FDA Studied the Health Claims of CBD Oil

The US Food and Drug Administration (FDA) took a look at the safety and effectiveness of CBD products Friday, as it weighs how to best regulate the hemp-derived compound.

During a lenghty public hearing the agency heard testimony from folks on all sides of the issue.

In opening the hearing, FDA Acting Commissioner Dr. Ned Sharpless said, “critical questions remain about the safety” of the products.

“While we have seen an explosion of interest in products containing CBD, there is still much that we don’t know,” Dr. Sharpless added.

To say the market for CBD products has exploded in the past year is an understatement.

Everything from oils to gummies to pills, creams and ointments are now for sale at supermarkets and specialty chains. You can even get massages infused with CBD, or cosmetics laced with the drug.

All of these products contain cannabidiol but not THC, the ingredient in marijuana that gives the high.

CBD products have come into the market not because of any new medical evidence, but because of a change in federal law.

Late last year, Congress passed a farm bill that lifted a decades-old ban on growing hemp. As long as the plant contains less than 0.3% THC, hemp can be grown legally anywhere in the United States by licensed farmers.

The bill specifically said the US Drug Enforcement Administration cannot regulate hemp products like CBD. So, it is now up to the FDA to manage the CBD market.

The Big Q: What do scientists really know about the health benefits and risks of CBD?

The Big A: Experts say “precious little”, and consumers should take care that they are not wasting their money.

“You have a flood of CBD products that are coming from hemp that are going out onto the market, and you’ve got all sorts of claims being made about those from people who are trying to sell them,” said Timothy Welty, Chairman of the department of clinical sciences at Drake University’s College of Pharmacy and Health Sciences, in Des Moines, Iowa.

The flood of CBD products has become so overwhelming that the FDA recently stepped into the fray.

The agency has sent out a flurry of warning letters to companies marketing CBD products, telling them to stop making unfounded health claims for the substance.

Companies have falsely claimed that CBD can stop cancer cells, slow the progression of Alzheimer’s disease, ease nerve pain and fibromyalgia, and curb withdrawal symptoms for people undergoing substance abuse treatment, the FDA letters state.

To date, there’s only 1 use for CBD that has significant scientific evidence behind it, curbing the symptoms of rare forms of epilepsy.

The FDA last year approved the drug Epidiolex to treat two forms of childhood epilepsy. The medical evidence has shown that the highly purified CBD in Epidiolex can ease seizures.

For the rest of CBD’s potential uses, there is too little evidence to make a firm conclusion yet.

The next potential medical use for CBD could be for the symptoms of anxiety disorder, said Drs. Welty and Yasmin Hurd, Chair of translational neuroscience and director of the Addiction Institute at Mount Sinai, in New York City.

Clinical trials suggest that CBD could help treat anxiety, but Dr. Welty feels there needs to be more study. Dr. Hurd is slightly more convinced, but agrees more study is needed.

“There is published evidence that CBD does decrease anxiety,” Dr. Hurd said. “That’s another indication where I can say I can believe the data; however, we still don’t know the dosing regimen that would be effective for anxiety. Those are studies that are ongoing.”

Other uses, as an anti-inflammatory, an aid for substance withdrawal, a sleep aid, a pain reliever have not been conclusively proven.

In some cases, the evidence runs counter to what people suspect.

There is not much reason to believe CBD would be an effective means of pain relief, said Dr. Ajay Wasan, Vice Chairman for pain medicine at the University of Pittsburgh Medical Center.

“If you think of it as a medicine, it would be a weak analgesic,” Dr. Wasan said. “It is really the THC component of medical marijuana which is the compound that gives you pain relief,” he explained.

“I’ve been surprised how much CBD has taken off and exploded with very little data,” Dr. Wasan said. “Most of the other herbal supplements, there are at least some studies on it before it becomes really popular. But for this, I have not seen anything.”

The bottom line, researchers said, is that people who want to try CBD for 1 reason or another should talk with their doctor 1st.

And, consumers might consider buying CBD products from a state-run program. Some states like Iowa have established such programs to make CBD available medicinally, Dr. Welty said.

“Those products are more reliable, because they have a system to monitor the purity of content,” he said. “You’re a little more sure that you are getting what you are paying for.”

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