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FDA v. Jack3d: Round 2

Jack3d is a dietary supplement manufactured by USPlabs and promoted by the giant supplement retailer GNC as producing “ultra-intense muscle-gorging strength, energy, power and endurance.” A key ingredient is DMAA, which the FDA doesn’t think is a proper dietary supplement ingredient at all and wants Jack3d and other products containing it removed from the shelves and the web. The FDA also questions its safety.

As discussed in a previous post on the subject, both USPlabs and GNC maintain Jack3d (pronounced “jacked”) is safe when properly used. Apparently few agree with them on this point: not the FDA, not the U.S. military, not the countries and athletic associations which have banned DMAA. And certainly not the parents of Michael Lee Sparling, a 22-year-old Army private. The Sparlings filed a lawsuit alleging Jack3d caused the death of their son, who went into cardiac arrest and died after using it.

Here is where we left off the last time we looked at DMAA:

Last April [2012], the FDA sent warning letters to several supplement manufacturers saying it had no evidence DMAA is a legitimate dietary ingredient and citing its risks. (Health regulators in other countries, such as Sweden and Denmark, have actually banned DMAA-containing supplements.) Heart attacks, heart failure, kidney failure and liver failure were among the health problems reported to the FDA, as well as 5 deaths. GNC responded that it was “completely opposed to this unilateral, factually and legally unfounded action by the FDA.”

Now to Round 2.

Ding!

The FDA has a separate web page devoted exclusively to DMAA, its dangers, and efforts to get it off the market. A sense of the agency’s frustration at the limitations imposed by the Dietary Supplement Health and Education Act (DSHEA) on its power to police the dietary supplement market comes through in a description of these efforts:

Unlike drugs, dietary supplements do not have pre-market approval for safety or effectiveness. If a safety issue arises post-market, FDA can investigate and take steps to remove products that may be unsafe from the market. However, in order for FDA to ban a compound in a dietary supplement, FDA is required under the statute to undertake a series of lengthy scientific and legal steps. In the interim, FDA can take direct action by issuing warning letters to industry to obtain removal of ingredients in dietary supplements and protect the public from potentially harmful products. FDA can also bring a seizure action to remove products from the market or obtain an injunction against a company to prevent it from manufacturing and distributing illegal products.

Note that the FDA must initiate a federal court proceeding and meet the applicable burden of proof before getting a court order permitting seizure or granting an injunction.

The FDA sent warning letters to 11 supplement manufacturers, accounting for “most of” the manufacturers using DMAA. As you may recall, the FDA does not have a complete list of all manufacturers or distributors of dietary supplements or know what supplements are out there because there is no requirement in the DSHEA that companies register themselves or their products with the agency. The letters raised the following issues:

  • Because DMAA had not been marketed as a dietary supplement ingredient prior to 1994 it was considered a “new dietary ingredient” (“NDI”). Manufacturers are required to notify the FDA of evidence supporting their conclusion that their use of NDIs is safe. The companies failed to do this.
  • The FDA was not aware of any evidence or history of use that indicated DMAA is safe. In fact, DMAA is known to narrow blood vessels and arteries which can elevate blood pressure and lead to cardiovascular events. Serious adverse events had been reported, including cardiac disorders, nervous system disorders, psychiatric disorders, and death.
  • Synthetically-produced DMAA is not a “dietary ingredient” and therefore cannot be used as an active ingredient in a supplement.

Eventually 10 of the 11 complied and agreed to stop making supplements containing DMAA; the remaining supplier is still in the market. The lone holdout was USPlabs. In fact, USPlabs seems to think the safety issue is cause for a bit of fun. The company puts a faux “Black Box Warning” on the Jack3d label:

This product produces an intense sensation of drive, focus, energy, motivation & awareness. In addition, it allows for rapid increases in strength, speed, power & endurance. Therefore, extreme caution must be exercised & should not be used by novice athletes. Use with caution under strict dosing products.

Such marketing cleverness!

