Are you ready for the Dietary Supplement Holocaust?

[VaughnTrue]

Many in the industry have been waiting on word from the FDA in regards to new NDI/DSHEA regulations. Although this is not in stone yet, the draft guidance written by the fda is now able to be viewed(Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues), and will most likely be 100% permanent within the next 2 weeks.

Here are a few exerts everyone should be aware of:

1. Is a NDI Notification required for a dietary supplement containing a NDI if the supplement contains only dietary ingredients that have been present in the food supply as articles used for food in a form in which the food has not been chemically altered?

No. Even though an ingredient that was used to make a conventional food before October 15, 1994 is a NDI (unless it was also marketed as a dietary ingredient before that date), a NDI notification is not required for a dietary supplement containing the NDI as long as the supplement contains only dietary ingredients that have been present in the food supply as articles used for food in a form in which the food has not been chemically altered (21 U.S.C. 350b(a)(1)).

An NDI = New Dietary Ingredient. So with the above in mind, we all can rest assured that companies won't have to file NDI's for every single ingredient as long as each ingredient in the product is proven to be DSHEA compliant and thus supplied within the food supply.

If I change the manufacturing process for a dietary ingredient that was marketed in the U.S. prior to October 15, 1994, and the changes alter the chemical composition or structure of the ingredient, does that make the ingredient a NDI?

Most likely. If the changes in your manufacturing process alter the chemical composition or structure of the ingredient, the resulting compound is probably a NDI and a notification to FDA would be required. For example, using a solvent to prepare an extract from a pre-DSHEA dietary ingredient creates a NDI because the final extract contains only a fractionated subset of the constituent substances in the original dietary ingredient. In addition, changes that alter the composition of materials used to make the ingredient, such as using a different part of a plant (e.g., using an extract of plant leaves where the root extract from the same plant is a pre-DSHEA dietary ingredient), would create a NDI.

In short, this means that any extracts are gone unless they are pure food material. This would mean pure botanical ingredients(1:1 extracts) are still fine, but things that differ from the original plant source(10:1 extracts etc) would not be considered OK anymore.

So for everyone that enjoys using 100:1 LongJack, or 10:1 maca...say bye bye.

1. What processes for manufacturing a dietary ingredient from an article of food present in the food supply do not result in chemical alteration?

Minor loss of volatile components, dehydration, lyophilization, milling, and formation of a tincture or a solution in water, a slurry, a powder, or a solid in suspension do not chemically alter an ingredient.[10] Examples:
* Leaves or roots of a plant consumed as conventional food (e.g., broccoli or carrots) are dried and ground for sale in powder form.
* A tincture is made by soaking pears in aqueous ethanol. The mixture is then milled and dried into a powder that is placed in a capsule.

So we're left with pure plant material and /ethanol water extracts(that do not change the chemical integrity of the original ingredient/plant).

Say goodbye to any ingredients that use weird/rare extraction methods.

1. If another manufacturer or distributor has already submitted a notification for a particular NDI, and I intend to market a dietary supplement containing the same NDI, should I also submit a NDI notification?

Yes. Section 413(a)(2) of the FD&C Act (21 U.S.C. 350b(a)(2)) makes clear that any dietary supplement that contains a NDI is deemed adulterated unless the manufacturer or distributor of the dietary ingredient or the dietary supplement submits a NDI notification at least 75 days before introducing it into interstate commerce. The statute places the obligation for submitting the notification on each manufacturer or distributor. The original notifier conducted its safety evaluation based on the characteristics and intended use of the specific product under review, including the composition and labeling of the dietary supplement that the notifier was proposing to market. Any other manufacturer or distributor who wishes to market its own dietary supplement containing the same NDI should submit a NDI notification to FDA explaining its own basis for concluding that this new product containing the NDI will "reasonably expected to be safe" under the conditions recommended or suggested in the new product's labeling. Manufacturing processes and specifications needed to establish the identity of a NDI are usually trade secrets that are not available in the NDI docket. It should be noted that the original notifier is under no obligation to share with other manufacturers and distributors any trade secrets or confidential commercial information that were part of the basis for a safety conclusion for the original notifier's product.

This gem states that even if "company A" received a NDI acceptance "for ingredient 1", "company b" must also put in an NDI for the same ingredient.

Bye bye small companies.



andddddd the true game changer...

1. Is a synthetic copy of a constituent or extract of an herb or other botanical a dietary ingredient?

No. A synthetic copy of a constituent of a botanical was never part of the botanical and thus cannot be a "constituent" of the botanical that qualifies as a dietary ingredient under section 201(ff)(1)(F) of the FD&C Act (21 U.S.C. 321(ff)(1)(F)).[13] Similarly, a synthetic version of a botanical extract is not an "extract" of a botanical under section 201(ff)(1)(F) because it was not actually extracted from the botanical.

This is where things get interesting. According to this, synthetic variations of any dietary ingredient are non-dshea due to the fact that they never originated in the food supply. This is what had me worried last week.

Everyone should know what this means. This means ANY synthetic ingredients are gone due to the fact that they were never in the food supply(the chemical itself may be found in food, but the ingredients used to make the synthetic chemical never were...thus need an NDI.

This means no more stimulants of any kind for the most part, no more thyroid metabolites, no more anything really.







