True Focus offers several very positive elements. The ingredients are excellent quality and all natural and without side effects. We like the fact they offer a product that is both vegan and vegetarian friendly, as well as being gluten, soy and dairy free. This allows many consumers to experience the benefits of this product. The fact they do not offer a clear money-back guarantee, we felt, placed them in a weaker position. Moreover, the lack of multi-purchase price deals left us feeling that this was slightly expensive, as with no options to reduce the cost per bottle, consumers will be stuck paying slightly more for each bottle.

Forums including reddit.com/r/Nootropics/ have more than 140,000 subscribers discussing products with names like Orange Brainwash and GodMode. Nootropics are blends of ingredients touted as a low-risk way to enhance learning, memory, motivation, and even serenity. These ingredients range from herbs such as water hyssop (Bacopa monnieri) and arctic root to chemicals such as vinpocetine.
If you are in or are able to come to London, you may be interested in also coming to a one day workshop we are hosting with Patrick Holford, our founder and one the UK’s leading nutritional therapists. We are excited to be running this workshop, which enables our supporters to access Patrick’s wealth of knowledge on nutrition and mental health. More details can be found below. If you are outside of the UK and are interested in this workshop or learning more about nutrition and mental health, please sign up for news on our Seminar series here. 
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Jump up ^ EFSA Panel on Dietetic Products, Nutrition and Allergies; European Food Safety Authority (EFSA), Parma, Italy (2011). "Scientific Opinion on the substantiation of health claims related to L-theanine from Camellia sinensis (L.) Kuntze (tea) and improvement of cognitive function (ID 1104, 1222, 1600, 1601, 1707, 1935, 2004, 2005), alleviation of psychological stress (ID 1598, 1601), maintenance of normal sleep (ID 1222, 1737, 2004) and reduction of menstrual discomfort (ID 1599) pursuant to Article 13(1) of Regulation (EC) No 1924/2006". EFSA Journal. 9 (6): 2238. doi:10.2903/j.efsa.2011.2238.
So with these 8 results in hand, what do I think? Roughly, I was right 5 of the days and wrong 3 of them. If not for the sleep effect on #4, which is - in a way - cheating (one hopes to detect modafinil due to good effects), the ratio would be 5:4 which is awfully close to a coin-flip. Indeed, a scoring rule ranks my performance at almost identical to a coin flip: -5.49 vs -5.5420. (The bright side is that I didn’t do worse than a coin flip: I was at least calibrated.)
Mosconi uses a pragmatic approach to improve your diet for brain health. The book is divided in three parts. The first one provides information regarding the brain nutritional requirement. The second one teaches you how to eat better. And, the third part tests you to find out where you are in terms of feeding yourself well. This includes an 80 question test that grades you as either Beginner/Intermediate/Advanced. “Beginner” entails you have little food awareness. You eat a lot of processed food. “Advanced” entails you eat very healthily, mainly organic foods. And, “Intermediate” falls in between.

There’s been a lot of talk about the ketogenic diet recently—proponents say that minimizing the carbohydrates you eat and ingesting lots of fat can train your body to burn fat more effectively. It’s meant to help you both lose weight and keep your energy levels constant. The diet was first studied and used in patients with epilepsy, who suffered fewer seizures when their bodies were in a state of ketosis. Because seizures originate in the brain, this discovery showed researchers that a ketogenic diet can definitely affect the way the brain works. Brain hackers naturally started experimenting with diets to enhance their cognitive abilities, and now a company called HVMN even sells ketone esters in a bottle; to achieve these compounds naturally, you’d have to avoid bread and cake. Here are 6 ways exercise makes your brain better.

Our top recommendation for cognitive energy enhancement is Brainol. This product is formulated from all natural ingredients. Brainol is a product that works internally. This herbal blend contains 19 key ingredients such as Huperzine A, L-Tyrosine, L-Theanine, St. John’s Wort, Phosphatidylserine, Bacopa Monnieri and Guarana, to name but a few. There are no unwanted side effects from these all natural ingredients.
Research does not support that drugs like Ritalin help students do well in school. Studies show that prescription stimulants do not help to improve learning or thinking in those who do not actually have ADHD. Further, research reveals that students who abuse prescription stimulants have lower GPAs than students who do not abuse the drugs.[14] Although Ritalin improves concentration, this effect is largely misunderstood among non-prescribed users. These illicit users mistakenly believe that they can use a drug out of its prescribed context, thinking they can reap the benefits intended for legitimate users.
