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Potential dangers of CBD oil

Lowell Schiller FDA regulator
FDA regulators fear effects on other meds
Psychoactive THC can be dangerous, say some critics of cannabis legalisation, but CBD is safe.

Now that truism has been called into question. Both its effect on other medications, and labelling and testing inconsistencies mean the jury is still out on CBD and will be for some time.

CBD, a cannabis extract, is sold online and prominently displayed in mainstream stores and specialty boutiques around the world – both pure and as a key ingredient in everything from tinctures and lotions to gummy chews, taffy, bath bombs, pet foods, human foods, and coffee additives. You can take CBD by pill or capsule, suck a lozenge, put a drop under your tongue, vape it, rub it on or soak in it.

In Europe about 5% have tried CBD, although in the UK the number is closer to 10%. A Gallup poll released in August found 14% of Americans use CBD products, the numbers higher among younger than older folks. While the European regulators have largely acted qs cheerleaders for CBD the same is not true in the USA.

Lowell Schiller, the US (Food and drug Administration (FDA’s) principle associate commissioner for policy said some CBD drug interactions have been found that consumers need to be aware of, including liver injury, drowsiness, suicidal thoughts and drug interactions.

Buyer beware?

University of Utah experts Karen Wilcox, professor and chairman of the department of pharmacology and toxicology, and Misty Smith, a research assistant professor in that department, point out that CBD may impact how medications – prescribed or over-the-counter – work. “I warn people most about potential drug-drug interactions,” Smith said, because cannabinoids and CBD can turn up or turn down metabolism of other drugs one takes for health conditions. For instance, CBD use strengthens the blood-thinning effect of the oft-prescribed blood thinner warfarin. Smith said some anxiety medication and antibiotics are among those that CBD may negatively interact with, likening it to warnings that grapefruit can create harmful interactions with certain medications. “The potential for drug interactions are huge,” Smith said. Nor does it necessarily require a high dose. “Multiple low doses taken chronically can have effects on drug metabolism as well,” she noted, adding that people are “taking CBD by multiple routes. They are putting it in everything at this point, or we think they are.” Could hemp-derived CBD products trigger a positive drug test? Officials say it’s unlikely, given a product would have less than trace amounts of THC, but it’s conceivable – if one used a lot and the products used happened to contain THC or be contaminated or did not contain true CBD oil.

In 2017, researchers bought 84 different CBD products from 31 companies and had them tested in a lab to see what they contained and how that compared to what was on their ingredient labels. The study, published in the Journal of the American Medical Association, found 69% did not match what their labels claimed, some having unacceptably high levels of THC, some having more CBD than stated, some even having no CBD at all. That was before CBD products became available nationwide because hemp’s status changed. There are now more products being marketed and states are scrambling to decide how or if to regulate all of them. Some states do more to regulate product than others.

Key questions

Dr. Amy Abernethy, the FDA’s principal deputy commissioner, and Schiller have a list of questions about CBD products the FDA – and presumably consumers – would like to see answered. They include how much is safe to consume in a day and whether the CBD form matters, whether drug interactions should be monitored and whether different groups, like the elderly or children, experience different impact. They also wonder about long-term exposure.

The relevant difference between hemp and its also-cannabis marijuana cousin is that hemp has at most just trace amounts of tetrahydrocannabinol (THC), the compound that provides marijuana’s high, and so CBD from hemp doesn’t have a psychoactive effect on users. The World Health Organization has said that “in humans, CBD exhibits no effects indicative of any abuse or dependence potential” and notes “no public health issues have been associated with use of pure CBD.” However, right now even those rooting for CBD to live up to its hype say the rules governing product sales are complicated and caution that use is buyer beware.

Legal status

Medicinal claims are illegal. Studies in humans are scarce. And product oversight is challenging and sometimes lacking. ‘It’s complicated’ said Dr. Peter Grinspoon, a contributor to the Harvard Medical School health blog.

