California Seizes More Kratom and 7-OH, but Online Orders Continue

By Pat Anson

With 7-OH consumers still awaiting final word from the DEA on whether the concentrated kratom alkaloid will be classified as an illegal Schedule One controlled substance, individual states are pursuing regulatory action of their own.  

In California, Governor Gavin Newsom announced the state’s enforcement efforts have so far resulted in nearly 8,000 “deadly kratom/7-OH items” being removed from store shelves. 

Trace amounts of 7-OH (7-hydroxymitragynine) alkaloid occur naturally in whole leaf kratom, but manufacturers have developed ways to concentrate 7-OH in tablets, gummies and shots, which are potent pain relievers with “opioid-like” effects.  

Although the DEA is only considering a ban on 7-OH – leaving natural leaf kratom alone – California says kratom and 7-OH products both pose “serious health risks.” 

California’s crackdown began last October, when state health officials issued a consumer warning claiming that kratom and 7-OH are dangerous and resulted in several overdose deaths. Enforcement actions stepped up in January, with state agents seizing millions of dollars worth of kratom and 7-OH products. To date, they’ve issued 181 citations. 

The state also warned vendors they could lose their licenses to sell alcohol if they sold kratom and 7-OH. That threat – in effect saying it was safe to sell beer, wine and other intoxicating beverages but not kratom and 7-OH – has resulted in a 98% compliance rate by Alcoholic Beverage Control licensees.

“If a product is sold in California, people should be able to trust that it follows the law. We’ve made the rules clear, giving businesses the opportunity to comply, and we’re holding accountable those who don’t. That’s how you protect kids and consumers while standing up for responsible businesses doing things the right way,” Gov. Gavin Newsom said in a news release.

But California’s enforcement efforts are uneven because they mainly target brick-and-mortar stores. Some online vendors are still shipping kratom and 7-OH products directly to California consumers, even though the California Department of Public Health (CDPH) said it has taken “significant enforcement action” against out-of-state kratom distributors.  

“CDPH has taken enforcement action on multiple orders of kratom shipped from out-of-state to California distribution facilities,” the agency said in a statement to PNN. "CDPH continues to monitor and enforce compliance with state law, including when products are sold or shipped directly to consumers in California. When CDPH becomes aware of unlawful kratom shipments, CDPH may take appropriate regulatory or enforcement action in coordination with local partners." 

The CDPH says it has the legal authority to ban kratom and 7-OH because they are “adulterated and misbranded” products that violate the California Health & Safety Code.

North Dakota Amends Kratom Ban

Dozens of other states, counties and cities have enacted laws banning or regulating kratom and 7-OH sales.

On Friday, North Dakota Governor Kelly Armstrong signed legislation that bans the sale, possession and use of 7-OH and other synthetic kratom products, and restricts the sale of natural kratom products to adults 21 and older.

Armstrong signed an executive order last month banning all kratom products, but under the new law passed by the North Dakota legislature during an emergency session, it will be legal again to sell natural leaf kratom as long as there are accurate labels and age restrictions.

“This is a victory for public health and safety, keeping dangerous synthetic kratom products off the shelves and protecting our young people from the adverse and unknown long-term effects of natural kratom, which is not regulated by the FDA but will now be subject to strict state regulations,” said Armstrong, who preferred a total ban on kratom.

Meanwhile, the DEA continues to slow walk enforcement action against 7-OH, even though it’s considered “an imminent threat to public health.” It’s been over a year since the FDA asked DEA to classify concentrated 7-OH as an illegal Schedule One substance, explicitly saying such a ban should not include natural kratom leaf.

DEA finally began the formal scheduling process for 7-OH in July, but federal health officials recently extended the public comment period until September 10. It’s not clear when DEA will act once that deadline passes or if it will make any changes in its scheduling order. 

As currently written, the order limits the amount of 7-OH to no more than 0.05% of a product by weight or volume, the equivalent of about 1 mg per tablet or gummie. That is well below the current dosage levels of 7-OH products. 