The experiment then is straightforward: cut up a fresh piece of gum, randomly select from it and an equivalent dry piece of gum, and do 5 rounds of dual n-back to test attention/energy & WM. (If it turns out to be placebo, I’ll immediately use the remaining active dose: no sense in wasting gum, and this will test whether nigh-daily use renders nicotine gum useless, similar to how caffeine may be useless if taken daily. If there’s 3 pieces of active gum left, then I wrap it very tightly in Saran wrap which is sticky and air-tight.) The dose will be 1mg or 1/4 a gum. I cut up a dozen pieces into 4 pieces for 48 doses and set them out to dry. Per the previous power analyses, 48 groups of DNB rounds likely will be enough for detecting small-medium effects (partly since we will be only looking at one metric - average % right per 5 rounds - with no need for multiple correction). Analysis will be one-tailed, since we’re looking for whether there is a clear performance improvement and hence a reason to keep using nicotine gum (rather than whether nicotine gum might be harmful).
Take the synthetic nootropic piracetam, for example. Since piracetam has been shown to improve cell membrane function and cause a host of neuroprotective effects, when combined with other cell membrane stabilizing supplements such as choline and DHA, the brain cells on piracetam can better signal and relay messages to each other for a longer period of time, which improves cognition and brain activity and decreases risk of a crash. So one example of an intelligent “stack” is piracetam taken with choline and DHA.
A third of participants in clinical trials on Modafinil have reported crippling headaches.  An additional 11% experienced nausea, while others reported an array of other side-effects ranging from nervousness to diarrhea.  Dizziness and insomnia may also result from Modafinil use.   I can attest that the side effects are very real.  In fact, I had to stop using Modafinil after 2 days when my headaches became so intense I ended up at the ER.
For example, a study published in the journal Psychopharmacology in 2000 found that ginkgo improved attention. A 2001 study in the journal Human Psychopharmacology suggested that it improves memory. Nevertheless, in a review of studies on ginkgo in healthy people, researchers found no good evidence that it improved mental abilities, according to a 2002 report in Psychopharmacology Bulletin.
(We already saw that too much iodine could poison both adults and children, and of course too little does not help much - iodine would seem to follow a U-curve like most supplements.) The listed doses at iherb.com often are ridiculously large: 10-50mg! These are doses that seems to actually be dangerous for long-term consumption, and I believe these are doses that are designed to completely suffocate the thyroid gland and prevent it from absorbing any more iodine - which is useful as a short-term radioactive fallout prophylactic, but quite useless from a supplementation standpoint. Fortunately, there are available doses at Fitzgerald 2012’s exact dose, which is roughly the daily RDA: 0.15mg. Even the contrarian materials seem to focus on a modest doubling or tripling of the existing RDA, so the range seems relatively narrow. I’m fairly confident I won’t overshoot if I go with 0.15-1mg, so let’s call this 90%.
The Blood Brain Barrier (BBB) is similar in structure to the intestinal barrier (6) and is usually highly selective, allowing certain required metabolic products such as short chain fatty acids and amino acids to pass into the brain from our wider circulation but protecting the brain from potentially damaging components. When the BBB is compromised, unwanted translocation may occur such as allowing a bacterial invasion, which can alter the function of immune cells that are responsible for regulating inflammation. Chronic inflammation is associated with many mental and physical health problems, so it is therefore suggested that poor gut health can have a direct correlation to poor mental wellbeing, as a result of a compromised intestinal barrier and the negative impact this has on our brain’s own structural barrier (BBB) and resulting inflammation.
The fish oil can be considered a free sunk cost: I would take it in the absence of an experiment. The empty pill capsules could be used for something else, so we’ll put the 500 at $5. Filling 500 capsules with fish and olive oil will be messy and take an hour. Taking them regularly can be added to my habitual morning routine for vitamin D and the lithium experiment, so that is close to free but we’ll call it an hour over the 250 days. Recording mood/productivity is also free a sunk cost as it’s necessary for the other experiments; but recording dual n-back scores is more expensive: each round is ~2 minutes and one wants >=5, so each block will cost >10 minutes, so 18 tests will be >180 minutes or >3 hours. So >5 hours. Total: 5 + (>5 \times 7.25) = >41.
