cbd oil safe for kids fda

6 Things Medical Experts Want You to Know About CBD and Kids

In June 2018, the Food and Drug Administration approved the first Cannabis-derived drug to treat Lennox-Gastaut syndrome and Dravet syndrome, two rare and severe forms of epilepsy.

Known as Epidiolex, the drug contains highly purified CBD and is approved for patients two years and older. While proven to treat severe forms of epilepsy, it is not without side effects. In clinical trials, researchers observed sleepiness, lethargy, elevated liver enzymes, decreased appetite, diarrhea, rash, insomnia, sleep disorder, and infections—all relatively acceptable risks, especially compared to debilitating seizures.

Doctors still do not know precisely how or why the best CBD oils are so effective in treating certain medical conditions, but studies continue to show immense potential. With this encouraging development, there is obvious interest in CBD’s medical application, especially for kids.

Keep these six points in mind when considering if CBD is safe for your children.

1. THC and CBD are not the same, especially in children.

Pure CBD, which contains no THC and produces no psychoactive effects, has generally been deemed safe and effective by the World Health Organization. Much less is understood about medical marijuana’s effects on children, and researchers have not yet examined THC’s capacity for safely treating severe developmental or behavioral conditions in children in a large clinical setting.

The American Pediatric Association opposes medical marijuana outside the FDA regulatory process, citing harm to adolescent health and development. However, the organization does support the “compassionate use” of THC products for children with debilitating conditions.

Other studies support these findings. One study published in Frontiers in Pharmacology administered a high dose of cannabinoids containing a ratio of CBD and THC to two children suffering from different forms of seizures. Both children attained full remission using the extract but also presented signs of THC intoxication.

Researchers replaced the treatment with a pure CBD isolate, which reduced intoxication symptoms and kept the seizures in remission after four weeks.

The study concluded that “due to the necessary chronic use of these products and the long half-life of THC, cannabis-derived products can cause intoxication in patients with clinical, cognitive, and motor impairments, with detrimental consequences.”

Clinical evidence so far points more towards the use of pure CBD over THC extract, particularly in children.

2. When it comes to whether CBD is safe for kids, research has focused mostly on disorders like epilepsy—less is known about other illnesses.

The limited, albeit promising, clinical evidence for treating childhood disease with CBD has focused primarily on rare and severe forms of epilepsy. Much less is known about other childhood diseases, though that is slowly changing.

It takes time to conduct clinical trials and formulate evidence-based conclusions. Even the World Health Organization, which recently issued a statement in favor of CBD, did not add CBD to its list of medications considered to be most effective and safe for adults or children.

The American Academy of Pediatrics only recently changed its stance to support the limited use of products to treat life-threatening conditions in children.

Bottom line: if you are wondering if CBD is a good option for your child, consult a doctor.

3. Not many CBD studies involve children, but those that do look promising.

The limited body of CBD research involving children looks promising, including applications for treating epilepsy, anxiety, nausea, and autism.

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Epilepsy

The most significant clinical CBD study in the US focuses on Epidiolex’s effectiveness in treating children diagnosed with Dravet syndrome or Lennox-Gastaut syndrome. In three randomized, double-blind, placebo-controlled clinical trials involving 516 patients, including children, pure CBD was effective in reducing the frequency of seizures when compared with placebo.

Another large CBD study included 137 children and young adults suffering from 12 different forms of epilepsy. The study found that almost 50 percent of the patients experienced a decrease in the frequency of seizures with minor side effects.

Anxiety

A 2016 study evaluating the effects of CBD products in treating a ten-year-old girl’s anxiety found that 12 to 25 mg of pure CBD oil daily effectively reduced anxiety and insomnia without harmful side effects. However, the study did not examine long-term effects of CBD in children and was limited to a sample size of one.

Nausea

In a meta-analysis of 22 studies involving children and adolescents, researchers found evidence for CBD’s ability to mitigate chemotherapy-induced nausea and vomiting, with insufficient evidence for CBD’s effectiveness in treating neuropathic pain, posttraumatic stress disorder, and Tourette syndrome.

Again, these studies lacked long-term follow-ups to evaluate potential side effects and were not designed to be statistically significant.

Autism

Israel is currently conducting one of the most extensive clinical trials looking at the link between CBD and autism in 120 children and young adults. The CBD oil contains zero or a low amount of THC, and results will be published at the end of 2018.

4. Researchers have reported few serious side effects in children.

A childhood epilepsy study in Australia found no serious adverse side effects in a study of 65 children under the age of 16. Side effects included worsening of pre-existing problem behaviors (12%), possible increase in seizures (12%), drowsiness or lethargy (8%), changes to appetite or weight (6%), gastrointestinal upset (6%), possible intoxication (4%), and temporary changes in sleep and mood (4%).

A similar epileptic study with 137 children found that CBD could effectively treat seizures in 50 percent of the patients, with side effects limited to tiredness (21%), diarrhea (17%), and reduced appetite (16%).

Importantly, many of these studies administered CBD in very high doses, in the range of 25 to 70 mg per day for a child, far beyond a typical dose for most CBD patients. Even at elevated doses, doctors reported few adverse side effects.

5. CBD can be pricey.

CBD is not regulated by the FDA, so it’s a buyer beware market. CBD can range from as little as $5.00 to as much as $60.00 for 100 mg, though a child’s dose would likely be lower.