Southern States Identified as Opioid Hotspots

By Pat Anson, Editor

If you suffer a sprained ankle, you’re 14 times more likely to get opioid pain medication at a hospital emergency room in Arkansas than one in North Dakota. That’s one of the unusual findings uncovered by researchers at Penn Medicine, who found a wide variability between states in opioid prescribing for a relatively minor injury.

Researchers analyzed private insurance claims for over 30,000 patients who visited hospital ERs in the U.S. for an ankle sprain from 2011-2015.

Nationwide, about 25% of the patients received an opioid prescription, with the chances of getting an opioid in Arkansas (40%) much better than in North Dakota (2.8%). The states with the highest prescribing rates were in the South and Southeast; while the lowest prescribing states were in the upper Midwest and Northeast.  

SOURCE: PENN MEDICINE

"Although opioids are not - and should not - be the first-line treatment for an ankle sprain, our study shows that opioid prescribing for these minor injuries is still common and far too variable," said M. Kit Delgado, MD, an assistant professor of Emergency Medicine and Epidemiology at Penn, who was lead author of the study published in the Annals of Emergency Medicine.

"Given that we cannot explain this variation after adjusting for differences in patient characteristics, this study highlights opportunities to reduce the number of people exposed to prescription opioids for the first time and also to reduce the exposure to riskier high-intensity prescriptions.”

Nearly two-thirds of the opioid prescriptions were for hydrocodone – a potent painkiller that was reclassified as a Schedule II controlled substance in 2014 to make it harder to obtain.

Most patients received only a 3-day supply of opioids for their ankle sprains, although 5% were given more than 30 tablets. Less than 1% of the patients were still getting opioid prescriptions 30 days after the initial one.  

The study period preceded the release of the CDC’s opioid guidelines and came before many states enacted laws that limit the supply of opioids for acute pain. Some health experts are calling for more specific guidelines for ankle sprains and other health conditions.

"There is a clear need for further impactful guidelines similar to the CDC guidelines that outline more specific opioid and non-opioid prescribing by diagnosis," said senior author Jeanmarie Perrone, MD, a professor of Emergency Medicine and director of Medical Toxicology at Penn Medicine.

"Medical, surgical, and subspecialty societies should convene to propose best practices similar to the popular 'Choosing Wisely' campaign, acknowledging that pain management for most diagnoses can be accomplished with non-opioids. And certainly, ankle sprains are a model example."

Alabama District Leads Nation in Opioid Prescribing

A recent study published in the American Journal of Public Health also found high opioid prescribing rates in the South, Appalachia and rural West.  Researchers at the Harvard T.H. Chan School of Public Health focused on opioid prescribing in congressional districts, rather than the state or county level.

"It is important for public health research to focus on geographical units such as congressional districts as it allows for elected representatives to be more informed about important issues such as the opioid epidemic. Because a congressional district has a named elected representative, unlike say a county, it brings a certain degree of political accountability when it comes to discussing the opioid epidemic," said S. V. Subramanian, professor of population health and geography.

The study found that Alabama's Fourth Congressional District had 166 opioid prescriptions per 100 people, the highest rate of any district in the nation. Congressional districts in Kentucky, Tennessee, Mississippi, Arkansas, Virginia, and Oklahoma rounded out the top ten areas with the highest prescribing rates. Other high prescribing rates were found in districts in eastern Arizona, Nevada, northern California, rural Oregon, and rural Washington.

The Republican congressman who represents Alabama’s 4th District said the opioid crisis is worse in rural areas because there are fewer jobs and opportunities.

“I think this crisis, particularly in rural America, corresponds directly to President Trump’s popularity in my district,” Rep. Robert Aderholt said in a statement. “People here have felt left behind and have seen their jobs and opportunities disappear. Due to the epidemic of depression, some people have turned to prescription drugs to dull the pain.  However, I believe that President Trump’s renewed focus on these areas and increasing jobs has resonated here strongly.”

Harvard researchers say the lowest opioid prescribing rates were concentrated in congressional districts in urban areas, including Washington, DC, New York, Boston, Atlanta, Los Angeles, and San Francisco.