FDA wants to strengthen oversight of cannabidiol

In December 2018 a federal law legalized hemp, a low-THC variety of marijuana. Since then, products containing CBD,?the non-intoxicating chemical related to THC, have proliferated into natural remedies for just about everything. CBD products, including pills, oils, and cosmetics to drinks, gummies, and even dog treats, could become a $22 billion by 2022, according to the market research firm Brightfield Group, reported Tim McDonnell in Elemental.


But wait!

Now medical researchers, policy analysts, marijuana industry insiders and federal regulators think they may not have defined the concept properly and are concerned about the quality of CBD derivatives. On June 20, the U.S. House of Representatives “approved an amendment to a package of upcoming spending bills that directs the FDA to come up with new regulations for CBD products,” McDonnell said.

In May the FDA hosted an all-day hearing on CBD. At that time officials asked experts whether claims about CBD were supported by science and how consumers can be assured about the quality of CBD products. The FDA sent letters to companies that sell CBD, claiming that they violated marketing laws. The agency is accepting public comments on possible CBD regulation until July 16. More than 2,700 comments have come in so far, and many cast CBD in a positive light. After the commenting period is over, new rules be issued quickly.

According to Amy Abernethy, the FDA’s principal deputy commissioner, “We must sort this out in service of public health. We will work as quickly as possible to define a way forward.”

At the federal level, it is legal to produce CBD if it is comes from legally-grown hemp, as opposed to marijuana, which remains a Schedule 1 narcotic. After that, the FDA will not allow marketing  of CBD as a dietary supplement or as a food additive. Only one CBD-containing product?, ?Epidiolex, which can be used to treat certain rare forms of childhood epilepsy?, is approved as a prescription drug.

For the most part, local laws are used to regulate CBD. New York City is banning CBD in food and drinks. Oklahoma is going to checks on facilities that produce CBD. Tampa Bay police arrested an elderly woman  carrying a bottle of CBD oil but dropped the charges. Security officers at the Dallas-Fort Worth International Airport have been stepping up their confiscations of CBD products. Still, without specific criteria from the FDA for how CBD can and cannot be used, consumers have no guidelines on specific products.

Because the federal government considered CBD illegal until last year, it was not readily available to medical researchers. While its physiological effects are not yet well understood, it seems to bolster the neurotransmitter serotonin, a mood stabilizer. It may also stimulate chemical receptors in the nervous system that produce a calming effect on people.

A May 2018 article in the New England Journal of Medicine described a study in which people with epilepsy treated with CBD had a 40-percent reduction in seizures, compared with 17-percent for people given a placebo. That study was funded by the company that produces Epidiolex. Because other clinical trials have produced similar outcomes, the drug?got approved by the FDA.

Other promising applications of CBD are in helping anxiety and psychological disorders, including schizophrenia, as well as in being anti-inflammatory for the skin. It may be effective in treating Alzheimer’s and Parkinson’s, abating cancer growth, stopping addictions and curing rheumatoid arthritis, but none of these uses have been conclusively tested.

Some experts believe that FDA regulations that keep questionable CBD products off of the market will ultimately result in products that are safe and effective for people wishing to use them.



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