GodMode is a brain supplement with a bold name and even bolder claims. Too bold, experts say.
Named after a gaming term for invincible players, the $50 bottle of 60 pills touted "FDA approved" ingredients until the maker was contacted by CNET. The pills, marketed to gamers, promise to "supercharge your memory," "improve your reaction speed 6-10%" and help you "think faster/smarter." Boss Level Labs, the Frisco, Texas-based company behind the pills, said GodMode may also reduce stress and anxiety.
Those are big claims for a bottle of tan-colored capsules you can buy off the internet. But that's the pitch that GodMode, which hit the market in October, sent me. I had to find out more.
What I learned is that more than a dozen scientists, health experts and universities I contacted either said the product is bogus or didn't want to discuss it at all. "No one in the department wants to talk about it because it is all hype and there is no scientific evidence" to support these types of claims, a Johns Hopkins University School of Medicine representative said.
When I spoke with the Food and Drug Administration, the agency said it had not, in fact, approved GodMode's ingredients nor does it do so for any similar dietary supplement.
Had I stumbled across 21st-century snake oil for button mashers?
Scott Miller, Boss Level Labs CEO and founder of game studio 3D Realms, said in an interview that he decided to create GodMode because he hadn't come across a supplement targeted at the game industry.
"If we're going to do a brain supplement," Miller recalled thinking, "is there really much of a better market than gamers, who are using their brains to enjoy their activity and succeed at it?"
Miller backed GodMode's FDA claims by citing the Dietary Supplement Health and Education Act of 1994, which states the FDA "regulates both finished dietary supplement products and dietary ingredients." Those regulations, however, are different from those the FDA applies to prescription drugs, which can't go to market until the agency approves them.
Manufacturers and distributors of dietary supplements and ingredients, on the other hand, are "responsible for evaluating the safety and labeling of their products before marketing." The FDA will only take action against adulterated or misbranded dietary supplements after they reach market. And the $41 billion supplement industry has long been cluttered with products claiming to provide all sorts of solutions, from weight loss to enhanced muscle growth.
Before being contacted for this story, GodMode's website said all 14 of its ingredients were "natural, vegetarian, safe, tested, and FDA approved."
Mention of FDA approval has since been dropped, except in a video on YouTube.
How it works
Some of GodMode's ingredients might sound more familiar than others. They include theobromine, which is found in tea and which Boss Level Labs said aids in memory, attention span, reaction time and problem-solving skills. Caffeine is an ingredient, as is yamabushitake, a mushroom extract the company said can reduce depression and anxiety and serve as a cognitive enhancer.
The other 11 ingredients are pterostilbene, bacosides A & B, forskolin, luteolin, huperzine A, CDP choline, acetyl-l-carnitine, betalains, theanine, lithium orotate and bioperine.
"These ingredients, most of them have been around for a long time," Miller said. "They're all super safe. They're basically plant and food extracts."
Ronnie Castro, 35, finished a 30-day trial of GodMode and said he plans to sign up for a monthly subscription. The network engineer from Los Angeles, who GodMode put me in touch with, said that around 30 minutes after taking the supplement he's able to jump right into his tasks at work in the morning.
"Everything is improved as far as focus and drive," Castro said. "When I'm on it, then I feel I don't have to warm up to do things."
Boss Level Labs chief science officer Shota Yamamoto said the ingredients in GodMode work in a few different ways: They can either increase natural neurotransmitters, like serotonin and dopamine, or increase blood flow to the brain.
Michael Platt, professor of neuroscience, psychology and marketing at the University of Pennsylvania, said people who aren't severely malnourished likely won't get those benefits from GodMode's ingredients, though.
"It would be unlikely that any of these ingredients contribute in some amazing new way to brain function, unless you were actually deficient in your diet," he said.
Without a randomized, double-blind, placebo-controlled clinical trial, which is generally considered the "gold standard," Platt said, it's hard to tell if people are reporting improved performance because of a placebo effect.
Miller said it can be too expensive for supplement manufacturers to conduct trials on their overall products, GodMode included. "So we rely on the trials that are out there for individual ingredients," he said. "There should be no surprising interactions between them to cause any issues."
Then there's the "FDA approved" issue. The FDA isn't authorized to review the safety and effectiveness of supplements before they hit the market, according to the administration's website. FDA spokeswoman Lyndsay Meyer said the agency doesn't approve the ingredients in dietary supplements either.
"Unless it's a prescription drug, your dietary supplement is not FDA approved," Meyer said. "It's not a gray area."
Miller maintains that the supplement industry is indeed regulated but that the FDA doesn't require manufacturers to run each new product through its system like it would with a pharmaceutical drug.
"They just rely on the fact that these ingredients are already sort of pre-approved, and then they let the industry mix and match the ingredients however they want," he said.
When I asked specifically about whether the FDA had approved GodMode as it was being advertised, Meyer said no dietary supplement can make such a claim.
"They are certainly not allowed to say that," she said.
Miller said the way the supplement industry sees it, the FDA banning and allowing certain supplements is an indication of what's "approved" or considered safe by the administration. He added that the FDA's response to GodMode's labeling is an indication of the agency's opposition to the overall industry.
"It doesn't surprise me that anything coming from the FDA is going to be negative towards the supplement industry," he said.
