comes right on the heels of a heated battle between St. Louis-area state senators this spring over a similar proposal.
Cohn’s bill has the same language as the legislation sponsored by conservative Republican state Sen. Nick Schroer of Defiance this year.
In April, Schroer’s proposal was met by fierce opposition from St. Louis Democratic state senators Karla May, Steve Roberts and Angela Mosley, who led a seven-hour filibuster to kill the bill.
“It reminds me so much of a street drug war,” said May, during a Senate floor debate on April 9, “where you got these people over here saying you can’t infringe on my territory…I don’t think we should be using law to create an unfair business advantage.”
Several Republican state senators backed the filibuster, saying they were also opposed to what they described as a “monopolistic attempt” by the marijuana industry to squash its competition.
Now the fight has been taken to a local stage, where both the St. Louis County Council and St. Louis city’s Board of Aldermen are considering an effective ban as well.
In January, St. Louis County Councilwoman Lisa Clancy proposed a nearly identical bill to Cohn’s and is only one vote away from the bill’s final passage. She said she hasn’t heard from the St. Louis senators who filibustered or industry members.
The bill tasks the county’s health department with enforcement — including seizing and destroying the products. She’s been working with the county health department, she said, to make sure its leaders understand how it will be implemented before taking it to a final vote.
Clancy, Cohn and Schroer all argue that it isn’t an industry war but a “public health crisis.”
The St. Louis city and county legislation differs from Schroer’s because he ended up carving out an exception for low-dose THC beverages that have been sold in Missouri’s bars and liquor stores for seven years. It still required things like high-dose gummies, THCA flower and vapes to only be sold in marijuana dispensaries.
Cohn sees the bill he filed on June 27 as a “placeholder,” he said, and he wants to have a discussion about how to move forward with regulation.
“I’m happy to have the conversations to get to the end result where we’re protecting kids and health and welfare,” he said. “It’s not only the idea that there’s not even an age limit on these things. You don’t know what people are putting in these synthetic products.”
Cohn has strong support from the city’s aldermanic president Megan Green, who co-sponsored the bill.
“The fact that largely untested, unregulated, and untaxed products can be purchased at gas stations by kids is simply not sustainable,” Green told The Independent in an email last week.
Mayor Cara Spencer did not respond to The Independent’s requests for comment regarding the issue.
St. Louis County Executive Sam Page didn’t mention a particular stance in his statement to The Independent, but said, “There needs to be robust discussion on what regulation would look like, and I appreciate Councilwoman Clancy leading these efforts.”
Hemp naturally has very little THC, the intoxicating component mostly associated with marijuana. But that potency can be increased with some science.
While marijuana products must be sold in dispensaries and be grown and manufactured in state-regulated facilities, intoxicating hemp products are completely unregulated by any governmental agency.
There’s no state or federal law saying teenagers or children can’t buy them or stores can’t sell them to minors. However, some stores and vendors have taken it upon themselves to impose age restrictions of 21 and up.
If the St. Louis bills pass, all intoxicating hemp products would be put under the state’s definition of marijuana — which would create a ban on available products.
Here’s why: Licensed cannabis dispensaries wouldn’t be able to sell these intoxicating hemp products either because the hemp used to make them has to be grown in Missouri and processed in licensed cultivation and manufacturing facilities – just as marijuana is. Nearly all of these products currently on the market are made from hemp grown in other states.
Marijuana licenses are also limited.
That’s why the state lawmakers who filibustered argued the legislation would cause a “marijuana monopoly.”
Another St. Louis player — Steven Busch, who owns St. Peters-based Krey Distributing — pushed for an alternative licensing structure this year that looks more similar to how alcohol and tobacco retailers are licensed.
He worked with Republican state Rep. Dave Hinman of O’Fallon on a bill to allow beverages, edibles and vapes to continue to be sold outside of dispensaries, but be licensed and regulated under the Division of Alcohol and Tobacco Control.
Hinman’s proposal required age restrictions and clear labeling on all products, as well as testing to be completed by independent labs that have the same accreditation the Missouri Division of Cannabis Regulation requires of licensed marijuana testing labs.
In the end, there were too many differing opinions among hemp industry members to get the bill passed.
A sticking point for Busch was THCA flower, which looks and acts like marijuana buds. He believes it shouldn’t be sold outside of a dispensary, and other hemp advocates ardently disagreed.
Busch said it’s a “slippery slope” for municipalities to pass laws that ban everything in this category.
“I think that some of it can be safe,” Busch said, “but some of it is really taking advantage of the Farm Bill and should be banned.”
Busch agreed with the carve out in Schroer’s bill that capped the amount of THC at five milligrams per can. It excluded drinks made with “synthetic” THC, or THC that has been converted from CBD using a chemical process.
Other advocates said the cap on THC was too low and limiting.
Hinman will be filing another bill next year, he said, incorporating all the conversations he had throughout the past legislative session.
“I don’t think we need to move everything into dispensaries,” he said. “And two, I don’t think it’s a good idea for city-by-city regulation. I believe 100% this should be done statewide through the state legislature.”
Missouri cities of Gladstone, Farmington and Chesterfield have already passed municipal ordinances that ban or highly restrict these products.
Last summer, Total Wine — the country’s largest liquor retailer — set the tone for the alcohol industry when it began carrying hemp-derived THC infused beverages at its seven Missouri stores.
One of its featured products was intoxicating hemp seltzers from St. Louis-based company Mighty Kind.
“It has been amazing for us,” Joshua Grigaitis, owner of Mighty Kind, told The Independent last summer. “When somebody like Total Wine comes on board, it helps the conversation along greatly.”
In some St. Louis bars, his products make up 30-40% of their sales, he said.
Grigaitis and his team have spent the last seven years educating people on how they make their products and why they can buy a THC product outside of a dispensary — because the 2018 Farm Bill legalized hemp.
He welcomes regulation, he said, because it would help the industry grow. But that conversation has stalled out among state lawmakers the last two years.
That’s why – not long after Grigaitis learned about Total Wine last year – former Gov. Mike Parson signed an executive order last August banning intoxicating hemp products and threatening penalties to any establishment with a Missouri liquor license or that sells food products for selling them.
Like the St. Louis bills, he tasked the state health department with enforcement.
Ultimately, Parson’s order was put on hold a month later, after a series of political and legal barriers.
Grigaitis said he can only speak for the hemp beverage industry but there are a number of testing and other compliance requirements that distributors and retailers like Total Wine require in order to “just do business.”
“Everybody has a list of things you have to do to qualify or be compliant,” he said. “So it’s not like this wild west.”
Clancy said she’s “not looking to put Mighty Kind out of business.”
“I’m not trying to ram anything through quickly without stakeholder input and getting something that works for those people,” she said. “My concerns are about the shady actors.”
Like Parson and Cohn, Clancy said she’s most concerned about the edibles. She said she has test results from edibles purchased from stores in the county and city.
“And what they’re finding is that these are made out of things like mulch,” she said. “I know people personally who purchased them from convenience stores and have gotten sick.”
In terms of beverages, Brian Dix, owner of St. Louis city-based Craft Republic alcohol distributing company, said the bill will just push people to go buy hemp beverages online. Some of his seltzers are top items in the Tik Tok shop.
“It’s a massive industry,” he said of online sales and social media marketing. “If the city is taking this kind of position, it doesn’t make me want to stay in the city.”
