Legalities surrounded supplements

[Dirty Dan]

Thanks to Anabolic Minds and it's awesome members not only would I consider myself fairly educated on what the latest and greatest supplements are, but also their delivery methods, dosing protocols, what they stack well with, and such forth.

What I am not educated on and interested in learning about, are the legalities that surround supplements/supplement companies in respect to FDA compliancies.

Before I get into my first question, I just want to make it clear that my intentions in creating this thread are not to cause any back and forth arguments between members or company reps. I understand sometimes we get passionate about our views, but I ask to just keep it civil please. I don't want to hear about which CEO of xyz company has been arrested for fraud, mislabeling, or whatever.

 

[Dirty Dan]

First question:

What got me thinking about the whole topic of supplementation legality, is 1,3 DMAA.

From what I understand (please correct me if I'm wrong on anything I may say) at a point in time 1,3 was the popular stimulant used in products. Then the FDA made the accusation that it is not a naturally occurring substance therefore, companies cannot put it in their products. Now it seems to be back, and more popular than ever.

I also know that Hi-Tech is in a current lawsuit against the FDA over the matter.

When you hear people speak negatively about the supplement industry, you typically hear two things. It's unregulated by the FDA, and filled with snake oil salesman.

My question is, if the supplement industry is unregulated by the FDA then how come they get to dictate which ingredients a company chooses to use?

A follow up question to that is:

If a supplement company is not allowed by the FDA to put non-natural occurring ingredients in their products, then why is big pharma allowed to release prescription drugs that contain synthetic manmade ingredients? Is it because big pharma is "regulated" and their products have to go through years of testing before they are released?

Now, I can understand if the FDA wants to regulate a supplement company over their product labels and making sure everything is labeled correctly and compliant. Why must they intervene on the actual ingredients being used? So long as those ingredients aren't federally illegal drugs.

 

[Jiigzz]

Pharmaceutical companies spend hundreds of millions, if not billions to bring a new drug to market - for standard approval, companies are generally required to undertake trials in animals initially, submit INDs (with a HOST of backing data for review), undertake clinical trials (3 phases), undertake an FDA review, and then further studies while the product is available for use. Guess how long that takes? 8 years.

In the case of supplements? Well, the above certainly does not take place. The FDA regulates supplements, it's just not very effective at doing it (or enforcing it), and there are restrictions on what you can and cannot use, and what you can and cannot claim. You arn't required to submit every new product to the FDA for approval before selling it, and so they only pick up on products ONCE they hit the market.

Night and day difference between the pharmaceutical industry and the supplement industry.

Here's a small exert:

Under the terms of the Dietary Supplement Health and Education Act of 1994 (DSHEA), supplements with established ingredients (meaning those that had been sold in the United States before 1994) can be marketed without any evidence that they are effective or safe. For new supplement ingredients, the DSHEA requires manufacturers to give the FDA evidence that a new ingredient should be safe. “Regrettably, this aspect of DSHEA has thus far not been enforced,” writes Dr. Pieter A. Cohen in a commentary in today’s New England Journal of Medicine.

Compare this hands-off approach with the strict rules and regulations for drugs. No drug can be sold until the FDA has proof clear proof that it is safe and effective. And every FDA-approved drug must be made to strict specifications.

 

[Audioph1x]

Jiigzz got it right. In so many words, the FDA merely decides which ingredients are allowed. They do not examine and approve/disapprove particular products, only the chemicals. This is not fact, only what I've gathered.

 

[smith_69]

Pharmaceutical companies spend hundreds of millions, if not billions to bring a new drug to market - for standard approval, companies are generally required to undertake trials in animals initially, submit INDs (with a HOST of backing data for review), undertake clinical trials (3 phases), undertake an FDA review, and then further studies while the product is available for use. Guess how long that takes? 8 years.

In the case of supplements? Well, the above certainly does not take place. The FDA regulates supplements, it's just not very effective at doing it (or enforcing it), and there are restrictions on what you can and cannot use, and what you can and cannot claim. You arn't required to submit every new product to the FDA for approval before selling it, and so they only pick up on products ONCE they hit the market.

Night and day difference between the pharmaceutical industry and the supplement industry.

Here's a small exert:

For those following along and don't get confused-
important to note- if a new supplement contains a new dietary ingredient- then you must submit.

 

[smith_69]

Further Jiigzz reply (again for those who don't know)

A dietary ingredient is a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any of the above dietary ingredients.

