U.S. health authorities are signing off on human trials of CBD to treat opioid addiction.

The U.S. Food and Drug Administration gave the green light this week to Ananda Scientific to start human testing of its CBD drug Nantheia ATL5, the company announced.

The trials will be run out of UCLA and are funded by the U.S. National Institute on Drug Abuse.

The federal clearance for CBD opioid-addiction research “further re-enforces our vision of developing CBD as a therapeutic for a number of key indications.” Ananda Scientific CEO Sohail R. Zaidi said in a statement.

The clearance comes two years after the FDA issued a warning letter to Massachusetts-based Curaleaf for marketing its CBD product’s potential to treat opioid addiction. Curaleaf scrubbed its website, though national drugstore chain CVS Health dropped some Curaleaf products anyway.

Ananda Scientific is privately held and has offices in Los Angeles and Greenwood Village, Colorado. A company spokesman reached by Hemp Industry Daily did not immediately say where the CBD comes from or if it is naturally derived or synthetic.

The only plant-derived cannabinoid medicine approved for human use in the United States remains Epidiolex, a CBD drug that treats rare forms of epilepsy and is owned by Ireland’s Jazz Pharmaceuticals.

(This opinion column appears in the February issue of Marijuana Business Magazine.)

Everyone in the hemp industry knows the story of Charlotte’s Web: A group of well-meaning brothers working under Colorado’s medical marijuana system developed a cannabis strain that worked miracles on a sick little girl named Charlotte.

Word spread about the awe-inspiring results of this low-THC, high-CBD extract. CNN paid Charlotte and the Stanley brothers a visit in 2013, and the story made the brothers rich and changed minds around the world about the value of a plant formerly sneered at by mainstream medicine.

It’s an inspiring story.

But what many folks in the hemp industry don’t know is how it happened, or how those well-meaning caregivers spread word of their product’s healing properties without inviting class-action lawsuits or the wrath of the U.S. Food and Drug Administration, which reminds CBD entrepreneurs at every turn that they can’t make medical claims.

Media Might

The secret behind the shocking business success of the company that became Charlotte’s Web Holdings is available to every creator in the hemp industry. It’s free and as close as your local newspaper. I’m talking about the press.

As we examine liability concerns in the cannabis industry, I want to share how the press can be your secret weapon in gaining global recognition without spending a dollar on advertising or hiring a lawyer to shield you from FDA sanctions.

The story of Charlotte Figi is a great example.

Charlotte and her caregivers didn’t start sharing their CBD story on prime-time television. Instead, a local newspaper reporter in Colorado Springs, Colorado, was the first to tell their story.

The caregivers and Charlotte’s family were completely honest about the girl’s disease and her treatment at a time when many parents would be considered criminals for giving their children an illegal drug.

And in an age when people guard their medical privacy and look at the media with suspicion, Charlotte’s advocates invited a local reporter and photographer to come see her progress firsthand.

What happened next was no surprise to folks who work in journalism.

Free To Tell It Like It Is

The local newspaper report about Charlotte Figi caught the attention of larger newspapers in Denver. More reporters started inquiring about this little girl, and they were again welcomed to find out more and share the story.

Media attention grew until the Denver correspondent for The New York Times wrote a piece about the Figis. That’s when CNN sent a team to Colorado Springs.

CNN does great work, but the network doesn’t have the manpower to discover every sick child experiencing a shocking medical outcome. Global media outlets read about those cases in newspapers.

You can review every news story ever written about Charlotte Figi. None of them tiptoes around CBD’s effects on the girl or use vague, lawyer-approved language like “may help support a healthy lifestyle.”

And none of the stories mentions any scary-sounding side effects of taking huge quantities of CBD (and yes, there can be some, even if they are rare).

Charlotte’s Lesson

The story of Charlotte’s Web should inspire everyone making healing products from cannabis.

Forget the slow-moving FDA. Forget the constant vigilance of label language and making sure customer testimonials don’t pop up on your site.

Instead, find out the names of your local newspaper reporters. Read their work and share it on social media. That gets a reporter’s attention faster than the fanciest news release.

And when you have a patient or a client finding amazing results from your products, get those folks in touch with a local reporter.

You can’t make medical claims. But reporters can share the story of your experience with no chance of government sanction. Sometimes those local newspaper stories turn into priceless global media exposure. Just ask the Charlotte’s Web pioneers.

As you may know, Charlotte died last year. Let her story inspire you to keep seeking the healing properties of the cannabis plant — and let the Stanley brothers’ experience show you how to avoid liability concerns while still letting everyone know how miraculous this plant can be.

