On hemp and CBD, the FDA and USDA are still playing catch-up
Yes, the recently signed farm appropriations bill legalized the cultivation of non-intoxicating hemp and the extraction of CBD-rich essential oil. And, yes, shops across America have been selling CBD oil and CBD edibles like they’re going out of style for some time now. However, as evidenced by recent crackdowns on CBD and hemp commerce, there are still stumbling blocks in place at the federal level, and federal agencies need to get up to speed.
There’s a term which is being bandied about by Washington D.C. lawmakers known as “the policy gap.” This refers to the gap between state laws and federal laws as they pertain to cannabis, and especially marijuana. But there are also serious policy gaps on an intra-federal level, as well as on a global level.
The recently enacted farm appropriations bill included provisions that handed the bulk of regulatory responsibilities related to the cultivation and processing of hemp over to individual states (where it belongs) to regulate the crop as they see fit.
[A PotNetwork News investigative report: Bomi Joseph’s “hops-derived” CBD was a world-changing cannabis alternative fought over by Isodiol and Medical Marijuana Inc. But he lied about his discovery — and his identity.]
Yes, this is a huge advancement in federal cannabis policy as it has forever divorced hemp from marijuana under federal law. However, in light of recent crackdowns, it has become obvious that there’s still quite a bit of baggage to unpack to get hemp and CBD settled in.
The new hemp rules have been in place for more than two months now. So what’s the problem?
Problem #1 — CBD as a food additive
While both online and brick and mortar retailers have been selling all ilk of CBD products like they’re going out of style — regardless of the federal stance on hemp — now that hemp and CBD are legal, the FDA is saying, “not so fast.”
Because CBD has not yet received GRAS status (generally regarded as safe), the FDA is not ready yet to sign off on CBD as a food additive.
Although the FDA has never made any moves whatsoever to penalize CBD companies from adding their products to foods, recently officials in some states have been taking it upon themselves to enforce the rule. For example:
- The New York City Department of Health has banned restaurants from selling CBD-infused foods.
- Michigan health officials ordered two Lansing coffee shops to remove cannabis-derived products from their shelves.
- Maine lawmakers had to scramble to implement emergency measures after regulatory officials there tried to squash CBD edibles.
- In Texas, the Tyler Police Department warned local businesses to remove CBD oil from their shelves or face charges.
- And Ohio is also cracking down on CBD edibles.
As a result of these actions, CBD makers and sellers are paying a high cost for missed opportunities.
Problem #2 — Interstate transport of hemp
Another provision of the farm bill’s hemp provisions allows the interstate transport of hemp. However, the USDA, which oversees agricultural matters, has completed its regulatory framework and no guidance has been issued on the matter.
As a result of this lack of guidance and widespread lack of awareness of the changes, state officials in Oklahoma recently detained a group of truck drivers who were hauling half a million dollars worth of hemp being imported from Kentucky. Two of the men were not able to post bail and spent more than a month in jail. Furthermore, the entire hemp shipment has been sent to Colorado for further examination and is likely to be unusable by the time the dust settles on this case resulting in a half a million dollars loss for the buyer.
Matters got bogged down even further during the recent government shutdown due to delays in the development of USDA rules and the approval of state-issued hemp regulations.
What’s being done about it?
It’s not that nothing is being done to remedy these problems. Whether or not the FDA and USDA have been dragging their feet on these issues is debatable, but there has been some forward movement. Moreover, lawmakers in Washington whose constituents have a horse in the race are eager to alleviate these issues and are holding a flame under both agencies asking them to speed things along.
What the FDA is doing about CBD
The FDA was not caught off guard by the farm bill. Prior to the bill coming up for a vote, the FDA had penned a memo stating that CBD does not meet the criteria of a controlled substance and should be removed from the DEA’s purvue.
Then, the very same day the bill was passed, FDA commissioner Scott Gottlieb issued a good-news-bad-news statement which caused both concern and optimism amongst stakeholders in the CBD market.
The bad news was a pronouncement of the FDA’s intentions to regulate all CBD-infused goods, including edibles and cosmetics. According to the statement, it remains “unlawful… to introduce food containing added CBD or THC into interstate commerce.” The statement also warned CBD makers to refrain from marketing the compound as a healthy dietary supplement.
“In view of the proliferation of products containing cannabis or cannabis-derived substances, the FDA will advance new steps to better define our public health obligations in this area. We’ll also continue to closely scrutinize products that could pose risks to consumers.” — FDA Commissioner Scott Gottlieb, official FDA statement
That first part of Gottlieb’s letter said nothing new as the FDA has had this same stance for years now. However, in the second half of the FDA’s letter, Gottlieb revealed the agency’s intention to begin collecting the intelligence needed to develop a framework for the regulation of CBD products. Also included in the message was a pledge to pursue pathways that would allow businesses to legally market products containing CBD and other hemp-derived compounds as health supplements.
“In addition, pathways remain available for the FDA to consider whether there are circumstances in which certain cannabis-derived compounds might be permitted in a food or dietary supplement. Although such products are generally prohibited to be introduced in interstate commerce, the FDA has authority to issue a regulation allowing the use of a pharmaceutical ingredient in a food or dietary supplement. We are taking new steps to evaluate whether we should pursue such a process.” — FDA Commissioner Scott Gottlieb, official FDA statement
On a side note, the announcement also addressed the non-cannabinoid-producing parts of the hemp plant stating that the FDA had completed evaluations of hulled hemp seeds, hemp seed protein, and hemp seed oil, and determined that the products can be classified as GRAS status. “These products,” the statement claimed, “can be legally marketed in human foods for these uses without food additive approval, provided they comply with all other requirements and do not make disease treatment claims.”