Even party drugs are going to work: Biohackers are taking recreational drugs like LSD, psilocybin mushrooms, and mescaline in microdoses—about a tenth of what constitutes a typical dose—with the goal of becoming more focused and creative. Many who’ve tried it report positive results, but real research on the practice—and its safety—is a long way off. “Whether microdosing with LSD improves creativity and cognition remains to be determined in an objective experiment using double-blind, placebo-controlled methodology,” Sahakian says.
Nootropics—the name given to a broad class of so-called "cognitive-enhancing" drugs—are all the rage in Silicon Valley these days. Programmers like nootropics because they’re said to increase productivity and sharpen focus without the intensity or side effects of a prescription drug like Adderall or modafinil. Some users mix their own nootropics using big bins of powders, purchased off the Internet or in supplement stores. And some take pre-made "stacks" that are designed to produce specific effects.
Since Racetams result in increased uptake and demand for acetylcholine, stacking choline with this nootropic will further enhance your results. Studies have shown that choline supplementation can improve performance on memory tests as well as social behavior. Choline also plays a key role in the production of phospholipids that are incorporated into brain cell membranes.
At this point, I began thinking about what I was doing. Black-market Adderall is fairly expensive; $4-10 a pill vs prescription prices which run more like $60 for 120 20mg pills. It would be a bad idea to become a fan without being quite sure that it is delivering bang for the buck. Now, why the piracetam mix as the placebo as opposed to my other available powder, creatine powder, which has much smaller mental effects? Because the question for me is not whether the Adderall works (I am quite sure that the amphetamines have effects!) but whether it works better for me than my cheap legal standbys (piracetam & caffeine)? (Does Adderall have marginal advantage for me?) Hence, I want to know whether Adderall is better than my piracetam mix. People frequently underestimate the power of placebo effects, so it’s worth testing. (Unfortunately, it seems that there is experimental evidence that people on Adderall know they are on Adderall and also believe they have improved performance, when they do not5. So the blind testing does not buy me as much as it could.)
I was contacted by the Longecity user lostfalco, and read through some of his writings on the topic. I had never heard of LLLT before, but the mitochondria mechanism didn’t sound impossible (although I wondered whether it made sense at a quantity level14151617), and there was at least some research backing it; more importantly, lostfalco had discovered that devices for LLLT could be obtained as cheap as $15. (Clearly no one will be getting rich off LLLT or affiliate revenue any time soon.) Nor could I think of any way the LLLT could be easily harmful: there were no drugs involved, physical contact was unnecessary, power output was too low to directly damage through heating, and if it had no LLLT-style effect but some sort of circadian effect through hitting photoreceptors, using it in the morning wouldn’t seem to interfere with sleep.
One fairly powerful nootropic substance that, appropriately, has fallen out of favor is nicotine. It’s the chemical that gives tobacco products their stimulating kick. It isn’t what makes them so deadly, but it does make smoking very addictive. When Europeans learned about tobacco’s use from indigenous tribes they encountered in the Americas in the 15th and 16th centuries, they got hooked on its mood-altering effects right away and even believed it could cure joint pain, epilepsy, and the plague. Recently, researchers have been testing the effects of nicotine that’s been removed from tobacco, and they believe that it might help treat neurological disorders including Parkinson’s disease and schizophrenia; it may also improve attention and focus. But, please, don’t start smoking or vaping. Check out these 14 weird brain exercises that make you smarter.
Brain Awake is produced by Irwin Naturals. The ingredients are natural and include some key ingredients. However, it also contained several other inactive ingredients that raised some concerns - namely, beeswax and silicone dioxide. We were not sure why these ingredients are included, and could not find any real explanation as to why they are contained within this product. That said, when we tested the ingredients in this product, they were as reported on the bottle.
I have a needle phobia, so injections are right out; but from the images I have found, it looks like testosterone enanthate gels using DMSO resemble other gels like Vaseline. This suggests an easy experimental procedure: spoon an appropriate dose of testosterone gel into one opaque jar, spoon some Vaseline gel into another, and pick one randomly to apply while not looking. If one gel evaporates but the other doesn’t, or they have some other difference in behavior, the procedure can be expanded to something like and then half an hour later, take a shower to remove all visible traces of the gel. Testosterone itself has a fairly short half-life of 2-4 hours, but the gel or effects might linger. (Injections apparently operate on a time-scale of weeks; I’m not clear on whether this is because the oil takes that long to be absorbed by surrounding materials or something else.) Experimental design will depend on the specifics of the obtained substance. As a controlled substance (Schedule III in the US), supplies will be hard to obtain; I may have to resort to the Silk Road.