USPlabs plays defense

USPlabs wrote the FDA back, defending its claim that DMAA is a dietary ingredient by arguing it is a constituent of a type of Chinese geranium. The FDA was having none of it. It notified the company on April 10 of this year that it found the information insufficient, with an official warning letter to follow. USPlabs was still defending its product in an April 12 New York Times story. However, on April 16, USPlabs announced it would phase out products containing DMAA.

The formal warning letter was issued nevertheless, on April 18. In a Gorski-style takedown of studies relied upon by USPlabs in its attempt to convince the FDA that DMAA is a dietary ingredient, the agency shredded the studies cited. Because the details of these studies would interest only those familiar with such things as “gas chromatography (GC)–mass spectrometry (MS) analysis” and methods of authenticating the source of plant materials (which is way more complicated than you might imagine), I will spare you the details. (You’re welcome.)

Actually, I couldn’t begin to understand what they are talking about, but I will share this amusing (to me) bit of comeback to USPlabs’ claim that DMAA is a dietary ingredient because it is “a dietary substance for use by man to supplement the diet by increasing total dietary intake.” The FDA retorted:

. . . the possibility that geraniums may have been consumed as a food or drink by humans does not demonstrate that DMAA is a dietary substance because, as explained above, the totality of the scientific evidence does not demonstrate the presence of DMAA as a constituent of geraniums.

Somehow the thought of people eating and drinking geraniums struck me as funny, although that possibility shouldn’t be at all surprising considering what I’ve learned about “complementary and alternative” medicine.

Because the FDA determined DMAA is not a legitimate dietary ingredient the agency found it unnecessary to address USPlabs’ contention that DMAA is safe.

During this controversy, USPlabs sued a retailer in Nevada for defamation. The complaint alleges that a Max Muscle retail outlet franchisee said Jack3d is “the equivalent of rat poison” in a radio interview.

NEW! IMPROVED!

Although the remaining stock of Jack3d is still available from some retailers, including GNC, USPlabs has reformulated the product, now sold as “Jack3d Micro” and promises to deliver another new Jack3d product in the future, although it does not say whether this product will contain the same ingredients as the Micro version. (It is, in addition, reformulating OxyElite Pro, which also contains DMAA.) The only common ingredient between the new and old versions is caffeine. Interestingly, a sales pitch for Jack3d Micro on the company’s website is presented as a comparison with the original DMAA-containing formula:
Jack3d comparison
There is no mention of the controversy about DMAA, although it does not appear that the original Jack3d is still sold on its website, unlike other internet outlets. The website still touts the safety and effectiveness of DMAA-containing products.

The faux Black Box warning is gone but the label does advise the purchaser to consult with a physician before using, especially if he is taking prescription medications or has certain pre-existing medical conditions, and to discontinue prior to surgery. It also advises the purchaser not to use the product if taking certain named medications as well as warning against using it in combination with other stimulants, such as caffeine-containing products, or alcohol. The label tells the purchaser to “consult your health care professional if you experience any adverse reaction to this product.” What it does not do is warn the purchaser of what those adverse reactions might be.

The FDA requires dietary supplement labels to list ingredients. Here is the ingredient list for Jack3d Micro.
Jack3d ingredients from jacked3dorg website
Assuming the role of a diligent consumer, but one with no background in medicine or science (in other words, me) I tried to locate reliable information about the safety and effectiveness of these ingredients. None of this information is available to the consumer on the USPlabs website as far as I could determine, although I only searched the website using specific ingredient names listed on the label. WebMD does have an easy-to-use way to search for information about dietary supplement ingredients, but not all of those found in Jack3d Micro were on their website. Of course, WebMD’s analysis must compete with the tremendous amount of hype about supplement ingredients from supplement sellers and other sources available on the internet.

Here’s the information not mentioned on the warning label that I thought a consumer should be concerned about, all from WebMD unless otherwise indicated. (Some ingredients have more than one name.)

3,4-Dihydroxycinnamic acid, caffeic acid (stimulant, ingredient in many foods, such as coffee)

  • Effects when taken by people unknown.
  • No information available on interactions with other supplements or drugs.
  • Insufficient evidence for use to enhance athletic performance and for exercise-related fatigue.
  • Not enough evidence to know if safe when taken as a supplement or to determine appropriate range of doses.