There is also the issue of purity. Consumer advocates recommend verifying that the product specifically contains CBD, not just “cannabinoids.” If a product does not disclose the amount of CBD, it could contain other cannabis plant parts such as the stem. Also find out how much THC, if any, is in the product before giving it to a child.

6. You need to speak to a professional about dosing.

Without federal guidelines, dosing should be done under the supervision of a doctor.

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A final word on administering CBD oil to your child

CBD is a promising remedy for many conditions ailing adults and children alike—when used appropriately. Select pure, quality CBD products from a reputable dispensary and always consult a doctor for dosing recommendations.

Parent perspectives on CBD use in children

CBD is short for cannabidiol, a chemical compound naturally found in marijuana and hemp. CBD is sold as oils, balms, gummies and other products. The C.S. Mott Children’s Hospital National Poll on Children’s Health asked a national sample of parents of children 3-18 years about the use of CBD in children.

Most parents say they either don’t know much about CBD use in children (46%) or they never heard of it prior to this poll (34%); 17% report knowing some, and only 3% say they know a lot about CBD use in children. Most parents (71%) have never used a CBD product themselves, while 24% have tried CBD and 5% use a CBD product regularly.

Parents say the factors that would be very important in deciding whether to give their child a CBD product are side effects (83%), if it was tested for safety in children (78%), how well it works in children (72%), recommendation of their child’s doctor (63%), approval of the US Food and Drug Administration (58%), and product reviews (41%).

Three-quarters of parents (73%) think CBD may be a good option for children when other medications don’t work. Most parents (83%) think CBD products should be regulated by the FDA, and three-quarters (74%) say CBD for children should require a doctor’s prescription. One-third of parents (35%) think taking CBD is basically the same as using marijuana.

Over 90% of parents have never given or considered giving their child a CBD product. Only 2% have given their child a CBD product, while 4% have considered CBD for their child; 1% say their child has used CBD without their permission.

Among parents who have given or considered giving CBD for their child, only 29% say they talked with their child’s healthcare provider about CBD use. Parents’ most common reasons for giving or considering CBD for their child include anxiety (51%), sleep problems (40%), ADHD (33%), muscle pain (20%), autism (19%), and to make their child feel better in general (13%).

Highlights

  • 3 in 4 parents say CBD for children should require a doctor’s prescription.
  • Among the 7% of parents who have given or considered giving their child a CBD product, only one-third talked with their child’s healthcare provider about CBD use.
  • While 83% of parents think CBD products should be regulated by the FDA, only 58% say FDA approval would be very important to their decision about whether to give a CBD product to their child.

Implications

Products containing cannabidiol (CBD) are sold online and in stores that specialize in CBD products, as well as in supermarkets and drugstores. CBD products come in many forms, including oils, topical ointments, tinctures, vaping, edibles and gummies. Some CBD products are marketed for children.

This Mott Poll demonstrates that even though CBD products are widely available, parents have limited knowledge about them and most have not even considered having their child use a CBD product. However, three-quarters of parents appeared to be open-minded about CBD products as an option when other medications don’t work.

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Parents also demonstrated some inconsistencies in their attitudes about CBD products for children, including the regulation of these products. For example, 83% indicated CBD products should be regulated by the US Food and Drug Administration (FDA), yet only 58% rated FDA approval as very important to their decision about using CBD for their child. Currently, only one CBD product has received FDA approval for use in children, as a treatment for a rare form of epilepsy. It’s unclear if parents recognize that none of the CBD products they see in stores are regulated by the FDA.

Parents indicated that side effects were their top consideration in determining whether they would have their child use a CBD product. There have been some reports of CBD’s side effects, including sedation and generalized fatigue, insomnia, and gastrointestinal disturbances. However, because CBD products have not undergone rigorous testing to achieve FDA approval, the rate and severity of side effects is unclear — both for short-term side effects like nausea, vomiting and abdominal pain, as well as potential long-term effects like liver toxicity. Other side effects may occur if CBD causes an interaction with other medications the child is taking. Because of the relatively low use of CBD products in children, their side effects in children are even less known or understood.

One-third of parents in this Mott Poll believe that taking CBD is basically the same as using marijuana, which is consistent with parents’ overall limited knowledge about CBD products. Marijuana contains a psychoactive substance, tetrahydrocannabinol (THC), that produces the “high” effect. To be legal under the federal Controlled Substances Act, CBD must have less than .3% of THC. Many CBD products purport to contain close to 0.0% THC. However, the lack of regulation of CBD products calls into question whether there is sufficient quality control in the production of various products to ensure that the amount of THC is consistent with what is reported on the product labeling. Thus, it is difficult for parents to know exactly what they are buying and how much THC their child may be exposed to.

A small but not negligible proportion of parents have given or considered giving their child a CBD product. Parent report of CBD use for children reflected the conditions noted in many CBD promotional materials, including anxiety, sleep problems, ADHD, autism, and seizures. A subset of parents considered CBD products to make their child feel better in general, not targeting any particular symptom or condition.

The role of child health providers in directing CBD use is another area of inconsistency highlighted in this Mott Poll. Although three-quarters of parents felt CBD for children should require a doctor’s prescription, only 63% rated the recommendation of their child’s doctor as a very important factor in deciding whether to give their child a CBD product. Moreover, among parents who tried or considered CBD for their child, only 29% discussed the topic with their child’s healthcare provider. It’s important for parents to inform their pediatrician or other healthcare providers about use of CBD products so that any potential side effects can be addressed.