He used to get his edge from Adderall, but after moving from New Jersey to San Francisco, he says, he couldn’t find a doctor who would write him a prescription. Driven to the Internet, he discovered a world of cognition-enhancing drugs known as nootropics — some prescription, some over-the-counter, others available on a worldwide gray market of private sellers — said to improve memory, attention, creativity and motivation.

“We didn’t see significant long-term effects from the dosage used,” said Wen-Jun Gao, a professor of neurobiology at the Drexel University College of Medicine, and one of the authors of the study. He added that the brain doesn’t fully stop developing until age 25 or 30, making cognitive enhancement potentially risky even for users who are well into adulthood.
When it comes to brain power, greens should be on your plate (and cover a lot of that plate) every meal. “Leafy greens are a great base. You swap out a lot of the empty carbohydrates you get from things like pastas or breads, and you can use some leafy greens,” says Psychiatrist Drew Ramsey, MD, author of The Happiness Diet and Eat Complete: The 21 Nutrients That Fuel Brainpower, Boost Weight Loss, and Transform Your Health. “Again, just lots of nutrient density.”
My worry about the MP variable is that, plausible or not, it does seem relatively weak against manipulation; other variables I could look at, like arbtt window-tracking of how I spend my computer time, # or size of edits to my files, or spaced repetition performance, would be harder to manipulate. If it’s all due to MP, then if I remove the MP and LLLT variables, and summarize all the other variables with factor analysis into 2 or 3 variables, then I should see no increases in them when I put LLLT back in and look for a correlation between the factors & LLLT with a multivariate regression.
How exactly – and if – nootropics work varies widely. Some may work, for example, by strengthening certain brain pathways for neurotransmitters like dopamine, which is involved in motivation, Barbour says. Others aim to boost blood flow – and therefore funnel nutrients – to the brain to support cell growth and regeneration. Others protect brain cells and connections from inflammation, which is believed to be a factor in conditions like Alzheimer's, Barbour explains. Still others boost metabolism or pack in vitamins that may help protect the brain and the rest of the nervous system, explains Dr. Anna Hohler, an associate professor of neurology at Boston University School of Medicine and a fellow of the American Academy of Neurology.
However, as a result of the efficacy of this type of stacking, the supplement world is saturated with brain-boosting blends, and it can be difficult to cut through the confusion and figure out what really works and what could be a waste of time and money, or downright dangerous. The fact is, when creating your own stack, you must carefully think about your specific needs and goals. For example, if you want to reduce anxiety and depression, but don’t necessarily care to enhance your cognitive performance or get through a day of work in a sleep-deprived state, you could just stick to a single nootropic that increases dopamine levels, such as Mucuna pruriens or tryptophan. Or if you wanted to reduce anxiety and depression while simultaneously improving your memory because you’re studying for a school or work exam, you could add Bacopa monnieri to the mucuna or tryptophan. Then, let’s say you want long-term cognitive performance to the mix that lasts an entire day: in this case, you’d add a racetam, and to avoid an end of day crash, a touch of choline or DHA. It’s a bit like cooking in the kitchen, isn’t it?
You have probably heard and you already love the term “soul food.” You should know that there’s “brain food” too. Natural supplements are the best way to express your gratitude for all the hard work your brain does for you around the clock. These products aren’t reserved only for the elderly users. On the contrary, if you start using them while you’re still young and sharp, you can ensure the proper protection against all those age-related mental deterioration processes.
