You thought DMAA was formally banned by the FDA? Not so fast, according to Hi-Tech Pharmaceuticals. We have the latest updates to the ongoing DMAA supplement saga here.
June 2017 Case Update: Motion to Reconsider Denied
On June 2, 2017, Judge Hunt published a short, three-page order denying Hi-Tech Pharmaceuticals’ Motion to Reconsider (which is discussed below). It’s a quick and easy read, so look at it below before seeing the next steps.
The judge seems to have placed the entire decision on this statement:
“This Court again points out that the ability to extract usable quantities of DMAA from geraniums is not the issue. The question is whether someone has extracted DMAA from geraniums or some other plant and placed that DMAA in a product, and it is obvious from the record that no one has done that. If someone had, there would not have been a dispute regarding whether DMAA was a botanical in the first instance.”
— Judge Willis B. Hunt, Jr.
The issue is that none of this was ever written into DSHEA 1994 by Congress, the law that governs the dietary supplement industry. It is a vague document (possibly intentionally), which could leave the door open to appeal.
And that’s exactly what Hi-Tech Pharma intends to do:
Jared Wheat’s Response and Plans Moving Forward
“I’m not surprised that he did not reverse himself, the order makes little sense to me and my attorneys. I think the judge (or his clerk who probably drafted this), dug an even bigger hole for himself. If the judge is now finding that DMAA can be extracted from Geraniums, which are now not obscure, where does he invent the requirement that one most show a “history” of extraction by Hi-Tech or some competitor? The opinion does not even address “constituent.”
From an appellate perspective, the order does help underscore some of the weaknesses of the original opinion. His emphasis on history of extraction (rather than extractability) gives us a huge target to shoot at: it is as if he saying that if we start extracting DMAA from geraniums in our lab, it becomes a botanical… That is completely unworkable and wrong.
The Court’s holding was erroneous and we believe will be vacated. There is no requirement under DSHEA –– in the statute, the legislative history, or the case law –– that a substance only qualifies as dietary ingredient if it can be extracted in “usable quantities or has a history of extactability.” In fact, DSHEA clearly states that the “constituents” of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical. Importantly, the Government agreed with this interpretation of DSHEA. Simply put, the Court’s conclusion otherwise impermissibly interjected its policy opinions in place of statutory interpretation. The Court’s conclusion is thus reversible legal error and will be reversed.
When Hi-Tech prevailed over the FTC in the 11th circuit from a ruling over an erroneous requirement to do double-blind placebo trials on the products themselves in April 2014 it took until May 2015 to get a decision from the 11th circuit. Many times it takes 18 months or longer to get a decision. In the meantime, it is business as usual until we get a ruling from our appeal to the 11th circuit—just like we prevailed over the FTC on appeal at the 11th circuit we have complete faith we will do so again against the FDA!”
— Jared Wheat, CEO Hi-Tech Pharmaceuticals
This should tell you what you need to know for the foreseeable future.
In the meantime, we’re diligently working on a massive update to our post how many times DMAA has been found in geraniums (hint: we’re up to 9 times right now), and although its basis in nature as not even argued anymore (the goalposts in this case oddly continue moving), our article will underline what a trainwreck of a witch-hunt this entire situation has been for the past half decade.
May 2017 Case Update: Hi-Tech’s Motion to Vacate Order
Hi-Tech has continued their fight, filing a Motion to Vacate the Order on Summary Judgement on April 17, 2017, followed by a Filing Supporting the Motion to Reconsider (May 8, 2017) and Support for a Motion to Stay (halt) the Case (May 8, 2017), where they argue several of the points discussed below from earlier this month:
Major Case Update: April 4, 2017
You can read what this means below, but first, here is a link to the Judge’s order:
The case is not over
Before we get into the details, here is what will happen next:
- Hi-Tech has 28 days to file a Motion to Reconsider, which they most certainly will do.
- If their motion fails, they will appeal to the 11th Circuit.
