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Public Hearing of Cannabis & Cannabis-Derived Compounds

 

Norman E. “Ned” Sharpless, Acting Commissioner of the FDA, official photo.

The Food and Drug Administration held a public hearing last month to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds. Norman Sharpless, the acting FDA commissioner, opened the meeting on May 31st by announcing that they are encouraging all comments concerning to the docket (FDA-2019-N-1482) regarding the regulation of these aforementioned products. These comments are still being collected until July 16th, 2019.

Commissioner’s Opening Remarks

The FDA has been regulating products containing any cannabis-derived compounds for a long time. Anything that will be added or require access to a FDA regulated product falls within their jurisdiction. However, thanks to the Farm Bill act of late 2018, they have become much more alert and active in such practices. There are tons of products now containing cannabis-derived compounds beginning to circulate throughout the United States. There are already several drug products that contain these cannabis compounds. One of their main concerns is that companies will start advertising such products as drug alternatives to traditional and proven methods. This is a type of marketing that puts others at risk. These products should not be used as substitutes to prevent, alleviate or cure serious medical afflictions such as cancer. Even attempting to sell these products for these specific means with unsubstantial therapeutic claims is a violation of the law.

The grey area now for the FDA is how to safely add such compounds to food or dietary supplements. Examples of such situations would be:

  • “How much CBD is safe to consume in one day?”
  • “What if someone applies a topical CBD lotion, consumes a CBD beverage or candy, and also consumes some CBD oil?”
  • “Will these products have different or negative effects if taken while on other prescription drugs?”
  • “What happens when someone chronically uses CBD for prolonged periods?”

According to Norman Sharpless:

“These and many other questions represent important and significant gaps in our knowledge.”

“To help us evaluate these questions, as well as potential pathways for CBD products, FDA has formed an internal working group to address these data gaps specifically. You’ll be hearing more from this group in the months to come.”

Departing Commissioner’s Previous Remarks

The former commissioner of the FDA, Matt Gottlieb, interviewed at the Brookings Institution event said it could take years for the FDA to create rules for CBD in food products.

“CBD didn’t previously exist in the food supply, and it exists as a drug under the statute,”

He stated that the current law only allows the FDA to

“…contemplate putting a drug that wasn’t previously in the food supply into the food supply if it goes through a rulemaking process.”

The former commissioner believes that the only way is if Congress passes a separate legislation for its lawful marketing.

“I think you need to come up with a framework that defines concentration levels, where you would create some kind of cutoff, and that would be up to the agency to do,”

“Congress would obviously give directions to the agency to do that.”

“CBD in high concentrations isn’t risk-free, and in low concentration, it probably is safe — I don’t want to make a declaration here. It’s also a question of whether it’s providing any kind of therapeutic benefit in those concentrations, although people seem to believe that it has some value. But this is a process that the agency would have to work through. I think the most efficient way to get to a pathway would be through legislation, probably that would just be legislation that would specifically address CBD.”

The Budget Plan

Having CBD in food and dietary supplements could mark huge steps for the CBD industry. The benefits are more than known by government officials. Its all going to come do to whether they can figure out these limitations on amounts allowed. Thankfully we still have actions that are leading us towards this hopeful future. The U.S. House approved a budget statement last week to delegate money for the FDA to set a

 “safe level for conventional foods and dietary supplements containing cannabidiol (CBD).”

The amendment came from Democratic Rep. Jerry McNerney of California. McNerney spokeswoman, Nikki Cannon, told Hemp Industry Daily.

“FDA action on CBD in foods is needed as soon as possible.” 

“The purpose of the amendment is to elevate the need for the FDA to move with all deliberate speed to set safe consumption levels.”

Its very apparent that lawmakers are making a valiant effort in order to get the FDA to move on this issue.

So for now, its just time to play the waiting game. Hopefully this process will speed up sooner rather than later. If the FDA can make these limits workable over the next few months rather than years, we will be looking at an even larger explosion in the popularity of CBD. It isn’t hard to see the many benefits, and even possible unproven up sides, that CBD has to offer to the populace. In the meantime feel free to browse our inventory here at the CBDipedia superstore. We have exemplary products, friendly customer service, timely delivery and one of the most innovative websites designed for ease of access and use. Try something out that may give you some relief in your daily pain or possible anxiety. Don’t forget to stop back to our news area for more updates and information on your latest and important cannabis and cannabis-derived compound news.

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