Study Shows Widespread Mislabeling of CBD Content Occurs for Over-the-Counter Products

https://www.newswise.com/articles/study-shows-widespread-mislabeling-of-cbd-content-occurs-for-over-the-counter-products

Newswise — In a new study, Johns Hopkins Medicine researchers tested more than 100 topical cannabidiol (CBD) products available online and at retail stores, and found significant evidence of inaccurate and misleading labeling of CBD content. The study also revealed that some of these nonprescription products contained amounts of delta-9-tetrahydrocannabinol (THC), the main active ingredient in cannabis that can cause a “high,” including some products that claimed to be free of THC. 

The study, published July 20 in JAMA Network Open, further found that some of the CBD products made therapeutic claims not approved by the U.S. Food and Drug Administration (FDA). To date, the FDA has only approved one prescription CBD product to treat seizures associated with rare epilepsy disorders, and two prescription THC products for nausea and vomiting associated with chemotherapy and for loss of appetite and weight loss associated with HIV/AIDS. 

“Misleading labels can result in people using poorly regulated and expensive CBD products instead of FDA approved products that are established as safe and effective for a given health condition,” says study lead author Tory Spindle, Ph.D., assistant professor of psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine. 

According to the National Institutes of Health’s National Center for Complementary and Integrative Health, CBD and THC are the most commonly known compounds in the plant Cannabis sativa. A key difference between the two is that THC can produce a psychoactive “high” effect at high doses, whereas CBD doesn’t. 

Under the Agriculture Improvement Act of 2018 (the Farm Bill), CBD products that contain less than 0.3% of THC are not considered federally illegal substances. This has made CBD products particularly popular and widely available to consumers virtually anywhere, but it also makes it difficult for the FDA to address unapproved claims and mislabeling. However, Spindle notes, “Recent research has shown that people who use CBD products containing even small amounts of THC could potentially test positive for cannabis using a conventional drug test.” This has not been determined for topical CBD products, but the authors are currently studying it. 

For the study, the research team purchased 105 CBD topical products — including lotions, creams and patches — online and at brick-and-mortar retail locations in Baltimore, Maryland, in July and August 2020. Products were tested using a technology called gas chromatography-mass spectrometry to identify the actual amount of CBD and THC they contained. 

Only 89 (85%) of the 105 tested products listed the total amount of CBD in milligrams on the label. Of the 89 products, 16 (18%) contained less CBD than advertised, 52 (58%) contained more CBD than advertised and 21 (24%) were accurately labeled. On average, the in-store products contained 21% more CBD than advertised and the online products contained 10% more CBD than advertised, though CBD label accuracy varied widely across products. 

THC was detected in 37 (35%) of the 105 products, though all were within the legal limit of 0.3%. Four (11%) of those 37 were labeled as “THC free,” 14 (38%) stated they contained less than 0.3% THC and 19 (51%) did not reference THC on the label. 

Of the 105 products, 29 (28%) made a therapeutic claim, mostly about pain/inflammation, 15 (14%) made a cosmetic/beauty claim (e.g., that they alleviate wrinkles or nourish/improve skin) and 49 (47%) noted they were not FDA approved. The other 56 (53%) products made no reference to the FDA. “It’s important to note that the FDA has not approved CBD products to treat any of the conditions advertised on the products we tested,” says Spindle, who also is a faculty member at the Johns Hopkins Cannabis Science Laboratory. 

“The variability in the chemical content and labeling found in our study highlights the need for better regulatory oversight of CBD products to ensure consumer safety,” says Ryan Vandrey, Ph.D., professor of psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine and the study’s senior author. Such regulation, the authors believe, would ensure CBD products meet established standards for quality assurance so consumers can make informed decisions about product selection and are not misled by unproven therapeutic or cosmetic claims. The study authors also caution that people should check with their health care practitioner before starting any CBD regimen. 

In addition to Spindle and Vandrey, other researchers who contributed to the study include Dennis Sholler and Edward Cone from the Johns Hopkins University School of Medicine, Timothy Murphy and Mahmoud ElSohly from ElSohly Laboratories, Ruth Winecker from RTI International, Ronald Flegel from the Substance Abuse and Mental Health Services Administration (SAMHSA) and Marcel Bonn-Miller from the Canopy Growth Corp. 