Our explanation and interpretation
You can read the information below, but if you’d rather watch and listen, take a look at Mike’s explanation and interpretation of what just happened and what will happen next:
The judge actually got most of this right. He did not argue that DMAA is not found in nature. After all of the evidence, it’s quite clear that DMAA can be found in geranium plants and oil (that post will be updated showing each time it’s been detected – it’s over half a dozen times).
However, the judge then made a conclusion based upon information that had never been argued by either side. He continually focused on the definition of the word “botanical”, and argues that DMAA is not a botanical in the spirit of what Congress meant when writing 1994 DSHEA, and that geranium-based DMAA supplements were never historically sold.
For instance, the judge writes,
“Nonetheless, it is inconceivable that in passing the DSHEA Congress intended for supplement manufacturers to take a chemical that heretofore had only been manufactured in a laboratory and to scour the globe in search of minuscule amounts of that chemical in obscure plants so that they could declare the substance a dietary ingredient under the statute. To hold otherwise would be to open the door to bogus claims that, for example, a given chemical had been detected in a fungus found only in a remote Tibetan river valley, and the FDA would be left to refute that claim – to prove a negative – which the instant case demonstrates is not easily done.”
Now here’s our argument to that:
Botanicals are only half the story
Botanicals are discussed in section C of the relevant portion of DSHEA. However, the judge completely ignored section F, which states “(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E);” – emphasis is ours on the word constituent, and it’s become quite clear that DMAA is a constituent of certain geranium stems, which have been in the food supply.
This may be the basis of Hi-Tech’s appeal.
Jared Wheat speaks out
He’s incorrectly interpreting Congress and DSHEA… So business as usual until we file the motion to reconsider—timeline 28 days we have to file motion to reconsider and likely he would take 6-8 weeks to rule. If we were to lose we will appeal.
- This is not the scenario of a rare Tibetan plant but common geraniums.
- There was no evidence that DMAA had not been extracted from plants in commercial quantities. To the contrary, we had a patent application for just such an extraction process in the record.
- There is no legislative history or support for the Court’s novel interpretation of DSHEA/definition of botanicals and no one had briefed his theory.
- If the judge’s point is that DMAA is in geraniums but wasn’t in the food supply prior to 1994, which is perhaps what he meant to say, then DMAA is not an adulterant, but rather an NDI needs to be filed, however geraniums were certainly in the food supply before 1994.
— Jared Wheat, Hi-Tech Pharmaceuticals CEO
Hi-Tech also provided a press release, arguing that DMAA is not illegal and that they will take this all the way to the Supreme Court if necessary!
Is it time to stock up?
Given the legal appeals process, we don’t think so just yet, but it may not be a bad idea to hit up our DMAA Supplements page and look for a few good deals, maybe buy a couple cans of Mesomorph just in case.
We’ll keep you abreast regarding the status of the updates, but for now, Hi-Tech will continue fighting this (likely all the way to the Supreme Court if they have to), but the good news is that DMAA is found in nature, but there are still arguments in the interpretation of 1994 DSHEA.
February 2017 Case Updates, with links explaining the most dramatic parts:
- DMAA *IS* FOUND IN GERANIUM OIL. THEY DOCTORED THE STUDIES.
- Hi-Tech Pharmaceuticals Issues Feb 2017 Press Release Regarding DMAA (this is the main story wrapped into one page)
- DMAA is SAFE. The Toxicology Report the FDA Doesn’t Want You to See
Mike’s March 1, 2017 explainer video on this case
If you have a lot of time, see where this case is as of March 1, 2017 in Mike’s video titled “A Supplement Conspiracy” where some of the documents referenced are in the links above, and more are coming:
Prior to the above revelations, this post was also updated November 17, 2016. Click here to skip down to this latest update if you’re already familiar with the case.
The noteworthy part is that these two supplements were released with the stimulant DMAA (1,3 dimethylamylamine), long after USPLabs threw in the towel in their fight against the FDA and “voluntarily” destroyed $8 million worth of Jack3d and OxyELITE Pro inventory.
In those HydroxyElite and Jack’d Up articles, we also noted that Hi-Tech Pharmaceuticals was suing the FDA over this, explaining that Hi-Tech claimed DMAA was never formally banned.
