Jump to content


Page contents not supported in other languages.
From Wikipedia, the free encyclopedia

Information on Side Effects and Warnings from the FDA[edit]

The following highlighted content is, apparently, worthy of a dispute:

Disputed Content

Side effects[edit]


In 2022, the FDA stated that "scientific studies show possible harm to the male reproductive system, including testicular atrophy, harm to the liver, and interactions with certain medications. The FDA has not found adequate information showing how much CBD can be consumed, and for how long, before causing harm. This is particularly true for vulnerable populations like children and those who are pregnant."[se 1] The full statement provides links to warning letters that the FDA sent to 5 companies, whom the FDA accused of marketing CBD-based products in a manner not consistent with safety or law. For instance, the first letter[se 2] did mark for disapproval a certain beverage product, which a third-party review describes as "a line of herbal teas in 12 oz. bottles infused with 33 mg of [CBD] extract";[se 3] in the letter, the FDA invites the reader to review the information on a web page the FDA has dedicated to cannabis-derived products (including CBD).[se 4] By 28 January 2023,[se 5] that page of resources included the following document:

Safety of CBD in Humans – A Literature Review
(As of December 12, 2019)
[se 6]

That document has a section titled "Safety related to ingestion", which states:

We reviewed four primary clinical trials that supported Epidiolex approval. In addition, a total of 94 trials (as of December 12, 2019) were identified through PubMed and ClinicalTrials.gov search that used single (34 trials) or repeated doses of oral CBD (60 trials); 30 of them were in patients with epilepsy or other seizure disorders. Twenty-four were silent on safety findings, while 21 trials included a conclusive statement (e.g., “CBD is well tolerated” from the author’s perspective) without providing detailed safety results. Below is a high-level summary of the notable safety findings in the repeated dose trials.

[…] ⬅ this is part of the content

The aforementioned summary lists a number of dosages used in various trials:

  • "One placebo-controlled trial assessed CBD’s effect at 750 and 1500 mg for 6 days."
  • "Repeated doses in [198] patients with epilepsy […] treated with 20 mg/kg/day CBD"
  • "Repeated doses in patients with [schizophrenia at] 600 mg/day for 6 weeks [or] 1000 mg/day for 6 weeks"
  • "Repeated doses in patients with […] fatty liver disease using 200, 400, or 800 mg/day CBD for 8 weeks"

The document goes on to state:

FDA’s review of the four randomized placebo-controlled trials describes Epidiolex’s attributable risks: somnolence (18%; 3% is severe), CNS adverse reactions such as agitation and sedation (1-4%), decreased appetite (16%), diarrhea (9%), and decreased weight (3%). Based on the information in these trials, the estimated risk of severe liver injury, irreversible liver failure that is fatal or requires liver transplantation, is 0.3 to 0.4%, although no cases of severe liver injury were reported. It also notes that it is clear that many patients will develop cannabidiol-induced adverse reactions; however, those observed in the development program would be expected to be detectable by patients and/or caregivers, self-limited, and reversible.



  1. ^ "FDA Warns Companies for Illegally Selling Food and Beverage Products that Contain CBD". US Food and Drug Administration. 21 November 2022. Archived from the original on November 23, 2022. Retrieved 23 November 2022. These companies are selling CBD containing products that people may confuse for traditional foods or beverages which may result in unintentional consumption or overconsumption of CBD. CBD-containing products in forms that are appealing to children, such as gummies, hard candies and cookies, are especially concerning.
  2. ^ "WARNING LETTER [to 11-11-11 Brands]". U.S. Food and Drug Administration. 2022-11-16. Archived from the original on 2022-12-02.
  3. ^ "Review: Mood33 CBD Herbal Teas". BevNET. Archived from the original on 2020-11-29.
  4. ^ "FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD)". U.S. Food and Drug Administration. 2022-11-16. Archived from the original on 2022-11-16.
  5. ^ "[archived] FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD)". 2023-01-28.
  6. ^ "Safety of CBD in Humans – A Literature (As of December 12, 2019)". 2019-12-12. Archived from the original on 2023-01-28.