In before every product on the market is creatine monohydrate, caffeine, and vitamin c.

















note: I could have mis-read/misinterpreted these. If you find that I made a mistake, please show me where I messed up

[tnubs]

UGH!

[Aleksandar37]

OP: you are citing somebody who is citing the fda. Who are you citing? Gotta love the telephone game and these chicken little posts:P

[DAdams91982]

I am not going to sit here and fret. You know the backlash that will be felt from herbalists, hippies and the anti aging community? (I am mostly referencing the extract excerpt), same for extraction methods.

[VaughnTrue]

OP: you are citing somebody who is citing the fda. Who are you citing? Gotta love the telephone game and these chicken little posts:P

I am citing the FDA themselves. The link is in the OP...

[Aleksandar37]

"1. Is a synthetic copy of a constituent or extract of an herb or other botanical a dietary ingredient?

No. A synthetic copy of a constituent of a botanical was never part of the botanical and thus cannot be a "constituent" of the botanical that qualifies as a dietary ingredient under section 201(ff)(1)(F) of the FD&C Act (21 U.S.C. 321(ff)(1)(F)).[13] Similarly, a synthetic version of a botanical extract is not an "extract" of a botanical under section 201(ff)(1)(F) because it was not actually extracted from the botanical.

This is where things get interesting. According to this, synthetic variations of any dietary ingredient are non-dshea due to the fact that they never originated in the food supply. This is what had me worried last week. "

So the FDA has the part about "This is where things get interesting"? I didn't find that in the original document.

[The Cold]

Thanks for posting this Vaughn, things are getting ugly.

[VaughnTrue]

"1. Is a synthetic copy of a constituent or extract of an herb or other botanical a dietary ingredient?

No. A synthetic copy of a constituent of a botanical was never part of the botanical and thus cannot be a "constituent" of the botanical that qualifies as a dietary ingredient under section 201(ff)(1)(F) of the FD&C Act (21 U.S.C. 321(ff)(1)(F)).[13] Similarly, a synthetic version of a botanical extract is not an "extract" of a botanical under section 201(ff)(1)(F) because it was not actually extracted from the botanical.

This is where things get interesting. According to this, synthetic variations of any dietary ingredient are non-dshea due to the fact that they never originated in the food supply. This is what had me worried last week. "

So the FDA has the part about "This is where things get interesting"? I didn't find that in the original document.

It's about halfway down on the site I linked. Every quote/word in quotes is directly from fda.gov

[Dwight Schrute]

Lovely.

[JeremyT]

Wow. Should start to stock up on everything that I would want for the next several years then. Fack.

[thebigt]

now i know why they can't reach a compromise on the budget crisis......they are to worried about what suppliment ingredients they will allow. good thing the government has their priorities right???????

[mattrag]

Yea, I can't remember what the bill # was but on Superhuman Radio on an episode last week they talked about this. Best thing to do is to stock up... If not buying your favorite pre workout/fatburner/test booster will be at the same level as ordering some "legal" steroid.

[thebigt]

Yea, I can't remember what the bill # was but on Superhuman Radio on an episode last week they talked about this. Best thing to do is to stock up... If not buying your favorite pre workout/fatburner/test booster will be at the same level as ordering some "legal" steroid.

they are releasing prisoners because of overcrowding due to drug offences......now they want to make criminals out of otherwise law abiding citizens. i am sorry, but this makes no sense!!!

[mattrag]

they are releasing prisoners because of overcrowding due to drug offences......now they want to make criminals out of otherwise law abiding citizens. i am sorry, but this makes no sense!!!

They probably want more ppl buying into the big pharma and less ppl trying to take health into their own hands. I'm sure the fine revenue generated from the violators of these new rules would assist the govt in building more prisons. haha

[thebigt]

They probably want more ppl buying into the big pharma and less ppl trying to take health into their own hands. I'm sure the fine revenue generated from the violators of these new rules would assist the govt in building more prisons. haha

they may get a fine out of me but then they have to pay for locking me up, not to mention all of those taxes they won't be getting from me. i am as law abiding as i can be, don't know why they would force me to break the law?

[AtomicFox]

This is so retarded.

[mattrag]

I honestly think it's more because the Pharmacy companies are scared that their new drugs won't be doing much better than some of the supplements consumers can buy OTC. But who really knows? Maybe too many ppl have been bringing up stupid law suits against OTC herbals...? I for one stand on the Pharmacy industry is trying to milk more money out of us.

[kingdong]

Wait, from what I saw it looked like will be fine(for the ost part) if companies get their NDI's. Am I wrong?

[swollen87]

so what are some of the types of things to be gone?

geranium?

ALL ph/ds ?

bulbine?

ecdy?

sorry if these are dumb ??s i just need to know what i need to stock up on....

[seccsi]

I wouldn't hit the panic button yet people. I've seen these types of posts/ideas ever since I got into weights over 11 years ago. Tons of threads on tons of different forums saying the supplement industry is about to completely die. It hasn't happened yet. Some things have changed, some things have been banned. Is this time different? It very well could be...maybe all the things Vaughn claim will happen. But no use in panicking until we know for sure...and if it is going to happen we will have plenty of real warning and places will have some amazing sales to push product. I wouldn't worry until you see a bunch of places like Nutra, Lockout, Netrition, Orbit putting a massive sale on everything.