CBD products need more testing

Published on Sunday, 16 June 2019 20:35
Written by The Boston Globe

If you believe the hype, one little bottle of CBD contains miracles. It treats diabetes; reduces stress; alleviates chronic pain and anxiety; even cures acne. Trouble sleeping? Panicky pet? CBD to the rescue.

All that, and so much more - at a bargain price as low as $40 for some formulas. This potent potable also comes mixed into body lotions, bath salts, coffee, smoothies, gummy bears, chocolate, cheese pizza, and dog biscuits.

The fad for cannabidiol, or CBD, has clearly gone mainstream. From virtually nothing a few years ago, sales of the cannabis-related compound have exploded into a billion-dollar market. CBD’s true believers tout one miraculous health claim after the next.

In light of the wide dissemination of these beliefs, CBD claims deserve careful scrutiny from the Food and Drug Administration - and some attention from state regulators, too.

Despite its ubiquity, CBD is still largely an unresearched substance in the United States. Exaggerated or unproven claims need to be challenged, and the industry shouldn’t be permitted to introduce CBD into food products until the compound is better understood.

CBD is the nonintoxicating, natural molecule extracted from the cannabis plant. CBD is found in marijuana, of course, but it’s also present in hemp, the related plant whose cultivation in the US was legalized by Congress in December.

Its proven medical uses are confined to a drug the FDA approved last summer to treat two rare forms of pediatric epilepsy.

It’s the first - and only - medicine derived from cannabis that has been green-lighted by the federal agency.

Because CBD is already sold as a drug, federal law technically bans its use in food and drink that crosses state lines.

“Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk, as these products have not been proven to be safe or effective,” Scott Gottlieb, then the FDA commissioner, wrote in a statement when hemp production was legalized.

But enforcement is largely left to states, where it has been uneven.

Earlier this year, New York City health officials banned bakeries and restaurants from selling food and beverages with CBD. Ohio and Maine have also moved proactively.

In Massachusetts, though, the sale of products containing hemp-derived CBD is still loosely regulated.

For instance, the state has not addressed sales of food and drink made with CBD. But it has at least issued guidance for commercial growers and processors of industrial hemp.

Among other things, the state Department of Agricultural Resources requires producers to label any product they make for human consumption that contains CBD with a warning stating the product is derived from industrial hemp, that it “has not been analyzed or approved by the FDA,” and that it “has not been tested or approved by the Massachusetts Department of Agricultural Resources.”

Now, maybe adding CBD to food is safe. And maybe it really can deliver medicinal benefits. But sorting through the safety and efficacy claims requires a more muscular FDA role.

Last month, the FDA held a much-awaited hearing on how to regulate CBD consumer products and got an earful on the need for a science-based approach to regulation.

“Currently, states are struggling with the lack of sound scientific research available in CBD and long-term health impacts, including those to children,” said a Virginia state official.

Most medical experts agreed that CBD holds potential medicinal properties, but more clinical trials are needed before allowing the hemp extract to be added to food and drink.

The hazy legal status of hemp-derived CBD until December, coupled with lack of funding, deterred studies in the past.

Now researchers need to determine how different doses affect consumers; how CBD affects children; how it interacts with medical conditions and medications; how it affects pregnant women; whether long-term use carries risks; and if the purported benefits are scientifically verifiable.

None of which is to say that CBD itself should be banned. Coke is still available, after all; the company just no longer claims that the beverage cures headaches and upset stomach.



Posted in The Bristol Press, Editorials on Sunday, 16 June 2019 20:35. Updated: Sunday, 16 June 2019 20:37.