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CBD News Roundup: Clinical Trial Confirms Benefits of Plus CBD Oil Product

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Written by The CBD Insider

Here are the biggest and latest CBD news stories:

  • A clinical trial has validated the benefits of daily supplementation with PlusCBD™ Oil Gold Formula softgels.
  • Hershey CEO says the company is waiting to add CBD to its products.
  • Thrive Market, an organic and natural products retailer, is forced to pull its CBD products.
  • The House of Representatives passed an amendment pushing the FDA to regulate CBD.
  • A study shows that CBD can cause liver damage, but the results are being disputed.

Table of Contents

  1. Clinical Trial Validates Benefits of PlusCBD™ Oil Product
  2. Hershey is Waiting to Add CBD to Its Candy
  3. Thrive Market Forced to Stop Selling CBD Products
  4. House Passes Amendment Pushing FDA to Regulate CBD
  5. Study Shows CBD Can Cause Liver Damage, But Researchers’ Methods Disputed

Clinical Trial Validates Benefits of PlusCBD™ Oil Product

A clinical trial that is the first of its kind has found evidence of benefits from CV Sciences’ PlusCBD™ Oil Gold Formula softgels.

The placebo-controlled, double-blind study was led by Dr. Hector L. Lopez and included scientists from The Center for Applied Health Sciences in Ohio and Lindenwood University.

Researchers had 65 over-weight, yet otherwise healthy participants (male and female) take one PlusCBD™ Oil Gold Formula softgel or a placebo every morning for six weeks.

After six weeks, the participants reported a decrease in appetite (-6.2%), improvement in sleep quality (+22%) and quantity (+21.3%), and increased pleasure from life (+12.5%).

The differences between those taking the PlusCBD™ Oil Gold Formula softgel and those taking a placebo were significant.

Safety biomarkers, such as liver function, cardiovascular health, cholesterol, and white blood cell count were also measured and remained at normal clinical levels throughout the study.

“HEMP (PlusCBD Oil™) supplementation at 15mg active CBD containing a broad array of minor phytocannabinoids, terpenes, tocopherols/tocotrienols, and fatty acids can improve self-reported psychometric measures of sleep, quality of life (life satisfaction) and reduce appetite, while demonstrating no adverse effects on standard biomarkers of safety,” the researchers concluded.

The researchers said further studies would analyze the effect of hemp extract products on inflammation, stress hormones, gene expression, as well as gather dosing information.

Hershey is Waiting to Add CBD to Its Candy

Hershey CEO Michele Buck went on CNBC’s “Squawk Box” and said the 125-year-old company is waiting to infuse their candy with CBD.

“It is a huge trend, so we’re evaluating it but have no plans at this point in time,” said Buck.

Despite the immense popularity of CBD, and large retailers beginning to sell CBD products, the FDA currently considers it illegal to add the cannabinoid to food and drink.

Consequently, most major stores are selling topicals, balms, and lotions while the FDA gathers more information and constructs a regulatory framework for CBD, which may reverse the current stance on CBD in food.

“Frankly, there’s some work to do from a regulatory perspective,” Buck said. “Currently, it is not legal to ship interstate a food product that has CBD.”

Back in September, Coca-Cola was talking to Aurora Cannabis about a potential partnership to create CBD-infused drinks, but nothing substantial has come from those discussions yet.

More recently in May, the CEO of Mondelez—the maker of Oreo—said the company was “getting ready” to add CBD to its snacks, but was waiting for more clarity on the space from the FDA.

As of now, the FDA has not enforced its policy, while some states, such as California and New York, have passed laws banning edible CBD products and are cracking down on them.

Thrive Market Forced to Stop Selling CBD Products

Thrive Market, an all-natural and organic foods online retailer, was forced to remove all CBD products from its site due to pressure from its customer payment processor.

According to a blog post on the Thrive Market website, the retailer “received a notice from our merchant processor demanding that we cease the sale of all hemp and CBD products on Thrive Market,” wrote CEO Nick Green.

Thrive Market had been selling hemp-derived CBD products from popular brands such as Charlotte’s Web for 18 months.

“Our decision was based on our review of the health research on CBD, the input of hundreds of our members, and the changing legal landscape that was finally recognizing what hemp farmers, scientists, and informed citizens have long known—that hemp is not the same thing as marijuana and that CBD is neither psychoactive nor harmful,” Green wrote.

Thrive Market is not the only company that has had trouble acquiring or maintaining financial services for hemp and CBD because institutions are afraid of legal risks.

Several hemp companies have had payment processors or banks deny service or drop them as clients recently, despite hemp becoming federally legal in December 2018.

Fortunately, the payment processor Square started a pilot program in late May for CBD companies, after Representative Andy Barr (R-KY) called for regulators to issue guidance to financial institutions that servicing hemp companies is legal.

Also, after pressure from Senator Jon Tester (D-MT) during a confirmation hearing earlier this month, a Federal Reserve official said she would clarify to banks and financial institutions that they can work with hemp businesses.

House Passes Amendment Pushing FDA to Regulate CBD

The House of Representatives has passed an amendment that would push the FDA to make CBD lawful for addition to food and drink.

The amendment was proposed by Rep. Jerry McNerney (D-CA) and added to the House Agriculture appropriations bill.

Essentially, this amendment would appropriate funds for the FDA to conduct a Health Hazard Evaluation and establish a safe level of CBD for foods and supplements.

Currently, the FDA considers CBD a drug; thus, it is illegal for it to be part of the food supply.

Congress members have vocalized their support for adding CBD to food and drink, including some who sent letters to the agency requesting that it move quickly in doing so.

Former FDA Commissioner Scott Gottlieb said that it might take years for the FDA to create a legal pathway for CBD to be added to food and drink.

However, he also suggested that Congress could pass legislation to speed up the process.

It seems that is what Congress intends to do.

Study Shows CBD Can Cause Liver Damage, But Researchers’ Methods Disputed

A study on the toxicity of CBD for the liver in mice revealed that some mice died within days of taking CBD, but the methods of the study are being disputed.

Led by Igor Koturbash, Ph.D., researchers at the University of Arkansas for Medical Science investigated the hepatotoxicity of Epidiolex, the first and only FDA-approved, CBD-based medication, in mice over two phases.

The researchers gave the mice what they claimed was “the allometrically scaled mouse equivalent doses (MED) of the maximum recommended human maintenance dose of CBD in EPIDIOLEX (20 mg/kg).”

Dosages for the mice would expect to be much smaller than the human maximum, likely around 0.3 mg/kg.

However, the researchers gave the mice 0, 246, 738, or 2,460 mg/kg in the acute phase, an apparent error in the dosage calculations.

At 2,460 mg/kg, this dose is 123 times higher than the human maximum.

Mice showed visible signs of toxicity at 2,460 mg of Epidiolex.

In the sub-acute phase, the mice were given doses of 61.5, 184.5, and 615 mg/kg over 10 days.

After three days of 615 mg/kg, four of the mice were put down because they showed signs of “overt toxicity,” such as “profound lethargy, loss of appetite, and body weight loss.”

Mice taking the lower doses showed no evident signs of liver toxicity throughout the 10 days.

The possibility that CBD may have adverse effects on the liver is not a new revelation.

Clinical trials on Epidiolex in humans showed that the medication caused a rise in liver enzymes, forcing some participants to withdraw.

A warning label on Epidiolex states that the medication could cause liver injury.

However, several other studies show that CBD could also help treat liver diseases.

While research exists on the potential for liver damage by Epidiolex, the methods used by the researchers at the University of Arkansas are suspect and do not give an accurate description of the potential dangers of CBD for the human liver.