Higenamine, Norcoclaurine (stimulant)

  • Insufficient evidence for use to enhance athletic performance.
  • Possibly unsafe when taken orally. Not studied in people therefore safety unclear.
  • Aconite (a plant) shown to cause serious heart-related side effects including arrhythmias and death; effects may be caused in part by higenamine in aconite. Warning about irregular heartbeat repeated in information, although it’s not clear whether this is based on additional evidence.
  • Not enough evidence to determine appropriate range of doses.

L-citrulline (amino acid)

  • Possibly safe.
  • Insufficient evidence for exercise performance. May not be effective for improving exercise performance. In one test, did not improve performance on treadmill and people taking it actually became exhausted more quickly than those who did not take it.
  • No information available on interactions with other supplements or drugs.
  • Not enough evidence to determine appropriate range of doses.

Grape seed extract 

  • Headache, abdominal pain, sore throat, nausea, and diarrhea may occur.
  • Very serious allergic reaction to this product rare, but warning to seek immediate medical attention if any of the following symptoms of a serious allergic reaction appear: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Arginine nitrate and Agmatine sulfate

These ingredients are not listed on WebMD. Best I can tell, arginine nitrate is L-arginine bonded to nitrate. It is all the rage now in bodybuilding products and a supposed improvement over L-arginine, an amino acid. Agmatine sulfate is the decarboxylation product of arginine. (And good for you if you know what that means.) I could not find any information on the safety and effectiveness of either of these ingredients, when used in a dietary supplement for Jack3d Micro’s intended purpose, from any source I considered reliable and unbiased. I do not know if these new forms of L-arginine would retain the safety issues of that substance. According to WebMD, L-arginine is possibly safe for most people when taken appropriately by mouth in the short term, but it can have unpleasant gastrointestinal side effects and can cause swelling of the airways. There is concern that it may increase the risk of death after a heart attack and has known moderate interactions with high blood pressure drugs and sildenafil (Viagra). It has not been studied for athletic performance.

The Score

I suppose if I were scoring Round 2, I would count it even. The FDA will eventually see most, if not all, of the dietary supplements containing DMAA off the market. Of course, since DMAA is not a dietary ingredient, it should never have been on the market in the first place. And, because DSHEA allows it, supplements containing DMAA were sold without manufacturers having to demonstrate their safety and effectiveness to the FDA. As it turns out, the FDA concluded DMAA was not safe.

USPlabs has reformulated Jack3d, but, again, DSHEA allows it to go on sale without the company having to provide all the information a consumer should consider before taking it or proving its safety and effectiveness to the FDA. The consumer can do this research on his own but information about all of the ingredients is not readily available. Some of the ingredients have a potential for causing harm and there is no adequate research showing they are effective for their intended use. And apparently there is no research on the safety and effectiveness of using these ingredients in this combination and at this dose. In other words:

Safety and effectiveness unknown. Use at your own risk.

Posted in: Herbs & Supplements, Legal, Politics and Regulation

Leave a Comment (29) ↓

29 thoughts on “FDA v. Jack3d: Round 2

  1. Davdoodles says:

    Dumb and DMAA…
    .

  2. playreader says:

    I appreciate SBM’s heads up to consumers about this seemingly bogus product. But I don’t see how it follows that you should advocate to ban it from the market using the coercive power of government. Freedom includes the freedom to make stupid choices.

  3. EbmOD says:

    Playreader-
    I consider myself quite libertarian. I understand where you are coming from regarding trying to keep govt out of our lives as much as possible. However, on issues such as this, a lassiez-faire type market doesn’t work well. A totally free market assumes ideals such as perfect competition, perfect knowledge, etc. These are severely compromised when dealing with complicated biochemistry, physiology, etc.

    The average person would have no way to know or understand the risks of taking such a product if the FDA wasn’t compiling data and analyzing it. Does some 20 year old kid that walks into a supplement store looking to add a little muscle deserve to die because he made a bad choice based on asymmetrical information? Of course not. I am no fan of govt, especially when it comes to influencing personal choice and the market, but I just don’t see a practical alternative.

