From the standpoint of absorption, the drinking of tobacco juice and the interaction of the infusion or concoction with the small intestine is a highly effective method of gastrointestinal nicotine administration. The epithelial area of the intestines is incomparably larger than the mucosa of the upper tract including the stomach, and the small intestine represents the area with the greatest capacity for absorption (Levine 1983:81-83). As practiced by most of the sixty-four tribes documented here, intoxicated states are achieved by drinking tobacco juice through the mouth and/or nose…The large intestine, although functionally little equipped for absorption, nevertheless absorbs nicotine that may have passed through the small intestine.
These brain enhancers allow users to go without sleep for extended periods of time. But in the long-term, insomnia is a hazardous side effect, not a so-called benefit. Lack of sleep is extremely detrimental to your brain health and function. It’s during sleep that your brain consolidates memories, cleans away toxins, repairs itself, and creates new brain cells. (52, 53, 54, 55)
Not that everyone likes to talk about using the drugs. People don’t necessarily want to reveal how they get their edge and there is stigma around people trying to become smarter than their biology dictates, says Lawler. Another factor is undoubtedly the risks associated with ingesting substances bought on the internet and the confusing legal statuses of some. Phenylpiracetam, for example, is a prescription drug in Russia. It isn’t illegal to buy in the US, but the man-made chemical exists in a no man’s land where it is neither approved nor outlawed for human consumption, notes Lawler.
And yet when enthusiasts share their vision of our neuroenhanced future it can sound dystopian. Zack Lynch, of NeuroInsights, gave me a rationale for smart pills that I found particularly grim. "If you're a 55-year-old in Boston, you have to compete with a 26-year-old from Mumbai now, and those kinds of pressures are only going to grow," he began. Countries other than the US might tend to be a little looser with their regulations and offer approval of new cognitive enhancers first. "And if you're a company that's got 47 offices worldwide, and all of a sudden your Singapore office is using cognitive enablers, and you're saying to Congress: 'I'm moving all my financial operations to Singapore and Taiwan, because it's legal to use those there', you bet that Congress is going to say: 'Well, OK.' It will be a moot question then.
With so many different ones to choose from, choosing the best nootropics for you can be overwhelming at times. As usual, a decision this important will require research. Study up on the top nootropics which catch your eye the most. The nootropics you take will depend on what you want the enhancement for. The ingredients within each nootropic determine its specific function. For example, some nootropics contain ginkgo biloba, which can help memory, thinking speed, and increase attention span. Check the nootropic ingredients as you determine what end results you want to see.
I’ve tried a few different ways of taking my nootropics—in the morning, in the afternoon, in addition to coffee, as a replacement for coffee—and so far, the effects I'm feeling are much more subtle than I expected. There’s no sweaty-palmed intensity, no eight-hour uninterruptible work sprints, and none of the hyperactivity you’d associate with a caffeine high. It’s just a sensation of being a little amped up, and of being slightly less distracted than normal.
Real extra virgin olive oil is truly a brain food. Thanks to the powerful antioxidants known as polyphenols that are found in the oil, including EVOO in your diet may not only improve learning and memory, but also reverse the age- and disease-related changes. (7) The oil also helps fight against ADDLs, proteins that are toxic to the brain and induce Alzheimer’s. (8)
Methylfolate and methyl B12 work together to control methylation reactions that repair your DNA and regenerate brain cells. The methylated forms are particularly important brain food — you have about three times as much methylfolate in your cerebrospinal fluid (the fluid around your brain and spine) as you do in your blood, where it’s working tirelessly to maintain your nerve connections and repair DNA mutations. Folate and B12 are particularly important for brain anti-aging.
