Our supplements & freedom are under attack again!

[VaughnTrue]

http://www.anh-usa.org/congressman-w...in-the-senate/


Fun.

[PinchTheBear]

If the FTC had general rulemaking authority, which Waxman’s language reinstates, the Agency would be expected to create a new legal requirement for all supplement companies. Such companies would have to perform at least two of these human studies before making any claims for their products.

Nothing like hyper-regulation to kill competition and subsequently destroy more than just the honest portion of the industry.


Edit: this is way too easy to not do: https://secure3.convio.net/aahf/site...rAction&id=543

[patmedown167]

Doesn't waxman have anything better to do?

[RatherBeLifting]

It's only a matter of time.

[deadpool9]

Nothing like hyper-regulation to kill competition and subsequently destroy more than just the honest portion of the industry.


Edit: this is way too easy to not do: https://secure3.convio.net/aahf/site...rAction&id=543

Sweet, excellent linkage.

I sent messages to both of my senators.
I sent messages similar to this back when McCain was trying to get his bill in, and both senators replied back with a positive response about limiting the FDA's power while keeping consumers safe.

[PinchTheBear]

Sweet, excellent linkage.

I sent messages to both of my senators.
I sent messages similar to this back when McCain was trying to get his bill in, and both senators replied back with a positive response about limiting the FDA's power while keeping consumers safe.

Nice. It'd be cool to get some positive feedback. Even if my letter's have no influence on my Gillibrand and Schumer, which is likely, it'll still feel like I have some policy-influence...

ahh the democratic illusion..

[jcosley]

CLIFFS on article?

[Starkk]

I believe I recall reading somewhere that the most effective strategy was to fax your senator, rather than email or call.

Brb, sending the first fax I've sent in at least five years.

[PinchTheBear]

CLIFFS on article?

-Senator Henry Waxman wants to pass an amendment to the Wall Street reform bill to give new power to the FTC
-These new powers will indirectly affect the Dietary Supplement Health and Education Act (DSHEA)
-If passed, the FTC will control supplement regulation, formerly under the DSHEA, and will have the power to implement detrimentally expensive laws and regulations.
-The supplement industry will suffer immense financial burdens.

[Justing2]

Big brother again trying to control everything we do.

[jcosley]

-Senator Henry Waxman wants to pass an amendment to the Wall Street reform bill to give new power to the FTC
-These new powers will indirectly affect the Dietary Supplement Health and Education Act (DSHEA)
-If passed, the FTC will control supplement regulation, formerly under the DSHEA, and will have the power to implement detrimentally expensive laws and regulations.
-The supplement industry will suffer immense financial burdens.

Thanks for the cliffs.

Here's my take. Why??? Our country's economy is still in the crapper and yet now we want to destroy and industry that is still making money. This in turn, will cause people to be out of job and make the employment rate rise even further. I swear, these idiots running our country could care less because they have there pockets filled with cash ...so why should they? Pathetic.

[cmagdy119]

bump

[deserusan]

They key point I took from this is that in order to make claims on a product, the FTC would require two clinical trials on the finished goods. Given the amount of BS claims in the industry and how everyone seems to clamor for clinical evidence (at least on here), I'm not sure what the big deal is. Don't you guys want clinical evidence so companies aren't cherry picking the functional claims on their products?

Personally, I think it's ****ty how this was slipped into a Wall Street reform bill, but the FTC has been pushing for measures like this for some time now. In some ways, class action lawsuits have protected consumers against egregious claims, but largely, the claims made in formal advertising are largely unsubstantiated. Think about it. A supplement company was just recently selling a non-DSHEA compliant OTC steroid, claimed it was like a SERM plagiarizing images from the National Cancer Institute, that turned out to desoxymethyltestosterone instead of methlyepitiostanol. Then you have their reps running rampant on forums telling consumers how safe it is and that they need a mild PCT (that they sell....lol) for successful usage. This is the type of thing which fuels this anti-supplement fire.

