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Company Recalls Injectable CBD Products Following FDA Warning Letter

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A Food and Drug Administration (FDA) letter warning a company about its marketing of injectable CBD products has led to a voluntary recall that the federal agency announced on Wednesday.

Biota Biosciences received the letter last month, with FDA directing the firm to cease sales of its line of CBD vials, which it markets as a pain reliever that serves as an alternative to opioids and can help with detoxification.

The agency said the company was violating federal statutes both by engaging in interstate commerce of an unapproved new drug and failing to properly label the products by neglecting to include directions for use.

“Injectable drug products can pose a serious risk of harm to users because they are delivered directly into the bloodstream and bypass many of the body’s natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis,” FDA wrote.

 

In a public response published on Friday, the company told consumers that “we would like to convey that the executive and management team at Biota Biosciences take full responsibility for these observations and understand the gravity of the risk to consumers by posting these unapproved claims and intended use on our website.”

Products subject to the recall include formulations of Cannabidiol (CBD) Complex, Curcumin Complex, and Cannabidiol + Curcumin. “All customers who received this product will have the choice to keep any remaining product or receive a full refund for returning unused products,” the firm said.

Since receiving FDA’s warning letter, the company says has pulled all the products, provided the agency with a “root cause and corrective action plan” and launched a voluntary recall of the vials.

According to the original warning letter, the CBD products meet the definition of a drug subject to FDA regulation because “they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body,” the letter continues.

FDA identified several examples of medical claims Biota Biosciences made about their CBD vials in advertising:

“Fighting the opioid epidemic… BIOTA Biosciences produces and distributes effective all-natural alternatives with no side-effects. Join the growing ranks of pain, oncology, psychiatry, naturopathy healthcare professionals utilizing BIOTA Sterile CBD Vials.”

“VISION: OPIOID-FREE FUTURE… Our goal is to supply the world with pharmaceutical grade, all natural products containing cannabidiol and other natural compounds. We believe strongly that pharmaceutical grade hemp oil will drastically reduce the need for opioid-based pain relief and eliminate the global opioid epidemic by providing a safe and natural alternative.”

“Instant relief for patients that are symptomatic of inflammatory auto-immune diseases”

While the products lack directions for use, the company has claimed that they bypass liver absorption and deliver CBD “directly into your bloodstream.”

Further, FDA stressed that even if the labels did contain usage information, they would still be in violation.

“New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA,” the letter states. “FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.”

The injectable CBD vials “are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes.”

“The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. According to your website, you manufacture many other types of CBD containing products. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.”

FDA gave Biota Biosciences 15 days within the receipt of the letter to notify them about corrective steps they’ve taken. Failure to resolve the issues could have resulted in “legal action without further notice, including, without limitation, seizure and injunction.”

In its public statement, Biota Biosciences said that so far “no adverse or serious adverse events have been reported in relation to these products.” FDA is urging consumers may have such experiences to report them to its MedWatch Adverse Event Reporting program.

This is one of the latest statements FDA has made about CBD companies that are not meeting its standards.

Earlier this week, the agency publicized a voluntary recall of another CBD product from a different company, notifying consumers about potentially high levels of lead in a batch of tinctures.

FDA has said that it is currently targeting companies that make especially outlandish and unsanctioned claims about the therapeutic potential of their cannabis products.

For example, it sent a warning letter to a CBD company owned by a former NFL player after advertisements it displayed suggested its products could treat and prevent a coronavirus infection.

FDA has previously issued warnings to other CBD companies that have made unsubstantiated claims about the therapeutic potential of their products.

Although the agency does not currently approve of CBD as a food item or dietary supplement, it is in the process of developing regulations that may allow for such marketing.

FDA Notifies Public About Recall Of CBD Product That Tested High For Lead

Photo courtesy of Flickr/Marco Verch.

Marijuana Moment is made possible with support from readers. If you rely on our cannabis advocacy journalism to stay informed, please consider a monthly Patreon pledge.

Kyle Jaeger is Marijuana Moment's Sacramento-based senior editor. His work has also appeared in High Times, VICE and attn.

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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.”

Former GOP Congresswoman Touts Psilocybin As Treatment For Alcoholism

 

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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

Marijuana Moment is made possible with support from readers. If you rely on our cannabis advocacy journalism to stay informed, please consider a monthly Patreon pledge.
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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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