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Feds Send Warning Letter To Another CBD Company Over Medical Claims

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The Food and Drug Administration (FDA) and Federal Trade Commission (FTC) sent a warning letter to a Florida-based CBD company on Tuesday, alleging that the business made several unsanctioned claims about the therapeutic benefits of their products.

The federal agencies accused Rooted Apothecary of unlawfully asserting that their cannabidiol products could treat symptoms of conditions such as ADHD, Parkinson’s disease, ear aches, ADHD and autism. Those claims appeared on the company’s website and social media accounts, they said.

Certain products appeared to be marketed as dietary supplements, which FDA currently prohibits as it works to develop an alternative regulatory scheme for CBD.

“Cannabis and cannabis-derived compounds are subject to the same laws and requirements as FDA-regulated products that contain any other substance,” Acting FDA Commissioner Ned Sharpless said in a press release. “We are working to protect Americans from companies marketing products with unsubstantiated claims that they prevent, diagnose, treat, or cure a number of diseases or conditions.”

“We’ve sent numerous warning letters that focus on matters of significant public health concern to CBD companies, and these actions should send a message to the broader market about complying with FDA requirements,” he said. “As we examine potential regulatory pathways for the lawful marketing of cannabis products, protecting and promoting public health through sound, science-based decision-making remains our top priority.”

FTC’s complaint with the company is that it violated a law that requires businesses that advertise medical claims about their products to have “competent and reliable scientific evidence” to back them up, which could include human clinical trials. Making or exaggerating such claims through “a product name, website name, metatags, or other means” without proper evidence is also prohibited.

Rooted Apothecary must respond to the agencies within 15 working days to explain what steps it’s taking to resolve the issues. If the company fails to do so, it is subject to legal action, including the possible seizure of its products or an injunction. It may also have to compensate customers.

FDA emphasized that CBD products—other than the prescription medication Epidiolex, for the treatment of intractable epilepsy—are not currently allowed. But it also reiterated that the agency is in the process of developing rules that could allow for the lawful marketing of the compound.

In April, FDA sent warning letters to three other CBD companies that it said was making unauthorized claims about the medical benefits of their products. FTC also submitted warning letters to three separate CBD companies for allegedly advertising misleading statements about their products last month.

These letters are examples of the agency’s use of enforcement discretion. Former FDA Commissioner Scott Gottlieb, who recently suggested that the federal government should be involved in regulating state marijuana programs, clarified in March that the agency is only going after companies that make especially misleading claims about their products.

Senate Majority Leader Mitch McConnell (R-KY), who championed a provision of the 2018 Farm Bill federally legalizing hemp and its derivatives, has urged FDA to clear a path for the lawful marketing of CBD products by using enforcement discretion while it develops an interim final rule. A bipartisan group of lawmakers made a similar request in a letter sent to the agency last month.

“The FDA is working quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD while using all available resources to monitor the marketplace and protect public health by taking action as needed against companies,” FDA Principal Deputy Commissioner Amy Abernethy said.

“We recognize that there is significant public interest in cannabis and cannabis-derived compounds; however, we must work together to fill in the knowledge gaps about the science, safety and quality of many of these products,” she said. “We are committed to advancing our regulation of these products through an approach that, in line with our mission, prioritizes public health, fosters innovation and promotes consumer confidence.”

Hemp Regulations Will Be Issued Within Weeks, Top USDA Official Says

Photo courtesy of Kimzy Nanney.

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Amazon Reaffirms Support For Marijuana Legalization And Says Former Workers Punished Over Cannabis Are Eligible For Employment

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Amazon is reaffirming its support for federal marijuana legalization, and it disclosed on Tuesday that its earlier decision to end drug testing for cannabis will also be retroactive, meaning former workers and applicants who were punished for testing positive for THC will have their employment eligibility restored.

The company’s move to end marijuana drug testing for many positions in June was widely celebrated by reform advocates and industry stakeholders. But at the time, Amazon only talked about ending the policy going forward.

In a new blog post, Beth Galetti, Amazon’s senior vice president of human resources, clarified that it has also “reinstated the employment eligibility for former employees and applicants who were previously terminated or deferred during random or pre-employment marijuana screenings.”

The reason for the move away from marijuana testing is multifaceted, Amazon said. The growing state-level legalization movement has made it “difficult to implement an equitable, consistent, and national pre-employment marijuana testing program,” data shows that drug testing “disproportionately impacts people of color and acts as a barrier to employment” and ending the requirement will widen the company’s applicant pool.

That said, unlike in its June announcement, Amazon’s new update places an emphasis on ending “pre-employment” drug testing for cannabis. It used broader language before, announcing that it will “no longer include marijuana in our comprehensive drug screening program.”

Amazon also reiterated that it would like to see Congress pass legislation to end federal cannabis prohibition. It cited the Marijuana Opportunity, Reinvestment and Expungement (MORE) Act and the Cannabis Administration and Opportunity Act (CAOA) as examples of bills that it supports.

For the latter legislation—which is being sponsored by Senate Majority Leader Chuck Schumer (D-NY), Senate Finance Committee Chairman Ron Wyden (D-OR) and Sen. Cory Booker (D-NJ)—Amazon participated in a public comment period and submitted feedback that it shared with lawmakers in the new blog post.

“We believe the time has come for reform of the nation’s cannabis policy and we are committed to helping lead the effort,” the company said in a letter to the senators. “As your bill would achieve similar objectives, we are pleased to endorse the Cannabis Administration and Opportunity Act as currently drafted.”

Amazon said it specifically supports key provisions to remove marijuana from the Controlled Substances Act, expunge prior cannabis convictions and use some marijuana tax revenue for community reinvestment.