[…] The 7 Best Brain Boosting Supplements | Live in the Now … – Indeed the right type of brain food can help our brains overcome any potential damaging … Know about the Foods and Supplements for Good Brain Health | Health Way … […] medicines, dietary supplements and organic food products. Justin has also been writing on best brain supplements for … […]
I have lots of problems with procrastination and productivity, most likely due to a mild case of ADHD, and recently it's been getting worse and worse. I was a bit hesitant to take Addium at first because I, like most people, had heard about it as a tool for students to use for cramming and it's results sound a little bit like the results of taking Adderall recreationally, which isn't my cup of tea. I was also hesitant to try it because it's marketing just makes it seem like it's a scam pill, and I unfortunately take quality of advertising rather seriously. I changed my mind (after another particularly trying week at work) after a friend of mine actually recommended it for me and told me that she was having great results from it. In my mind, I figured that if a real person,someone I know and trust, tells me in real life that I should maybe try it...then I may as well give it a shot. I ordered the Addium and as soon as I got it, I started taking it immediately. The Addium actually works. I can't believe it. It's helped a lot with my productivity at work. I'm taking just one tablet per day and it seems to be doing the trick. I think the best part about it is that it's not something that you have to continuously take every day.
-Phosphatidylserine, which occurs naturally in high concentrations in the brain and has been shown to lower stress, cortisol and physical fatigue, improve attention-deficit and forgetfulness and increase mental processing and memory. Research indicates an effective dose of 100 mg three times daily, but anything over that may lead to adverse side effects like insomnia.
As a general class, nootropics are not usually addiction-forming. Two of the strongest hallmarks of addiction-forming drugs is that they cause users to develop dependency and experience withdrawal when the drug use is eliminated or reduced. While there are some reports of nootropic users experiencing brain fog after use is discontinued, these side effects are not considered to be akin to withdrawal effects of addiction-forming drugs.
A record of nootropics I have tried, with thoughts about which ones worked and did not work for me. These anecdotes should be considered only as anecdotes, and one’s efforts with nootropics a hobby to put only limited amounts of time into due to the inherent limits of drugs as a force-multiplier compared to other things like programming1; for an ironic counterpoint, I suggest the reader listen to a video of Jonathan Coulton’s I Feel Fantastic while reading.
We felt that True Focus offered a good product but the price was slightly high compared to others. Their website doesn’t show a clear money-back guarantee though, which definitely reduced their rating. We found that their customer reviews were mixed and saw that some consumers did not mind paying a little more for a product that is more consumer friendly.
Obviously, as you can see, there are a host of benefits to the better living through science to be had through optimizing your brain with specific compounds. So, putting aside the intriguing topic of psychedelics for the moment (yes, yes, I know you probably want to know how to microdose with LSD or psilocybin), what’s the difference between a smart drug and a nootropic, and how do you choose which to take? You’re about to find out.
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.
I have elsewhere remarked on the apparent lack of benefit to taking multivitamins and the possible harm; so one might well wonder about a specific vitamin like vitamin D. However, a multivitamin is not vitamin D, so it’s no surprise that they might do different things. If a multivitamin had no vitamin D in it, or if it had vitamin D in different doses, or if it had substances which interacted with vitamin D (such as calcium), or if it had substances which had negative effects which outweigh the positive (such as vitamin A?), we could well expect differing results. In this case, all of those are true to varying extents. Some multivitamins I’ve had contained no vitamin D. The last multivitamin I was taking both contains vitamins used in the negative trials and also some calcium; the listed vitamin D dosage was a trivial ~400IU, while I take >10x as much now (5000IU).
But there’s a surprising lack of skepticism in the room. That’s because this is a weekly meetup of amateur biohackers. In fact, positivity is one of their ground rules. Members share experiences with ketogenic diets, biofeedback apps, sensory-deprivation tanks, and, lately, a class of smart drugs known as “nootropics.” Their primary obsession is brain enhancement.
There are plenty of brain supplements on the market, but none with the same combinations of potent and promising ingredients. If you want to maximize your ability to excel – at everything you do – your brain must be firing on all cylinders – all day, every day. You must protect and preserve your brain function, as it will diminish – it’s the reality of being human.
Apkarian and colleagues imaged the brains of 68 participants and gave them personality tests. The researchers then randomly assigned the participants to groups that either received no treatment, sugar pills or a pain-killing drug. Those given pills were not told if they received a placebo or an active drug. Participants took the treatment for two weeks, stopped for one week and then repeated this cycle.