  4. elburto says:

    *headdesk* Has FBA reproduced by budding?

    Playreader – It is not “coercive” to regulate potentially dangerous supplements.

    People buying the original Jack3d assumed that because the product was being sold openly, it must be safe.

    When you go grocery shopping, do you make a note of every ingredient in your food/drinks, then research them all before you eat? If you’re given a prescription by your GP do you look up every ingredient, active and inactive, to make sure there are no hidden surprises?

    How would you check the thousands of ingredients in your food/drink/drugs if you had no internet? What if you had reading difficulties or sensory impairments?

    People deserve the freedom to not have to research every single component or ingredient of their food, drinks, medications, laundry products, etc. It is not an abuse of power for governments to force the withdrawal of a dangerous product, any more than it is an abuse of power to stop a toddler chewing on a live wire.

    WRT geraniums – They’re often used in salads. Back in her diet-obsessed days in the 80s, my mother (and her friends) used to add geraniums, nasturtiums, and other edible plants, to their grim little salads. Apparently they have a disinctive peppery taste.

  5. elburto says:

    I overtyped a key sentence. Here it is, sandwiched between the originally intended locations.

    to make sure there are no hidden surprises?

    Fortunately, you don’t have to. You know that your cereal isn’t laced with uranium, that there isn’t rat poison in your salad.

    When you’re prescribed a medication you can be sure that it contains what it’s supposed to contain, and has undergone testing. But what if the free market treated food and drugs the way they treat supplements, and you had to research everything you ingested?

    How would you check the thousands of ingredients in your food…

    Another point – supplement labels often aren’t worth the ink used to print them.

    Certain imported substances that have been checked (here in my country) have claimed to be “natural dietary aids”, with innocuous-looking labels. Further inspection has revealed the presence of amphetamines, thyroid supplement, anti,anxiety drugs, etc.

    Male-targeted “enhancement” products frequently contain Viagra, stimulants, and other assorted nasties.

    Your “interference is oppression” stance assumes that manufacturers/suppliers give a shit about anything but making money, and are printing accurate ingredient labels.

  6. elburto says:

    I overtyped a key sentence. Here it is, sandwiched between the originally intended locations.

    to make sure there are no hidden surprises?

    Fortunately, you don’t have to. You know that your cereal isn’t laced with uranium, that there isn’t rat poison in your salad.

    When you’re prescribed a medication you can be sure that it contains what it’s supposed to contain, and has undergone testing. But what if the free market treated food and drugs the way they treat supplements, and you had to research everything you ingested?

    How would you check the thousands of ingredients in your food…

    Another point – supplement labels often aren’t worth the ink used to print them.

    Certain imported substances that have been checked (here in my country) have claimed to be “natural dietary aids”, with innocuous-looking labels. Further inspection has revealed the presence of amphetamines, thyroid supplement, anti,anxiety drugs, etc.

    Male-targeted “enhancement” products frequently contain Viagra, stimulants, and other assorted nasties.

    Your “interference is oppression” stance assumes that manufacturers/suppliers give a toss about anything but making money, and are printing accurate ingredient labels.

  7. WilliamLawrenceUtridge says:

    Freedom includes the freedom to make stupid choices.

    This is of cold comfort when someone you know dies because of “health freedom”.

  8. David Gorski says:

    Of course, the key thing about “health freedom” and “informed consent” is that freedom isn’t free if choices aren’t informed, and choices aren’t informed if manufacturers are allowed to use misinformation and pseudoscience to promote their products. In reality, the only “freedom” that “health freedom” entails is freedom from pesky government laws and regulations that limit what quacks can say and do in promoting their quackery, while the only “consent” that “health freedom” entails is what I like to call misinformed consent.

  9. daedalus2u says:

    I see that some of the ingredients in these supplements act through nitric oxide pathways. Those pathways are extremely complicated, are coupled to each other, and are separately regulated by physiology in every separate part of the body on every separate length, time and concentration scale that is important.

    These pathways are too important and too complicated and too closely regulated to be able to “improve” their performance by whacking at them with non-physiological supplements, and particularly with non-physiological xenobiotic compounds.

