In the last few years “Nootropics” have surged in popularity. As the creator of a leading nootropic stack we have decided to put together a resource for new and experienced Nootropic fans. We hope with better education people can make informed decisions about which Nootropics they want to use. It is also critical that individuals planning to use Nootropics differentiate between the prescription drugs, the unapproved drugs and the approved dietary supplements. So let’s begin:
We define Nootropics as any substance that improves mental function this includes prescription drugs, dietary supplements, “unapproved ingredients” and functional foods.
What are the categories of Nootropics? What is the legal status of Nootropics?
Prescription drugs– are designed to treat and cure diseases and are not meant to be used casually. Using prescription drugs without a prescription is generally not advised and is illegal.
Unapproved Ingredients (“New Drugs”) – A number of nootropics would be considered unapproved drugs by the FDA because they have not been submitted to the FDA as a New Dietary Ingredient. Many supplement companies either through ignorance or for more nefarious reasons market these products as dietary supplements even though they include ingredients that have not been approved. If you are not sure if the ingredient in your supplement has been submitted to the FDA go to http://www.regulations.gov/ and search for the ingredient to see if there has been a “New Dietary Ingredient” filling sent to the FDA.
Approved Dietary Ingredients – Dietary Supplements are legal and have components that can be found in nature. There legal status is subject to change at any time should the FDA feel they are unsafe.
Functional Foods – Functional foods are generally legal as long as they contain approved dietary ingredients.
We believe it is very important to understand which ingredients are approved and which aren’t. Unapproved ingredients are not only illegal but should also make you question the supplier. If they are willing to sell unapproved ingredients what kind of quality checks do they have in place? If they are willing to side step FDA regulations what are short cuts are they taking?
From the FDA:
“Under section 350b(a)(2), there must be a history of use or other evidence of safety establishing that the dietary ingredient, when used under the conditions recommended or suggested in the labeling of the dietary supplement, will reasonably be expected to be safe. If this requirement is not met, the dietary supplement is deemed to be adulterated under 21 U.S.C. 342(f)(l)(B) b ecause there is inadequate information to provide reasonab1.e assurance that the new dietary ingredient does not present a significant or unreasonable risk of illness or injury.”
Adderall – amphetamine based prescription drug for the treatment of attention deficit hyperactivity disorder
Ritalin – One of the oldest used FDA approved prescription drugs for treating hyperactivity
Dexedrine – Central Nervous System stimulant with an amphetamine based action mechanism
Vyvanse – FDA approved in 2008 for maintenance treatment of Adult ADHD
Concerta – ADHD medication that is extremely similar to Ritalin in its chemical makeup
Focalin – Central Nervous System stimulant. A refined version of Ritalin
Modafinl – Sold under the trade name Provigil and classified as a Schedule IV controlled substance It improved wakefulness promoting agent.
Adrafinil– Wakefulness drug without FDA approval. Sold in Europe under the name Olmifon
DMAA – Used in supplements until banned by the FDA do to controversy regarding its chemical makeup and potential overdose dangers.
Picamilon – a prescription drug in Russia that never received an NDI submission. Current controversy involves GNC selling dietary supplements with the ingredient.
Noopept – prescription drug in Russia not approved by the FDA for use the US. Athough it has beend sold in the US as a dietary supplement no NDI has been filled by the FDA
Sulbutiamine– A derivative of thiamine (vitamin B1) sold under the brand name Arcalion It has been studied in Europe for its effects with chronic post infectious fatigue.
Sunifram – A new compound structural similar to piracetam. Clinical studies with mice has shown it as a potential cognitive enhancer.
Piracatem – Classified in the broader group of Racetams. Pramiracetam
Oxiracetam– Racetam studied in Russia for treatment of mild cerebral trauma
Coluracetam – code name MKC-231 was first studied in the mid 1990s as a choline uptake enhancer
Aniracetam– In the Racetam family. First made in the 1970s and studied for treatment of CNS disorders.
Adrafinil- Used in France as an experimental treatment for narcolepsy
St. Johns Wort
The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.