A period after yourfirst word in a setence oh noes! my typ ng is wong!~!!
Yall always try to attack my spelling i can give a fuck less this the internet not a work email. Be more focused on irrelevant things to the topic :deuces:
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Deuces too, eh?
Nevermind, a teenage girl wrote that.
All upset because of garbage reading comprehension. Iz ok bb.
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More like 89â hasslehoff and bust
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It always concerns me when people are dismissive of what the FDA does.
Earlier this year the FDA told Charlotteâs Web that CBD is not GRAS - even with all the data they submitted for it.
Then they said that hemp derived products are not allowed in food or dietary supplements and only one (CBD) has been approved as a drug, Epidiolex.
Then they issued warning letters for labeling and when they did so the USDA came out and said hemp derived products are not okay except for a specific list (hemp oil, hemp hearts, hemp seeds, etc.)
Then they issued a specific warning to consumers specific to adverse events being reported across the country (which then lead to bans of hemp derived products in 18 states).
Now they have issued warning letters for what everyone here is calling âmedical claimsâ. But thatâs not all these letters were about. And I think its appropriate to talk about that - because we could be fearful of articles like this and call them fearmongering. Or would could treat them like all other regulated industries treat these kinds of notices - as indicators of the current direction of enforcement at the Agency.
"The letters also cite violations related to drug misbranding (e.g., the products lack adequate directions for use) and the addition of delta-8 THC in foods, such as gummies, chocolate, caramels, chewing gum, and peanut brittle. "
Let me be more specific - since it seems like perhaps people did not read the warning letters (which are linked in the article and available free to the public).
To ATLRx - not related to medical claims, but instead utilization of unapproved FOOD ADDITIVES in FOOD. And it is not GRAS - they are specific about this, call out CBD being used in gummies as food.
To BioMD Plus - not related to medical claims, but again because of unapproved food additives.
For Delta 8 Hemp - unrelated to medical claims, but again because of unapproved food additives and that selling these products in interstate commerce is is a violation of the FD&C statutes.
For Kingdom Harvest - unrelated to medical claims, but again because of unapproved food additives being added to âconventional foodsâ specifically honey and coffee.
And for M Six Labs - unrelated to medical claims, but again because of unapproved food additives:
All of these companies have 15 days from receiving these letters to respond. Without responding they will then face forfeiture of their assets, the inability to continue selling these products at all, and potentially jail time and hundreds of thousands of dollars in fines.
Iâve been the one receiving a warning letter and a consent decree in my pharma days - your whole business stops, they come and chain up the doors and you cannot even go inside!
FDA has been specific and clear. And now they are starting enforcement. Everyone here should take notice that all of these letters state that you cannot use CBD because it is A DRUG - and not eligible to be a food additive.
A couple of these warning letters talk about D8 - because its new and there are adverse events, and people are making weird medical claims on social media. But all of these letters talk about adulterated food products containing unapproved food additives.
Adulterated food products lead to involuntary recalls on a national level. So expect to see that or a voluntary recall in about 2 weeks.
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Koi got the same complaint a few years ago about adterated food
They are still selling gummies
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Ftc seems to be likely to enforce this stuff too
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Just glad something will maybe be done about the legitimate snake oils that are sold to cancer patients and sick people. Not a fan of federal government or federal entities of sorts, but maybe the FDA will put their foot down on the people profiting off of snake oil.
Only issue I can see is just more government interference/power. Although in this instance, itâs bettering the people. I hope they donât use this opportunity to push more pharma medâs and propaganda though.
Who am I kidding this will probably be used to monopolize on it and squash small dogs over time.
So what about cbd tinctures, sprays, patches, smokes, etc⌠that are not a part of âfoodâ, but are sold on their own. Since they are âeatenâ or âingestedâ technically, are they coming for those too?
The entire vitamin and supplement section of the grocery store, and products that are advertised every night on TV with false claims are all non-FDA approved products. This doesnât make the products illegal to sell as long as the FDA disclaimer is there.
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I see your point. Thanks. Hard to believe that bigger companies like Koi, etc⌠would put themselves in a position to get on the wrong side of the FDA. Truly no win.
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Make more $ than you have to settle for. Plenty of businesses do that.
Thatâs the 2022 American way
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You know this has been going on forever right. Just donât make medical claims directly from your company.
Feds are always badâŚalways.
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Pharma already started conspiring, we just wonât find out about it for like 50 years
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Itâs no secret
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Oh that theyâre after cannabinoids is no secretâŚIâm talking about the imminent scandals we are bound to witness associated with their involvement in compounding and synthesizing cannabinoids
Theyâll fuck it up somehow
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Agreed which is why Iâm worried about this
What I think FDA will do is just make it harder for small people to approve their CBD products, in favor for corporations or synthetic alternatives.
Thatâs no conspiracy. The big boys are already making plans and laying the groundwork with shell companies and LLCs.
On the bright side, pharma-grade cannabinoid formulations is a space 99% of this forum wonât be interested or prepared to participate in. Pharma-grade cannabinoids wonât be competing with adult use rec cannabis and that isnât going anywhere.
âŚin my humble opinion.
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They will try to overstep it into rec if they get a good monopoly on medical.
Like I said, I think the FDA is in kahootâs with these companies to push small game out and approve syntheticâs for these companies to sell without issue.
I can see why it seems like a good move, FDA is putting the foot down on snake oil, but it wonât go that way. It will never.