 

[EasyEJL]

When you hear people speak negatively about the supplement industry, you typically hear two things. It's unregulated by the FDA, and filled with snake oil salesman.

People also say that the moon landing was a fake. the supplement industry is regulated by the FDA, just not the same way as the drug companies

My question is, if the supplement industry is unregulated by the FDA then how come they get to dictate which ingredients a company chooses to use?

They do regulate them. and similarly to pharma, they dictate what ingredients you are allowed to use. They restrict non-safe ingredients - lead, arsenic, etc. From pharma they require proof the new chemicals are safe, from supplements they more or less only require proof that it's part of the natural food chain

Now, I can understand if the FDA wants to regulate a supplement company over their product labels and making sure everything is labeled correctly and compliant. Why must they intervene on the actual ingredients being used? So long as those ingredients aren't federally illegal drugs.

But those ingredients are federally illegal drugs - they are chemicals that are not part of the food chain, with no proof of safety in humans.

 

[smith_69]

People also say that the moon landing was a fake. the supplement industry is regulated by the FDA, just not the same way as the drug companies




They do regulate them. and similarly to pharma, they dictate what ingredients you are allowed to use. They restrict non-safe ingredients - lead, arsenic, etc. From pharma they require proof the new chemicals are safe, from supplements they more or less only require proof that it's part of the natural food chain




But those ingredients are federally illegal drugs - they are chemicals that are not part of the food chain, with no proof of safety in humans.

hence the legal battle over what is "A dietary ingredient is a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any of the above dietary ingredients." and the dr who prove and disprove this

 

[double s]

I work in the Life Sciences Industry by trade.

The huge difference, before a pharmaceutical company can mass produce a drug, they need to get the blessing of the FDA (clinical trials, data etc etc) where as with supplements, the FDA only gets involved when something serious happens i:e death. (ephedrine and the USP labs thing years ago).

They have been talking for years about the FDA being more active in the supplement industry but they are soo backlogged, it will probably never happen.

 

[The_Old_Guy]

The 1,3 DMAA thing was pretty well laid out by De__eB IIRC (and taking a lot of liberty with the actual numbers), In order to produce the amount of DMAA in a single bottle, a 10 tons of Acacia would have to be processed. Highly doubtful this is occurring.

 

[Adizzle1]

I think your getting B-methylphenylethylamine and 1,3-DMAA confused as B-MPEA is found it Acacia and what I believe what DE_EB wrote about. 1,3-DMAA is not found in Acacia at any amount.

 

[The_Old_Guy]

I think your getting B-methylphenylethylamine and 1,3-DMAA confused as B-MPEA is found it Acacia and what I believe what DE_EB wrote about. 1,3-DMAA is not found in Acacia at any amount.

Probably confused, thanks

 

[De__eB]

Right the math I did was for Acacia and BMPEA

 

[EasyEJL]

hence the legal battle over what is "A dietary ingredient is a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any of the above dietary ingredients." and the dr who prove and disprove this

really the only battle ongoing at all is "is a chemically identical ingredient that is lab made the same as the compound coming from a natural source and extracted". Even that isn't much of a battle. The FDA gets to define it, everyone else gets to suck it up. The FDA has to approve of anything you sell as meant to be ingested. With supplements it's an implied approval (with them assuming you source it from nature) until they ask you to show that the ingredient is available in nature.


That was the whole reason the DSHEA was created. Before that there was literally no true legal way to sell supplements. That doesn't mean anyone selling them was arrested, but they were not legal for human consumption as there were no FDA rules covering them.

 

[De__eB]

really the only battle ongoing at all is "is a chemically identical ingredient that is lab made the same as the compound coming from a natural source and extracted". Even that isn't much of a battle. The FDA gets to define it, everyone else gets to suck it up. The FDA has to approve of anything you sell as meant to be ingested. With supplements it's an implied approval (with them assuming you source it from nature) until they ask you to show that the ingredient is available in nature.


That was the whole reason the DSHEA was created. Before that there was literally no true legal way to sell supplements. That doesn't mean anyone selling them was arrested, but they were not legal for human consumption as there were no FDA rules covering them.

That's not really the argument at this point, in fact the FDA has sort of changed their verbiage over the past year or two in that regard.

Industry organizations were keen to point out that if chemically identical ingredients were adulterated per se, then even thing as simple as Vitamin C products would become exponentially more expensive.

