TheLabGuy
Board Rep
Lots of supplement companies say that they have a legal Ephedra product---that's legal.
What do you think about the subject?
What do you think about the subject?
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Is Ephedra Legal?
- Thread starter TheLabGuy
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They used to sell it everywhere then they made it illegal. I had a bottle of Stacker II I bought a long time ago which were packed with it. I finally just threw them away last year. I don't like the jittery feel it gives you.
yes it is legal but it is "illegal" to market it for weight loss in the US.
MasterChemist
Registered
MasterChemist
Registered
Sorry about that stuff at the bottom I did not intend to post it so many times....
yes its legal never mind ephedra get pure ephedrin HCL this way you know EXACLY the amount your getting.
te lays are they cant sdell it as a ft burner or energy pills or any of that.
they are allowed ot sell it as an ORAL NASAL DECONGESTANT and i thinl thelimit per tab is 8mg/tab. (but on line from over seas you can find more MG per tab)
umm maybe because it IS FUKIGN LEGAL!
for medical uses NOT fatloss or energy as posted above. and it has been for a few years now!
same goes for canada aswell.
Would be interested to see YOUR true intent...
LAM is spot on, especially with his use of quotation marks.
This one pops up from time to time here.
Ephedra is an herb. Its sale - or the sale of its alkaloids, such as ephedrine HCL - as a dietary supplement is not legal in the USA.
Guidance for Industry: Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk; Small Entity Compliance Guide
I. Introduction
On February 11, 2004, FDA published in the Federal Register a final rule that established a regulation declaring dietary supplements containing ephedrine alkaloids adulterated under the Federal Food, Drug, and Cosmetic Act because they present an unreasonable risk of illness or injury under the conditions of use recommended or suggested in labeling, or if no conditions of use are suggested or recommended in labeling, under ordinary conditions of use (69 FR 6787). The final rule became effective on April 12, 2004. FDA has prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121). This guidance document restates in plain language the legal requirements set forth in 21 CFR 119.1 concerning dietary supplements containing ephedrine alkaloids. This regulation is binding and has the full force and effect of law.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
II. Questions and Answers
Page Last Updated: 09/15/2009
_____________________________________
So if I'm reading this correctly, Ephedra (the herb) or ephedrine HCL (the OTC medication) are legal if sold alone as decongestants, but not if combined with other agents and sold as a dietary supplement.
In Canada most supplement stores sell these "decongestants" in 8mg tablets, by the case.
Ephedra is an herb. Its sale - or the sale of its alkaloids, such as ephedrine HCL - as a dietary supplement is not legal in the USA.
Guidance for Industry: Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk; Small Entity Compliance Guide
I. Introduction
On February 11, 2004, FDA published in the Federal Register a final rule that established a regulation declaring dietary supplements containing ephedrine alkaloids adulterated under the Federal Food, Drug, and Cosmetic Act because they present an unreasonable risk of illness or injury under the conditions of use recommended or suggested in labeling, or if no conditions of use are suggested or recommended in labeling, under ordinary conditions of use (69 FR 6787). The final rule became effective on April 12, 2004. FDA has prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121). This guidance document restates in plain language the legal requirements set forth in 21 CFR 119.1 concerning dietary supplements containing ephedrine alkaloids. This regulation is binding and has the full force and effect of law.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
II. Questions and Answers
- What does the regulation state about the legal status of dietary supplements containing ephedrine alkaloids?
The regulation states that dietary supplements that contain ephedrine alkaloids are adulterated under section 402(f)(1)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(f)(1)(A)). It is illegal to market an adulterated dietary supplement.
- What is the basis for concluding that dietary supplements containing ephedrine alkaloids are adulterated?
Dietary supplements that contain ephedrine alkaloids present an unreasonable risk of illness or injury under conditions of use recommended or suggested in the labeling, or if no conditions of use are recommended or suggested in the labeling, under ordinary conditions of use (21 CFR 119.1).
- What scientific evaluation did FDA rely upon when issuing the final regulation on dietary supplements containing ephedrine alkaloids?
