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5 Things to Know about Delta-8 Tetrahydrocannabinol – Delta-8 THC

Delta-8 tetrahydrocannabinol, also known as delta-8 THC, is a psychoactive substance found in the Cannabis sativa plant, of which marijuana and hemp are two varieties. Delta-8 THC is one of over 100 cannabinoids produced naturally by the cannabis plant but is not found in significant amounts in the cannabis plant. As a result, concentrated amounts of delta-8 THC are typically manufactured from hemp-derived cannabidiol (CBD).

It is important for consumers to be aware that delta-8 THC products have not been evaluated or approved by the FDA for safe use in any context. They may be marketed in ways that put the public health at risk and should especially be kept out of reach of children and pets.

Here are 5 things you should know about delta-8 THC to keep you and those you care for safe from products that may pose serious health risks:

1. Delta-8 THC products have not been evaluated or approved by the FDA for safe use and may be marketed in ways that put the public health at risk.

The FDA is aware of the growing concerns surrounding delta-8 THC products currently being sold online and in stores. These products have not been evaluated or approved by the FDA for safe use in any context. Some concerns include variability in product formulations and product labeling, other cannabinoid and terpene content, and variable delta-8 THC concentrations. Additionally, some of these products may be labeled simply as “hemp products,” which may mislead consumers who associate “hemp” with “non-psychoactive.” Furthermore, the FDA is concerned by the proliferation of products that contain delta-8 THC and are marketed for therapeutic or medical uses, although they have not been approved by the FDA. Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of federal law, but also can put consumers at risk, as these products have not been proven to be safe or effective. This deceptive marketing of unproven treatments raises significant public health concerns because patients and other consumers may use them instead of approved therapies to treat serious and even fatal diseases.

2. The FDA has received adverse event reports involving delta-8 THC-containing products.

From December 2020 through July 2021, the FDA received adverse event reports from both consumers and law enforcement describing 22 patients who consumed delta-8 THC products; of these, 14 presented to a hospital or emergency room for treatment following the ingestion. Of the 22 patients, 19 experienced adverse events after ingesting delta-8 THC-containing food products (e.g., brownies, gummies). Adverse events included vomiting, hallucinations, trouble standing, and loss of consciousness.

National poison control centers received 661 exposure cases of delta-8 THC products between January 2018 and July 31, 2021, 660 of which occurred between January 1, 2021, and July 31, 2021. Of the 661 exposure cases:

  • 41% involved unintentional exposure to delta-8 THC and 77% of these unintentional exposures affected pediatric patients less than 18 years of age.
  • 39% involved pediatric patients less than 18 years of age
  • 18% required hospitalizations, including children who required intensive care unit (ICU) admission following exposure to these products.

3. Delta-8 THC has psychoactive and intoxicating effects.

Delta-8 THC has psychoactive and intoxicating effects, similar to delta-9 THC (i.e., the component responsible for the “high” people may experience from using cannabis). The FDA is aware of media reports of delta-8 THC products getting consumers “high.” The FDA is also concerned that delta-8 THC products likely expose consumers to much higher levels of the substance than are naturally occurring in hemp cannabis raw extracts. Thus, historical use of cannabis cannot be relied upon in establishing a level of safety for these products in humans.

4. Delta-8 THC products often involve use of potentially harmful chemicals to create the concentrations of delta-8 THC claimed in the marketplace.

The natural amount of delta-8 THC in hemp is very low, and additional chemicals are needed to convert other cannabinoids in hemp, like CBD, into delta-8 THC (i.e., synthetic conversion). Concerns with this process include:

  • Some manufacturers may use potentially unsafe household chemicals to make delta-8 THC through this chemical synthesis process. Additional chemicals may be used to change the color of the final product. The final delta-8 THC product may have potentially harmful by-products (contaminants) due to the chemicals used in the process, and there is uncertainty with respect to other potential contaminants that may be present or produced depending on the composition of the starting raw material. If consumed or inhaled, these chemicals, including some used to make (synthesize) delta-8 THC and the by-products created during synthesis, can be harmful.
  • Manufacturing of delta-8 THC products may occur in uncontrolled or unsanitary settings, which may lead to the presence of unsafe contaminants or other potentially harmful substances.

5. Delta-8 THC products should be kept out of the reach of children and pets.

Manufacturers are packaging and labeling these products in ways that may appeal to children (gummies, chocolates, cookies, candies, etc.). These products may be purchased online, as well as at a variety of retailers, including convenience stores and gas stations, where there may not be age limits on who can purchase these products. As discussed above, there have been numerous poison control center alerts involving pediatric patients who were exposed to delta-8 THC-containing products. Additionally, animal poison control centers have indicated a sharp overall increase in accidental exposure of pets to these products. Keep these products out of reach of children and pets.

Why is the FDA notifying the public about delta-8 THC?

A combination of factors has led the FDA to provide consumers with this information. These factors include:

  • An uptick in adverse event reports to the FDA and the nation’s poison control centers.
  • Marketing, including online marketing of products, that is appealing to children.
  • Concerns regarding contamination due to methods of manufacturing that may in some cases be used to produce marketed delta-8 THC products.

The FDA is actively working with federal and state partners to further address the concerns related to these products and monitoring the market for product complaints, adverse events, and other emerging cannabis-derived products of potential concern. The FDA will warn consumers about public health and safety issues and take action, when necessary, when FDA-regulated products violate the law.