We had no updates for quite some time, but given the stellar reviews that HydroxyElite has been receiving (apparently it’s rumored to be better than the original OxyELITE Pro, if anyone can believe that), it was time to start knocking on some doors and ask what’s really going on.
It turns out that a lot has been happening behind the scenes during early 2015, and this post will discuss the entire Hi-Tech vs. FDA legal saga, with updates over time:
DMAA Court Documents
After some digging, we’re happy to say that we have four legal documents pertaining to this case. Any of you DMAA lovers or supplement industry critics/fans absolutely must read these.
The PDFs are available to all of our readers below:
The court documents
- Document 1: Hi-Tech Pharmaceuticals vs. US FDA Original Lawsuit Filed (November 7, 2013)
- Document 2: Order Granting Parties’ Joint Motion for Clarification (August 28, 2014)
- Document 3: FDA / US Government’s Motion to Dismiss (December 11, 2014)
- Document 4: US District Judge’s Response on Motion to Dismiss (April 21, 2015)
(Links are to PDFs that open in a new tab)
Before we discuss the above court docs, let’s first backtrack and see how we got here in the first place. Click here to skip to the 2015 updates if you already know the history.
The Quick DMAA History
The story goes something like this:
- DMAA supplements (especially USPLabs’ Jack3d and OxyELITE Pro) were best-selling hits from 2009-2012.
- In 2012, the FDA issued warning letters to several manufacturers, stating that DMAA is not a “dietary supplement ingredient”, with claims regarding its lawful marketing.
Such companies were USP Labs, Fahrenheit Nutrition, Nutrex Research, Gaspari Nutrition, SEI Pharmaceuticals, iSatori, MuscleMeds, and others.
But notably, Hi-Tech Pharmaceuticals was not sent a warning letter, although they had several of the top-selling DMAA-based products (in the form of their fat burners). More on that later.
Nearly every company stopped producing DMAA-based supplements, except for USPLabs. The guys behind Jack3d and OxyELITE sent a response letter claiming that DMAA was indeed naturally found, citing three studies.[3,4,5]
Note that USPLabs’ official responses are not available on the FDA’s website, and likely will not be made available without a Freedom of Information Act filed.
- The FDA objected to USPLabs’ response on multiple grounds in a letter dated April 18, 2013.
- At that same time, USPLabs stated that they would no longer produce DMAA-based supplements, issuing a press release that they still stood behind the legality and safety of their products, but decided to stop their manufacture for business reasons.
- Three months later, in July of 2013, USPLabs also agreed to destroy $8 million in Jack3d and OxyELITE Pro.
- Another four months later, in November of 2013, the US Marshals (at the request of the FDA) raided Hi-Tech Pharmaceuticals and seized $2 million worth of raw 1,3 Dimethylamylamine and DMAA-based products, without a warning letter or a seizure notice.
As supplies of Jack3d and OxyELITE Pro dwindled from retail stores, this effectively marked the end of DMAA. Right?
This isn’t yet over – not even by a longshot.
Here is where Hi-Tech Pharmaceuticals steps in to pick up where USPLabs left off.
The Hi-Tech Pharmaceuticals FDA Lawsuit over DMAA
Hi-Tech Pharma took issue with two things up above:
- $2 million worth of their inventory was seized, and they were never warned about it or given what they claimed to be due process.
- According to Hi-Tech, the FDA never formally banned DMAA in the first place. There was never any “Final Agency Action” taken, nor were any laws ever formally written regarding 1,3 dimethylamylamine.
Hi-Tech’s stance is clear: warning letters do not constitute law, and DMAA is natural, safe, and legal per the FDA’s DSHEA Act.
By the FDA’s own laws and definitions, it has never been proven to be “adulterated” or “misbranded”, and thus cannot be detained.
So on November 7, 2013, Hi-Tech Pharmaceutical sued the FDA… with very little press coverage.
You can see the original lawsuit filed in Document 1, shared above.
The TL;DR of Hi-Tech’s Lawsuit
In the 22-page PDF unearthed by PricePlow, there’s a lot of interesting information that’s actually quite easy to digest. Here are the bullet points:
- The suit was filed specifically against Margaret Hamburg, Kathleen Sebelius, and the FDA.
