You know something is peaking when Kim Kardashian gets involved.

The famous-for-being-famous superstar is throwing a cannabidiol (CBD) themed baby shower to stop her from “freaking out” over the birth of her fourth child (whether it’s pregnancy-safe is not an issue here: Kardashian isn’t carrying the baby — a surrogate is).

The news generated hyperventilating headlines around the world and added to the huge consumer hype around the marijuana compound.

But it also begs the question: has the craze for CBD moved out of regulators’ control, and what impact may the flow-on effects — when people realise many off-the-shelf products don’t work — have on companies working on legitimate treatments?

Botanix Pharmaceuticals (ASX:BOT) director Matt Callahan says a reckoning would be great news for legitimate products, as is Kardashian’s high-profile backing of the industry.

“[With CBD] I think probably the genie is out of the bottle but like all things that are introduced very quickly, the state governments and people themselves become their own regulators of what’s quality and what’s not quality,” he told Stockhead.

“There’s going to be a separation of the snake oil ‘it’s good to fix everything’, and the clinically supported diseases where the drug is going to have an effect. The only way to get that information is to run clinical studies that are placebo controlled.”

What happens in the US is important because it is the biggest pharmaceutical market in the world and the largest cannabis market; researcher New Frontier Data is forecasting $US7bn in cannabis sales this year.

Botanix is currently putting cannabis-based treatments for psoriasis, acne and dermatitis through their clinical paces, and wants to have a study designed for the new anti-microbial skin infection indication “within the next quarter or two”.

Read: The Pot Seat: Botanix’s Matt Callahan says synthetics are the future of cannabis drugs

Medlab Clinical (ASX:MDC) and Rhinomed (ASX:RNO) are two other ASX-listed companies that have plans to sell clinically-trialled cannabis products into the giant US pharmaceutical market.

Cat is out of the bag

Marijuana is legal either recreationally, medicinally, or both in 33 of the 50 US states.

As of December, CBD made from hemp became legal federally after the 2018 Farm Bill was voted into law.

This has encouraged a boom in CBD products from coffee infusions to ice cream, and from beer to herbal supplements, but with very few benchmarks in place to allow consumers to assess quality, or even the contents of products.

Outgoing FDA boss Scott Gottlieb last week said the Food and Drug Administration (FDA), which regulates safety across all of these areas, had issued letters to three companies to stop making unsubstantiated health claims about CBD in more than a dozen products.

These included that CBD stops cervical cancer cell growth, slows the progression of Alzheimer’s, and had “demonstrated” the ability to help with pain associated with migraines and irritable bowel syndrome.

“I believe these are egregious, over-the-line claims and we won’t tolerate this kind of deceptive marketing to vulnerable patients,” he said.

Read: Cannabis stocks guide: Here’s everything you need to know

But celebrities, such as Kardashian saying she wants a CBD baby shower to calm herself pre-birth (no word on whether the surrogate is invited to the party), suggest the genie is out of the bottle in terms of what people believe the compound can do, versus what it has been clinically proved to do, and in the efficacy of products available.

The author of a 2017 study that found 70 per cent of CBD products were mislabeled, has been widely quoted in the media saying he doesn’t trust any US CBD product.

“You’re really flying by the seat of your pants when you buy this stuff,” said Marcel Bonn-Miller, now an advisor to a cannabis company and formerly of the University of Pennsylvania.

Callahan says they tested Botanix’s acne treatment against five cannabis topical creams now on the market in the USA, Canada and Australia, and found the amount of CBD actually in the creams was nowhere near what was stated on the packet.

For example, their researcher found TheraGreen topical pain relief, made by Green Roads, had 24.5mg of CBD in a tube when the packaging said it had 300mg.

“I honestly can’t give any good advice for what to look for because there’s no standards. You can’t believe the stuff on the label,” Callahan said.

Food versus medicine

Back in Australia, Medical Cannabis Council general manager Blaise Bratter believes the industry will split in two: there will be food grade CBD and pharma grade CBD.

In Australia, only pharma grade CBD is allowed in products and they must be prescribed by a doctor.

In the UK, until February when the EU food safety body laid down rules saying CBD was a “novel” food product, hemp-derived CBD foods and supplements were legal but anything containing THC required a prescription.

Currently in the US there are many off-the-shelf CBD products but only one approved drug, Epidiolex for two rare forms of childhood epilepsy.

Callahan believes medical-grade CBD products won’t be tainted by association with the unregulated forms currently being spruiked, as they’ll rely on the strengths of data and FDA approval.

He cites Botanix’s skin treatments as an example: he says they’re the only ones doing clinical trials on cannabis skin products and, after FDA approval, will be the only cannabis skin treatments doctors can prescribe and insurers reimburse.