Regulating CBD in the U.S. could take years, says FDA director

American legalization of hemp gave rise to hopes of federal regulation of the CBD. Food and Drug Administration had announced to tackle the task, but it seems to be more complicated than it sounds. Indeed, the regulation of CBD would require Congressional action to allow its addition to food products, according to the director of the federal agency, who has decided to resign. This could delay CBD regulation by several years.

The complex status of CBD

It was at a Brookings Institution that FDA Director Scott Gottlieb spoke out on the subject. He did not question the regulation of CBD, but explained that legal constraints prevented its addition to food, and that the agency's prerogatives on this point were limited. Since CBD is the active ingredient in Epidiolex, a drug approved by the agency, As such, it cannot be added to food preparations. The only case in which it can be added is if it has been previously consumed in food.

The agency's director acknowledges that legislators« intention in the Farm Bill was to allow the trade of hemp-derived CBD. However, he maintains that »the current state of the law allows the FDA to authorize the addition of a drug not previously used in food only if it has gone through a legislative process". He cites similar cases such as growth hormones or fish oil, and points out that this takes an average of two to three years. Nevertheless, CBD's complex status, its association with cannabis and the problem of its source, could make the process even longer.

«We've never done this before», explains Scott Gottlieb, «it would be an entirely new legislative process». At the same time, he announced that the FDA remains committed to the process, and will set up a working committee later this week to examine possible legal avenues to submit to legislators. It is also expected to recommend concentration levels by assessing risks and potential therapeutic effects. The commission will hold public hearings and is expected to issue recommendations later this summer.

Despite the lack of regulation, CBD-flavored edibles are booming in the U.S. and become a major consumer trend. Some states (New York, Maine) are cracking down on shops selling them, on the pretext that federal regulations are not yet in place. The situation has led some members of parliament and manufacturers to to protest against the lack of regulation. «The FDA shouldn't waste its resources trying to get CBD toothpaste back in the tube, nor should it leave it unregulated.» considers Jessica Wasserman of Greenspoon Marder which represents CBD companies. Maine MP Chellie Pingree agrees: «They should have left the generally recognized safe products alone. We can't leave them [growers] in the dark halfway through.».