Cannabis industry asks FDA for uniform production, packaging standards

(This is an abridged version of a story that appears at HempIndustryDaily.com.)

The ideal standard for the cannabis industry, according to both hemp and marijuana insiders, would be to have a single set of rules around key business operations, from production to packaging and labeling.

But entrepreneurs aren’t sure what those rules should be.

At Friday’s landmark cannabis review by the U.S. Food and Administration (FDA), CBD manufacturers joined with academics, consumer packaged goods manufacturers and agriculture officials to ask a panel of regulators to give the cannabis industry a uniform set of guidelines.

“We need clear, simple, consistent, national regulations,” Betsy Booren of the Grocery Manufacturers Association said.

The FDA review was the result of hemp no longer being a controlled substance, leading to countless new hemp-derived products being sold in stores and online.

But when the FDA panel asked how much CBD people should take in a single dose – or what daily limits should be – hemp entrepreneurs said they weren’t sure or would need to check and follow up.

Dr. Ned Sharpless, acting head of the FDA, made clear that dosing is going to figure largely in the FDA’s approach to cannabis-derived products in food, drugs and cosmetics.

“While we have seen an explosion of products containing CBD, there is still much that we don’t know about them,” Sharpless said.

“How much CBD is safe for a consumer per day? How much is too much?”

The dosing challenge also came up when a Colorado doctor testified about families treating epileptic children with CBD.

Asked how parents can know how much CBD to give their kids, Dr. Kevin Chapman was blunt.

“They’re making it up as they go along,” he said, speaking on behalf of the American Epilepsy Society.

Sharpless gave no indication how long it would take the FDA to answer dosing questions or to establish any other rules that would bring a national standard to the CBD industry.

Not all hearing attendees are convinced that expediency was the best course of action, however.

GW Pharmaceuticals, the only manufacturer with an FDA-approved drug from cannabis – which happens to be derived from marijuana – testified, calling for regulators to “maintain the integrity of the FDA-approval process for medicines.

Alice Mead, vice president for GW, warned that CBD can cause liver problems and sleepiness.

Kristen Nichols can be reached at [email protected]

2 comments on “Cannabis industry asks FDA for uniform production, packaging standards
  1. Marco Spaghettio on

    CBD and THC have no toxicity and pose no danger in and of themselves.

    Regulations need only require purity of product and clear quantity labeling, such as in aspirin and common vitamins supplements. It is then up to the consumer to research and consult with their health care providers to determine dosage.

    Note the only decent was from GW, also the only party present with a financial interest in the delay of CBD and THC regulation. Typical pharmaceutical company.

    Reply

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