- Hi-Tech claims that,
DMAA is found in the geranium plant, and has been the subject of at least a dozen peer-reviewed scientific studies (making it one of the most studied botanical products in the US).
- The FDA has engaged in a campaign of intimidation against supplement companies such as themselves.
- The FDA has declined to engage in the rulemaking process necessary to formally ban DMAA,with no public discussion or comment.
- It is the FDA’s job to implement and enforce DSHEA in compliance with federal law:
- They explain DSHEA further, discussing the definitions of “adulterated”
- There is much discussion over the burden of proof regarding safety and efficacy. Hi-Tech states that “before commencing an action, the FDA must provide the responding party ‘appropriate notice and opportunity to present views” regarding the matter’.
- The lawsuit then discusses the FDA’s campaign against the industry, giving a history similar to ours shown above, and also mentioning that Hi-Tech was never a recipient of a warning letter.
- Hi-Tech then discusses the damages done to them by the FDA’s actions.
- Hi-Tech repeatedly states that,
- “Unless and until there has been a proper rule making procedure pursuant to DSHEA, Hi-Tech may continue to market and manufacture DMAA containing products.”
- “Unless and until there has been a proper rule making procedure pursuant to DSHEA, Defendants may not detain DMAA containing products marketed or manufactured by Hi-Tech.”
- Hi-Tech then makes their requests, such as having their DMAA detention order set aside, they want the FDA’s actions declared as unlawful, they request injunctive relief, and they want attorney’s fees.
At that point, Hi-Tech went to work creating more DMAA supplements, including HydroxyElite (which is nearly an OxyELITE Pro clone, with an added ingredient) as well as Jack’d Up (a product similar to the original Jack3d with DMAA).
When those products were released in 2014, PricePlow got keyed into the situation, but without the details shown in these PDFs.
The FDA’s move is next:
August 2014: FDA attempts to try two different lawsuits
According to court documents, things remained quiet (or at least behind-the-scenes) for nearly a year.
Then the fighting broke out. Now, see Document 2, dated August 28, 2014, and an official docket text of the following:
ORDER granting the parties’  Joint Motion for Clarification and to inform the parties that the dismissal of Civil Action 1:14-cv-2479-WBH was merely a procedural action to get an extra case number off the Court’s docket after the two cases had been merged. The joint preliminary planning report is due on September 30, 2014 and the remaining deadlines are adjusted in accordance with that date.
Signed by Judge Willis B. Hunt, Jr on 8/28/14. (ddm)
Perhaps any of you lawyers out there can clarify for us in the comments, but this seems to be an order written by the US District Court judge, clarifying that the two ongoing suits in different jurisdictions had been joined and would be tried as one trial.
So it looks like they merged two cases, then closed one case to get the case number off the docket, but the judge clarified that the “case closure” had “no substantive effect whatsoever”. Such a case closure does not constitute any legal decision/victory/loss. Fair enough.
Point being, there seems to have been a lot of legal wrangling and confusing practices going on by one or both parties, and this clarifies that there is one court case to be tried in one Federal jurisdiction. This makes sense because the legality of the seizure of goods is quite related to the legality of DMAA, so it might as well all get played out together.
But that is only the procedural stuff at the beginning…
December 2014: FDA attempts to throw out lawsuit
Next, see Document 3, dated December 11, 2014, with a docket text of
“REPLY BRIEF re  MOTION to Dismiss Hi-Tech Pharmaceuticals, Inc.’s Complaint Against FDA and HHS Defendants filed by United States of America. (O’Neal, David)”
In this 18-page PDF, you can read how the FDA attempted to get the case dismissed. The FDA argues that Hi-Tech’s arguments (in the bullet points describe above by us) are simply wrong, and states their case as to why Hi-Tech’s arguments hold no merit.
Amongst other things, they cite various other legal decisions, court cases, and laws from the past.
We encourage you to read as much of this motion as possible. At that point, unless you’re a lawyer, we’re confident that you’re likely come to the same conclusion as us (discussed in our brief commentary below).