My impression after the first two days (2 doses of 400mg each, one with breakfast & then lunch) was positive. I did not have the rumored digestion problems, and the first day went excellently: I was up until 1:30AM working and even then didn’t feel like going to bed - and I probably should have since I then slept abominably, which made the second day merely a good day. The third day I took none and it was an ordinary day. This is consistent with what I expected from the LEF l-threonate & TruBrain glycinate/lycinate, and so it is worth investigating with a self-experiment.
Harriet Hall, MD also known as The SkepDoc, is a retired family physician who writes about pseudoscience and questionable medical practices. She received her BA and MD from the University of Washington, did her internship in the Air Force (the second female ever to do so), and was the first female graduate of the Air Force family practice residency at Eglin Air Force Base. During a long career as an Air Force physician, she held various positions from flight surgeon to DBMS (Director of Base Medical Services) and did everything from delivering babies to taking the controls of a B-52. She retired with the rank of Colonel. In 2008 she published her memoirs, Women Aren't Supposed to Fly.
Paul Phillips was unusual for a professional poker player. When he joined the circuit in the late 1990s he was already a millionaire: a twentysomething tech guy who helped found an internet portal called go2net and cashed in at the right moment. He was cerebral and at times brusque. On the international poker scene Phillips cultivated a geeky New Wave style. He wore vintage shirts in wild geometric patterns; his hair was dyed orange or silver one week, shaved off the next. Most unusual of all, Phillips talked freely about taking prescription drugs - Adderall and, especially, Provigil - in order to play better cards.
To our volunteers: We could not have asked for a more committed, creative, tireless group of voluneers. We hope you count yourself as fierce advocates who helped build a youth-positive city, because we always have. Thank you for giving Brainfood programs a place in your life and for bringing your energy and skills to our community. You took our spark and turned it into a fire, and we’re so grateful.
*Result may vary. If you are pregnant, nursing, have a serious medical condition, or have a history of heart conditions we suggest consulting with a physician before using any supplement. The information contained in this website is provided for general informational purposes only. It is not intended to diagnose, treat, cure, or prevent any disease and should not be relied upon as a medical advice. Always consult your doctor before using any supplements.
People charged with doing simple tasks did not exhibit much of an increase in brain function after taking Modafinil, but their performance on complex and difficult tasks after taking the drug was significantly better than those who were given a placebo. This suggests that it may affect “higher cognitive functions—mainly executive functions but also attention and learning,” explains study co-author Ruairidh Battleday.
These little chemicals prompt the immune system to kick in and fight back against the stress through inflammation, as though stress is an infection. While inflammation helps protect us against illnesses and repairs the body when you do something like cut yourself, chronic inflammation is a different animal. It’s been linked to autoimmune diseases like multiple sclerosis, anxiety, high blood pressure and more. (2)
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.”
I eventually met Seltzer in an underground food court not far from the Pentagon. He's slim, with a shaved head, and he spoke precisely, rarely stumbling over his words. I asked him if he had any ethical worries about smart drugs. After a pause, he said that he might have a concern if somebody popped a neuroenhancer before taking a licensing exam that certified him as, say, a brain surgeon, and then stopped using the drug. Other than that he couldn't see a problem. He said that he was a firm believer in the idea that "we should have a fair degree of liberty to do with our bodies and our minds as we see fit, so long as it doesn't impinge on the basic rights, liberty and safety of others". He argued: "Why would you want an upward limit on the intellectual capabilities of a human being? And, if you have a very nationalist viewpoint, why wouldn't you want our country to have the advantage over other countries, particularly in what some people call a knowledge-based economy?" He went on: "Think about the complexity of the intellectual tasks that people need to accomplish today. Just trying to understand what Congress is doing is not a simple thing! The complexity of understanding the gamut of scientific and technical and social issues is difficult. If we had a tool that enabled more people to understand the world at a greater level of sophistication, how can we prejudice ourselves against the notion simply because we don't like athletes to do it? To me it doesn't seem like the same question. And it deserves its own debate."
