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Phenibut can be lawfully marketed in a dietary supplement and food and beverages as a non-dietary ingredient as long as it's GRAS for the intended use which a company can do themselves with a self affirmed GRAS, and they don't need to notify the FDA.

There's no reason to remove this information, it's cited directly from the FDA.

"This warning letter does not address whether phenibut can be lawfully marketed in dietary supplements as non-dietary ingredients. For non-dietary ingredients intended for use in dietary supplements to be lawfully marketed in a dietary supplement, the substance must be used in accordance with a food additive regulation or be generally recognized as safe (GRAS) for its intended use (see section 201(s) of the Act (21 U.S.C. § 321(s))."[1]

A company may self-affirm generally recognized as safe status for intended use without notifying the FDA prior to marketing. which is also detailed on the article for generally recognized as safe itself but if we need more citations for it I can add more.[2] Gettinglit (talk) 04:22, 17 September 2024 (UTC)[reply]

References

  1. ^ https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/evol-nutrition-associates-inc-dba-red-dawn-energy-576309-04102019
  2. ^ https://www.cspinet.org/case/secret-gras-rule

Note that 1) the CSPI page does not specify phenibut, and 2) the FDA quote is a boilerplate footnote disclaimer appearing at the bottom of warning letters for any illegal compound. As the warning letters indicate, the FDA would disallow any dietary supplement containing a dangerous compound like phenibut.

Do you have one example of a marketed supplement containing phenibut in the US (after review by the FDA)? Don't think so. Your insistence on using the CSPI-FDA footnote is WP:SYNTH. Zefr (talk) 04:32, 17 September 2024 (UTC)[reply]

Yeah, this is an article about phenibut not some putative product which might contain it. Stick to the good secondary sources I say! I've done edits. Bon courage (talk) 04:36, 17 September 2024 (UTC)[reply]
I think your edits are reasonable. I too believe this is an article about Phenibut, not some product that might contain it, which is why I made the edits. Gettinglit (talk) 05:40, 17 September 2024 (UTC)[reply]
1. The CSPI page does not need to specify Phenibut. It's just giving a citation that companies can self affirm GRAS because some people (like yourself) apparently don't know it's a thing.
2. The FDA footnote is not for "any", which is why it specifically says Phenibut and will say different substances and even has different footnote wording depending on the substance.
3. As the warning letters indicate, it does not address whether phenibut can be lawfully marketed in dietary supplements as non-dietary ingredients because it would come down to the specifics of the GRAS affirmation.
4. I don't need an example of a supplement containing Phenibut in the US, also not specific to supplement as you could have a non-dietary ingredient in food or beverages. The fact is that a company can lawfully get a self affirmed GRAS for a condition of use and lawfully market Phenibut as a component of a supplement, food, bev.
5. Self affirmed GRAS doesn't require a review from the FDA. It doesn't even require a notification to the FDA.
6. If you don't like the CSPI (a very well known watchdog nonprofit) citation I could add 100 showing self affirmed GRAS is a thing and you can take your pick? Or I could cite the law itself but I'd be afraid you wouldn't read it compared to a condensed article. Like this court case.[1] and the same case but talked about by the AHPA instead of a law firm.[2] Gettinglit (talk) 05:36, 17 September 2024 (UTC)[reply]

References

  1. ^ https://www.engage.hoganlovells.com/knowledgeservices/news/federal-court-sides-with-fda-and-upholds-gras-rule
  2. ^ https://www.ahpa.org/blog_home.asp?display=85

"Self-affirmed GRAS" still requires notification as a novel ingredient to the FDA, which would reject a phenibut application. This is an orphan case you are proposing - self-affirmed GRAS exists, but there is no FDA-reviewed product containing phenibut, and it's reasonable to say there won't be one.

I don't get your insistence on making this edit, which is a) borrowing an exception from a footnote that will never apply, and b) gibberish to the general encyclopedia user. Zefr (talk) 06:10, 17 September 2024 (UTC)[reply]

No it does not. It's a voluntary process for self-affirmed GRAS. Because the FDA is not the ones making the review or "application" for the FDA. It's basically giving the FDA a nice "heads up" you "may" do it if you wanted to.
If it's self-affirmed GRAS (you are not seeking the FDA to determine if its GRAS or not because it was already done) it's a voluntary notification process, no requirement to do so. A watchdog group for customer safety sued the FDA in court to try and change the law that allows this claiming concerns of safety but the FDA defended the rule and it was upheld. "It also finalized the administrative procedure for any person to voluntarily notify FDA the basis of a conclusion that a substance is GRAS."[1]"The (FDAs) final rule was issued on August 17, 2016,1 and established a voluntary—rather than a mandatory procedure—for notifying FDA of GRAS determinations."[2]
FDA published the final GRAS Rule in August 2016. The GRAS Rule establishes a voluntary pathway under which “any person” can determine that a food substance is GRAS under conditions of its intended use and inform FDA of its determination by filing a GRAS notice.
As the above summary suggests, FDA’s GRAS notification process established in regulation is voluntary. Companies may, but are not required to notify FDA that a substance is GRAS for its intended use. Companies may self-affirm the GRAS status of an ingredient for a particular intended use without notifying FDA, a pathway recognized by FDA in the preamble to the GRAS Rule and in guidance for industry. The ability of manufacturer’s to self-certify food substances as GRAS without FDA’s approval or knowledge can be controversial and spurred the litigation in opposition to the GRAS Rule. (as I described above the FDA was sued by a watchdog group but was defended by the FDA and upheld in federal court) [3]
"A substance that will be added to food is subject to premarket approval by FDA unless it is generally recognized, among qualified experts, to be safe under the conditions of its intended use."[4]
And my edit was for clarification, I think the same could be said to what was currently there so why don't we just remove it all and just list it as "unscheduled" since that's what it is federally it's an unscheduled, uncontrolled substance and then also put Alabama Schedule II there and then more specific info in the legal section if people wanted more specifics about it. Gettinglit (talk) 03:16, 20 September 2024 (UTC)[reply]
  1. ^ https://www.engage.hoganlovells.com/knowledgeservices/news/federal-court-sides-with-fda-and-upholds-gras-rule
  2. ^ https://www.ahpa.org/blog_home.asp?display=85
  3. ^ https://www.arnoldporter.com/en/perspectives/advisories/2021/10/federal-district-court-upholds-fda-gras
  4. ^ https://www.fda.gov/food/generally-recognized-safe-gras/about-gras-notification-program
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