FDA Activity at USA CBD Expo in Las Vegas

[raghanded]

edit: read like dipshit

[anon1342]

@O.M.O

Incorrect. The Hemp Extract Bill has passed in NY. There are new labeling and testing regs coming into play 2nd week of March, 2020. A whole new round of licencing overseen by the Dept of Health begins in January of 2021. CBD products manufactured in NY must be produced as dietary supplements, its been that way for over 2 years.

Thanks for that. Do you have a link for the new regs/licensing etc? Here’s what the NY dept of ag has on their website at the moment:

https://agriculture.ny.gov/system/files/documents/2019/12/changestonewyorksindustrialhempprogram.pdf

[anon1342]

@O.M.O

In short, NY is not deferring to the FDA. NY is choosing its own path and yes, adopting FDA guidelines for dietary supplement manufacturing.

Actually no. You seem to misunderstand the significance/difference between state and federal regulations. Currently NY state does defer to FDA regs, as FDA regs are the reason it is currently illegal to sell CBD in NY state. It appears new NY regs/licensing will change this to some degree which is great news.

When NY adopts new state law, it will cover sales in NY state. Any sale crossing state lines will remain illegal per FDA regs.

[Sidco_Cat]

Excellent analysis and explanation.

[O.M.O]

The state is transitioning from a research program to a commercial licencing program, beginning January 2021. Currently CBD sales are legal and allowed in NY by NY research partners as long as its in their declared scope of research. People and business out side of NY’s Hemp Pilot program are not protected or enabled by its provisions.

[anon1342]

Again, this spews off your keyboard without a supporting link. The NY dept of ag webite makes clear CBD sales are currently illegal for everyone. There’s no safe harbor sale for research partners or pilot program participants.

Please support your ridiculous claims or admit you have no idea what you’re talking about.

[O.M.O]

NY Processor, combo lisc. #76

[anon1342]

yep. nope.

nothing there says you can sell shit because you’re a pilot or research program or partner.

[Phytoalchemy]

I was under the impression those 15 warning letters were for “medical claims”, were they not?

[anon1342]

No. All the letters are linked for your reading pleasure. The fact those companies are still not selling online should be a big wakeup call.

https://www.fda.gov/news-events/press-announcements/fda-warns-15-companies-illegally-selling-various-products-containing-cannabidiol-agency-details

[Estokha]

I love that we live in a country where half the government is trying to support you while the other half want to throw your ass in jail.

[O.M.O]

The medical claims are what brought the FDA’s attention.

[O.M.O]

[Phytoalchemy]

Word I see that now. I guess another way of looking at it would be that 15 companies is a fairly small portion of the number of active operators.

I’m sure the FDA doesn’t need cooperation from state agencies in regards to ecommerce. But I wonder how much groundwork the FDA can do without state cooperation. For example, in Vermont the state AG department has made it clear they have no intention of enforcing the FD&C on state registered businesses in VT. This can be further illustrated by the letter which was sent to the FDA commissioner by the secretary of the VT AG dept:

" Dear Commissioner Gottlieb,

The Vermont Agency of Agriculture, Food & Markets (the Agency) requests that Food and Drug Administration (FDA) review its exclusion of hemp–derived cannabidiol (CBD) products from the definition of a dietary supplement for several reasons.

Hemp–derived CBD–products have been used as a dietary supplement prior to the public disclosure of the ‘investigational new drug‘ application for the CBD isolate. The Agency believes that a prior market for hemp derived–CBD products cannot be well–documented as a result of its legal status under previous Farm Bills. However, anecdotally, and a multitude of stories on the internet, indicate that CBD had been used, and sold, whether legal or not at the time, by members of the public for relief of minor pains and calming effects.

Secondly, the derived products from raw hemp extracts, contain other botanicals, cannabinoids and amino acids, which differ significantly from the pharmaceutically–produced CBD isolate.

We respectfully request, the FDA use the Secretary‘s discretion to pursue a pathway to introduce these products into interstate commerce, as we believe they are substantially different from the new drug investigation. The pathway include allowing the hemp industry to market food as containing hemp derived CBD products for non–listed medical conditions for use by the public.

As background, any decisions made by the FDA related to this issue, will have a significant impact on Vermont‘s small, rural, agricultural economy. The Agency initiated its Hemp Pilot Program fully in July of 2018. In that time, the Agency registered 461 growers, with over 3,200 acres registered. This burgeoning agricultural commodity is critical to our state, as the primary agricultural business, dairy, decreased significantly in the same time period as farmers struggle to compete in the fluid milk market.

For 2019, to date, about 200 applicants want to register in excess of 2,000 acres to grow hemp, and many are first time or younger farmers, which we are hoping to revive and keep alive our working landscape.

While the State of Vermont may not be able to compete with other states on the quantity of hemp produced within its boundaries it will, as proven with other Vermont agricultural products like maple syrup and dairy, be able to compete with the rest of the nation on producing quality hemp and cannabinoid products derived from hemp. In order to do this, we need a clear path from the FDA that allows our producers to continue to produce and sell dietary supplements or nutraceutical products and offer them into interstate commerce."

So, perhaps were moving into an era where ecommerce of anything but topicals, seeds, etc is moot, and in state retail will be the only king (and that’s only in states that would protect their businesses). That would definitely hurt the national industry and I’d expect to see a bank run on a lot of CBD investment given interstate ecommerce was one of the big selling points of backing CBD companies.

[anon1342]

@Phytoalchemy

For example, in Vermont the state AG department has made it clear they have no intention of enforcing the FD&C on state registered businesses in VT. This can be further illustrated by the letter which was sent to the FDA commissioner by the secretary of the VT AG dept:

Not just VT. Many states flipped FDA the bird and adopted specific safe harbors for CBD product sales. However, selling by website across state lines enacts FDA regs again making the product illegal. So, plan accordingly or expect FDA action.

As far as 15 warning letters – that was just the latest round. The full CBD warning list is 70ish? They’re all on the site linked.

[anon1342]

So? You want to cut and paste the words you like from a regulation to make a new regulation?

The sentence says "may undertake research projects to study … sale "

That takes some fucktarded sorcery to read as “authorizes sales”. Particularly when the department of ag states specifically sales are illegal.

[Roguelab]

you should come to the Netherlands
We have 680 dispensery s (coffee shops)
They All my sell weed to custumers
With some regulations
But not 1 is allowed to buy it
Wholesale
For over 30 years

[Estokha]

If im ever headed that way i’ll bring ya a gift and share some smoke

[anon81723932]

Do you think it will ever be outright legal? What have been barriers to complete legalization?