    Anything artificial that seems to give you more “energy”, isn’t doing so by improving on the efficiency of 3 billion years of evolution. Any increased “energy” can only be due to diverting “energy” from somewhere else.

    Increased strength following exercise doesn’t come from the tearing down of muscles during the exercise, it comes from the improvement that occurs during the rebuilding of the muscles torn down during exercise.

    The wikipedia page reports it is a thermogenic stimulant, a stimulant that increases heat production. It very likely does so by mitochondria uncoupling, which lowers the ATP production by mitochondria by dissipating the mitochondria potential as heat instead of making ATP. Taking stimulants during exercise is a good way to get overuse injury. Stimulants don’t increase energy production, what they do is divert energy away from things like healing so you can use it in muscle. They also remove the “safeties” like pain and fatigue which are there to protect from overuse injury. There can be times when you want to over-ride those “safeties”, such as when you are running from a bear. You never want to do that during practice or normal exercise where the point is to try and improve long term performance.

    That is very likely what killed those people, the DMAA blocked feelings of fatigue and pain, perhaps even induced euphoria, and they ran themselves to death.

  10. ntheodorakis says:

    <blockquote.
    I see that some of the ingredients in these supplements act through nitric oxide pathways. Those pathways are extremely complicated, are coupled to each other, and are separately regulated by physiology in every separate part of the body on every separate length, time and concentration scale that is important.

    Yeah, I was also puzzled by the inclusion of citrulline. Naively, if you think arginine would boost NOS activity, then wouldn’t citrulline decrease its activity? (leaving aside the issue of NOS having multiple complicated regulatory mechanisms, as you indicate)

    Nick

  11. qetzal says:

    elburto alluded to another reason that “health freedom” arguments are highly problematic. People know that “real drugs” are subjected to substantial testing and review before FDA approval. People also know of lots of other government programs that regulate safety – things like regulation of pesticide use on food crops. So it’s not really the consumer’s fault if s/he assumes anything sold freely for consumption in the US must be safe. The overall US regulatory system has taught them to make that assumption!

    Anyone who truly supports health freedom should want to see the same rules and regulations applied to ALL health-related industries. That would mean that Pfizer should be just as free to sell its drugs on store shelves and make unsupported safety and efficacy claims as any supplement maker.

    I’ve yet to see a health freedom advocate support such a plan though.

  12. daedalus2u says:

    Citrulline is the product of the NOS enzymes. Arginine + O2 goes to NO plus citrulline (two cycles of the enzyme). The Km for eNOS is a few orders of magnitude lower than the actual concentration of arginine in blood, or in the cells where the eNOS enzyme is. There are endogenous inhibitors (the best known is asymmetric dimethyl arginine), there is arginase which converts arginine into ornithine plus urea, there is eNOS uncoupling where NO plus superoxide oxidizes a Zn-S couple and “uncouples” eNOS so it makes superoxide instead of NO.

    There are some pathways that recycle citrulline back into arginine and some claims that this is “better” than simply giving arginine, but there is no good data that shows this (that I am aware of).

    All of these control mechanisms are there for a reason, and they make the simple-minded approach of “more arginine = more NO”, not work.

    There have been no long term placebo controlled studies of arginine on vascular outcomes mediated through NO (that I am aware of). The longest term trial I am aware of was ~6 months for peripheral artery disease and showed placebo worked better.

  13. ntheodorakis says:

    I am a little familiar with NOS enzymology inasmuch as a few years ago I was part of a project in trying to correlate vascular tetrahydrobiopterin (BH4, another NOS cofactor) levels with eNOS in our particular mouse model. We had some crazy idea that as eNOS levels increased, BH4 would not, and thus eNOS would get uncoupled and produce ROS, yada yada, bad for the mouse. But it turned out our hypothesis was wrong, so we never published it (and for other reasons).

    It’s been awhile since I followed the NOS literature, but I seem to remember some studies in which Arg can stimulate NO production in cultured cells, even though by classical enzymology and Km’s and concentrations it should not, and there was some handwaving about possible compartmentalization or colocalization of eNOS and Arg transporters in caveolae, or something. Anyhoo, I don’t remember anything about citrulline being talked about in any other way except as an end-product, which is why eating citrulline sounded backwards to me.