Kristen Nichols is editor of Hemp Industry Daily. She can be reached at [email protected].

Hemp businesses walk a fine line when describing the health benefits of their products: Make a claim without evidence or wording that misleads consumers, and soon the legal fees will pile up.

The U.S. Food and Drug Administration has guidelines for acceptable claims to make on labels for dietary supplements – the closest fit for certain hemp products, although the FDA does not currently consider CBD or any other hemp extracts a dietary supplement.

Claims by dietary supplement makers often fall under what are called “structure/function” claims. Saying “calcium builds strong bones” is an example of a structure/function claim, according to the FDA. Another example would be, “Vitamin C supports a healthy immune system.”

“Structure/function is essentially when you would like to make a claim about how the ingredient or product affects a structure or function of a human being,” said Douglas Kalman, vice president of Scientific Affairs at Nutrasource, a company that helps brands with health product development and market entry.

But just because structure/function claims are allowed, it doesn’t mean companies get to fudge the truth.

The U.S. Federal Trade Commission, which oversees advertising and marketing, says “claims in advertisements must be truthful, cannot be deceptive or unfair, and must be evidence-based.”

The agency has already gone after CBD companies that claimed their products treated diseases including cancer, high blood pressure and Alzheimer’s.

Steering clear of legal action

Kalman, who spoke recently on a webinar on labeling claims, has this advice for companies to make sure what they say about their product can withstand legal scrutiny:

• Have a scientifically backed study so the results can be translated into structure/function claims, with substantiated evidence.
• Not every company can afford to conduct a study, or a finished product to do the study on, so promoting the effects of a particular ingredient using established research might be best option available. Still, Kalman urges companies to work with an attorney and any relevant agency to vet the claims before putting them on labels.
• Work with an accounting firm that understands the IRS tax codes that can be utilized by dietary supplement companies, including ingredients. Kalman said there are research and development tax credits available to help with certain expenses, such as salaries or equipment.

When making a structure/function claim, products must have a disclaimer reading: “This statement has (or These statements have) not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

“The disclaimer must appear in bold type on the same display panel as the structure/function claim,” according to the American Herbal Products Association’s guidance.

Legal victory

The importance of proper labeling and research to substantiate a claim was highlighted this month in a federal case where a customer sued Target Corp. over a vitamin called biotin, which the retailer sold under its private label Up & Up.

Biotin was marketed as supporting healthy hair and skin. The plaintiff in the case bought it to help with hair loss, but he said he received no benefit.

The 9th Circuit Court of Appeals ruled in Target’s favor, with one judge writing that, “Simply put, manufacturers may make structure/function claims about a nutrient’s general role on the human body without disclosing whether the product will provide a health benefit to each consumer.”

Further, the court found that the claim regarding biotin was not misleading and that it was backed by scientific evidence and contained the proper disclaimer, according to Natural Products Insider, which reported the decision.

“This is a big win for the industry,” said Erica Stump, an attorney whose law firm represents food and dietary supplement companies.

“Now the 9th Circuit is out there saying that these are valid structure/function claims and they have been substantiated by competent, reliable, scientific evidence. It doesn’t matter that it didn’t work on this one person.”

Ivan Moreno can be reached at [email protected]

U.S. drug regulators have withdrawn their proposal to regulate over-the-counter CBD, handing the industry another setback after years of delay from the Food and Drug Administration.

The proposal in question appears to be on pause because of the changing administration. The delay was widely anticipated but still frustrating for CBD operators awaiting the rules.

The FDA sent the proposal to the White House Office of Management and Budget last July, a final stop before new regulations go public.

But the FDA withdrew its CBD proposal last Thursday, a day after President Joe Biden was inaugurated. The withdrawal came hours after the Biden administration issued a memo to all federal agencies telling them to withdraw pending rules, such as the FDA’s CBD guidance.

Details of the proposal were never released. They were sent more than a year after the FDA started a fresh review of CBD and other cannabinoids.

There is no legal deadline for the FDA to clear a path for legal over-the-counter CBD. But the agency has repeatedly confirmed that they know the product is commonly sold and that regulatory safety standards are overdue.

The Trump White House OMB reportedly met to discuss new CBD rules with CBD makers and retailers including GW Pharmaceuticals and chain retailer General Nutrition Centers (GNC).

The FDA did not immediately return a message Monday from Hemp Industry Daily asking about the delay.