Here is the history of edits in chronological order:

Edit History
date user description
26 November 2023 →‎Side effects: Expanded citations and quotes regarding the FDA's safety information and warning letters.
26 November 2023
Bon courage Restored revision 1186873379 by WikiLinuz (talk): Undue detail and bevnet.com is unreliable
26 November 2023 Undid revision 1186920713 by Bon courage (talk) It is not an unreliable source, and all of the information is germane to the section and topic within the section. It is highly useful contextual information.
26 November 2023
Bon courage Restored revision 1186920713 by Bon courage (talk): As before

The dispute introduced by @Bon courage is characterized by the following statements:

  • (A) The disputed material has undue detail.
  • (B) The disputed material uses the unreliable source "bevnet.com".

Here I address each of those statements:


(A) Undue Detail[edit]

  • What exactly is undue? Surely not everything.

    If there is unnecessary detail, then perhaps that particular detail should be removed, or summarized better, or integrated more concisely in other parts of the text.

    User ("Author"), too, is a reader and editor of Wikipedia, and the very fact that Author wrote the text in question is proof that at least one reader finds this information valuable, and wishes that such information had been available from the very beginning—that is to say, at least one editor cared enough to have gone to the considerable effort to construct the text in question, along with its citations.

    So, why should the opinion of Bon courage override the opinion of Author, especially when Author wants to supply information and Bon courage wants to hide information.

  • The disputed content is useful, because it expresses the context in which the FDA statement was made; it answers questions like the following:

    • Why did the FDA make such a statement?

    • What is the basis for the FDA's claims?

    • What are further sources of information that might be useful to a reader who would like to delve deeper into the subject of side effects and regulatory activity?

    Author was completely unaware that the FDA's statement was the result of the FDA writing warning letters to various companies; when Author read the FDA's statement in full, Author wished that such information had been presented in the Wikipedia article, and so took the time to integrate such information for the benefit of future readers.

    Why should future readers not benefit from this useful information?

  • The text in question appears in a section of the article titled "Side effects"; at the top of this section, it states:

    Research indicates that cannabidiol may reduce adverse effects of THC, particularly those causing intoxication and sedation, but only at high doses.[44] Safety studies of cannabidiol showed it is well tolerated, but may cause tiredness, somnolence, sedation, diarrhea, or changes in appetite as common adverse effects with the most common being somnolence and sedation. Side effects of CBD are dose related.[45] Epidiolex documentation lists sleepiness, insomnia and poor quality sleep, decreased appetite, diarrhea, and fatigue.[6][46]

    However, until Author introduced the disputed content, there was no information on either dosing or prevalence of side effects. These details, introduced by Author, are not undue, but are in fact very important, exactly as implied by the existing text.

  • Perhaps, editor Bon courage believes that such information could be better integrated into the existing text in this section; if so, then why doesn't Bon courage do that integration rather than lazily just delete everything? If Bon courage is uninterested in performing such work, then Bon courage should defer to Author, who was motivated enough to actually write the useful content in the first place.
  • While reading through the sources to construct the disputed content, Author attempted to be very careful about ensuring that the chronological availability of information is also represented accurately; that is to say, it is valuable for the reader of the article to be presented with the accurate context in which the FDA made its statement, and that context is dependent on when certain information was available to the FDA and to the companies who were being warned, and to the general public at the time of the warning.

    More concretely, Author wondered:

    • What kind of product was the FDA warning about?

    • What was the dosage that was delivered by such a product?

    • How did that dosage compare to the dosages on which the FDA was basing its claims?

    • What exactly is the nature of the side effects that the FDA lists (what kind of liver problems, and what is the risk)?

    • When did the FDA know such information (especially with regard to the timing of the warning letters), and when was such information available to the public (especially via the FDA's website)?

    Author was concerned that the FDA's warning letter may have prompted a company to change its product's dosage; consequently, Author found a third-party review of the product in question from around the time (and from before the warning letter), so as to ensure that the context of the warning letter could be presented as accurately as possible.

    All of these questions are pertinent, and all of the answers are valuable; in short, the content in question is properly detailed, and no details are undue.