  14. Angora Rabbit says:

    Interesting! I spotted the NOS donors too and wondered if the users would get a vascular rush?

    But when I see citrulline etc my first thought is “urea cycle.” Citrulline is the starting recipient for N disposal as safe urea, rather than as dangerous charged ammonia. It is absorbed in the gut via Y+ transporters. The problem is that same transporter is also used for lysine (an essential AA), arginine, ornithine, etc. So taking this cr*p daily also poses a risk for basic amino acid imbalance and lysine deficiency. Note that FDA requires ingredients be listed in order of abundance, and their label nicely dodges how much of each basic AA is added.

    Having said that, the one saving grace from outright nutritional deficiency from this cr*p is these users are often protein-obsessed and eating well in excess of their protein requirements. So they could get enough lysine from meals at other times. But because this class of user is often protein obsessed, they have a much higher nitrogen load. Hepatic portal circulation sends this supplement straight to liver, and daily use will induce their disposal enzymes and get rid of the citrulline and arginine, and maybe some other basic AAs. Until of course they destroy their livers.

    So apart from the side effects, they are really making expensive pee. Or should that be really expensive pee?

  15. Jann Bellamy says:

    The comments about the biochemistry at work here are fascinating. I can’t really follow everything you are saying but sort of get the gist of it.

    This makes me wonder: do the people creating these formulas know just enough to be dangerous or do they understand what they are creating and don’t care? Are they like naturopaths, and simply don’t have sufficient education to fully understand the science, or are they like M.D.s who practice homeopathy, and surely know better? I wonder what their level of education is? Could they have enough chemistry and biology to create this stuff and yet not enough to fully understand what they are doing?

  16. daedalus2u says:

    This is a vasoconstrictor, so it lowers NO levels. Lowering the NO level is a generic method for triggering “fight-or-flight” and diversion of ATP away from things like healing. All the stimulants of abuse do much the same thing. At some dosage this will produce euphoria (before it kills you). The DEA could likely ban it based on it being a euphoria producing agent.

    Jann, I am pretty sure that the manufacturers of this don’t know and don’t care about side effects. They are just trying to make money. Probably for most people if you follow the instructions it won’t be that bad. But it is likely difficult to not use a little bit more, and then a little more than that, and pretty soon you are getting toxic effects like from solvent huffing. The toxicity effects are likely similar to those from solvents. If you have any other conditions associated with low NO, like a seizure disorder, this could be really bad for you.

    As a general rule, anything that produces euphoria is very likely also extremely dangerous. How you are feeling is not a reliable indication of your physiological status, especially if you are in any kind of altered state.

  17. Angora Rabbit says:

    Thanks, Daedalus2u. I wasn’t sure if citrulline would VC or VD, since it would also provide carbon skeleton for additional arginine synthesis.

    Jann, I’ve always assumed these folks know just enough to either screw themselves up, or to skate just close enough to plausibility without actually having to demonstrate efficacy. I lean toward the latter since presumably they’ve all filed a patent somewhere on these formulations. I do think a hefty portion really believe they are right and it works, but don’t care about showing efficacy.

    I joke with my nutritional biochem students that, if they do make money from info from my class, they ought to give me a percentage from gratitude. Mind, I’m not holding my breath.

  18. Guy Chapman says:

    @playreader: I think that protecting people from companies profiting by making claims they cannot back up, for products they cannot prove meet acceptable safety standards, is a proper role for government. Why would it not be? Choice is only meaningful when it is informed choice. Choice in this case was being made on the basis of misleading and partial information supplied by a company with a vested interest in not telling you the product was potentially dangerous.

  19. Jeff says:

    “…the FDA does not have a complete list of all manufacturers or distributors of dietary supplements or know what supplements are out there because there is no requirement in the DSHEA that companies register themselves or their products with the agency.”