This research was supported by the Substance Abuse and Mental Health Services Administration (SAMHSA). 

COI: Tory Spindle has served as a consultant for Canopy Health Innovations, Ryan Vandrey has been a consultant or received honoraria from Canopy Health Innovations, MyMD Pharmaceuticals, Mira1a Therapeutics, Syqe Medical Ltd. and Radicle Science, and Marcel Bonn-Miller is employed by the Canopy Growth Corp. The other authors declare no conflicts of interest. 

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https://www.foxla.com/news/more-than-600-southern-california-grocery-store-pharmacists-authorize-strike

LOS ANGELES – More than 600 pharmacists and pharmacy workers at Ralphs, Vons, Albertsons and Pavilions stores in Southern California could walk out following an “overwhelming” membership vote to authorize union leadership to call for a strike.

No dates have been set for a strike and negotiations with the stores have continued.

United Food and Commercial Workers (UFCW), which represents workers across seven locals, has filed Unfair Labor Practice charges against the stores with the National Labor Relations Board, claiming they have engaged in “unlawful and unfair treatment.” The accusations include retaliation against pharmacists who engage in union activity, attempting to bribe pharmacists with bonuses rather than negotiating wage increases and hiring temporary workers to undermine union activity.

The seven locals make up the largest union grocery contract in the country.

“Southern California’s essential pharmacists have made their voices heard with this vote,” the union locals said in a joint statement Friday. “This vote gives union leaders the authorization to call for a strike and lays the groundwork to allow more than 600 pharmacists across California to stand up to protect their rights and ensure they have the ability to effectively serve their patients and communities.”

John Votava, a spokesperson for Ralphs, told CNS the store is continuing to negotiate in good faith and that the strike authorization does not mean there will be a strike or work stoppage.

“Our company is committed to continue to negotiate in good faith with the union locals until an agreement is reached that meets the needs of our pharmacy associates and ensures our customers have access to affordable medicines while keeping stores competitive,” Votava said.

Votava called the Unfair Labor Practice allegations a “fear tactic UFCW can use to call a strike and cause disruption for our company, associates and communities.” He said the National Labor Relations Board has not investigated the claims.

“Ralphs follows the law and has not been notified of any wrongdoing,” Votava said.

Albertsons, which owns Pavilions and Vons, did not respond to a request for comment.

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Paul Volkman MD files moves Post Rain-Khan to vacate conviction under 2255 needs Doctors of Courage and youarewithinthenorms.com to publish his legal stance to have convictions case overturned

alldocappeal

 The above link is to the 16 page pdf of the paperwork that has been – or will be – filed with our court system.

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Why Amazon wants to buy One Medical

https://www.beckershospitalreview.com/disruptors/why-amazon-wants-to-buy-one-medical.html

Amazon’s plan to buy One Medical for $3.9 billion will give the retailer a larger foothold in selling healthcare services to employers, an arena the company entered in 2019, the Wall Street Journal reported July 22. 

Six things to know about the deal and Amazon’s previous endeavors to disrupt healthcare:

1. One Medical is an app and website members use to book appointments, track health records and renew prescriptions.
2. One Medical has yet to turn a profit since going public in 2020. In the first three months of 2022, losses reached $90 million.
3. The acquisition of One Medical will pit Amazon against other companies such as UnitedHealth Group’s Optum, CVS Health and hospital systems that increasingly employ physicians, according to the report. 
4. Amazon’s earlier forays into healthcare include a $1 billion deal for a business to ship prescriptions nationwide and a venture to remake healthcare that companies offer to U.S. workers. They haven’t met with much success, according to the report.
5. In 2019, Amazon launched Amazon Care, a telehealth service it first offered to its employees. Last year, it said it would expand the offering to other companies.
6. Amazon also launched its own pharmacy business after buying online pharmacy PillPack two years ago, but the service has failed to gain meaningful traction, critics say.

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The Supreme Court just let a Trump judge seize control of ICE, at least for now

https://www.vox.com/2022/7/21/23273467/supreme-court-ice-texas-united-states-biden-mayorkas

Apparently President Biden isn’t in charge of the executive branch anymore.

On Thursday evening, the Supreme Court handed down a brief, 5-4 decision that effectively places Drew Tipton, a Trump-appointed federal trial judge in Texas, in charge of many of Immigration and Customs Enforcement’s (ICE) decisions about which immigrants to target.

