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FDA. CBD.

FDA. CBD. Restart CBD Austin TX
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On Thursday March 5th 2020, the U.S. Food and Drug Administration (FDA) issued an update to Congress on the status of rulemaking for CBD. While hemp and cannabinoids derived from hemp such as Cannabidiol (CBD) were legalized under the 2018 Farm Bill, FDA retained their authority to develop a regulatory framework for CBD products, just like any other food, beverage or supplement.

FDA. CBD. Restart CBD Austin TX

Strangely, the FDA seems to note no difference between cannabinoids derived from hemp and those from marijuana, even though the 2018 Farm Bill clearly differentiates the two and FDA acknowledges the same in the Executive Summary of the March 2020 report.

The FDA simply does not regard the efforts and products from American hemp farmers as any different than products from federally illegal marijuana. This causes a real, negative effect on rural hemp economics and is inconsistent with federal law.

CBD is estimated to have been consumed by over 40 million Americans in the last few years, without negative effects. Archaic FDA policies claim to be benefiting the public health good — but the only true beneficiaries seems to be large global pharmaceuticals. Meanwhile, American hemp farmers, and rural economies suffer because of FDA bureaucracy.

The FDA already has the plan to introduce federally legal cannabinoids into foods, beverages, and supplements. Why are they stalling? They are at least two years behind in developing regulations for CBD, a federally legal cannabinoid. If the DEA had not rushed and scheduled Epidiolex (the only product approved by the FDA at this time) in a hurried manner in 2018, then the fears of CBD inclusion in foods, beverages and supplements would probably have been overcome by now.

Even though the 2018 Farm Bill  “federally legalized CBD”, this actually happened with Section 7606 of the 2014 Farm Bill.

The FDA has been involved in warning letters since 2015.  In fact, the FDA has been studying CBD in consumer products since at least the end of 2014.

The FDA already knows that CBD is safe, and has for at least two, perhaps even five years. The evidence is there: it’s in FDA’s writings, and it’s within FDA’s warning letters to dozens of CBD companies. Link to FDA warning letters.

Earlier in 2018, The HHS- the agency charged with oversight of FDA clearly told the DEA in the “Girior Letter” that Epidiolex¹ — containing only CBD as an “active” ingredient— should not be scheduled because it had no human abuse liability and did not meet the requirements for scheduling.

Because of timing (pre-2018 Farm Bill), the DEA insisted (probably incorrectly) that CBD was a scheduled substance and therefore Epidiolex had to be scheduled. Because the FDA commented at length on the safety profile of CBD, the default scheduling was at the very lowest level possible, Schedule V. In the view of HHS (FDA), if CBD was not a controlled substance, then the scheduling would need revisiting.

Some of the legal “experts” around the industry suggest that because Epidiolex was the source of an IND — an Investigational New Drug — that CBD is not available for the use of consumers in the form of supplements or food/beverages. This is ridiculous.

This brings us back to 2020 and the recent news from the DEA about de-scheduling Epidiolex. The DEA finally got around to correcting its administrative error from 2018 and that’s generally good news.

For the DEA, de-scheduling of any drug is a very rare event (only 3 times in the last 20 years) and the significance of the recent de-scheduling of Epidiolex has probably been lost due to a tumultuous (and unprecedented) news cycle.

“The FDA has approved only one CBD product, a prescription drug product to treat two rare, severe forms of epilepsy. It is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement. … Some CBD products are being marketed with unproven medical claims and are of unknown quality.” March 5, 2020.

However, in over 5 years of monitoring, studying and regulating CBD, the FDA has never, once, pulled a CBD product from a store shelf, from online distribution, or fined or shuttered any producer of federally legal cannabinoid products.

The clear implication, cast in the context of the FDA’s own writings on CBD, is that FDA views CBD as inherently safe for public consumption.

Further, we are unaware of any serious adverse effects from any federally legal CBD products. Massive amounts of CBD, contained within millions of oil drops, softgels, chewables, tablets, etc. have been consumed by Americans without report of harm.

The absence of any comment on observed serious effects demonstrates what the FDA already knows: CBD is safe for consumption in food, beverages and supplements.

In the last 5 months, there have been multiple legislative proposals in both the U.S. Senate and the U.S. House of Representatives and U.S. Senate that would “force the FDA’s hand” on the regulation of CBD, as opposed to leaving it up to their own, archaic devices. These legislative proposals have lacked the connection to agriculture to truly make an impact. This is not to say that there aren’t proposals out in the world that could alleviate some of these issues, such as H.R. 5587 introduced by House Agriculture Chairman Rep. Collin Peterson, but its passage is deemed unlikely.

The FDA states that they need more data, more time but that seems unnecessarily bureaucratic and ignorant of the Congressional intent of the 2018 Farm Bill to promote hemp farming.

The harmful effect of this slow-movement of federal regulatory development by FDA has devastating effects on the entire hemp economic value chain because it simply robs the industry of its biggest potential customer: American food product manufacturers.

The lack of clarity from FDA has stalled the slowed production from the farm to finished goods which is effectively blocked until the FDA puts forth a regulatory framework addressing CBD products.

Lack of clarity from the FDA negatively impacts

  • farmers
  • processors
  • mainstream food and beverage manufacturers
  • consumers who want products that contain federally legal cannabinoids, and they want them to be from reliable, sustainable sources that meet modern product manufacturing standards.

This market is ready-to-go as soon as FDA pushes the “GO” button by simply recognizing CBD as safe for foods, beverages and supplements and enforcing standard, modern production standards that it enforces on all all foods, beverages and supplements.

At this time with the fear of a global pandemic with COVID-19 and other negative health worries we have seen a quick response by governmental agencies, including FDA, to meet public needs based upon common sense and urgency. The standard, established bureaucratic timelines have been ignored, trumped by the public and political need to provide solutions for a safer and healthier population.
Ironically, the legislative path to regulating CBD was initially proposed by former FDA Commissioner Gottlieb after the Farm Fill was passed, and again in 2019.  And we are still waiting.

This is why the decision to deschedule Epidiolex (cannabidiol) is promising, even if very late. It’s also worth noting that this is the third time in 22 years that a substance has been removed from the CSA. Of course, this indicates a greater availability of Epidiolex, which is great news for those in need of its prescribed use case, but doesn’t do much to alleviate the plight of American hemp farmers.

Current FDA Commissioner Dr. Stephen Hahn recently stated “>we’re not going to be able to say you can’t use these products….it would be a fool’s game to stop it”.

FDA is slow-playing its ability to quickly recognize federally legal cannabinoids as foods, beverages, or supplements. While the report does give a slight positive indication that a path for cannabinoids as supplements might happen, the question of when remains unanswered.  We may need congressional action to move it forward.

Most importantly to hemp farmers seeking a market for their floral material, there seems to be no quick path to CBD’s inclusion in food and beverages, despite the clear market intentions — and consumer demand — for these products.

The negative effects on America’s hemp farmers, including those still with a harvest from 2019, is devastating because the anticipated demand has been rejected by the FDA. WHY?

The net effect of FDA’s Congressional Report on CBD is to perpetuate the status quo, where products from uncertified producers, not meeting clear FDA production standards, fills a nebulous grey market because the larger food and beverage companies are fearful of FDA recriminations for advancing product development. This is not sustainable.

It’s time the FDA moves their position forward and allow access to cannabinoids for the benefit of everyone including consumers and hemp farmers.

Ask your state representatives to urge the FDA to move this forward.

 

(excerpted from FDA, Floral Hemp, and CBD –What a mess! –GenCanna)