FDA took this action based upon the well-known pharmacology of ephedrine alkaloids, the peer-reviewed scientific literature on the effects of ephedrine alkaloids, and the adverse events reported to have occurred in individuals following consumption of dietary supplements containing ephedrine alkaloids (69 FR at 6788).
Page Last Updated: 09/15/2009
_____________________________________
So if I'm reading this correctly, Ephedra (the herb) or ephedrine HCL (the OTC medication) are legal if sold alone as decongestants, but not if combined with other agents and sold as a dietary supplement.
In Canada most supplement stores sell these "decongestants" in 8mg tablets, by the case.
MasterChemist
Registered
Actually no it is not.. and obviously the conversation was about fat burning pills. So lets stay on the subject not get distracted.
Judging by your ability to articulate your self I would advise against getting into a pissing contest on the boards with me.
MasterChemist
Registered
Like I stated legal for sale but not for weight loss...
FDA Statement on Tenth Circuit's Ruling to Uphold FDA Decision Banning Dietary Supplements Containing Ephedrine Alkaloids
no shocker since we all know that Monsanto's bitch I mean the FDA is a joke...
FDA Statement on Tenth Circuit's Ruling to Uphold FDA Decision Banning Dietary Supplements Containing Ephedrine Alkaloids
no shocker since we all know that Monsanto's bitch I mean the FDA is a joke...
MasterChemist, settle down. Ephedra and ephedrine alkyloids such as ephedrine HCL are legal for sale as OTC decongestants in the USA. If a supplement company sells it as a legal ephedra product, they are allowed to do so - provided they sell it as a decongestant.
It may not be combined with other actives and sold as a dietary supplement because doing so creates an adulterated dietary supplement. It is similarly illegal to mix aspirin with a multivitamin and sell it as a dietary supplement, - although it is perfectly legal to mix aspirin and caffeine and sell it as a migraine remedy (OTC medication). Caffeine exists in foods we normally consume, so it may be added to dietary supplements without changing their status to "adulterated".
Now kiss and make up, okay? (And when you do, kindly take pix and PM them to me thankyouverymuch.)
It may not be combined with other actives and sold as a dietary supplement because doing so creates an adulterated dietary supplement. It is similarly illegal to mix aspirin with a multivitamin and sell it as a dietary supplement, - although it is perfectly legal to mix aspirin and caffeine and sell it as a migraine remedy (OTC medication). Caffeine exists in foods we normally consume, so it may be added to dietary supplements without changing their status to "adulterated".
Now kiss and make up, okay? (And when you do, kindly take pix and PM them to me thankyouverymuch.)
MasterChemist
Registered
Good info
Built has good info on it. But a little more clarity, 1) the alkaloids of ephedra are Ephedrine (no HCL), and some others. The HCL is a synthetic version they don???t use the alkaloids from the plant to make the synthetic, they use much cheaper starting materials. So Ephedrine HCL is a synthetic and chemically altered drug, which has been around forever at no time, has been able to be sold as dietary supplement. Granted people have been using it like one for years.
The reg (CFR 119) speaks to Ephedrine Alkaloids, which include, Ephedrine, Nor ephedrine, Pseudoephedrine and a host of others, even if they are naturally occurring, naturally occurring.
Built has good info on it. But a little more clarity, 1) the alkaloids of ephedra are Ephedrine (no HCL), and some others. The HCL is a synthetic version they don???t use the alkaloids from the plant to make the synthetic, they use much cheaper starting materials. So Ephedrine HCL is a synthetic and chemically altered drug, which has been around forever at no time, has been able to be sold as dietary supplement. Granted people have been using it like one for years.
The reg (CFR 119) speaks to Ephedrine Alkaloids, which include, Ephedrine, Nor ephedrine, Pseudoephedrine and a host of others, even if they are naturally occurring, naturally occurring.
Just to add to this --- if I recall correctly, the court has instructed the FDA that they are prohibited from prosecuting cases in which less than 10mg Eph are marketed at dietary supplements. Believe this was from the Appeals Court after the Utah decision.
