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Re: Smooth_Legend post# 69559

Wednesday, 09/23/2020 1:11:27 PM

Wednesday, September 23, 2020 1:11:27 PM

Post# of 82644
We have FDA SENIOR POLICY ADVISOR SHARON MAYL saying that he had hoped guidance for CBD in non-drug products would have been published by yesterday.

Waiting For Cannabidiol Guidance? US FDA Reminds Industry Of ‘Many Other Requirements’
22 Sep 2020

Expectations are high and climbing for US regulators’ guidance on lawful use of hemp-derived ingredients in dietary supplements but firms using the substances in their products could be brought down to earth by existing manufacturing and marketing regulations.
The Food and Drug Administration, two months after submitting a “Cannabidiol Enforcement Policy” draft guidance for White House clearance to publish the document, on 22 September published an unrelated draft guidance on studies for bioequivalents of an approved cannabidiol-based drug. The FDA also announced a public meeting to discuss sex and gender differences in the use and response to cannabidiols (see related story).
However, the draft guidance that the supplement industry, in addition to personal care and food product firms as well as the consumer health sector overall, awaits in pitched anticipation remains under review by the Office of Management and Budget.
Sharon Mayl, senior advisor for policy in the FDA Office of the Commissioner, says the agency also is anxious for progress on providing guidance for using cannabidiols in non-drug products subject to its regulatory oversight.
“Unfortunately, it hasn’t been issued,” Mayl said on 22 September during a Food and Drug Law Institute regulatory conference.


“I was sort of hoping that it would be issued by the time I gave this talk but it hasn’t. So, I can’t say a lot about that, but I think that’s something that should be on your radar as something to look for,” she added in a presentation updating the agency’s cannabis policies during the conference conducted online.
‘Just One Step’
Supplement industry stakeholders offering products containing cannabidiols (CBDs) and other cannabinoids already can look for the FDA’s manufacturing and marketing regulations, Mayl noted.
Because cannabinoids have been studied and are used as approved pharmaceutical ingredients, they are excluded from use as dietary ingredients under FDA regulations; the agency for two years, while  considering a pathway for lawful use in non-drug products, has allowed sales of products containing the ingredients that are compliant with the FDA’s other regulations for supplement manufacturing and marketing. (Also see "FDA To Consider Regulatory Shift Making Cannabis Ingredients Officially Eligible For Use In Dietary Supplements" - HBW Insight, 28 Dec, 2018.)
On Capitol Hill, legislation has been introduced in the House to waive the exclusion against using hemp-derived CBDs and other cannabinoids in dietary supplements. (Also see "US Bill For CBD Supplement Path Draws Mixed Industry Response" - HBW Insight, 12 Sep, 2020.)
Mayl pointed out that more is needed than eliminating the prohibition for marketing of supplements containing the ingredients to be regulatorily compliant. Good manufacturing practices and labeling rules are prominent among other requirements.
“There are many other regulatory requirements that apply to those products and simply removing the prohibitions that Congress included [in the Dietary Supplement Health and Education Act] is just one step,” she said.

“That’s not the only hurdle. There are still safety standards that are very much involved,” she added.
And so far, the FDA doesn’t have data supporting safety for CBDs and other cannabinoids. “If there is safety data out there, we really want you to come to us,” Mayl said.
Standard Neither Higher Or Lower
Moreover, the agency is interested in allowing the use of ingredients that benefit public health. “We really do want to know if this is a product that has therapeutically beneficial effect and we want to have a way to get that product on the market,” Mayl said.
Without proof of safety for CBDs’ use as dietary ingredients, though, the FDA is concerned that consumers using supplements containing the ingredients may be foregoing approved treatments for some chronic and serious conditions as well as that the substances may be unsafe in non-drug products.
“We are not holding CBD to a higher safety standard than we would for any other ingredients that are being put into products that we regulate. We are not holding it to a lower standard either,” Mayl said.
As an example, she noted the potential for male reproductive toxicity from using cannabinoids is a concern. “If this were a sweetener and not CBD, how would people want FDA to treat this product?” Mayl said.
Docket Open ‘Indefinitely’
Mayl, who works in the FDA’s initiative looking at its cannabinoids regulatory policy, also reminded stakeholders during her presentation that a dearth of safety data has been submitted not because the agency hasn’t asked.
The cannabinoids policy docket – FDA-2019-N-1482 – had been reopened at several points before late 2019, when “we reopened it indefinitely,” Mayl said.
Additionally, to encourage businesses and others, the FDA is allowing data and other information to be submitted to the docket confidentially.
A centerpiece of opening the docket was a public meeting the agency conducted in May 2019, its first on hemp- or cannabis-based ingredients. However, while the FDA asked for discussions of its explicit questions about specific areas of data around cannabinoids’ safety, the meeting was somewhat a wash for adding to its information. The same could be said for some 4,500 comments submitted to the docket. (Also see "FDA ISO Data On CBD Safety In Supplements, Sees Potential As Well As Risks " - HBW Insight, 20 Nov, 2019.)
“There were, quite frankly, a lot of questions posed in the meeting notice but not a lot of information that addressed the questions,” Mayl said, adding, “While there were a lot of comments there just wasn't a lot of data submitted.”
Meanwhile, the FDA has submitted around 90 warning letters to domestic and international businesses marketing cannabinoid-containing products in the US. The firms’ violative claims for the ingredients to treat myriad diseases or conditions attracted regulatory attention, but some also have been warned about GMP problems.  (Also see "Drug Claims For CBD, Detoxification Supplements Make Warning List Along With Pandemic Fraud" - HBW Insight, 10 Jun, 2020.) 

https://hbw.pharmaintelligence.informa.com/RS150491/Waiting-For-Cannabidiol-Guidance-US-FDA-Reminds-Industry-Of-Many-Other-Requirements

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Edit: "And so far, the FDA doesn’t have data supporting safety for CBDs and other cannabinoids."

This line is same old bs, by repeating this and not awarding responsible companies who follow dietary supplement regulations by similar regulations like UK and Australia are implementing, FDA themselves are creating this public health hazard.

If there's only handful of companies who will possibly win by FDA guidance then one them is definetely us! Taking account what Hahn said "We're not going to be able to say you can't use these products. It's a fool's errand to even approach that" I bet we get daily safety dose suggestion after OMB review.

As Sharon was waiting news by yesterday, news is imminent and game is on! After positive news those who are not buying today will be buying at $1+