After follow-up interviews for this story, a Boss Level Labs spokeswoman told me that Miller plans to change GodMode's label to say "FDA regulated" instead of "FDA approved," which he said would conform to the FDA's standards.
In response, an FDA representative said: "Companies and individuals who manufacture or market supplements are responsible for ensuring that their products are safe and properly labeled. Labeling cannot be false or misleading, and the FDA makes determinations on a case-by-case basis after careful analysis of the labeling in full context."
Alpha Brain didn't respond to multiple requests for comment.
Qualia spokesman Darrell Grable said the "exhaustive research that went into formulating" the supplement is what separates it from many others. That research includes examining the effects of individual ingredients and how they interact with one another to affect the brain, according to Qualia. Though the company lists research about the efficacy of individual ingredients on its site, it hasn't produced any peer-reviewed research backing the product altogether.
In October, Qualia shared the results of a pilot study that showed improved cognitive performance after use of the supplement. However, that study didn't follow conventional research rules that prescription drug makers must follow. It was not a double-blind study or did not include a control group.
Qualia President James Schmachtenberger said the study wasn't intended to provide statistically significant data, but rather was designed to guide the nature of a traditional, placebo-controlled clinical trial the company plans to conduct with a third party early this year. "We want to be able to provide the sort of clarity and peace of mind that a broader audience would usually look for," he said.
Another product called Mod ($30) advertises a lot of the same gaming benefits as GodMode: Just pop two capsules and you'll have "laser-like focus," "increased mental clarity," "faster reflexes," "supercharged energy" and "superior brain power," according to Mod.
Mod didn't respond to multiple requests for comment.
Unfortunately, research has shown that many dietary supplements are not only ineffective, but also potentially dangerous.
Questionable tonics became popular back in the late 19th century. Then referred to as "patent medicines" and later as "snake oil," they promised to cure ailments such as tuberculosis, indigestion and even cancer. But the ingredients in most of these "medicines" were merely vegetable extracts and a lot of alcohol, according to the Hagley Museum and Library. Some even had morphine, opium or cocaine in them. The Pure Food and Drug Act of 1906 helped weed out drugs with unsafe ingredients and misleading advertising, but there's still no federal system for reviewing the safety of dietary supplements before they go to market. That's left up to the manufacturers and distributors of a product.
More than 20,000 emergency room visits a year are related to dietary supplements, according to a study in the New England Journal of Medicine. Another study in the Journal of the American Medical Association found that the 237 supplements recalled by the FDA between 2004 and 2012 contained unapproved drug ingredients.
GodMode and Qualia said none of their customers has gone to the ER as a result of taking their products.
In November, a study commissioned by startup Hvmn to demonstrate the effectiveness of its so-called cognitive enhancer Sprint backfired. The company's goal was to prove that the supplement was more effective than caffeine, but CNBC reported the study instead found that in many ways, Sprint was less effective than a cup of coffee. Hvmn CEO Geoffrey Woo told CNBC that he doubted the validity of the study because the result wasn't consistent with previous studies showing caffeine had more effects than a placebo.
Candy Tsourounis, professor of clinical pharmacy at the University of California, San Francisco, said it's not likely that an over-the-counter supplement can carry out the functions that GodMode and other brain supplements claim to offer.
"I just don't see these supplements as being the cure-all," Tsourounis said.
Tsourounis said she doesn't encourage use of GodMode and is uncomfortable recommending a product with so much caffeine. (Two GodMode capsules, the recommended dosage, have 75 mg of caffeine, while a cup of coffee has between 95 mg and 165 mg of caffeine.)
When someone drinks a cup of coffee, however, they're drinking it over a longer period of time, so the release of caffeine is a lot slower, Tsourounis said.
With a supplement like GodMode, caffeine is released in the body all at once. That can trigger heart palpitations, headaches, the shakes or nervousness for some people, Tsourounis added.
Miller maintains that the caffeine levels in GodMode aren't high but said that the company plans to release a caffeine-free version of the supplement later this year for people who'd rather avoid it.
GodMode lists supporting studies under each ingredient on its website. But something to keep in mind is that studies use different methods to measure cognitive improvement. In addition, Tsourounis said, studies for supplement ingredients often use too few people or take place over too little time to be conclusive.
By comparison, when a new herb is discovered for use in prescription drugs, she said, there are studies to figure out the best dosage. That kind of work isn't required in the supplement industry. As a result, even if an ingredient might actually be effective, it's unknown whether a product is using the right amount to create the desired effect.
"There's so many unknowns," Tsourounis said.
That doesn't mean people aren't willing to take a gamble on a product that promises to boost focus, reaction speed or cognitive abilities.
Dennis Delgado, a computer programmer in San Leandro, California, who GodMode also put me in touch with, has swapped out morning coffee in favor of two GodMode capsules before he starts his day. About 20 minutes in, he said he's more focused and his productivity is increased.
"I was using it for gaming-related things, but then I started seeing benefits overlapping to concentration for programming," said Delgado, who is 26.
Unlike with coffee, he added, he doesn't experience a crash after the effects wear off. He also hasn't had any strange side effects.
"I haven't grown a weird appendix yet," he joked.
If that's enough of a sell to get you to buy a bottle of GodMode, be our guest. But steer clear if you're under 18 or are pregnant or nursing, the company said. And don't take it with caffeine or other stimulants.
Even invincibility has its limits.
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