Except for Epidiolex, CBD is a Schedule I drug in the US as of April 2024[edit]

Epidiolex is the only Schedule V form (an FDA-approved drug) of CBD in the United States, as described in the Federal Register in this document. All other CBD forms and products are classified as Schedule I, which is the current status of the FDA and FTC, according to this dated 6 Feb 2024.

According to the WP description of Schedule I substances (applying to CBD, except Epidiolex), there is "no currently accepted medical use in treatment in the United States; and There is a lack of accepted safety for use of the drug or other substance under medical supervision."

This can be clarified in the infobox for the US under Legal status.

From the US Department of Justice announcement on 30 Apr 2024, the legal position for regulating THC products is likely to be relaxed, but the FDA position and concerns about CBD were not discussed in the news (last sentence in the CNN report). The above link indicates the FDA is a long way from being assured about the long-term safety of CBD. Zefr (talk) 00:05, 2 May 2024 (UTC)[reply]

Epidiolex was removed from Schedule V by the DEA on April 6th, 2020
These were announcements of a petition by GW Pharm to declassify the Schedule V status of Epidiolex. Is there an official DEA statement? Zefr (talk) 05:01, 3 May 2024 (UTC)[reply]
And the DEA has confirmed CBD is an unscheduled substance
"This notice also announces that, as the result of a recent amendment to federal law, certain forms of cannabis no longer require DEA registration to grow or manufacture. The Agriculture Improvement Act of 2018, which was signed into law on Dec. 20, 2018, changed the definition of marijuana to exclude “hemp”—plant material that contains 0.3 percent or less delta-9 THC on a dry weight basis. Accordingly, hemp, including hemp plants and cannabidiol (CBD) preparations at or below the 0.3 percent delta-9 THC threshold, is not a controlled substance, and a DEA registration is not required to grow or research it."
"(1) HEMP.—The term 'hemp' means the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a Δ9-THC concentration of not more than 0.3 percent on a dry weight basis." Gettinglit (talk) 01:56, 3 May 2024 (UTC)[reply]
FDA is the determining party on CBD uses and products. There is no change from the Feb 2024 position given above. CBD remains a Schedule I drug. CBD from hemp can only be used in research to determine its properties and safety - see #16 here. Zefr (talk) 05:01, 3 May 2024 (UTC)[reply]
FDA regulations is not the same as being a scheduled drug on the CSA. Possesion of CBD with less than 0.3% D9-THC is legal as an uncontrolled substance according to the CSAs broad hemp definition execution and the DEA itself and you dont need a license to obtain or handle it.
Cannabis over 0.3% D9-THC is a schedule I drug. Cannabis under 0.3% THC is not a schedule I drug, it's an uncontrolled substance and specifically excluded on the CSA (which the DEA confirms). If CBD comes from Cannabis under 0.3% THC it's not a scheduled drug. Possession of CBD that meets thst criteria is a legal, unscheduled substance that you will not be arrested for the possession of. There's several cases where police have given back Cannabis products after lab testing because it's legal if it's under 0.3% D9-THC Gettinglit (talk) 05:17, 3 May 2024 (UTC)[reply]
You are treating hemp-derived CBD as if it is the national standard, but hemp CBD is a minor source only for research, and is highly restricted by the FDA. It is WP:UNDUE in terms of the national policy for mention in the infobox. The article's section on the United States has the content:
"The FDA retains regulatory authority over hemp-derived CBD, while the DEA is not involved in the regulation of legally-compliant hemp and hemp products. The 2018 Farm Bill requires that research and development of CBD for a therapeutic purpose would have to be conducted under notification and reporting to the FDA."
There are no hemp-CBD products on the US market, and interstate commerce is disallowed. The FDA position is the existing restrictive rule on CBD, as explained and sourced above and in the article. Please stop warring over the infobox legal status which is supported by the Federal Register and FDA sources. Zefr (talk) 15:31, 3 May 2024 (UTC)[reply]
Hemp derived CBD is quite literally a standard by the FDA per the page you used stating it's an uncontrolled substance while Cannbis over 0.3% D9-THC is one that you're somehow misquoting.
The DEA stated it's an uncontrolled substance and does not require a license to research. Interstate commerce is protected by the farm bill as well. We are talking about possession of a substance. Possession of CBD from hemp under 0.3% THC is specifically excluded from the CSA[1] and the DEA admits it's an uncontrolled substance that does not require a license to obtain or use.[2]
You don't need a license be in possession of CBD made from Cannabis under 0.3% D9-THC, what your claiming is incorrect and not supported by the controlled substance act or DEA which is what regulates what is a scheduled substance.
Please stop revert waring and get an admin to review the citations if you're that confident because I am that my citations are correct and you are very weirdly going out of your way to mis-quote the FDA page and confuse the FDA (which by the way your own citation says Cannabis under 0.3% D9-THC is legally an uncontrolled substance) with the controlled substance act and DEA. Gettinglit (talk) 05:15, 4 May 2024 (UTC)[reply]


