(BPT) - Online, at drug stores, in the kiosk at the mall—today, products claiming to be CBD are everywhere. As parents search for a solution to help their kids calm down, sleep better, or manage seizures, they’re increasingly reaching for CBD products available in stores or online. Instead of a call to the doctor, parents may give their children CBD in anything from oil and lotion, to bath bombs and gummi candy. Is this safe? Are there potential dangers of giving a child CBD that isn’t federally regulated or approved by the U.S. Food and Drug Administration (FDA)?
The CBD safety myth
Millions of Americans are self-treating with CBD., Many view these products as natural, gentle, and safe for all to use: a kind of supplement instead of a medicine. As a result, CBD has flown somewhat under the radar when it comes to scrutiny of safety and effectiveness, manufacturing protocols and accuracy of labels. In fact, there is no way for consumers to ensure that products purchased in a store or online contain any CBD, contain only CBD or that they are exactly the same each time you purchase. The fact is, only FDA-approved CBD products are federally regulated and required to meet quality, content and dosing standards. They are rigorously tested in controlled clinical trials to understand the safety profile and potential benefit.
Only one CBD product, Epidiolex® (cannabidiol) oral solution, has been studied and approved by the FDA for seizures associated with Lennox-Gastaut syndrome, Dravet syndrome and tuberous sclerosis complex in patients one year of age and older. It is only available by a doctor’s prescription, and can’t be purchased in places like a coffee shop or mall kiosk. FDA-approved medicines are studied to understand how they may interact with other medicines and approved for specific medical conditions . Because FDA-approved products have been studied in rigorous clinical trials and are manufactured to the highest standards, parents of children with these conditions can be confident that the product is consistent from batch to batch and that its risk profile and effectiveness are well understood.
Hidden dangers for children
FDA approved medicines meet strict requirements for testing, manufacturing and quality control. As a result, consumers know exactly what they’re getting. This is not the case for unregulated CBD products.
Further, an analysis of contaminants in cannabis products showed contaminants and toxins that should never be ingested by anyone, such as heavy metals and pesticides. For example, in Washington State, a laboratory analysis revealed that 84.6% of legalized cannabis products contained significant quantities of pesticides. Let’s not forget about the conditions in which the products are made. Who is growing the plants, and where? What standards do they follow? What are the ingredients, exactly? If a CBD product isn’t federally regulated, there is no way for parents to know what they are really giving their child.
Doctors warn that CBD can interact with other medicines or cause side effects, and the use of CBD products should always be monitored by a health care provider. But parents may not be telling their doctors that they’re giving CBD to their kids and this could be a hidden danger.
Researchers believe CBD-based treatments hold great promise for a range of medical conditions, but more studies in humans are needed. Only FDA-approved CBD products are appropriate and demonstrated to be safe for approved conditions.
Far from oils, bath bombs, or gummi candy, FDA-approved cannabinoid medicines have demonstrated the potential to positively impact children and families when used as approved. They may provide an effective medicine for appropriate patients, along with assurances that they have been studied to understand the safety and efficacy profile. And always, the first step for a parent who has health concerns is to talk to a doctor about what’s right for their child.
To learn more, visit www.StraightFactsCBD.com.
Epidiolex Important Safety Information & Indications
What is the Most Important Information I Should Know About EPIDIOLEX (cannabidiol)?
Do not take if you are allergic to cannabidiol or any of the ingredients in EPIDIOLEX.
EPIDIOLEX may cause liver problems. Your doctor may order blood tests to check your liver before you start taking EPIDIOLEX and during treatment. In some cases, EPIDIOLEX treatment may need to be stopped. Call your doctor right away if you start to have any of these signs and symptoms of liver problems during treatment with EPIDIOLEX:
• loss of appetite, nausea, vomiting
• fever, feeling unwell, unusual tiredness
• yellowing of the skin or the whites of the eyes (jaundice)
• unusual darkening of the urine
• right upper stomach area pain or discomfort
EPIDIOLEX may cause you to feel sleepy, which may get better over time. Other medicines (e.g., clobazam) or alcohol may increase sleepiness. Do not drive, operate heavy machinery, or do other dangerous activities until you know how EPIDIOLEX affects you.
Like other antiepileptic drugs, EPIDIOLEX may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any signs of depression or anxiety, thoughts about suicide or self-harm, feelings of agitation or restlessness, aggression, irritability, or other unusual changes in behavior or mood, especially if they are new, worse, or worry you.
Take EPIDIOLEX exactly as your healthcare provider tells you. Do not stop taking EPIDIOLEX without first talking to your healthcare provider. Stopping a seizure medicine suddenly can cause serious problems.
What Else Should I Know When Taking EPIDIOLEX?
The most common side effects of EPIDIOLEX include increase in liver enzymes, sleepiness, decreased appetite, diarrhea, fever, vomiting, feeling very tired and weak, rash, sleep problems, and infections.
EPIDIOLEX may affect the way other medicines work, and other medicines may affect how EPIDIOLEX works. Do not start or stop other medicines without talking to your healthcare provider. Tell healthcare providers about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and cannabis-based products.
What Additional Information Applies to Women?
If you are pregnant or plan to become pregnant, EPIDIOLEX may harm your unborn baby. You and your healthcare provider will have to decide if you should take EPIDIOLEX while you are pregnant.
If you become pregnant while taking EPIDIOLEX, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry (by calling 1-888-233-2334). The purpose of this registry is to collect information about the safety of antiepileptic medicines during pregnancy.
Because many medicines like EPIDIOLEX are passed into breast milk, talk to your healthcare provider about the best way to feed your baby while taking EPIDIOLEX.
What is EPIDIOLEX (cannabidiol)?
EPIDIOLEX is a prescription medicine that is used to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex in patients 1 year of age and older.
It is not known if EPIDIOLEX is safe and effective in children under 1 year of age.
Please refer to the EPIDIOLEX Medication Guide and Instructions for Use for additional important information.
You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also contact Greenwich Biosciences at 1 833-424-6724 (1-833-GBIOSCI).
 The Annie E. Casey Foundation: Kids Count Data Center. https://datacenter.kidscount.org/data/tables/99-total-population-by-child-and-adult#detailed/1/any/false/37,871,870,573,869,36,868,867,133,38/40/416,417. Accessed 7_28_20.
 Gallup.com. https://news.gallup.com/poll/263147/americans-say-cbd-products.aspx. Accessed July 28, 2020.
 Food and Drug Administration. Warning Letters and Test Results for Cannabidiol-Related Products.
 EPIDIOLEX [package insert]. Carlsbad, CA: Greenwich Biosciences, Inc.; 2020.
 Dryburgh et al. 2018. Cannabis contaminants: sources distribution, human toxicity and pharmacologic effects. British Journal of Clinical Pharmacology (2018) 84, 2468-2476.