    This is not accurate. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 required that all makers and distributors of food products (including supplements) register with the FDA. The Food Safety Modernization Act strengthened those regulations:

    http://www.contractpharma.com/issues/2011-01/view_fda-watch/food-safety-legislation/

    As Jann Bellamy states, the FDA has determined that DMAA does not meet DSHEA’s definition of a dietary ingredient. Most independant research labs and all the major supplement trade groups agree with the agency’s position.

    In other words, the regulations in DSHEA were perfectly adequate to remove DMAA from the marketplace.

  20. kathy says:

    It’s a pity that people have been educated to be so suspicious of the FDA. Without a governmentally funded organisation there would be no agency that is free from conflict of interest. I don’t imagine they are stained-glass saints, but at least they aren’t trying to sell you something.

    Oh, I almost forgot … there used to once be another source of unbiased information and opinion – the universities – but, as we’ve read on this blog, too many of these are selling their birthrights for a bowl of porridge. The same goes for scientific journals. They were traditionally the groups who had the knowledge not to be bluffed or intimidated, and who also didn’t depend on any commercially/ideologically tainted source for funds.

  21. Jeff says:

    Kathy: Most of the FDA’s budget comes from user fees, not taxes:

    http://www.forbes.com/sites/henrymiller/2012/05/23/fda-user-fees-use-consumers-badly/

  22. Jeff says:

    Correction: According to the article, user fees make up about 25% of the FDA’s total budget, but most of the costs for approving drugs.

  23. daveschlac says:

    Daedalus2u,

    I see you are still the resident expert on Nitric Oxide.

    Are you still confident on its importance to human health? Weren’t you trying to get a product to market?

    On Topic: I have some body builder friends who have tried Jack3d once, said it is seriously powerful stuff and that they would never use it again.

  24. Earthman says:

    “Such marketing cleverness!”

    Such lack of ethics

  25. Jann Bellamy says:

    @ Jeff:

    You are correct in stating that the companies must register, although there is still no requirement that the supplements be registered. I am curious, then, about the Office of Inspector General’s statement in a recent report, “Dietary Supplements: Companies May Be Difficult to Locate in an Emergency,” referenced in my previous post with a link:
    http://www.sciencebasedmedicine.org/index.php/at-your-own-risk/

    “Because no comprehensive list of dietary supplements or dietary supplement companies exists, the universe of supplements and companies is unknown.”

    Unfortunately, the companies do not have a good track record on complying with the registration requirement, perhaps because the penalties for non-compliance are weak. Taking a company off the registration list is possible, but no civil penalties are provided for in the statute, although the FDA asked for this authority, it was in the House version of the bill, and was supported by the Obama administration. The OIG concurred that penalties should be increased.

  26. Coot says:

    That ingredient label is confusing. Looks like Jack3d is a collection of 3 distinct sub-products:

    ENOS Super Performance System – 2247 mg

    CNS Contractile Simulant System – 182 mg

    Vitamin C – 50 mg

    But all 3 are mixed together in one powder which is measured out by scoops.

    Wouldn’t it make more sense to simply list the ingredients of the power in descending order of importance?

  27. Elmo says:

    I’ve been cycling jack3d now for a year. I love it ! I think it’s the best supplement ever. It is effective, but you STILL need to have the effort to go to the gym/run. I do agree with you all that there needs to be a limit like a “prescription” per say. However, Jack3d is fine as long as you’ve never had any heart issues. Also people are dying to because they are taking insane amounts of it like the whole tub. So my case is that if we are stopping the selling of “Jack3d” then why don’t we stop alcohol/ beer as people have die from taking too much of that as well right ? How about MC’ds… how can you consider THAT healthy?

  28. WilliamLawrenceUtridge says:

    Since it’s never been properly studied, you don’t really know that, do you? It might selectively kill people with no underlying heart issues, but some unusual biological quirk that is otherwise harmless. And further, I don’t believe in the case of Private Sparling there was any claim that he was taking large amounts of this lab-produced stimulant before dying of a massive heart attack.

    If people consumed McDonalds and alcohol like they consume Jack3d (several times per day, every day), then yes they would also be considered unhealthy. But both are foods, and neither have an illegitimate stimulant disguised as a molecule possibly found in low doses of one particular species of geranium.

    Anyway, hope you don’t die from it.

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