Gettinglit - facts and US government sources: 1. The most up-to-date source on the status of CBD regulation in the US is the FDA guideline dated Feb 2024. Parts 1. and 2. cover all we need to state about CBD as a Schedule I drug and hemp CBD as a limited exception under restriction for product development by the FDA. CBD is a Schedule I substance mainly because there is an "absence of a currently accepted medical use of the plant in the United States" and because long-term safety of its use has not been established (FDA).

2. regarding hemp CBD as an ingredient in food or supplement products, the FDA issued 6 warning letters in 2023 (search: "cbd and hemp" in 2023) for illegal branding of hemp CBD products, indicating the federal restrictions on hemp CBD uses, labeling, and interstate commerce, as I mentioned above.

3. following the Controlled Substances Act (CSA) confirming CBD as under Schedule I, the FDA oversight of CBD is reiterated by a) the unchanged 2020 position of the DEA, b) the unchanged 2020 review by the Congressional Research Service (CRS), and c) a 2023 FAQ for employees of Customs and Border Protection.

4. Summarizing about CBD: a) when from cannabis, it is a Schedule I controlled drug (FDA, DEA, CRS, and CBP sources); and b) when from hemp, it is "uncontrolled", but with tight restrictions by FDA regulations against product or ingredient development, research, and interstate commerce (FDA, CRS sources).

5. Epidiolex is a Schedule V drug under the CSA (FDA, DEA, CRS sources).

6. Compromise: This version of the US legal status in the infobox represents what the federal government publications say, but does not acknowledge the minor exception for hemp CBD (if from a hemp source with less than 0.3% THC). A combined version of the US legal status on CBD in the infobox could be:

Schedule I for all products except Epidiolex (Schedule V) [FDA, DEA, CRS refs]; uncontrolled for research if derived from hemp with less than 0.3% D9-THC [FDA ref sections 2. and 16.]

Notice to admin Bbb23 for review/comments. Zefr (talk) 18:29, 5 May 2024 (UTC)[reply]