If you want to the government to "chill out" hold companies to a higher standard who make BS claims and have reps who will say just about anything to make a sale. The other day I saw a rep claim their herbal AI is safe to use with just about any hormone as OTC PCT aide. It's the lack of respect for human health that occurs on here daily all the way up to the BS TV ads you see claiming ridiculous results with little to no effort which is why the FTC is now becoming more empowered to regulate the industry. Essentially they are saying consumers are too stupid to see through it all and they need to protect you from yourselves. My question for all of you is why do you let it happen here? Why do you let companies make BS claims with no clinical support?

Just some food for thought from a guy who support clinical research on finished products.

[VaughnTrue]

In b4 it costs $250,000 to release an innovative and dshea compliant compound.

[deserusan]

In b4 it costs $250,000 to release an innovative and dshea compliant compound.

A small clinical trial costs about $10-20K. To properly prepare an NDI notification to the FDA costs about $2K if you know how to pull research. Where are you getting $250,000 from?

[pumpingjoe]

They key point I took from this is that in order to make claims on a product, the FTC would require two clinical trials on the finished goods. Given the amount of BS claims in the industry and how everyone seems to clamor for clinical evidence (at least on here), I'm not sure what the big deal is. Don't you guys want clinical evidence so companies aren't cherry picking the functional claims on their products?

Personally, I think it's ****ty how this was slipped into a Wall Street reform bill, but the FTC has been pushing for measures like this for some time now. In some ways, class action lawsuits have protected consumers against egregious claims, but largely, the claims made in formal advertising are largely unsubstantiated. Think about it. A supplement company was just recently selling a non-DSHEA compliant OTC steroid, claimed it was like a SERM plagiarizing images from the National Cancer Institute, that turned out to desoxymethyltestosterone instead of methlyepitiostanol. Then you have their reps running rampant on forums telling consumers how safe it is and that they need a mild PCT (that they sell....lol) for successful usage. This is the type of thing which fuels this anti-supplement fire.

If you want to the government to "chill out" hold companies to a higher standard who make BS claims and have reps who will say just about anything to make a sale. The other day I saw a rep claim their herbal AI is safe to use with just about any hormone as OTC PCT aide. It's the lack of respect for human health that occurs on here daily all the way up to the BS TV ads you see claiming ridiculous results with little to no effort which is why the FTC is now becoming more empowered to regulate the industry. Essentially they are saying consumers are too stupid to see through it all and they need to protect you from yourselves. My question for all of you is why do you let it happen here? Why do you let companies make BS claims with no clinical support?

Just some food for thought from a guy who support clinical research on finished products.

What a surprise--big companies want to increase the barrier of entry.

[VaughnTrue]

A small clinical trial costs about $10-20K. To properly prepare an NDI notification to the FDA costs about $2K if you know how to pull research. Where are you getting $250,000 from?

You and I both know the massive costs involved in bringing a new ingredient to market...couple those with a minimum of 2 studies and it's going to get pricey.

A simple human study is cheap...but that will simply show human safety. Conducting a study with enough participants to create statistically valid claims is going to cost quite a bit more. We were quoted at about 45k per 50 person study by 2 large universities.


If you can get them for 10-20k, and actually have enough info to make legit claims and have statistical significance, then you guys shouldn't even blink at this idea.

[Segansational]

As a consumer and someone who works in research at a hospital, I would love to see companies actually have to prove that their supplement does what it claims. However, the cost for this and the type if regulation that the govt would likely use would effectively kill any innovation in this industry, along with 99% of companies. Do I think there should be some regulation so that we aren't getting tainted supps? Absolutely. Do I have a solution or think that this bill is the answer? No.

[iForce Dave]

What a surprise--big companies want to increase the barrier of entry.

As a consumer and someone who works in research at a hospital, I would love to see companies actually have to prove that their supplement does what it claims. However, the cost for this and the type if regulation that the govt would likely use would effectively kill any innovation in this industry, along with 99% of companies. Do I think there should be some regulation so that we aren't getting tainted supps? Absolutely. Do I have a solution or think that this bill is the answer? No.

its undeniable that this would primarily hit small companies. larger companies can shell out the required $ with no prob, but the vast majority of small supp companies (those primarily online and on the boards, private labels, etc) would have a VERY hard time, depending on the cost. If the cost hits a certain level, it would be impossible for most.