The arguments back and forth now from the FDA are related more to quantity. And it's an important argument.

The burden of proof for 'safety' in supplement products is very low, because the operating assumption is that hey, anything in a dietary supplement is something that has already been consumed by humans.

Where that gets hazy is when you have ingredients that have technically been consumed by humans safely, but at mere fractions of the dose being used in supplements.

The exact natural quantity of DMAA in Geranium is still up for debate so I'll point back to BMPEA/Acacia

It's unlikely any human has ever even consumed 1 mg of BMPEA from natural acacia rigidula.

Supplements contained anywhere from 20 to 100mg of BMPEA per serving.

So the FDAs position is how do we know this is safe if we're not relying on history of human consumption and we don't want to bog the industry down in having to spend millions on safety studies before going to market.

Writing laws and regulations is extremely difficult. Getting them to serve their intended purpose (make sure there's a decent expectation of safety) without having unintended consequences (stifling innovation and blocking otherwise great ingredients from the market) is tough.

DSHEA needs a significant refresh, in 1994 the industry was much smaller, large manufacturers and suppliers were much less sophisticated, and the amount of money going into research of synthesis and extraction techniques was a mere fraction of what it is now. The industry has come a long way in the past 20+ years.

At the end of the day though, every company that persists in flaunting the law makes it that much harder for industry associations to push for a pro-industry agenda at the FDA. It's short-sighted and driven by greed at the expense of the future of the industry.

 

[smith_69]

De__eB

"It's short-sighted and driven by greed at the expense of the future of the industry." I would change this too, at the expense of the consumer.

 

[The_Old_Guy]

...That was the whole reason the DSHEA was created. Before that there was literally no true legal way to sell supplements.

Not to dredge up another thread, and IANAL, but if something is not *specifically illegal*, then there is no law (obviously) against doing it in the USA. How is me going out back, ripping a bunch of Oak leaves off the tree, and drying and smoking them - in violation of something that doesn't exist? If there's no law against it, you can do it (yeah "freedom" and "'merica")... if enough people start doing it with adverse outcomes, there will damn sure be a law to come around and spoil the fun

But before DSHEA, supp companies had way more leeway and weren't in violation of anything that wasn't already illegal.

I would not want to live in a country where every single thing I could do, had to be "ok'd" by the federal government by codifying a law to do so. Imagine how long that list would be, LOL - "The Book Of What You Can Do"

 

[EasyEJL]

Not to dredge up another thread, and IANAL, but if something is not *specifically illegal*, then there is no law (obviously) against doing it in the USA. How is me going out back, ripping a bunch of Oak leaves off the tree, and drying and smoking them - in violation of something that doesn't exist? If there's no law against it, you can do it (yeah "freedom" and "'merica")... if enough people start doing it with adverse outcomes, there will damn sure be a law to come around and spoil the fun

But before DSHEA, supp companies had way more leeway and weren't in violation of anything that wasn't already illegal.

I would not want to live in a country where every single thing I could do, had to be "ok'd" by the federal government by codifying a law to do so. Imagine how long that list would be, LOL - "The Book Of What You Can Do"

You do live there.........

Supp companies didn't have more leeway at all. We're not talking about you ripping oak leaves off the tree and using them yourself, we're talking about you taking oak leaves off, packaging them and selling them to consumers. two wildly different things. There are laws/regulations against anything that isn't covered by another FDA regulation specifically allowing it not being allowed to be sold to the public as an ingestible item.

 

[The_Old_Guy]

You do live there.........

Supp companies didn't have more leeway at all. We're not talking about you ripping oak leaves off the tree and using them yourself, we're talking about you taking oak leaves off, packaging them and selling them to consumers. two wildly different things. There are laws/regulations against anything that isn't covered by another FDA regulation specifically allowing it not being allowed to be sold to the public as an ingestible item.

How can you say there wasn't more leeway? - Ephedra Sinica and 1 Step Prohormones were being sold. They were legally sold - you can't arrest someone without a law being in place that is broken by the sale. I disagree with your statement that before DSHEA "there was no true legal way to sell supplements". For that to be true, it would mean they were illegal to sell, and that means there had to be a law against them. What law prevented the sale of Ripped Fuel in 1995? If it isn't illegal/against a regulation, code, etc... you can do it.

