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In the latest episode of Call Me Cannabinoids, Pete interviews Anthony Almada of IMAGINutrition, Inc., a nutrition industry executive, entrepreneur, brand co-creator, and expert in the hemp CBD industry. Pete and Anthony discuss Epidiolex, the FDA’s recent letter to Curaleaf and what that means for the CBD industry, the “transdermal train wreck”, and the industry’s need for more information about CBD and other cannabinoids.

About Anthony Almada

Anthony has been interested in nutrition and health for most of his life–he even began working at health food stores at age 15, before he could even drive. He has an academic background in nutrition, biochemistry, and exercise chemistry. His career in the natural health sector spans work with Metagenics, Inc.–one of the largest dietary supplement brands that sells to doctors–and extended into human studies on the effects of dietary supplements on diseases like Lou Gherig’s Disease.

In 1989, he first learned about botanical extracts through a friend who worked for Indena. He developed an interest in botanical extracts–and then hemp became part of the public consciousness. As colleagues began to move into working for the hemp industry, Anthony took notice–particularly of the fact that anecdotal evidence and scientific research don’t yet match up.

“There isn’t evidence to support these amazing claims–or that evidence doesn’t apply to what’s being sold and what’s being marketed,” he says. “So there’s an enormous gap. And that’s what made me very intrigued and excited about pursuing this.”

Epidiolex and Existing CBD Research

According to Anthony, the majority of research that does exist surrounds the prescription drug Epidiolex. But he’s excited for future CBD research that will reveal whether CBD in itself is the active ingredient, or if there are other constituents accompanying CBD that are responsible for its reported effects.

“Is CBD the active ingredient, or could there be other things that are the ingredient independent of CBD? We don’t know–nobody knows–but we will find out,” he says.

So far, the large Epidiolex studies funded by GW Pharmaceuticals are our main source of scientific information about CBD. According to Anthony, one of the biggest question marks surrounding Epidiolex is whether the drug itself is working to suppress seizure activity in epileptic patients, or if it’s actually working to increase the amount of seizure medication in their blood.

One recent study also indicated that CBD can alter the liver’s metabolism, resulting in altered metabolism of certain drugs or agents. Anthony says this phenomenon, if proven true, could “put people at risk because it can delay how fast a drug is cleared or removed from the blood and therefore you get high blood levels which can be toxic.”

Researchers could learn more about the effects of CBD on seizures by giving their control subjects only Epidiolex to see whether they observe a reduction or cessation of seizures in the absence of anti-epileptic prescription medication, according to Anthony. He also says dosage is key; Epidiolex delivers an incredibly high dose of CBD to its patients (the drug itself is 90% CBD, and delivers around 10 to 20 mg per pound of body weight).

“The doses of CBD that have been used for anxiety, schizophrenia, and Parkinson’s–the doses that are being used in these clinical studies with drug-form CBD not commercially available–are so much higher than what people are using or what’s being recommended,” he says.

CBD Health Claims Trigger FDA Scrutiny

A major issue CBD companies are facing is the presence of claims in their materials–whether on or off label (for example, a brochure or a blog post). The problem is, many of the health claims adopted by CBD brands on the market are from studies that aren’t attributed to their specific product, which could land them in hot water with the FDA.

“Most of these companies are not selling CBD,” Anthony says. “They’re selling an extract that happens to contain CBD as a minority constituent.

“They’re making these claims regarding cancer and a number of other diseases–inflammation, chronic inflammatory diseases–and all those studies are still coming from something different than what was being sold. But CBD is a catch-all lightning rod magnet that everyone has heard about.”

Regardless of CBD’s popularity and how effective it may or may not prove to be through more extensive study, Anthony says it’s illegal to make health claims about CBD. Companies should steer clear of claiming that CBD can be used to treat or cure any illness, especially cancer–a word Anthony says is a “flashpoint for the FDA.” The recent FDA letter to Curaleaf is indicative of the response companies get from the FDA when they step too far into claims territory.

CBD Brands Should Steer Clear of Transdermal Claims

Many CBD companies with products on the market currently have topical products they’ve advertised as being transdermal (a product that enters the bloodstream via topical application). But Anthony says it’s a major no-no for a brand to call their topical product transdermal. In fact, stating that a topical product does anything more than a cosmetic product is considered a drug claim.

“Anything that claims to go through the skin and deliver something to the blood and into systemic circulation is, by definition, a drug,” he says.

Anthony referenced a study published in the Journal of the American Medical Association that examined whether sunscreen ingredients were transdermal. Sunscreen ingredients did, in fact, pass through the skin into the bloodstream, raising concerns that those products might be toxic or even carcinogenic once they pass through the skin. Transdermal products are an entirely different product category than topicals.

“Now they need to do carcinogenicity, cancer, and long-term toxicology studies,” he says. “So if you do have a transdermal product, don’t mention it.”

FDA, Epidiolex, and CBD: The Big Question

The biggest question weighing on many CBD companies is how the FDA will choose to regulate CBD in light of GW Pharmaceuticals’ intellectual property claim on Epidiolex. One notable statement in FDA’s letter to Curaleaf was its mention of Epidiolex’s standing as a drug prior to CBD dietary supplements’ availability on the market. This, in essence, classifies CBD as a drug and not a dietary supplement.

“There is an investigational new drug authorization for Epidiolex which got published in 2014.
It states that the FDA is unaware of anybody having marketed CBD–or a product labeled to contain CBD–before the Epidiolex investigational new drug authorization was issued,” he says.

While this statement gives FDA the power to pull a CBD product from the market, Anthony says they would do so to “massive public outcry.” He draws a parallel with the early prescription statin drugs and red yeast rice, an active ingredient. Red yeast extracts may be sold in dietary supplements, but only if the ingredient content is below a certain amount. Otherwise, the company receives a warning letter from the FDA and may be pulled from the market if necessary adjustments aren’t made.

“The same thing could happen if you have more than a certain amount of CBD in your extract,” Anthony says.

As for the near future of the industry, Anthony says it’s important for brands to keep an eye on any changes to the FDA’s current guidelines, as well as the warnings that are being issues so they can position themselves well, do right by the consumer, and increase the body of evidence as an industry.