April, 2015: FDA motion fails. This case is GOING TO COURT
Finally, see Document 4, dated April 21, 2015, with a docket text of
“ORDER: the Government’s motion to strike, , is DENIED. The Government’s motion to dismiss, , is DENIED without prejudice. Hi-Tech’s motion to stay, , is GRANTED. The parties are DIRECTED to confer and to present to this Court, within two weeks, a proposed scheduling order that provides a timetable for further discovery and the filing of the Government’s motion for summary judgment and the subsequent pleadings discussed above.
Signed by Judge Willis B. Hunt, Jr., on 4/21/15. (jta)”
This order, written by Judge Willis B. Hunt, Jr., DENIES all motions of the US Government to strike and dismiss this case. He states that “it is clear that certain evidentiary issues need to be developed”, and then orders the two parties to set a timetable for discovery and to begin filing motions for the court case.
In short: this case is going to court, get ready to play ball!
We expect this suit to go into 2016 and beyond, and will post any updates when possible. Make no mistake: simply having the court case not get thrown out is a major victory, and signals that the judge sees at least some kind of merit to Hi-Tech’s arguments.
Until more happens, we fully expect Hi-Tech to continue to sell their DMAA-based supplements, until “Final Agency Action” is declared, as will likely be decided by this court case.
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First, note that we’re obviously not lawyers.
It seems that Hi-Tech Pharmaceuticals has some reasonable arguments, and they at least deserve to have their voice heard in court. Having never received a warning letter (at least not publicly) makes the seizure of their DMAA products seem extremely odd.
Nary a warning letter??
It is rumored that the FDA did not send Hi-Tech Pharmaceuticals a warning letter because it was probable that they would sue and force a court case like this one as early as 2012 or 2013. The FDA largely succeeded in getting DMAA off the market while the media was able to smear it during that timeframe. In that aspect, the FDA seems to have played their cards well.
Remember where the burden of proof lies
A major thing not discussed here at length is the burden of proof. As DSHEA is written, the burden is currently on the FDA to prove that a compliant supplement is dangerous or adulterated (Section 402 (21 U.S.C. 342)). On occasion, the FDA (and often the FTC) seemingly try to circumvent this law through various means, such as those discussed in Hi-Tech’s original lawsuit against them. That is why the court system exists – to solve, rule, and judge how the law is to be applied.
The FDA says “No, you prove it.” USP says “Here’s proof. You prove that it isn’t.” Then the FDA says “That proof isn’t good enough. Here’s some other geranium plants that don’t have it.”
This can go on forever.
Hi-Tech’s legal team has already won some major decisions – we can’t believe it’s easy to get a judge to publicly slap such a large government agency, as was the case in Document 4. In that regard, we consider it to be progress.
Interesting strategic differences
So far, we’ve noticed that Hi-Tech’s lawyers and the Judge both write their arguments and statements in clear and concise English that nearly any high school graduate can understand. The US Government’s lawyers, however, are writing their arguments in extremely difficult-to-understand, bureaucratic-driven verbiage. It is basically incomprehensible for an untrained eye.
Perhaps this is how all of the US Government Agency’s legal writing sounds, but it doesn’t seem like this particular judge cares too much for it.
For whatever reason, we get the impression that the FDA did not want to take this to court. That’s often the case for anyone, mind you – court cases are expensive and time-consuming. But with this judge, Hi-Tech Pharma will apparently get at least some chance at a fair fight, and that’s about all anyone in the industry can ask for.
Got your popcorn ready?
Hi-Tech doesn’t seem to pick many fights that they can’t win. This is not the first time they’ve stood up for the industry and proper enforcement of DSHEA. No doubt, they’re a polarizing company, but being polarizing doesn’t mean that you don’t deserve your day in court just like anybody else.
We’ll keep this up to date with as much information as possible. Until then, you can see what DMAA supplements are still out there on the web, read about Jack’d Up or HydroxyElite, or sign up for alerts below or on our Hi-Tech Pharmaceuticals page.
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This section will be updated over time:
November 2015 statement regarding USPLabs
Update Regarding recent USPLabs allegations: “Hi-Tech continues to support and defend the legality of DMAA, and will maintain the status quo until their case is heard in court. They are not involved with the recent allegations against USPLabs”.