Interesting - I had been lead to believe the Chinese export a great deal of raw Ephedra for the manufacture of ephedrine HCL. However, I've read about pseudoephedrine being grown from yeast fed with dextrose and treated with something; I wonder if perhaps it's sometimes cost effective to make ephedrine HCL from the plant? Or is this a false memory I'm having? (I've been known to have more than one or two of those)
MasterChemist
Registered
Couple points
This ruling reinforced the FDA rule which made Ephedra with Ephedrine Alkaloids illegal to sell a dietary supplement.
Ephedrine HCL has never been a dietary supplement it has always been an OTC DRUG.
Ephedra with alkaloids has never been approved as an OTC drug. Only Ephedrine HCL.
There for if Ephedra with alkaloids is labeled as a drug with drug claims such as "Use as a decongestant" it would be considered an unapproved new drug and therefore misbranded.
If Ephedrine HCL is a drug and must be Manufactured, Distributed and sold to the consumer as an OTC drug. If the proper license and permits. As retail establishment you would need an OTC permit for distribution of OTC drugs.
In the US anyways.
So Ephedrine HCL is a drug has always been a drug and never a dietary supplement.
Ephedra with alkaloids used to be able to be sold as a dietary supplement but sec 119 made it unable to be sold. And since it was never approved as a drug it can???t be sold as a drug either.
This ruling reinforced the FDA rule which made Ephedra with Ephedrine Alkaloids illegal to sell a dietary supplement.
Ephedrine HCL has never been a dietary supplement it has always been an OTC DRUG.
Ephedra with alkaloids has never been approved as an OTC drug. Only Ephedrine HCL.
There for if Ephedra with alkaloids is labeled as a drug with drug claims such as "Use as a decongestant" it would be considered an unapproved new drug and therefore misbranded.
If Ephedrine HCL is a drug and must be Manufactured, Distributed and sold to the consumer as an OTC drug. If the proper license and permits. As retail establishment you would need an OTC permit for distribution of OTC drugs.
In the US anyways.
So Ephedrine HCL is a drug has always been a drug and never a dietary supplement.
Ephedra with alkaloids used to be able to be sold as a dietary supplement but sec 119 made it unable to be sold. And since it was never approved as a drug it can???t be sold as a drug either.
Gotta love your convoluted drug and supplement laws. They're even worse than ours: in Canada, it is legal to own and use anabolic steroids. It is illegal to purchase them or to sell them unless by prescription.
MasterChemist
Registered
Interesting - I had been lead to believe the Chinese export a great deal of raw Ephedra for the manufacture of ephedrine HCL. However, I've read about pseudoephedrine being grown from yeast fed with dextrose and treated with something; I wonder if perhaps it's sometimes cost effective to make ephedrine HCL from the plant? Or is this a false memory I'm having? (I've been known to have more than one or two of those)
Maybe they used to make it from a plant but I highly doubt it today. Most drugs are made in china right now very little in us. The us does still have alot of finshed goods palnts though.. The Blending, Packaging distribution part.
In the case of Ephedrine HCL. Its sales are being regulated more and more due to Meth production. So I would imagine they even track the starting materials now.
MasterChemist
Registered
Yea steroids in the US... Not a good thing.. They are becomming more and more strict and lowering the dosage that is considered distribution... You can get them medically prescribed to you but your tet levels have to be pretty low, and if your test levels are low.. taking test does not address the actuall problem.. which is andropause.
MasterChemist
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That don't even make sense. He said it was illegal to sell and market it as a dietary supplement.
On 12 April 2004, the FDA issued a final rule banning the sale of ephedra-containing dietary supplements.
That does not make it illegal for other uses.
How does it not address the actual problem?
jmorrison
Registered
HIS ability to articulate himself? You sound like Borat with downs.
Negged hard.
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Word.
yahh the guys an A-hole.
after the rest of his posts im not even mad, now he just looks like a dumbass that likes to use big words to make up for his short commings.
mehh w/e
negged