I don't believe you live in the USA as you seem not to understand what makes something a Schedule I substance in the USA.
1. The FDA regulations for drugs, food, supplements, cosmetics has nothing to do if something is a Schedule I substance or not. Ephedra and Phenibut aren't allowed to be in foods, supplements, cosmetics and don't have an accepted medical use in the USA, but they're not Schedule I substances as a result because that's not how the law works here.
2. If CBD was illegal to sell in foods/products and was a Schedule I it would be the DEA busting down doors and people going to jail for possession and distribution of a Schedule I substance, not a warning letter asking them to stop within 15 days.
3. Following the CSA confirming CBD is not a Schedule I substance if derived from Cannabis under 0.3% D9-THC, there is nothing that mentions Cannabidiol in the CSA[1] or even the "unchanged position by the DEA" which if you bother to read my citation from the DEA they admit it's an uncontrolled substance you don't need a license for.[2]
Are you just hoping people aren't actually checking your citations or something?
This notice also announces that, as the result of a recent amendment to federal law, certain forms of cannabis no longer require DEA registration to grow or manufacture. The Agriculture Improvement Act of 2018, which was signed into law on Dec. 20, 2018, changed the definition of marijuana to exclude “hemp”—plant material that contains 0.3 percent or less delta-9 THC on a dry weight basis. Accordingly, hemp, including hemp plants and cannabidiol (CBD) preparations at or below the 0.3 percent delta-9 THC threshold, is not a controlled substance, and a DEA registration is not required to grow or research it.
4. That's what my current positioning says "Unscheduled if derived from hemp with less than 0.3% D9-THC but may be considered Schedule I if a component of marijuana with more than 0.3% D9-THC"
5. Also not accurate which is why Epidiolex no longer has the C-V on its label and logo anymore, they don't need to post a federal register claim to de-schedule something, just to make something scheduled. The CEO of pharma company of Epidiolex even confirmed Epidiolex is no longer a Schedule V so maybe you should sue them because they're on the stock market and would be committing fraud by doing so but they're not because it was removed from Schedule V
6. "Unscheduled if derived from hemp with less than 0.3% D9-THC but may be considered Schedule I if a component of marijuana with more than 0.3% D9-THC"
Has nothing to do with research or this or that, it's about possession itself.
Possession of CBD is not a Schedule I substance in the United States of America.[1]Cite error: A <ref> tag is missing the closing </ref> (see the help page).[2]
Gettinglit (talk) 19:16, 5 May 2024 (UTC)[reply]
If I understand correctly, there is a distinction between substances based on percentage of CBD, with low CBD being unscheduled, and high CBD being scheduled. Is that correct?
If so, then do we have evidence determining whether people using plant medicine typically use high or low CBD doses? I am imagining that almost no users consume low does CBD, in which case Wikipedia should say that CBD as a drug is scheduled. If users typically consume low dose CBD, then based on what I am reading, we should report it as unscheduled.
I am imagining that this low dose CBD is actually a chemical trace in hemp, and that naturally it would be like eating an inedible pile of fiber to get a therapeutic dose, or in any other kind of chemical preparation, it would require drinking large amounts of water with traces of CBD in it. What is the appearance of a therapeutic dose of this low-level CBD substance? Bluerasberry (talk) 21:32, 7 May 2024 (UTC)[reply]
Bluerasberry - the low- vs. higher-dose issue refers to the amount of THC in hemp as defined in the US Agriculture Improvement Act of 2018 (Farm Bill) and by FDA here. The Act was not about CBD, but rather about "federal authorities relating to the production and marketing of hemp," and "all derivatives, extracts, cannabinoids," which would include CBD. Hemp cultivars with less than 0.3% THC could be legally used to extract CBD - stated by the FDA: "These changes include removing hemp from the Controlled Substances Act, which means that cannabis plants and derivatives that contain no more than 0.3 percent THC on a dry weight basis are no longer controlled substances under federal law." However, the FDA retained control over how hemp-derived CBD could be used in products and marketed, stating in the above 2024 guideline: "subject to the same authorities and requirements as FDA-regulated products containing any other substance. This is true regardless of whether the cannabis or cannabis-derived compounds are classified as hemp."
There are no FDA-approved CBD products - from cannabis or hemp - on the US market (except Epidiolex) because CBD remains under Schedule I as a compound with no proven medical use or adequate safety evidence, as stated in items 3-10 of the 2024 FDA guideline. Zefr (talk) 21:56, 7 May 2024 (UTC)[reply]
  1. If someone goes to the legal farm and eats one of these legal hemp plants, then is that legal?
  2. Can someone dry one of these legal hemp plants and sell it as a legal CBD product?
  3. If someone does eat a dried legal hemp plant from the farm, then is a mouthful of leaves a therapeutic dose? Would anyone conceivably market this dried hemp as a CBD product?
I am trying to understand if leaves on a farm are legal, but if selling those same exact leaves as a CBD product is illegal. It looks like some non-zero amount of CBD is legal, so would anyone call a substance with that legal amount a "CBD product"? Bluerasberry (talk) 22:10, 7 May 2024 (UTC)[reply]