As with any thesis, there are exceptions to this general practice. For example, theanine for dogs is sold under the brand Anxitane is sold at almost a dollar a pill, and apparently a month’s supply costs $50+ vs $13 for human-branded theanine; on the other hand, this thesis predicts downgrading if the market priced pet versions higher than human versions, and that Reddit poster appears to be doing just that with her dog.↩

All of the coefficients are positive, as one would hope, and one specific factor (MR7) squeaks in at d=0.34 (p=0.05). The graph is much less impressive than the graph for just MP, suggesting that the correlation may be spread out over a lot of factors, the current dataset isn’t doing a good job of capturing the effect compared to the MP self-rating, or it really was a placebo effect:

[…] 2. Blueberries: Also called “brainberries” by Dr. Steven Platt, MD author of Superfoods Rx: Fourteen Foods Proven to Change Your Life, blueberries have one of the highest antioxidant capacities of all fruits and vegetables and are known to improve memory and cognitive function. They have memory-protecting properties and have even been associated with the prevention of Alzheimer’s disease. Add some blueberries to your breakfast and you may not need to check that to-do list several times throughout the day. Also Read The 7 Best Brain Boosting Supplements […]
Coconut oil was recommended by Pontus Granström on the Dual N-Back mailing list for boosting energy & mental clarity. It is fairly cheap (~$13 for 30 ounces) and tastes surprisingly good; it has a very bad reputation in some parts, but seems to be in the middle of a rehabilitation. Seth Robert’s Buttermind experiment found no mental benefits to coconut oil (and benefits to eating butter), but I wonder.
Recent findings also suggest that taking extra vitamins could help preserve memory, especially as we age. Researchers at Australia's University of Sydney tested 117 people in a retirement home by putting them through a battery of mental tests that included remembering a string of words, listing as many words as possible that begin with a certain letter of the alphabet, and doing mental addition and subtraction. Those who regularly took vitamin C, they found, scored higher on the tests.

i chose to Omega 3 (GNLD) for my brain cells and coffee and tomato sauce as my antioxidants since they are cheap out here. organic fruits and veges are also cheap out here to fruits for 3$ can take me 7days! Its a matter of choice where you live but do exercise too! i have a selction of gym staff; dumb bells, a bench, skip rope for convenience within my room, work out 45min three times a week. I have developed great memory and processing speed and find the medicine/surgery course real fun
That really says it all: there’s an initial spike in MP, which reads like the promised stimulative effects possibly due to fixing a deficiency (a spike which doesn’t seem to have any counterparts in the previous history of MP), followed by a drastic plunge in the magnesium days but not so much the control days (indicating an acute effect when overloaded with magnesium), a partial recovery during the non-experimental Christmas break, another plunge, and finally recovery after the experiment has ended.
Of course learning, working memory and cognitive control represent just a few aspects of thinking. Farah concluded that studies looking at other kinds of cognition - verbal fluency, for instance - were too few and too contradictory to tell us much. Both Chatterjee and Farah have wondered whether drugs that heighten users' focus might dampen their creativity. After all, some of our best ideas come to us not when we sit down at a desk but rather when we're in the shower or walking the dog - letting our minds roam. Jimi Hendrix reported that the inspiration for "Purple Haze" came to him in a dream; the chemist Friedrich August Kekule claimed that he discovered the ring structure of benzene during a reverie in which he saw the image of a snake biting its tail. Farah told me: "There is some evidence that suggests that individuals who are better able to focus on one thing and filter out distractions tend to be less creative.
My general impression is positive; it does seem to help with endurance and extended the effect of piracetam+choline, but is not as effective as that combo. At $20 for 30g (bought from Smart Powders), I’m not sure it’s worthwhile, but I think at $10-15 it would probably be worthwhile. Sulbutiamine seems to affect my sleep negatively, like caffeine. I bought 2 or 3 canisters for my third batch of pills along with the theanine. For a few nights in a row, I slept terribly and stayed awake thinking until the wee hours of the morning; eventually I realized it was because I was taking the theanine pills along with the sleep-mix pills, and the only ingredient that was a stimulant in the batch was - sulbutiamine. I cut out the theanine pills at night, and my sleep went back to normal. (While very annoying, this, like the creatine & taekwondo example, does tend to prove to me that sulbutiamine was doing something and it is not pure placebo effect.)
The drug methylphenidate is marketed as the brand Ritalin and used to treat children and adults with ADHD. As of 2011, according to the U.S. Centers for Disease Control and Prevention, 11 percent of Americans aged 4-17 were diagnosed with ADHD.[13] The high number of people diagnosed with ADHD means that there is a vast amount of prescription drugs to treat this condition in medicine cabinets across the US. Ultimately, some of these drugs get diverted into the hands of non-prescribed users, such as college students who believe they may be able to improve their studying and performance on exams by taking these drugs.