Last month, in an attempt to speed things up, Rep. Ron Wyden wrote to Gottlieb asking that the FDA revise “outdated regulations,” which “limit producers from taking full advantage of the industrial hemp market.”
The recent rash of states cracking down on CBD-infused foods has also prompted a swift response from lawmakers. Another letter was sent to the FDA complaining that the crackdown on the sale of CBD foods and beverages has “spurred a tremendous amount of confusion among product manufacturers, hemp farmers, and consumers of these products.”
The letter, which was signed by a group of 12 House members led by Rep. Chellie Pingree (D-ME) reads in part, “In light of the aforementioned state enforcement actions and the resulting confusion, we are calling on FDA to swiftly provide guidance on lawful pathways for food products with CBD.”
The letter also put forward a short list of questions intended to generate some answers that might reduce the confusion surrounding the FDA’s CBD-related activity.
When will FDA provide guidance on lawful pathways for food products with CBD? For example, it would seem the GRAS Notification Program would be one such pathway.
Has FDA advised states—such as New York, Maine or Ohio—that have recently taken enforcement actions against food products with CBD?
When will FDA hold a public hearing on the regulation of products containing CBD?
“States are looking for immediate leadership from the Federal Government to eliminate confusion around this issue. Furthermore, numerous states are pursuing legislative efforts that would allow for the intrastate commerce of food products with CBD, potentially leading to a patchwork of state regulations.”— Letter to FDA from a group of 12 U.S. Reps.
And now we wait. Although the letter asked the FDA to respond to by Friday, how long it might take for the FDA to make a move on the matter is still anyone’s guess, but with all that’s at stake, the pressure is on for FDA to move on the matter.
What the USDA is doing about hemp commerce
Recently, authors of farm bill’s hemp provisions sent a letter to the U.S. Department of Agriculture asking the agency to “expeditiously” review its policy toward hemp “as Congress intended.”
In the letter, the USDA was asked to issue guidance to ensure that hemp growers are able to transport hemp and its derivatives across state lines legally.
The letter reads, “Our states have seen tremendous success in researching and developing market opportunities for hemp through the state pilot programs, and we are hopeful that the growth and innovation we’ve seen through the pilots will continue to expand now that the domestic production of hemp and hemp products is legal.”
The full intentions are of USDA officials are not yet clear nor has any particular timeline been laid out for resolving these issues. However, the agency is expected to deal with the matter expeditiously. We’ll keep you posted.
The United Nations’ role
The United Nations also figures into the equation. In its recommendation to the DEA to reschedule CBD last fall, the FDA wrote, “CBD and its [extracts] do not have a significant potential for abuse and could be removed from the [Controlled Substances Act].”
The DEA replied to the FDA stating that to de-schedule CBD would violate international treaties.
The FDA replied suggesting that the scheduling of CBD should be “revisited promptly” if and when international treaty obligations change.
There is fresh hope that international treaties could be revised, but no one is holding their breath.
Last summer, after thoroughly investigating the benefits and safety of CBD, the UN-based World Health Organization came to the conclusion that CBD has benefits for the world’s population and is safe for human consumption.
Just in the past week, industry insiders were pleasantly surprised when advocates brought to light an internal WHO letter dated Jan. 24 calling for whole-plant marijuana and its resins to be removed from a 1971 drug treaty and down-scheduled from Schedule IV where it has been since a 1961 drug convention was signed by UN representatives from countries across the globe.
"If cannabis is deleted from Schedule IV and remains in Schedule I only, this will allow member states to implement less stringent national control regulations on cannabis and cannabis-based preparations. Additionally, it will abolish the regulatory barriers pertaining to Schedule IV and facilitate medical and scientific research of new cannabis-related preparation and medicines." — World Health Organization spokesperson
The letter goes on to state that "pure cannabidiol CBD should not be scheduled within the international drug control conventions."
Even if these new recommendations make it to the UN floor for a vote, which is not a sure thing, there’s no guarantee of passage. Changes to the 1971 treaty, require a two-thirds majority, while changes to the 1961 Convention requires a simple majority vote. Drafting these changes such that they might garner enough votes might be a daunting task.
On the other hand, the Secretary-General of the UN António Guterres is also the former Prime Minister of Portugal and has been instrumental in decriminalizing all drugs that country. He is widely suspected that he will throw his support behind the changes.
The ideal scenario
The ideal scenario — or scenarios — for the hemp industry and for marketers of CBD-infused products would be these:
The FDA grants GRAS status to CBD approving it as an allowable food additive. (And perhaps someday approve of CBD health benefit claims.)
The USDA concludes the federal side of the hemp regulatory equation so that states can implement hemp cultivation and commerce programs.
The U.N. is able to make the necessary changes to global agreements pertaining to cannabis that would allow hemp and CBD production to continue unimpeded.
Although the FDA and USDA are expected in due time to play their roles according to script, the UN’s stance on the matter is not expected to progress quickly. Also, considering how the world is proceeding on implementing cannabis reform without the UN’s blessing, UN cannabis policy is expected to very little real-world impact on these matters either way.
“CBD now is too big to fail… We see a path in the very near future that the FDA will be formally approving of these products to be sold alongside the vitamin C’s and D’s and melatonins of the world.” Jonathan Miller, general counsel for the US Hemp Roundtable (source: Quartz.com)