1. A partial answer about hemp CBD as a food additive is given in the 2020 Congressional Research Service report, stating that hemp foods (such as seeds) containing trace amounts of CBD "may be lawfully marketed under certain circumstances—pursuant to FDA approval as a food additive (by regulation) or a determination that the substance is GRAS. FDA has not approved hemp as a food additive but has evaluated three GRAS notices related to hemp seed-derived ingredients (hulled hemp seeds, hemp seed protein, and hemp seed oil)."
2. The FDA views a food or supplement product by how it's labeled and marketed, stated here. Several examples of companies trying to label and market hemp CBD products are among numerous recipients of FDA warning letters for mislabeling and illegal marketing, example. Search the warning letters database for "hemp and cbd" to see more warning letters.
The comment above that DEA would be "busting down doors" pursuing hemp CBD violations is unrealistic during this time in the US of several states independently legalizing marijuana (cannabis). The DEA's official fact sheet (April 2020) on marijuana (cannabis) states " the FDA and DEA have concluded that marijuana has no federally approved medical use for treatment in the U.S. and thus it remains as a Schedule I controlled substance under federal law." As CBD is an extract of marijuana, it falls under Schedule I. Hemp-derived CBD - if from hemp with less than 0.3% THC - is exempt, but its development into products is under strict FDA supervision, and there are no FDA-approved hemp CBD foods or supplements.
3. Growing hemp is legal in the US under the 2018 Farm Bill, explained in the article's US section. There are no proven "therapeutic" uses or products of CBD, whether from cannabis or hemp, in the US other than Epidiolex. Zefr (talk) 23:06, 7 May 2024 (UTC)[reply]
@Zefr: I appreciate your answers. I read them, followed the links, enjoyed them, learned from them, and they are relevant and interesting. They do not answer my questions though.
I am asking if it is legal in the United States to sell CBD products which test below the legal limit.
For social context, it appears that the big stores in the United States - Amazon, Wal-Mart, Target - are openly selling labeled CBD products including edibles, creams, and concoctions. They operate legally, do they not?
The FDA does not judge dietary supplements and non-pharmaceutical consumer products to give them approval, so when you say, "there are no FDA-approved hemp CBD foods or supplements", I expect that, because at a defined low level of CBD, it gets no more regulation than other herbal supplements with no effect.
Yes or no: Has the FDA legalized retailers to sell OTC consumer products marketed as containing CBD, where that amount is low, sub-therapeutic, and has no effect? Bluerasberry (talk) 14:02, 8 May 2024 (UTC)[reply]
Bluerasberry - good thoughtful points. The answer appears to be "no" based on this 2024 FDA definition for selling CBD supplement products.
The answer further would be no because the FDA acts on OTC CBD supplements when they are mislabeled or marketed with health claims, similarly for herbs or extracts, as you stated. If mislabeled or mismarketed with unapproved claims by a manufacturer, the FDA first warns the company, then may engage the Federal Trade Commission to issue penalties, as done for several hundred companies last year (only a few selling CBD).
The CBD supplement market in the US is in a gray zone limbo of a) CBD not having sufficient evidence of health effect or long-term safety (defining it under Schedule I); b) an uncertain market future; and c) companies and retailers widely selling CBD supplements. It is evident FDA/FTC/DEA cannot pursue all violations, which may be determined by relaxed state-to-state policies on cannabis and its derivatives.
We are straying a bit from the initial issue of this discussion: in identifying US legal status of CBD for the article infobox, we have both an exemption for low-THC hemp CBD as unscheduled existing simultaneously with FDA pessimism and restrictions about CBD efficacy and safety under Schedule I of the Controlled Substances Act. Zefr (talk) 22:02, 8 May 2024 (UTC)[reply]
Possession and sale of high CBD extract and even high purity CBD isolate is legal in the United States as it's not a controlled substance unless it contains more than 0.3% D9-THC. You don't need a Cannabis plant with more than 0.3% D9-THC to grow, extract, isolate CBD. There are strains of Cannabis specifically high in CBD (and CBG) without THC that goes over the legal limit.
However, marketing it for medical uses or as a dietary supplement or component is in violation of FDA regulations, but this does not make it a Schedule I substance unless it contains more than 0.3% D9-THC.
In the USA you cannot market Mitragyna speciosa, Piracetam, Phenibut, Vinpocetine, Ephedra as a dietary supplement or make medical claims under FDA regulations but this is not the same as being a Schedule I controlled substance which would mean the simple possession of it is illegal.
For example Phenibut and Piracetam have in their infobox "Unapproved "New Drug" (as defined by 21 U.S. Code § 321(p)(1)). Use in dietary supplements, food, or medicine is unlawful; otherwise uncontrolled" the "otherwise uncontrolled" part is because they're not scheduled substances. They're not automatically Schedule I because the FDA says you cannot market it as a supplement or food.
Zefr seems to be confused on what makes something a Schedule I substance in the USA which is the Controlled Substance Act and the DEA that enforces it, which we have clarified, from both the CSA and the DEA itself, CBD is not a scheduled or controlled substance if it's made from Cannabis with less than 0.3% D9-THC. The FDA has quite literally nothing to do with if something is a Schedule I substance or not.