“Most people assume that because it’s a supplement, it can’t be bad for you because it’s natural,” says Louis Kraus, M.D., a psychiatrist with Rush University Medical Center in Chicago. In 2016, he chaired a committee that investigated nootropics for the American Medical Association. After reviewing the science, the committee found little to no evidence to support the efficacy or safety of nootropics.

Maca root has been used by indigenous people groups in South America for thousands of years. It’s part of the mustard family found primarily in Andean regions and some of its primary uses include improving sexual function, memory and learning as well as reducing the effects of osteoporosis. The standard effective dose ranges from 1,500 to 3,000 mg.
All health content on bbcgoodfood.com is provided for general information only, and should not be treated as a substitute for the medical advice of your own doctor or any other health care professional. If you have any concerns about your general health, you should contact  your local health care provider. See our website terms and conditions for more information.
By analyzing the brain images, the team found that these patients, compared with people who weren’t susceptible to the placebo, had a difference in volume between the right and left sides of the limbic system in the brain, which is involved in instinct and mood. There were also differences in the number of nerve cell connections between the prefrontal cortex and other brain areas. Personality questionnaires revealed that these people had a higher self-awareness and openness than nonresponders.
Still, putting unregulated brain drugs into my system feels significantly scarier than downing a latte or a Red Bull—not least because the scientific research on nootropics’ long-term effects is still so thin. One 2014 study found that Ritalin, modafinil, ampakines, and other similar stimulants could eventually reduce the “plasticity” of some of the brain’s neural networks by providing them with too much dopamine, glutamate and norepinephrine, and potentially cause long-term harm in young people whose brains were still developing. (In fact, in young people, the researchers wrote, these stimulants could actually have the opposite effect the makers intended: “Healthy individuals run the risk of pushing themselves beyond optimal levels into hyperdopaminergic and hypernoradrenergic states, thus vitiating the very behaviors they are striving to improve.”) But the researchers found no evidence that normal doses of these drugs were harmful when taken by adults.
Last spring, 100 people showed up at a Peak Performance event where psychedelic psychologist James Fadiman said the key to unleashing the cognition-enhancing effects of LSD — which he listed as less anxiety, better focus, improved sleep, greater creativity — was all in the dosage. He recommended a tenth of a “party dose” — enough to give you “the glow” and enhance your cognitive powers without “the trip.”

Takao Hensch, a Harvard professor of cellular biology and part of a Boston Children’s Hospital team, found that the drug encouraged the brain to learn new skills as quickly as the sponge-like brain of an infant in her patient Shannon, an otherwise normal 14-year-old girl who suffers from extremely poor eyesight brought on by amblyopia, commonly known as lazy eye. In a matter of months, the drug helped Shannon’s brain relearn how to use her eye which resulted in markedly improved vision.
As mentioned above, eating foods that are rich in indigestible fibre such as vegetables and fruits, as well as eating good fats that are found in grass-fed butter, nuts and seeds, olive oil, coconut oil and avocado, provide bacteria with prebiotics that help to produce the ‘friendly’ short-chain fatty acids such as butyrate. Avoiding processed foods that contain calcium propionate, which lead to higher levels of propionic acid - the not so friendly short-chain fatty acid - is also another key strategy to support the gut-brain link.
Chocolate or cocoa powder (Examine.com), contains the stimulants caffeine and the caffeine metabolite theobromine, so it’s not necessarily surprising if cocoa powder was a weak stimulant. It’s also a witch’s brew of chemicals such as polyphenols and flavonoids some of which have been fingered as helpful10, which all adds up to an unclear impact on health (once you control for eating a lot of sugar).
According to the US Food and Drug Administration, "Piracetam is not a vitamin, mineral, amino acid, herb or other botanical, or dietary substance for use by man to supplement the diet by increasing the total dietary intake. Further, piracetam is not a concentrate, metabolite, constituent, extract or combination of any such dietary ingredient. [...] Accordingly, these products are drugs, under section 201(g)(1)(C) of the Act, 21 U.S.C. § 321(g)(1)(C), because they are not foods and they are intended to affect the structure or any function of the body. Moreover, these products are new drugs as defined by section 201(p) of the Act, 21 U.S.C. § 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling."[33]
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