Originally published at: Hi-Tech Appeals to Get its Wrongfully-Confiscated DMAA Back
Update December 28, 2017: Hi-Tech Pharmaceuticals has appealed the Magistrate Judge’s decision denying their request to release the recently-confiscated DMAA. This is the last “short-term” stand to get DMAA back, outside of the greater DMAA lawsuit appeal, which is the longer-term play. You can download the appeal here, then see… …(Read more on the PricePlow Blog)
Originally published at: Hi-Tech Appeals to Get its Wrongfully-Confiscated DMAA Back
They’re trying to ban it because it’s effective. Same as ephedrine, picamilon, and kratom. None of them are dangerous, yet the FDA came down on all of those.
Personally, I’m not a fan of DMAA in mainstream pre-workouts. I see it akin to PEDs and those who choose to really exceed in performance can still seek it out very easily. However, I’m very interested in the story and watching the fight. Jared’s got some balls.
You’re just simply not right about this.
The FDA goes after ingredients that result in significant numbers of AERs.
Ephedrine was the single most predominant AER generating supplement when it was banned.
DMAA was the single most predominant AER generating stimulant when the FDA went after it.
Kratom was the single most predominant AER generating supplement when the FDA/DEA went after it. It’s still causing more AERs than anything else, even though congress/the DEA backed off on banning it.
Picamilon was actually stumbled upon in a different FDA enforcement action, where they found it on the label of another product they were already targeting with enforcement action over a different non-compliant ingredient.
Technically, they’re factually wrong about Picamilon, and if you or any other company wants to fund a legal campaign to preserve the ingredient, I’m more than happy to provide the expert witnesses and data to back it up.
But nobody felt like dying on the cross of Picamilon. Who sells enough Picamilon to be worth a six figure legal battle? What, I go spend $200k making sure it stays legal, so 500 other companies can sell it? When there are other viable alternative ingredients I can sell?
At what dose?
Not that Armstrong is even remotely credible, but they allegedly found 142mg DMAA per serving of Jack3d in whatever tub they tested (see page 5), and many were three-scooping it and mixing it with OxyELITE Pro!!
Hi-Tech isn’t coming remotely close to those doses, and that matters.
Again, at what dose? Because you know those “ephedra” products were not dosed responsibly nor tested, nor were they being used reasonably.
From one study:
For one product, lot-to-lot variations in the content of (-)-ephedrine, (+)-pseudoephedrine, and (-)-methylephedrine exceeded 180%, 250%, and 1000%, respectively. Half of the products exhibited discrepancies between the label claim for ephedra alkaloid content and actual alkaloid content in excess of 20%. One product was devoid of ephedra alkaloids.[CITATION]
This is the same garbage that’s been going on for 20 years - the problem are the ingredient suppliers and the contract manufacturers not following the laws, topped off with proprietary blends.
But you and I both know that 25-75mg ephedrine alongside 200mg caffeine is ridiculously safe for the vast vast vast majority of people.
If I had the cash, I would gladly die on the Picamilon cross. There are a lot of people who used that to stay level and the FDA hurt them with that decision. I wonder why they would do such a thing???
I dunno what dose, ask the people who submitted AERs. Dose is irrelevant.
It’s not up to the FDA to decide whether companies are dosing an ingredient responsibly.
It’s up to them to investigate ingredients that are generating AERs, and remove them from the market.
The FDA has no regulatory authority to say what dose you can or can’t put in supplements beyond several food-based dose restrictions that are already in place. They have no way to add new ingredients to that list, and no enforcable authority to enforce a new dose regulation if they wanted to.
Then it’s time to ban caffeine too, by that logic.
That there is a very good point and should be addressed. Poor manufacturing/dosing was ultimately the cause of the ephedrine ban, IMHO. None of those AERs happen if you have 25mg max dose.
Caffeine has hundreds (thousands?) of studies on safety threshold and tolerance, and has been abundantly consumed in efficacious doses via purely natural sources for tens of thousands of years.
Natural DMAA has not once ever in human history been consumed in an active natural dose. And I don’t see a single published human safety threshold study on DMAA specifically, as opposed to finished product studies of prop-blended formulas.
