Editing Nootropic (section)

==Unproven marketing claims==
Nootropics include both [[prescription drug]]s and [[dietary supplement]]s marketed to enhance brain function, but while [[U.S. Food and Drug Administration|FDA]]-approved drugs have proven benefits and oversight, many dietary supplements lack evidence, may contain unapproved or hidden [[drug|drugs]], and pose safety and regulatory risks.<ref name=opss/>

In the United States, nootropics are commonly advertised with unproven claims of effectiveness for improving cognition. Manufacturers' marketing claims for dietary supplements are usually not formally tested and verified by independent entities.<ref>{{Cite web |date=2019-02-11 |title=FTC and FDA Send Warning Letters to Companies Selling Dietary Supplements Claiming to Treat Alzheimer's Disease and Remediate or Cure Other Serious Illnesses Such as Parkinson's, Heart Disease, and Cancer |url=https://www.ftc.gov/news-events/news/press-releases/2019/02/ftc-fda-send-warning-letters-companies-selling-dietary-supplements-claiming-treat-alzheimers-disease |access-date=2025-02-06 |website=Federal Trade Commission |language=en}}</ref> In 2019, the US FDA and [[Federal Trade Commission|FTC]] [[FDA warning letter|warned]] manufacturers and consumers about possible advertising fraud and marketing scams concerning nootropic supplement products.<ref name="ftc">{{cite web |date=February 11, 2019 |title=FTC and FDA Send Warning Letters to Companies Selling Dietary Supplements Claiming to Treat Alzheimer's Disease and Remediate or Cure Other Serious Illnesses Such as Parkinson's, Heart Disease, and Cancer |url=https://www.ftc.gov/news-events/press-releases/2019/02/ftc-fda-send-warning-letters-companies-selling-dietary |access-date=May 11, 2019 |publisher=US Food and Drug Administration, US Federal Trade Commission}}</ref><ref name="fda-fraud">{{cite web |date=December 22, 2018 |title=Health fraud scams: Unproven Alzheimer's disease products |url=https://www.fda.gov/consumers/health-fraud-scams/unproven-alzheimers-disease-products |archive-url=https://web.archive.org/web/20190913120205/https://www.fda.gov/consumers/health-fraud-scams/unproven-alzheimers-disease-products |url-status=dead |archive-date=September 13, 2019 |access-date=May 11, 2019 |publisher=US Food and Drug Administration}}</ref><ref name="fda">{{cite web |url=https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-nootropics-llc-aka-advanced-nootropics-565256-02052019 |title=FDA Warning Letter: Peak Nootropics LLC aka Advanced Nootropics | vauthors = Correll Jr WA |date=February 5, 2019 |publisher=Office of Compliance, Center for Food Safety and Applied Nutrition, Inspections, Compliance, Enforcement, and Criminal Investigations, US Food and Drug Administration |access-date=May 11, 2019}}{{dead link|date=May 2025|bot=medic}}{{cbignore|bot=medic}}</ref><ref name="fda2">{{cite web |url=https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tek-naturals-565026-02042019 |title=FDA Warning Letter: TEK Naturals | vauthors = Correll Jr WA |date=February 5, 2019 |publisher=Office of Compliance, Center for Food Safety and Applied Nutrition, Inspections, Compliance, Enforcement, and Criminal Investigations, US Food and Drug Administration |access-date=May 11, 2019}}{{dead link|date=May 2025|bot=medic}}{{cbignore|bot=medic}}</ref> The FDA and FTC stated that some nootropic products had not been [[drug approval|approved]] as a prescription drug effective for any medical purpose, were not proven to be safe, and were illegally marketed in the United States under violation of the [[Federal Food, Drug, and Cosmetic Act]].<ref name=ftc/><ref name=fda-fraud/>

In 2018 in the United States, some nootropic supplements were identified as having misleading ingredients and illegal marketing.<ref name="schultz">{{cite web | vauthors = Schultz H |date=May 17, 2018 |title=Some shady ingredients find home in nootropics category |url=https://www.nutraingredients-usa.com/Article/2018/05/17/Some-shady-ingredients-find-home-in-nootropics-category# |access-date=May 11, 2019 |publisher=NutraIngredients-USA.com, William Reed Business Media Ltd}}</ref><ref name="heid">{{cite web | vauthors = Heid M |date=January 23, 2019 |title=Nootropics, or 'Smart Drugs,' Are Gaining Popularity. But Should You Take Them? |url=https://time.com/5509993/nootropics-smart-drugs-brain/ |access-date=May 12, 2019 |publisher=Time}}</ref> In 2019, the FDA and FTC warned manufacturers and consumers about possible advertising fraud and marketing scams concerning nootropic supplements.<ref name="ftc" /><ref name="fda-fraud" />

Over the years 2010 to 2019, the FDA warned numerous supplement manufacturers about the illegal status of their products as unapproved drugs with no proven safety or efficacy at the doses listed on the products, together with misleading marketing.<ref name="ftc" /><ref name="fda-fraud" /><ref name="fda" /><ref name="fda2" /><ref name="cerebral">{{cite web |url=https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm198452.htm |archive-url=https://wayback.archive-it.org/7993/20170112195041/https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm198452.htm |url-status=dead |archive-date=January 12, 2017 |title=FDA Warning Letter: Cerebral Health LLC | vauthors = Singleton ER |date=January 7, 2010 |publisher=Office of Compliance, Center for Food Safety and Applied Nutrition, Inspections, Compliance, Enforcement, and Criminal Investigations, US Food and Drug Administration |access-date=May 12, 2019}}</ref><ref name="unlimited" />