How to report complaints and cases of accidental exposure or adverse events:

If you think you are having a serious side effect that is an immediate danger to your health, call 9-1-1 or go to your local emergency room. Health care professionals and patients are encouraged to report complaints and cases of accidental exposure and adverse events to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem.
  • Complete an electronic Voluntary MedWatch form online or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.
  • Complete a paper Voluntary MedWatch form and mail it to the FDA.
  • To report adverse events in animals to the FDA’s Center for Veterinary Medicine, please download and submit Form FDA 1932a found at: www.fda.gov/ReportAnimalAE.

For more information about Delta-8 THC: CDC HEALTH ALERT NETWORK (HAN)

CBD drug interactions: Is CBD safe to take with prescription medications?

If you’ve visited a store that sells health and beauty products lately, you may have noticed that products containing CBD, or cannabidiol, seem to be all the rage. Oil, chocolate, supplements, even carbonated beverages, are filling up shelves—enticing shoppers with claims that using one of these products will cure insomnia, alleviate anxiety, reduce inflammation, or treat PTSD.

And shoppers are buying it, so to speak—one recent report indicated that CBD sales are expected to hit $16 billion by 2026, up from just over $1 billion in 2018. But what exactly is CBD, and is it safe for people who are using prescription medications? Before using it, it’s important to learn about the potential CBD drug interactions.

Is CBD marijuana?

While CBD is one of the active ingredients in marijuana, using CBD itself will not get you high (the component that does that is called tetrahydrocannabinol, or THC). CBD is really just a molecule within the hemp variety of the cannabis plant, and there is at least some anecdotal evidence and preliminary research suggesting that the extraction created from this molecule has some health benefits.

CBD is thought to act on certain receptors in your brain and other parts of the body, in ways that could relieve pain, or help certain health conditions, like childhood seizure disorders. However, as with any “natural” product, the fact that it comes from plants doesn’t automatically render it innocuous. For some people, particularly those taking certain prescription medications, using CBD is risky. It has anticoagulant effects that can thin blood; it can also modestly lower blood pressure. These effects could be dangerous for people with certain medical conditions.

“Herbal products are drugs,” says Rita Alloway, Pharm.D. , research professor of nephrology at the University of Cincinnati College of Medicine. “Just because [something] is herbal … doesn’t mean it can’t interact with any of the pharmaceutically manufactured drugs that you may be taking.”

Does CBD interact with medications?

Case in point: tacrolimus , an immunosuppressive medication used to prevent organ rejection in patients who have had heart, liver, or kidney transplants. CBD interferes with the metabolism of tacrolimus, according to research conducted by Dr. Alloway , who specializes in post-transplant immunosuppression. And because tacrolimus is a narrow therapeutic index drug (meaning the window between efficacy and toxicity is very small), this interference can lead to clinically significant negative outcomes (such as kidney problems or organ rejection), she says.

Are the concentrations in commercially available CBD high enough to cause this interaction? The evidence doesn’t really say one way or another. Dr. Alloway’s research involved a high dosage of CBD that wouldn’t be found in a retail product. However, it “highlights that a drug interaction is there,” she says. Plus, tacrolimus is metabolized in the body by a group of enzymes called cytochrome P450 and CBD is a known inhibitor of this process. What does that mean? If CBD inhibits the metabolism of tacrolimus, the patient can end up with too-high levels of tacrolimus in the body. In light of this, she urges anyone taking tacrolimus to speak with their transplant team before using CBD. Don’t get your hopes up, though—using herbal remedies, particularly those with potential interactions, is generally frowned upon by doctors looking after transplant recipients (including Dr. Alloway).

As for other drugs, well, most haven’t been studied yet. There is preliminary evidence that CBD could have a similar effect to grapefruit juice, impairing how your body metabolizes drugs, and raising serum levels of those medications in your body. And, because cytochrome P450 is responsible for the metabolism of numerous medications , proceed with caution before mixing any prescription pharmaceutical with CBD, Dr. Alloway says.

How about CBD’s therapeutic benefits?

Despite the not-so-great news about CBD for patients using tacrolimus, for some people, CBD is actually life-changing in a positive way. In 2018, for example, the CBD-derived medication Epidiolex received FDA approval for the treatment of Lennox-Gastaut syndrome and Dravet syndrome, two very rare and very severe forms of epilepsy.

But claims that CBD aids in the treatment of certain mental health and psychiatric conditions, don’t pass muster, says Roger McIntyre, MD , professor of psychiatry and pharmacology at the University of Toronto.

“There is no role right now for CBD in managing mental disorders that I [treat], such as depression, bipolar disorder … anxiety and ADHD,” he says. “We just don’t have the evidence that supports [it].”

Furthermore, most prescription medications used to manage these conditions are metabolized by cytochrome P450, making it entirely possible that CBD could interfere with—rather than enhance—treatment.

Dr. McIntrye, who co-authored a 2018 study that concluded that healthcare providers need more information about drug-drug interactions with CBD and psychotropic medication, says much of the information out there is confusing and contradictory. Therefore, he echoes Dr. Alloway’s statement that it is absolutely prudent that patients clear the use of CBD with their doctor before giving it a go.

“[The provider] knows the individual and knows what other treatments they may or may not be taking,” Dr. McIntyre explains. “They have a panoramic view of the patient’s medications, and would have [a better idea] of whether the patient is taking another medication that may have an interaction.”