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.


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.


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

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