The short answer is yes and no.
It really depends on what we're talking about when we say Nootropics.
If we're talking about natural Nootropics like; caffeine, L-theanine, Lion's Mane, etc. then yes, they are FDA approved.
That being said, in this article I will take a closer look at the harsher Nootropic compounds.
The Growing Popularity of Synthetic Nootropics
In October 2015, the FDA issued warning letters to two companies that manufacture and sell dietary supplements containing certain Nootropic substances.
The substances include 1-phenylpiracetam and phenibut. Both of the dietary supplements are not FDA approved and carry health risks (such as hepatotoxicity) that have not been evaluated by the FDA.
Nootropics, also known as "Smart drugs", are becoming increasingly popular in the United States. The most popular Nootropic supplement is Adderall, a combination of amphetamine salts that increases concentration and boosts focus levels. It can be helpful in cases of attention deficits but is not an alternative for the treatment of depression or ADHD.
The growing popularity of Nootropics prompted the FDA to issue its warning letters to two companies that sell dietary supplements containing the chemicals in question. The letters were not sent to the companies for making Nootropics themselves, but for selling products that contain these ingredients.
The products of both companies were marketed as dietary supplements and not as drugs, meaning they do not have to be approved by the FDA.
How Are Nootropics Regulated?
To become approved, dietary supplements are subject to a rigorous approval process.
Each substance that is added to the list of approved dietary supplements must be tested for safety and effectiveness.
Most of the time, these products go through a "New Dietary Ingredient Notification" process in which the manufacturer has to provide information about the product and clinical evidence that it is safe and effective.
The manufacturer must then submit the application to the FDA.
If the FDA is concerned that the submission is inadequate, it can send a letter to the company stating why it thinks more information is needed. The company must respond and provide its response as well as more details.
If the FDA is still not satisfied with the response it can send a letter to the company stating that it will not be accepting the application. In this case, the manufacturer cannot sell any more of the product.
5 Synthetic Nootropics That Are Actually FDA-Approved
Modafinil is often confused with Adderall due to similar names. It belongs to the class of drugs known as eugeroics, which means it has the ability to increase wakefulness and energy.
It has been approved by the US Food & Drug Administration (FDA) for treating excessive daytime sleepiness associated with narcolepsy or other sleep disorders.
The drug works by increasing levels of certain neurotransmitters in the brain that promote wakefulness and alertness.
It is taken orally, typically in the morning. This drug has been proven effective at improving alertness in healthy people. It is also used in professional settings, such as for shift work sleep disorders.
Ritalin is a medication that is chemically similar to amphetamine. It is used most commonly for the treatment of attention deficit hyperactivity disorder (ADHD).
It helps improve the symptoms of ADHD by increasing levels of two neurotransmitters, dopamine and norepinephrine. It may also increase levels of serotonin in some parts of the brain.
This drug belongs to a class called stimulants, which means that it can increase energy and alertness in users. However, it also may increase blood pressure, heart rate and body temperature in some users.
It is typically taken orally, one to four times a day. It must be taken regularly for at least 4 weeks before the effects are noticed.
Adderall is a prescription medication used for the treatment of ADHD. It belongs to a class of drugs called amphetamines, which means it increases concentration and energy levels.
It works by increasing levels of neurotransmitters that regulate these functions, especially dopamine and norepinephrine.
It must be taken orally, typically in the morning with food or on an empty stomach. Overdosing on this drug can cause serious health complications, such as stroke, heart attack or seizures.
Armodafinil is used for treating excessive sleepiness due to narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. It belongs to the class of drugs known as eugeroics, which means it has the ability to increase wakefulness and energy.
It works by increasing levels of certain neurotransmitters in the brain that promote wakefulness and alertness.
It is taken orally, typically in the morning. It must be taken regularly for at least 4 weeks before the effects are noticed. It can also have negative side effects, including headache, nausea, difficulty concentrating and depression.
Vyvanse is an amphetamine medication used for the treatment of ADHD. It has also been known to treat narcolepsy and other sleep disorders. It belongs to a class of drugs called amphetamines, which means it increases concentration and energy levels.
It works by increasing levels of neurotransmitters that regulate the functions, especially dopamine and norepinephrine. It must be taken orally, typically in the morning with food or on an empty stomach.
Overdosing on this drug can cause serious health complications, such as heart attack or stroke.
Lastly, it's worth pointing out that there are literally 100's if not 1000's of different Nootropics on the market today.
Most of these are natural Nootropics like; Bacopa monnieri, Lion's Mane, L-Theanine, Caffeine etc. which are all perfectly legal, approved and fine to ingest.