In my last post, I talked about the idea that there is a resource that is necessary for self-control…I want to talk a little bit about the candidate for this resource, glucose. Could willpower fail because the brain is low on sugar? Let’s look at the numbers. A well-known statistic is that the brain, while only 2% of body weight, consumes 20% of the body’s energy. That sounds like the brain consumes a lot of calories, but if we assume a 2,400 calorie/day diet - only to make the division really easy - that’s 100 calories per hour on average, 20 of which, then, are being used by the brain. Every three minutes, then, the brain - which includes memory systems, the visual system, working memory, then emotion systems, and so on - consumes one (1) calorie. One. Yes, the brain is a greedy organ, but it’s important to keep its greediness in perspective… Suppose, for instance, that a brain in a person exerting their willpower - resisting eating brownies or what have you - used twice as many calories as a person not exerting willpower. That person would need an extra one third of a calorie per minute to make up the difference compared to someone not exerting willpower. Does exerting self control burn more calories?
This product has very nice labeling - very easy to understand and the directions for taking it are immediately at the top of the label in the back. You only have to take or or two tablets a day (preferably with meals) so I 've been taking one a day with my noon meal. I'm a bit surprised that it seems already (after two weeks) that I'm remembering things better (my husband even remarked on it!). Normally, I rely on him for my memory about most things (that, and post-it notes) but I seem to be doing better since taking this supplement. My husband also noticed that I'm in a better mood (more playful and wanting to do things). It has definitely altered my mood - it is winter now where I live and because you don't get as much sunshine and every spare moment is taken up by shoveling, you can get a bit more down in the dumps, which I normally do every year.. It hasn't been like that this year and I feel this supplement has a lot to do with that. Thanks #Vitacern!!!!
And without those precious nutrients, your brain will start to wither. In a recent Bulletproof Radio podcast episode [iTunes], I talked with neuroscientist Dale Bredesen about why neurodegeneration happens. One of the three most common causes of brain aging is a lack of specific brain nutrients (check out the episode to hear about the other two main causes of brain aging, and what you can do about them).
Our current natural brain health formula contains Cordyceps-Sinensis Extract as well as the complete balance of brain health supporting nutrients that work perfectly together to help your body elevate essential acetylcholine levels while increasing the neurological components (neurotransmitters) needed to help you stay alert, focused, mentally driven and calm.
This doesn’t fit the U-curve so well: while 60mg is substantially negative as one would extrapolate from 30mg being ~0, 48mg is actually better than 15mg. But we bought the estimates of 48mg/60mg at a steep price - we ignore the influence of magnesium which we know influences the data a great deal. And the higher doses were added towards the end, so may be influenced by the magnesium starting/stopping. Another fix for the missingness is to impute the missing data. In this case, we might argue that the placebo days of the magnesium experiment were identical to taking no magnesium at all and so we can classify each NA as a placebo day, and rerun the desired analysis:
Brain Pill™ is a mental health enhancing and successfully marketed dietary supplement with a balanced composition of scientifically proven nutrients for accelerating and restoring brain function and thereby enhancing the cognitive performance and creating positive impact on behavioral outcomes.Hence the aim of the study is assessment of the effects of Brain Pill supplementation on memory performance in healthy adults with subjective memory complaints.
Your co-worker in the cubicle next to you could now very likely be achieving his or her hyperfocus via a touch of microdosed LSD, a hit of huperzine or a nicotine-infused arm patch. The fact is, concepts such as microdosing, along with words like “nootropic” and “smart drug” (yes, there’s a difference between the two, as you’re about to discover) are quickly becoming household terms, especially due to all the recent media hype that has disclosed how popular compounds such as smart drugs and psychedelics are among Silicon Valley CEOs and college students, along with the smart drug movies “Limitless” and “Lucy“ and popular TV shows like “Limitless”, “Wormwood” and “Hamilton’s Pharmacopeia”.