[deserusan]

You and I both know the massive costs involved in bringing a new ingredient to market...couple those with a minimum of 2 studies and it's going to get pricey.

A simple human study is cheap...but that will simply show human safety. Conducting a study with enough participants to create statistically valid claims is going to cost quite a bit more. We were quoted at about 45k per 50 person study by 2 large universities.


If you can get them for 10-20k, and actually have enough info to make legit claims and have statistical significance, then you guys shouldn't even blink at this idea.

If it's a DSHEA compliant ingredient, typically there is a ton of research to support at least a basic NDI filing. That is not a massive cost and covers you with the FDA and their basic NDI requirement. In terms of human clinical research to support safety on a finished product, you're right, the tests are rather inexpensive compared to something statistically "sound" looking clinical endpoints to support functional claims but to my knowledge they weren't specific and how "statistically sound" the test must be. Based on your own quote there, you are still about $160K short of your original claim using more participants than you really need to be considered statistically relevant in a double blinded placebo controlled study with a crossover. This why having a PhD, MD, etc on staff helps because often they can write a study for you and let's be honest, something for human consumption should be reviewed by someone with advanced education at minimum. I know a few small companies do this quite successfully.

Again, none of this would be moving forward so rapidly had certain companies not been so brazen in the past 24 months.

[deserusan]

Do I think there should be some regulation so that we aren't getting tainted supps?

GMP enforcement should help with this. However, it needs to be enforced.

[VaughnTrue]

Pretty sure the "brazen" goes back further than 24 months.

[deserusan]

Pretty sure the "brazen" goes back further than 24 months.

Ok....March 2006 was when the FDA made it clear that it was now viewing OTC hormones as unapproved drugs. This was the first real enforcement action post the 2004 ASA if memory serves me right. That puts us over 48 months. After that point, selling dimethyldrostanolone was like playing with fire yet so many companies kept doing it. Actually the number doing it increased exponentially also introducing more non-compliant hormones on the market up until the BB.com raid. Gauging the FDA/FTC is all about analyzing the precedent set and enforcement action. So from a historical perspective, it looks like March 2006 was when the FDA fired it's first shot after the 2004 ASA as a warning saying "don't do it again."

[VaughnTrue]

I'm not disagreeing with you dan...simply saying that ANY company who released ANY non-dshea ingredient was part of these brazen.

[tdog69]

So much for our government helping small companies, their pockets just get deeper and deeper.

This will crush startup companies and anyone recapping raws and putting them out there for consumers at a decent price.


But in the end we as the consumers take a hit to our bank accounts, because we are limited to the ridiculous mark up prices of the larger companies controlling the market.

They might as well limit all free advertising and why they are at it rewrite the constitution.


These morons just don’t get it, take away the OTC PH/DS and adults and teens will just turn to the black market. Hell they have already increased production in underground labs and your average Joe will become a felon. Sometime I just don't understand there train of thought, sense when do adults need someone telling them what is safe or not safe.

Instead of calling the next generation “Generation X” it should be the “Pansy Generation” sense the government is putting bumper pads on everything to protect us.

[pumpingjoe]

[Segansational]

From the sounds of it, this has even greater implications beyond just regulation of supplements as it gives the FTC autonomous power over multiple industries. But don't quote me on this as I have yet to read the actual legislation. If anyone can find a link, post it up.

[GeneGnomeX]

Completely agree with Dan.

In b4 it costs $250,000 to release an innovative and dshea compliant compound.

"Innovation" usually means no evidence of efficacy in this industry.

[VaughnTrue]

Completely agree with Dan.



"Innovation" usually means no evidence of efficacy in this industry.

Beta alanine? Alpha yohimbine? The list is huge...plenty of great things came out b4 any legit literature was available

[deserusan]

What a surprise--big companies want to increase the barrier of entry.

We were doing clinicals when we were 20 times smaller. It's matter of priority. Some company owners prefer buying Ferraris, etc. Some will put their profits into more long term strategic goals.

I don't recall getting a letter from the FDA or raided because of these. More than likely, it's because we regulated ourselves.