 

[EasyEJL]

How can you say there wasn't more leeway? - Ephedra Sinensis and 1 Step Prohormones were being sold. They were legally sold - you can't arrest someone without a law being in place that is broken by the sale. I disagree with your statement that before DSHEA "there was no true legal way to sell supplements". For that to be true, it would mean they were illegal to sell, and that means there had to be a law against them. What law prevented the sale of Ripped Fuel in 1995? If it isn't illegal/against a regulation, code, etc... you can do it.

again, commercial code requires FDA approval (whether explicit like in the case of pharma or implicit like in the case of selling bananas) of all items sold for human ingestion. The specifics for "what is a supplement vs a drug" was vague and unspecific before the DSHEA. Just because something was being sold doesn't mean it was legal - it means that the FDA wasn't following up on them. Superdrol wasn't compliant with the DSHEA and thus was illegal, yet how many bottles were sold by how many different companies? There wasn't that much money being made on it before, and not that many people negatively affected by it that the FDA bothered. But before the DSHEA the FDA was completely open as to what they considered a "mislabeled drug" or a "non supplement" and there were tons of arrests, material seizures, etc.

Mentioning Ripped Fuel is a good example - ephedra IS a naturally found in the food chain item, so was legal until specific laws were passed against it. Cocaine was used in coca cola at one point, because it is extracted from the food chain. That doesn't mean you can plop out any chemical you like and it's legal to sell for human consumption until legislators make a specific law against it. There already are blanket laws for that.

Companies prior to the DSHEA were at risk for selling anything as a supplement. You may want to read a bit about the history before that time

this article has a bit about it

Invalid Link Removed

 

[The_Old_Guy]

Invalid Link Removed

Thanks for the link. I still disagree with your statement that (paraphrase) "There was no legal way to sell supplements before DSHEA" That would mean all supplements were sold "illegally". The only way something is "illegal" is if it violates a law. If there was no law saying you couldn't sell Vitamin C Tablets - Then you could sell Vitamin C Tablets. Obviously this is assuming it was healthy Vitamin C, I'm not saying, and never have, that "You could do anything without repercussions".

So, I would need to see some proof that in was a violation of some law, to sell Vitamin C before 1994. I mean according to that logic, Ripped Fuel in 1990 should have been illegal, yet you just said it was ok because it was natural?

I don't want to turn this into a bad thing, so just show me what made selling Vitamin C before 1994, illegal (meaning that there was a law that was broken) :thumbsup:

(And I get the part about the FDA seizures etc re: low dose Cod Liver Oil, etc... I'm, talking about 100% above board Vitamin C being illegal to sell before '94 )

...That was the whole reason the DSHEA was created. Before that there was literally no true legal way to sell supplements.

Edit: LOL, I just saw who wrote that article: Peter Barton Hutt - Ironic

 

[EasyEJL]

(And I get the part about the FDA seizures etc re: low dose Cod Liver Oil, etc... I'm, talking about 100% above board Vitamin C being illegal to sell before '94 )

it was generally not prohibited if it was from rosehips - as they are a plant legal to sell and with a history of safety in food use outside of being used as a vitamin C source. The problem partially is that there weren't laws making things illegal. There were laws allowing a regulatory agency (FDA) to determine what was legal for sale. And although there is the whole comment period, etc for them to change regulations, it still was mostly at whim. The vaguer the regulations were, the more it was possible for any given FDA agent to decide "this isn't legal".

There isn't a law specifically for every street specifying what the legal speed limit for that street is. There is a blanket law that allows the state/county/city to in a regulatory fashion determine what the speed limit should be.

There isn't a law requiring auto manufacturers to meet a certain MPG average. I'm not even sure if there is a law that allows the EPA to set those, but they set them as a regulatory piece of ludicrousness (the newest one is 54.5 mpg for cars and light-duty trucks by Model Year 2025). Manufacturers who don't comply are fined.

There isn't a specific law defining your local building codes. But there is a law allowing the local government to define those codes, and provide legal penalties for not following them.

I can come up with thousands of examples of things there isn't a specific law for as an item that in the end isn't "legal". None of them would of course carry criminal penalties, but they do carry fines, asset seizure, etc.

so the DSHEA really heavily clarified that, so that what was legal to sell wasn't virtually entirely at the whim of whoever was running the FDA at the moment, or the FDA agent that decided to inspect your facility.

 

[The_Old_Guy]

Your Post

I'm down with the "Clarification" and "No Longer on a whim" parts. Thanks for the reply.