A Romanian psychologist and chemist named Corneliu Giurgea started using the word nootropic in the 1970s to refer to substances that improve brain function, but humans have always gravitated toward foods and chemicals that make us feel sharper, quicker, happier, and more content. Our brains use about 20 percent of our energy when our bodies are at rest (compared with 8 percent for apes), according to National Geographic, so our thinking ability is directly affected by the calories we’re taking in as well as by the nutrients in the foods we eat. Here are the nootropics we don’t even realize we’re using, and an expert take on how they work.
The NIDA research study focused on 10 healthy male participants. The men were subjected to two rounds of PET brain scans after consuming either Provigil (200 mg or 400 mg) or a placebo. The scans demonstrated that the Provigil users had an increase in the amount of dopamine in the brain. Dopamine is a key neurological messenger in the brain’s reward system. Cocaine and methamphetamine have a similar effect on the brain, but they are more potent and faster-acting than Provigil. As cocaine and amphetamines are addiction-forming, the reasoning here is that Provigil may also be addictive.
One of the other suggested benefits is for boosting serotonin levels; low levels of serotonin are implicated in a number of issues like depression. I’m not yet sure whether tryptophan has helped with motivation or happiness. Trial and error has taught me that it’s a bad idea to take tryptophan in the morning or afternoon, however, even smaller quantities like 0.25g. Like melatonin, the dose-response curve is a U: ~1g is great and induces multiple vivid dreams for me, but ~1.5g leads to an awful night and a headache the next day that was worse, if anything, than melatonin. (One morning I woke up with traces of at least 7 dreams, although I managed to write down only 2. No lucid dreams, though.)
So the chi-squared believes there is a statistically-significant difference, the two-sample test disagrees, and the binomial also disagrees. Since I regarded it as a dubious theory, can’t see a difference, and the binomial seems like the most appropriate test, I conclude that several months of 1mg iodine did not change my eye color. (As a final test, when I posted the results on the Longecity forum where people were claiming the eye color change, I swapped the labels on the photos to see if anyone would claim something along the lines when I look at the photos, I can see a difference!. I thought someone might do that, which would be a damning demonstration of their biases & wishful thinking, but no one did.)
To our Brainfood students and youth supporters: It’s your potential that inspired us, your laughter that sustained us, your incredible talent that challenged us to dig deep and build programs that you deserve. Whether you were with us for one year or one week, know that there’s probably a Brainfood staffer who has bragged about how awesome you are. We hope that what you learned in Brainfood sticks with you, even if it’s just using that pumpkin chocolate chip muffin recipe to make someone’s day a little brighter. You’ve given us hope and made us so very proud. Thank you. Now go out there, get what’s yours, and bless the world with your many, many talents.
the larger size of the community enables economies of scale and increases the peak sophistication possible. In a small nootropics community, there is likely to be no one knowledgeable about statistics/experimentation/biochemistry/neuroscience/whatever-you-need-for-a-particular-discussion, and the available funds increase: consider /r/Nootropics’s testing program, which is doable only because it’s a large lucrative community to sell to so the sellers are willing to donate funds for independent lab tests/Certificates of Analysis (COAs) to be done. If there were 1000 readers rather than 23,295, how could this ever happen short of one of those 1000 readers being very altruistic?
But what does this all have to do with food? Our gut helps keep our body’s immune responses and inflammation under control. Additionally, gut hormones that enter the brain or are produced in the brain influence cognitive ability, like understanding and processing new information, staying focused on the task at hand and recognizing when we’re full. (3)
However, despite these apparent good results, it’s recommended that you don’t run to the pharmacy just yet. The long term effects of taking Modafinil haven’t been studied conclusively or in-depth yet; to the contrary and in direct opposition to the many claims that Modafinil is completely safe, 50% of modafinil users report a number of short term side effects, such as mild to severe headaches, insomnia, nausea, anxiety, nervousness, hypertension, decreased appetite, and weight loss.
