Hemp CBD

The FDA’s stance on hemp CBD

The cannabis industry heralded the approval of recent legislation that legalized the growing of hemp and the marketing of products derived from it.

Actually, to say industry proponents heralded hemp’s return to legality is likely an understatement. Based on the deluge of press releases that came pouring into my inbox after the bill became a law, there was almost downright giddiness from many cannabis business interests, especially among those who view the law as paving the way for expanding sales of a whole range of products infused with cannabidiol (CBD).

CBD is a component found naturally in all cannabis plants that does not produce a high when ingested. Many companies are selling CBD oils and tinctures, as well as products infused with CBD, including food and drink items, and there’s growing interest in the compound’s health and wellness benefits. The New York Times recently ran an article underscoring the surging popularity of the compound, with a headline proclaiming “CBD is Everywhere.”

CBD plant

Like all other cannabis products, CBD had been illegal ever since the federal cannabis prohibition took effect. However, with signage of the Agricultural Improvement Act of 2018 (commonly referred to as the Farm Bill), the production and marketing of hemp with THC levels lower than 0.3% once again became legal. This change should theoretically pave a pathway for selling CBD products.

But Wait!

Notice that pesky “theoretically” thrown into the last sentence? The signing of the Farm Bill also means federal agencies, such as the Food and Drug Administration (FDA), are now involved. And take it from me, a former healthcare reporter and consultant who dealt with the agency on a near daily basis for years, matters get complicated when the FDA takes a stance.

FDA Commissioner Scott Gottlieb, M.D. issued a lengthy statement shortly after the Farm Bill’s approval that attempted to explain the agency’s stance on CBD. In short, I take the statement as a warning to the burgeoning CBD industry.

But don’t just take my word for it. For example, Gottlieb wrote, “In particular, we continue to be concerned at the number of drug claims being made about products not approved by the FDA that claim to contain CBD or other cannabis-derived compounds.” In addition, Gottlieb said that it remains illegal to introduce food containing added CBD into interstate commerce or to sell CBD products, as, or in dietary supplements, regardless of whether the manufacturer derived the product from hemp.

Confused Yet?

Cannabis farm

Perhaps it’s best to look for some silver linings when trying to understand the FDA’s stance. While Gottlieb’s statement isn’t exactly promising to the industry, he did leave the door open for the FDA to allow products infused with CBD derived from legal hemp to enter the market.

Makers of food products containing CBD derived from legal hemp could push the FDA to allow the compound to be regulated as a dietary supplement. Additionally, there are currently, federal restrictions in place forbidding products containing CBD derived from legal hemp into interstate commerce. In his statement, Gottlieb indicated the FDA is open to finding a pathway where such products could be sold across state lines.

In addition, the FDA indicated that it is open to approving pharmaceutical products containing CBD as an active ingredient if there is rigorous clinical trial data to substantiate the therapeutic claims made by the drug maker, Gottlieb said.

Bottomline: Do not lose hope! The FDA’s cautious reaction to the potential for legal CBD sales is completely normal for an agency that takes its public health mission very seriously. Continue to organize with like minded businesses that want to engage with the FDA and lawmakers to ensure rational changes are made to laws so safe CBD products have a place on the market.

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