Curiously, the letter also says “we have refrained from commenting on areas where we do not have a particular view, including regulation, permitting, taxation, and interstate commerce.”

It’s that last point that raises some eyebrows, as it stands to reason that any policy on interstate cannabis commerce would be of interest to a business that delivers products across the U.S. and presumably has the infrastructure to expand its delivery services into the marijuana industry when prohibition ends.

“We are proud to largely end pre-employment testing of marijuana as a condition of employment. And we are enthused by the notable momentum in the country toward recognizing that today’s status quo is unfair and untenable,” Amazon concluded. “We are eager to work with you to secure passage of this legislation.”

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Arizona Marijuana Tax Revenue Exceeds $20 Million In August, State Reports

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Arizona collected more than $20 million in medical and adult-use marijuana tax revenue in August, data released by the state this week shows.

Medical cannabis taxes were slightly higher at $6,388,816 last month, compared to $4,542,166 collected from the recreational market, according to the Department of Revenue. The state also took in an additional $9,515,016 from the marijuana excise tax.

However, these figures are preliminary and may change, as some businesses could need additional time to send in data.

July’s cannabis tax revenue was slightly higher compared to August, with the state taking in about $400,000 more in the prior month.

While medical cannabis taxes are still outpacing those from the adult-use market, that gap has been generally been narrowing in the months since recreational sales first launched in January. That’s a trend that’s been observed across numerous states after adult-use marijuana is legalized.

However, Arizona’s medical marijuana market is well-established, and some industry experts don’t necessarily expect recreational sales to overtake the medical program for some time.

Overall cannabis tax revenue from January through August totaled $115,701,426, according to the data the Department of Revenue is reporting so far.

Other states are also seeing a windfall in marijuana tax dollars as more markets mature and sales continue to increase.

For example, Maine recreational marijuana sales broke another record in August, exceeding $10 million for the first time since the adult-use market launched in October 2020.

Adult-use cannabis sales in Illinois exceeded $120 million in August, state officials recently reported. It’s the second highest sales record since the state’s recreational market launched last year and the sixth month in a row that sales surpassed $100 million.

Massachusetts marijuana sales have topped $2 billion since the state’s adult-use market launched in late 2018, the Cannabis Control Commission reported last week.

California collected about $817 million in adult-use marijuana tax revenue during the 2020-2021 fiscal year, state officials estimated last month. That’s 55 percent more cannabis earnings for state coffers than was generated in the prior fiscal year.

A recent scientific analysis of sales data in Alaska, Colorado, Oregon and Washington State found that marijuana purchases “have increased more during the COVID-19 pandemic than in the previous two years.”

In July alone, at least three states saw record-breaking sales for recreational cannabis. The same goes for Missouri’s medical marijuana program.

Michigan marijuana sales broke another record in July with more than $171 million in cannabis transactions, according to data from the state’s regulatory body. There were $128 million in adult-use sales and $43 million in medical cannabis purchases.

Throughout the pandemic, many states allowed cannabis retailers to remain open—with governors and regulators in several markets declaring marijuana businesses to be essential services—and some jurisdictions issued emergency rules allowing curbside pickup, delivery services or other more relaxed policies in order to facilitate social distancing.

California Smokable Hemp Bill Heads To Governor, While Measure On Cannabis Use In Hospitals Advances

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Maine Marijuana Sales Broke Another Record In August, Exceeding $10 Million For First Time

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Maine recreational marijuana sales broke another record in August, exceeding $10 million for the first time since the adult-use market launched in October 2020.

The state’s Office of Marijuana Policy reported that the state’s 53 adult-use cannabis shops brought in about $10.2 million in marijuana purchases last month. And that translates into about $1 million in tax revenue for the state, which has a population of just 1.3 million.

By comparison, Maine cannabis sales for recreational consumers amounted to just $1.1 million during the first month of retail sales less than a year ago. That record has been broken each subsequent month.

While August proved to be a record-breaking month for marijuana purchases—with 133,969 sales transactions—it’s only slightly higher compared to July, when the state saw about $9.4 million in adult-use purchases. Those figures don’e include medical cannabis sales, which are tracked separately.

Via Maine Office of Marijuana Policy.

According to the Portland Press Herald, regulators have credited summer tourism for the sales spike.

But in general, states across the U.S. have seen similar trends over recent years. And marijuana sales records have been consistently broken over the past year despite the coronavirus pandemic.

Adult-use cannabis sales in Illinois exceeded $120 million in August, state officials recently reported. It’s the second highest sales record since the state’s recreational market launched last year and the sixth month in a row that sales surpassed $100 million.

Arizona brought in about $21 million in medical and adult-use marijuana tax revenue in July, state officials recently reported on a new webpage that enables people to more easily track how the industry is evolving.

California collected about $817 million in adult-use marijuana tax revenue during the 2020-2021 fiscal year, state officials estimated last month. That’s 55 percent more cannabis earnings for state coffers than was generated in the prior fiscal year.

A recent scientific analysis of sales data in Alaska, Colorado, Oregon and Washington State found that marijuana purchases “have increased more during the COVID-19 pandemic than in the previous two years.”

In July alone, at least three states saw record-breaking sales for recreational cannabis. The same goes for Missouri’s medical marijuana program.

Michigan marijuana sales broke another record in July with more than $171 million in cannabis transactions, according to data from the state’s regulatory body. There were $128 million in adult-use sales and $43 million in medical cannabis purchases.

Throughout the pandemic, many states allowed cannabis retailers to remain open—with governors and regulators in several markets declaring marijuana businesses to be essential services—and some jurisdictions issued emergency rules allowing curbside pickup, delivery services or other more relaxed policies in order to facilitate social distancing.

Marijuana Legalization Doesn’t Lead To Increased Youth Use, American Medical Association Study Finds

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