My first time was relatively short: 10 minutes around the F3/F4 points, with another 5 minutes to the forehead. Awkward holding it up against one’s head, and I see why people talk of LED helmets, it’s boring waiting. No initial impressions except maybe feeling a bit mentally cloudy, but that goes away within 20 minutes of finishing when I took a nap outside in the sunlight. Lostfalco says Expectations: You will be tired after the first time for 2 to 24 hours. It’s perfectly normal., but I’m not sure - my dog woke me up very early and disturbed my sleep, so maybe that’s why I felt suddenly tired. On the second day, I escalated to 30 minutes on the forehead, and tried an hour on my finger joints. No particular observations except less tiredness than before and perhaps less joint ache. Third day: skipped forehead stimulation, exclusively knee & ankle. Fourth day: forehead at various spots for 30 minutes; tiredness 5/6/7/8th day (11/12/13/4): skipped. Ninth: forehead, 20 minutes. No noticeable effects.
Christopher, love your heart for Pete’s security in who he is to The Lord. So cool. Brother, God does judge. Jesus is even referred to as “the righteous judge” (2 Timothy 4:8). In the first 5 verses of Romans 2, the judgment of God is even mentioned 3 times. Matthew 25:46 speaks of what will happen when God judges – that some “will go away into eternal punishment, but the righteous into eternal life.” Those who believe in Jesus Christ as their Lord and Savior who died for their sins and rose again will be and are “by grace… saved through faith” (Ephesians 2:8-9) in Jesus as such, having their sins forgiven and the righteousness of Jesus credited to them. (Romans 4:22-25) Thank you, Lord!
Gamma-aminobutyric acid, also known as GABA, naturally produced in the brain from glutamate, is a neurotransmitter that helps in the communication between the nervous system and brain. The main function of this Nootropic is to reduce the unnecessary activity of the nerve cells and helps calm the brain. . Thus it helps improve various conditions, like stress, anxiety and depression by decreasing the beta brain waves and increasing the alpha brain waves. As a result, cognitive abilities like memory power, attention, and alertness also improve. GABA helps drug addicts recover from addiction by normalizing the brain’s GABA receptors which reduce anxiety and craving levels in the absence of addictive substances.
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.
Please take care when you’re out there on the web or in the world shopping for something to help that in progress novel or craft project of yours along. Take all care when planning on taking anything, be it a nootropic, smart drug, or brain enhancer, and do your research before buying. Make sure your so-called ‘best brain pill’ really is the best brain pill for you.
Googling, you sometimes see correlational studies like Intake of Flavonoid-Rich Wine, Tea, and Chocolate by Elderly Men and Women Is Associated with Better Cognitive Test Performance; in this one, the correlated performance increase from eating chocolate was generally fairly modest (say, <10%), and the maximum effects were at 10g/day of what was probably milk chocolate, which generally has 10-40% chocolate liquor in it, suggesting any experiment use 1-4g. More interesting is the blind RCT experiment Consumption of cocoa flavanols results in acute improvements in mood and cognitive performance during sustained mental effort11, which found improvements at ~1g; the most dramatic improvement of the 4 tasks (on the Threes correct) saw a difference of 2 to 6 at the end of the hour of testing, while several of the other tests converged by the end or saw the controls winning (Sevens correct). Crews et al 2008 found no cognitive benefit, and an fMRI experiment found the change in brain oxygen levels it wanted but no improvement to reaction times.
Although piracetam has a history of “relatively few side effects,” it has fallen far short of its initial promise for treating any of the illnesses associated with cognitive decline, according to Lon Schneider, a professor of psychiatry and behavioral sciences at the Keck School of Medicine at the University of Southern California. “We don’t use it at all and never have.”
Pomegranate juice. Pomegranate juice (you can eat the fruit itself but with its many tiny seeds, it's not nearly as convenient) offers potent antioxidant benefits, says Kulze, which protect the brain from the damage of free radicals. "Probably no part of the body is more sensitive to the damage from free radicals as the brain," says board-certified neurologist David Perlmutter, MD, author of The Better Brain Book. Citrus fruits and colorful vegetables are also high on Perlmutter's list of "brainy" foods because of their antioxidant properties -- "the more colorful the better," he says. Because pomegranate juice has added sugar (to counteract its natural tartness), you don't want to go overboard, says Kulze; she recommends approximately 2 ounces a day, diluted with spring water or seltzer.
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."