If it was Schedule I, the mere possession of CBD would be illegal, but it's not as long as it's not a component of Cannabis with more than 0.3% D9-THC. Hold out your hand of CBD isolate to a DEA agent or police officer and you are in no risk of arrest, hold out your hand of D9-THC or Cocaine to a DEA agent or police officer and you are at risk of arrest.
You can also hold out your hand with CBD isolate to an FDA agent and you are also not at risk of arrest or punishment unless you're marketing it with claims to treat a medical condition or market it as a supplement or food product specifically which companies can get around by a "self affirmed GRAS" anyway or marketing it as a "hemp product" without having a supplement facts panel or nutrition facts panel.
That's why I feel the current "Unscheduled if derived from hemp with less than 0.3% D9-THC but may be considered Schedule I if a component of marijuana with more than 0.3% D9-THC." is the most accurate and informative and this articles legal section goes into more detail about it's ability to be marketed as a supplement. Gettinglit (talk) 01:32, 9 May 2024 (UTC)[reply]
I am unsure about all of this.
Zefr's sources are authoritative, give some clarity for questions, but also do not address the everyday common knowledge that CBD products are ubiquitous and marketed by the most conservative retailers.
Gettinglit, I agree that there is no risk of arrest, but even before some states legalized cannabis, I had the everyday experience in Seattle of seeing recreational cannabis openly marketed with signage in busy storefronts and in conventional advertising. There are some things which the law prohibits but for which there is no enforcement of prohibition.
I found something with insight but which does not answer questions. At NC State University's Cannabis Research Program they have a guide for farmers to comply with CBD guidelines. They say compliance is difficult. If I am understanding this correctly, all of the plants naturally grow to contain more than the legal limit of CBD. The farmer must not let the crop mature, but instead must harvest them early in opposition to maximizing production. This report says that misinformation is everywhere, and they recommend their own testing data as an authority.
My takeaway from this is that the legal limit of CBD is very low, below even the natural level that all mature plants produce before processing. I do not want to draw conclusions, but I doubt that a raw plant has a therapeutic dose. I wonder what consumer products have a compliant amount of CBD.
I doubt my ability to untangle this or consider further. I am reading this conversation but I am not sure I will be able to understand this without having a clear authoritative source explain and reconcile the regulations against the marketplace sales which are plain to see. Bluerasberry (talk) 15:06, 9 May 2024 (UTC)[reply]
Bluerasberry notes above the NC State University Cannabis Research Program intended to help hemp farmers grow CBD-rich hemp with low amounts of THC. The same concern is presented by the USDA Agricultural Marketing Service for hemp farmers in this 2021 Federal Register document (see section on ''DEA and Controlled Substances" concerning hemp breeding for high CBD levels and whether DEA "crime labs" should be used for the CBD assays).
These two government sources - one state and one federal - show the legal flux and challenges for the US hemp CBD industry. The Federal Register document devotes most of its discussion to the variable CBD production among hemp cultivars (cntrl f; search cbd).
Illustrating further incontinuity and confusion in the US hemp industry was a report yesterday that, in Virginia - North Carolina's state neighbor to the north - hemp CBD farming and extract production have collapsed due to opposition against cannabis by the Virginia governor. Zefr (talk) 16:16, 9 May 2024 (UTC)[reply]
I believe you are mistaken in regard to CBD content limits. There is no legal limit for CBD in the USA in regards to being scheduled. There is only a legal limit for D9-THC specifically. CBD is not a Schedule I (or any schedule) substance per the CSA and DEA. Only if it contains D9-THC over 0.3% THC which is a Schedule I.
For example a gram of pure CBD isolate is not illegal, it's not scheduled. But 95% CBD isolate that contains 5% D9-THC is illegal because it would be over 0.3% D9-THC. This legal limit is specific to D9-THC, not CBD or anyother cannabinoid which I believe you may have mistaken to mean a legal limit for CBD. Gettinglit (talk) 19:28, 9 May 2024 (UTC)[reply]
The 0.3% refers to a 'source rule' - any CBD derived from a source that doesn't meet that requirement is Schedule I. So one should not say that 'isolate' or any other form of CBD is 'not illegal' as a blanket statement.
There's also the 'drug exclusion rule' - once a drug has been approved (for example Epidiolex) that includes a substance as an active ingredient, all other uses of that ingredient are disallowed by the FDA in food or beverage without specific approval.
Honestly, though, this discussion is untimely. Given current movements in the US's executive branch, all of this will change in a few months. Just let the article be for a while and wait for new sourcing, which should be along soon. MrOllie (talk) 19:58, 9 May 2024 (UTC)[reply]
Fyi - the pending federal rescheduling of marijuana is for the potential recreational and medicinal uses of THC, with CBD not included (last sentence).
The 2024 FDA report indicates it doesn't have enough safety evidence on CBD to warrant changing use recommendations. Zefr (talk) 00:42, 10 May 2024 (UTC)[reply]