January 2016 Statement Regarding USPLabs Jack3d Case Dismissal
Not directly related to this lawsuit, but a wrongful death case against USPLabs over Jack3d has been dropped by the courts. One important comment was that “the court found no scientific evidence that the product is harmful or hazardous.” There are several other good quotes, including some updates from Hi-Tech’s Jared Wheat, whose case is discussed in the article below:
October 2016 Mini-Update
The case is moving slowly, which is common for a large federal case, but it does continue to move forward. In the summer and fall of 2016, Hi-Tech Pharmaceuticals and the Government were still going through discovery proceedings, but nothing major has been revealed yet. Stay tuned for more updates.
November 2016 Deliberative Process Privilege Order
The latest news is that Hi-Tech Pharmaceuticals seems to have caught the FDA from withholding certain information from this case. Hi-Tech’s legal team has been asserting that the FDA’s process log is deficient.
You can download the PDF here — our explanation is below:
The FDA is using something known as Deliberative process privilege, which is a common-law principle that is being used in this case to protect the internal deliberations of an agency — meaning that the FDA does not need to show their deliberations about why they did something. Such a principle protects the government from exposing its reasoning.
However, as the judge in this case sees it, this principle only has to do with deliberations, not actual facts of the case. So if they made a decision about why XYZ is bad based on PDQ data, they don’t need to disclose in court their discussions about why XYZ is bad, but they do need to provide PDQ data.
As such, the Honorable J. Clay Fuller ordered that the FDA produce all data used in its decision-making by Friday, November 18.
While seeing the deliberations would have been fascinating, this is a victory for Hi-Tech Pharma (we’re not sure how big) in that they get to examine the data. And we’re confident that this data will show what we’ve known all along – when taken as directed and without medical conditions or other prescription drugs, DMAA is not unsafe.
We’ll see — and we’ll keep updating this post as the case goes on.
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- PricePlow Blog; $8 Million Worth of Jack3d and OxyELITE Pro… Down the Drain; July 17, 2013
- Roosevelt, M; Warning Letter to USP Labs; April 24, 2012; Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm302167.htm
- Li, J.S., M. Chen, and Z.C. Li. “Identification and Quantification of Dimethylamylamine in Geranium by Liquid Chromatography Tandem Mass Spectrometry.” Analytical Chemistry Insights 7 (2012): 47–58; Retrieved from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3422085/
- Ping et al. A study on the chemical constituents of geranium oil. Journal of Guizhou Institute of Technology. 1996. 25(1):82-85.
- Fleming, Heather L., Patricia L. Ranaivo, and Paul S. Simone. “Analysis and Confirmation of 1,3-DMAA and 1,4-DMAA in Geranium Plants Using High Performance Liquid Chromatography with Tandem Mass Spectrometry at Ng/g Concentrations.” Analytical Chemistry Insights 7 (2012): 59–78; Retrieved from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3512447/
- Thomas, J; Response Letter to USP Labs LLC Concerning DMAA; Food and Drug Administration; April 18, 2013; Retrieved from http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CFSAN/CFSANFOIAElectronicReadingRoom/ucm350199.htm
- PricePlow Blog; USPLabs Discontinues DMAA – Jack3d Advanced in the Works; April 16, 2013
- Putnam, J; U.S. Marshals seize more than $2 million in adulterated dietary supplements from Georgia company; Food and Drug Administration; November 18, 2013; Retrieved from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm375458.htm
- Food and Drug Administration; Guidance for Industry: What You Need To Know About Administrative Detention of Foods; Small Entity Compliance Guide; Updated March 2013; Retrieved from http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/FoodDefense/ucm342588.htm
- Food and Drug Administration; 4. Safety of Dietary Supplements and Burden of Proof on FDA.; Dietary Supplement Health and Education Act of 1994; Retrieved from http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/ucm148003.htm#sec4
- United States District Court, Northern District of Georgia; “Civil Local Rules”; http://www.gand.uscourts.gov/sites/default/files/Local_Rules_List.pdf