The decision was largely along party lines, except that Justice Amy Coney Barrett joined the Court’s three Democratic appointees.

The decision in United States v. Texas is temporary, but the upshot of this decision is that Tipton will effectively wield much of Homeland Security Secretary Alejandro Mayorkas’s authority over how ICE officers prioritize their time for as much as an entire year — and that’s assuming that the Biden administration ultimately prevails when the Court reconsiders this case next winter.

At issue in this case is a perfectly standard decision Mayorkas made last September. Federal law provides that the secretary of homeland security “shall be responsible” for “establishing national immigration enforcement policies and priorities.” Pursuant to this authority, Mayorkas issued a memo to ICE’s acting director, informing him that the agency should prioritize enforcement efforts against undocumented or otherwise removable immigrants who “pose a threat to national security, public safety, and border security and thus threaten America’s well-being.”

Then-secretaries of homeland security issued similar memos setting enforcement priorities in 2000, 2005, 2010, 2011, 2014, and 2017.

Not long after Mayorkas handed down his memo, however, the Republican attorneys general of Texas and Louisiana went to Tipton, a Trump judge with a history of handing down legally dubious decisions halting Biden administration immigration policies, asking Tipton to invalidate Mayorkas’s memo. Tipton obliged, and an especially conservative panel of the United States Court of Appeals for the Fifth Circuit allowed Tipton’s order to remain in effect.

DOJ asked the Supreme Court to stay Tipton’s decision, temporarily restoring an elected administration’s control over federal law enforcement while this case proceeds. But the Court just refused. And it did so without explanation.

Additionally, the Court’s order announces that the justices will hear this case in December, after which it will decide whether Tipton’s decision should be permanently vacated.

This is not a close case, at least under existing law. Not only is there a federal statute that explicitly gives Mayorkas, and not Tipton, the power to establish “national immigration enforcement policies and priorities,” but Tipton’s order is also inconsistent with a legal doctrine known as “prosecutorial discretion.” That doctrine gives the executive branch discretionary authority to determine when to bring enforcement actions against individuals who allegedly violated the law.

The Supreme Court has instructed judges like Tipton to be very reluctant to second-guess these kinds of discretionary judgments by law enforcement agencies. As the Court held in Heckler v. Chaney (1985), “an agency’s decision not to take enforcement action should be presumed immune from judicial review.”

This presumption is especially strong in the immigration context. The Court has said that “a principal feature of the removal system is the broad discretion exercised by immigration officials.” Even after an enforcement agency decides to bring a removal proceeding against a particular immigrant, the Court explained in Reno v. American-Arab Anti-Discrimination Committee (1999), it “has discretion to abandon the endeavor.” And it may do so for any number of reasons, including “humanitarian reasons or simply for its own convenience.”

It is still possible that, after the Court hears this case in December, a majority of the Court will vote to vacate Tipton’s order and restore Mayorkas’s lawful authority. But even if that happens, that still means that Tipton will be allowed to exercise unlawful control of a federal law enforcement agency for months.

It won’t be the first time this happened, either. Last year, a Trump judge named Matthew Kacsmaryk handed down a similar order requiring the Biden administration to reinstate a Trump-era immigration policy known as “Remain in Mexico.” Though the Court eventually ruled against Kacsmaryk, it allowed his order to remain in effect for 10 months, leaving Remain in Mexico in place for that entire time.

And even after the Court ruled against Kacsmaryk, it sent the case back down to him with several legal issues unresolved — permitting Kacsmaryk to seize control of much of the nation’s border policy again, if he chooses.

Now, the best-case scenario for Mayorkas — and for the rule of law in the United States — is that the Supreme Court will treat Tipton’s order much like it treated Kacsmaryk’s, permitting an unlawful seizure of the Biden administration’s authority to remain in effect for only months, instead of permanently.

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DEA Policy Reversal on Allowed Prescription Annotations for Schedule II Prescriptions

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SUMMARY OF UPDATES TO GUIDELINES FOR PRESCRIBING CONTROLLED SUBSTANCES FOR PAIN

https://www.mbc.ca.gov/About/Meetings/Material/31001/ip-AgendaItem2-20220714.pdf

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