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FDA didn’t sound overly positive with data and timing today ? Any thoughts
Yeah FDA didn’t sound overly positive from data or timing standpoint
Was it bad ?
$CWBHF green while $CVSI $ELLXF $YCBD red and dropped.
CuraLeaf issue does not help short term sentiment i suppose
what do you make of this section though:
Dietary Supplement Labeling
Information on your website and social media accounts suggests that you may intend to market your CBD products as dietary supplements. For example, a disclaimer on your website includes the statement “Cannabidiol (CBD) is a natural constituent of industrial hemp and is a dietary supplement.” You also display a photo of a CBD product with a supplement facts panel that appears to be your “CBD Tincture” (Relax version) on your social media accounts. Furthermore, you state under the disclaimer section on your “CBD Lotion,” “CBD Pain-Relief Patch,” “CBD Tincture,” and “CBD Disposable Vape Pen” products’ webpages that “Cannabidiol (CBD) . . . is a dietary supplement.” Based on these observations, it appears you intend to market your CBD products as dietary supplements. However, they cannot be dietary supplements because they do not meet the definition of a dietary supplement under sections 201(ff)(3)(B) and 201(ff)(2)(A)(i) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B) and 321(ff)(2)(A)(i).
FDA has concluded based on available evidence that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i) and (ii). Under those provisions, if an article (such as CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act, 21 U.S.C. 355, or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. There is an exception if the substance was “marketed as” a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for CBD.2 FDA is not aware of any evidence that would call into question its current conclusion that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, but you may present FDA with any evidence that has bearing on this issue.
Furthermore, your “CBD Lotion” product’s labeling states that it is intended to be applied directly to the skin; your “CBD Pain-Relief Patch” product’s labeling states that it is intended to be applied to the body for transdermal use; and your “CBD Disposable Vape Pen” products’ labeling states that they are intended for inhalation. The FD&C Act defines the term “dietary supplement” in section 201(ff)(2)(A)(i) as a product that is “intended for ingestion.” Because these products are not intended for ingestion, this is an additional reason why your “CBD Lotion,” “CBD Pain-Relief Patch,” and “CBD Disposable Vape Pen” products do not meet the definition of a dietary supplement under the FD&C Act. Furthermore, with respect to your “CBD Tincture” products, the “Suggested Use” section of these products’ labeling includes both “edible” uses and topical uses. To the extent that your “CBD Tincture” products are intended for a delivery method other than ingestion, as evidenced by the labeling describing topical uses, this is an additional reason why these products also do not meet the definition of a dietary supplement under the FD&C Act.
.CuraLeaf gets CBD warning letter from FDA https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/curaleaf-inc-579289-07222019
CuraLeaf gets CBD warning letter from FDA https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/curaleaf-inc-579289-07222019
CW now in 7000 locations . They updated count on the investor relations page
https://investors.charlottesweb.com/overview/default.aspx
I love it
Ohio CBD bill passed now to governor desk
it did.
2019 CW guidance sales $120-$170m
As far as food and beverages go, FDA could very well say no CBD isolates. Hemp extract only. Where does that leave NBEV etc ?
Food and beverages not even in CW $120-$170m guidance. Only CBD pure play to give guidance by the way. If Food and beverages were to open up just gravy. But I expect CW to do it right if they do and keep with their most trusted brand / story theme.
You assume CW or anyone else would be starting from scratch? Also that there would be no grace period for certain ?
. FDA feedback by late summer or fall https://hempindustrydaily.com/fda-to-provide-update-on-cbd-review-by-late-summer-or-fall-official-says/
FDA feedback by late summer or fall https://hempindustrydaily.com/fda-to-provide-update-on-cbd-review-by-late-summer-or-fall-official-says/
We are getting pulled down with CGC and the weeds
$CWBHF - Charlotte's Web Is Spinning Quickly https://seekingalpha.com/article/4274469-charlottes-web-spinning-quickly?source=tweet
spread seems to be somewhat widening between bid and ask ....... maybe short squeeze soon
CVS, Walgreens To Lead $23 Billion CBD Market By 2023 via @forbes https://www.forbes.com/sites/brucejapsen/2019/07/11/cvs-walgreens-to-lead-23-billion-cbd-market-by-2023/#4247981952ca
I will email IR and post response . Will buy more if “you’re” correct .
looked like MM games to me. one sell took it down
CV would still need approval from Japan's version of the FDA. so "you're" wrong
But they still have to have a medical approval in that country if we are talking the smoking cessation drug ....Japan has their own version of fda. I think that patent was for smoking cessation drug? Correct me if wrong
Fair enough opinion ....I was thinking the international and the hemp food biz. What other strategic moves could we make then?
ELLXF having nice day does anyone think CW takes them out
have a great day DY !
I believe all countries have their own drug approval process and a patent does not allow you to sell a drug without approval. EU, Japan, China all have their own FDA type agencies to approve the smoking cessation drug.
We are up more than any CBD stock and some of others had press releases today
wow big push there
CEO said there are no imminent plans to use New Harvest.
Did not SpaceLady say that the CV CEO said at the annual meeting there are no imminent plans to use the New Harvest name? Im just trying to understand what you are saying. What plans do you think they have for New Harvest? A complete rebranding ? A premium brand ?
60mg oil now available through website
your DD is valuable to this board and i appreciate your posts
big volume again
no sir i am long and pro CV ......made many pro CV comments and think its a steal here
ELLXF trying to get off the mat as well. CVSI and YCBD lagging at moment. All 4 should do well somepoint if CBD becomes massive theme I think it will imo
CW the undisputed leader and market seems to be starting to see how this will be a wellness monster company imo