Reconciling federal regulations for CBD against its national marketplace sales[edit]

The 2020 Congressional Research Services report has a useful summary of the US CBD market (bold and underline are my emphasis). These market conditions exist in 2024:

there are three markets for CBD: 1) hemp-derived CBD, 2) marijuana-derived CBD (a Schedule I controlled substance), and 3) pharmaceutical CBD (only Epidiolex)... Although some industry analysts foresee a strong market for marijuana-derived CBD, it remains prohibited (aside for lawful research purposes) under the CSA if the product does not meet the statutory definition of hemp in 7 U.S.C. §1639o. At the retail level, consumer products labeled as containing CBD are being sold in food and beverages, dietary supplements, and other product categories—despite FDA’s position that CBD may not be sold in food and beverages or dietary supplements.

Points to clarify for this discussion and the article:

1. marijuana-CBD is a Schedule I controlled substance while low-THC hemp CBD is unscheduled and being widely sold in the US as supplement, seed (i.e., food/beverage) and cosmetic products.

2. can CBD products be sold as a) dietary supplements or b) as an ingredient in food? a) No. "FDA has concluded that CBD products are excluded from the dietary supplement definition" and b) No. "FDA has concluded that it is a prohibited act to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which CBD has been added."

Hemp seed, hemp seed protein powder, and hemp seed oil are considered GRAS and can be used in human food because hemp seed does not contain CBD.

3. the American CBD retail market is robust and expected to grow, mainly due to hemp CBD. However, the future of the market is stuck in limbo, with some signs of an economic standstill. Zefr (talk) 18:15, 9 May 2024 (UTC)[reply]

I believe your #1. point would support my legality info box stating...
"Unscheduled if derived from hemp with less than 0.3% D9-THC but may be considered Schedule I if a component of marijuana with more than 0.3% D9-THC"
I don't understand what you disagree with about that because you are quoting information that supports it.
We (seem to) (now) both agree that CBD derived from hemp under 0.3% D9-THC is not a Schedule I substance? Gettinglit (talk) 19:47, 9 May 2024 (UTC)[reply]