Also, do you really want the FDA deciding acceptable doses for more ingredients? Do you really want them to have the regulatory authority to add those on a whim too? Do you really want dose-based safety threshold information to become an easy straw for the FDA to grasp? Look at the headaches in making global products that are compliant on the US, Canadian, Eurozone, and Australian markets due to differing ingredient and dose requirements by jurisdiction.
Think a little harder about that and I’m almost certain that’s the last thing you want in the FDAs repertoire
Regarding picamilon, there are numerous other GABAergic natural compounds you can take that are just as effective.
And there are dozens of non GABAergic anxiolytics you can take that are effective.
You can also still buy all the picamilon you want, I just can’t sell it as a dietary supplement.
Good point, and no I don’t (unless there’s no thermogenic ingredients left, which is where things would head if companies didn’t fight), but dosing does matter. Hence the issues with powdered caffeine, which apparently happened to not be so safe, right?
These bans do not solve the root of the problem, which is crooked Chinese suppliers and poor/illegal manufacturing practices compounded by proprietary blends and further exacerbated improper use. No wonder ephedra was such a mess!
Why should the bad actors ruin it for the good ones?
You try writing a law that applies only to bad actors and get back to me when you’ve figured it out.
You try convincing consumers who walk into a storefront and see nothing but two preworkouts and a price tag in front of them to buy the quality product instead of the cheaper product and get back to me when you’ve figured it out.
Like we both know, the overwhelming majority of customers are not engaged customers. They aren’t on priceplow. They aren’t on the bb.com/am forums.
Agreed. If you are going to ban any ingredient that could be potentially harmful at any dose we’d be getting rid of a lot of useful compounds. Including caffeine.
Damn, @De_eB dropping some hot takes.
I’m definitely biased against the FDA (and most forms of controlling government agencies, but that’s a different thread…) but you’re putting up some compelling points, my man.
@De_eB, turns out I’m not nearly as well read as I thought! I’m not one to turn down constructive criticism, so thanks for the clarification! Personally, I don’t like ingredient banning, and I’d prefer if the FDA cracked down on labeling, among other things.
Anyway, I appreciate the valuable (invaluable? ) information!
Supplement companies yell really loudly every time the FDA acts, and the FDA isnt very readily transparent about their intentions.
Most of what you’ll read is pro supplement sources claiming that the FDA is some pharma industry pawn that just doesnt want you to have safe effective supplements so that you have to use more drugs
I’ve got a lifetime hot take achievement award from the good bro forum society.
We were able to prove under 100mg daily was safer than Vitamin C. DMAA is safe, found in geranium, and Hi-Tech will ultimately prevail or DSHEA is dead. The indictment was an end run around our fight in civil court for DMAA, They indict us for red yeast rice and DHEA with bad testing alleging the products had 4- or 5- Androstenediol in the product. Mike has the lab tests that show it is BS and the government used a test method that could not distinguish whether our products contained 1-DHEA, 4-DHEA or ordinary 5-DHEA. Their test identified its Formula C19H30O2 and the Molar mass of 290.44 g/mol…well guess what else has that epiandrosterone (the EA in DHEA) along with 1243 other compounds.
Hi-Tech will win both civil case on DMAA and the ruse of a criminal case
@Jared_Wheat, I assume you are THE Jared Wheat? Very cool to have you around! I seriously hope you win this whole thing!
Thanks Jeremy…I appreciate you rooting for us. We will win as we are on the right side of the law.
We’ve discussed this in the past. Here are my fixes:
No proprietary blends (sorry Jared!)
All products (and foods) must disclose exactly where they’re bottled/capped/manufactured. Mark Glazier and I talk about this in an upcoming video – Tequila distilleries do this, why not supplements or foods?!
Permanent injunctions for those who knowingly/purposefully adulterate supplements. ie CRAZE type situations. Those people should never make any ingestible ever.
FDA needs to stop playing whack-a-mole with small brands and start hitting the contract manufacturers as well - and way harder. You say “you try writing a law”, and I’ll tell you that it’s already written – FDA 21 CFR Part 111. This of course takes money that the administration doesn’t want to spend.
IMHO, that knocks out a lot of the wrongdoing, would have prevented ephedra from being a total trainwreck, likely saving lives. Less bathtub supplements, at least.
Point being, after the DMHA fiasco (which I just realized we never blogged about, hmm), it’s clear that something different needs to be done, and playing whack-a-mole with ingredients or brands isn’t the answer.