CBD is readily obtainable in most parts of Europe and the United States, though its exact legal status is in flux. European countries and their oversight agencies have different rules governing who can grow hemp and how CBD products can be manufactured, among other things. The variety of hemp products creates its own confusion. While CBD is relatively new Europewide, hulled hemp seed, hemp seed protein powder and hemp seed oil have been legally marketed for some time in human foods. The seeds don’t naturally contain either CBD or THC. CBD oil is extracted from hemp seeds through a high-pressure process. Some manufacturers say hemp makes good food, calling it “one of the most nutrient-dense plants on the planet,” likening it to spinach and kale.

Others maintain more study is needed to determine precisely what the benefits are. Medical marijuana is far better researched in laboratories than CBD from hemp. Plus, in marijuana studies, it’s not always clear whether effect is related to THC or CBD or both. People may be conflating the impact of one and claiming it for the other, experts warn. Controlled studies in humans have been few, though preclinical studies in animals suggest health benefits from CDB.

Still, experts warn findings in animals don’t always translate to treatment for humans. A 2017 landmark review by the U.S. National Academy of Sciences, Engineering and Medicine looked broadly at cannabinoids and found “substantial evidence” they could help chronic pain, reduce nausea from chemotherapy and reduce spasticity in patients with multiple sclerosis. They found somewhat less evidence it might help with sleep-related issues for those with chronic pain. There’s less evidence that cannabinoids helps with PTSD, anxiety and traumatic brain injury. The review found insufficient evidence to back conclusions that marijuana helps with immune system disorders and warned that smoking cannabis during pregnancy is linked to low birth weight. CBD from hemp wasn’t the focus of those studies. And so far, the US Food and Drug Administration has approved just one CBD-derived drug, Epidiolex, which is used for seizures in a specific form of epilepsy in children.

Anecdotal evidence of health benefits is more plentiful, but it’s not the currency in which the regulatory bodies trade. The US FDA is “concerned” about the proliferation of CBD-containing products marketed for therapeutic or medicinal uses that haven’t been approved by the FDA. Making claims of health benefit is illegal and puts patients at risk, implying more efficacy and oversight than have been applied, FDA officials warn. Worse, folks may forgo proven treatments to try them. Gallup said those in its poll who tried CBD products said they used it mostly because of pain, anxiety or insomnia – but sellers can’t say it helps with any of those things. “We don’t hold a grudge against them, but we also don’t hold them to a lower standard or safety or absolve them of other requirements. Consumers have a right to expect the same level of FDA protection with respect to hemp and derivatives like CBD as they would expect with respect to any other substance,” said Lowell Schiller, the FDA’s principle associate commissioner for policy, to the National Industrial Hemp Council 2019 Hemp Business Summit in August. He said the FDA encourages research into proposed therapeutic uses. “If there were evidence demonstrating that a CBD product meets the drug approval standard for a new indication, and an application was submitted and approved, that would be a big win for public health.” But absent studies and FDA approval, CBD sellers are not supposed to make any type of health-related claim about their products. The agency has issued warning letters about that.

“Drug testing can produce false positives. The other things is, if you have a sluggish metabolism, maybe minute amounts of THC could accumulate.” He said he tells people if their job depends on drug testing, they shouldn’t take the product. Others warn that people sometimes fail drug tests because they use other cannabinoids, then blame it on CBD, not understanding that THC is really not part of hemp’s profile. FDA experts do not tell people not to use CBD products, nor encourage use. But they do say there’s plenty to consider as the industry and its products evolve and regulations and research continue to shake out.

Wild West

Because of patchwork oversight from country to country, a dearth of clinical studies in humans and how quickly some products were moved to market once the USA Farm Bill passed, some experts call the landscape surrounding CBD the Wild West. It will be settled, but it isn’t yet. And consumers have to trust that products contain what they say they do, which has been an ongoing complaint about some supplements, which are largely unregulated unless they make health claims.

Some countries, and US States, requires registration of each formulation of a CBD product, so someone who produces lavender CBD bath bombs and lemon grass CBD bath bombs must register them separately, paying a fee and listing ingredients for each product line in order to sell them. They are also required to have a certificate of analysis so consumers can see a lab examined the batch of product and did not find heavy metals or other contaminants, while also listing what it does contain.

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