FDA Guidelines & Statements

A WORD FROM SAMANTHA DIAVATIS

QUICK LINKS

FDA General Wellness Guidelines
An FDA issued guidance document to help provide clarity on the CDRH’s compliancy policy for general wellness products.

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FDA Verbiage Reference Sheet
Learn the types of things we can and can not say in regards to complying with our designation as a General Wellness Product.

READ MORE

A WORD FROM SAMANTHA DIAVATIS

QUICK LINKS

FDA General Wellness Guidelines
An FDA issued guidance document to help provide clarity on the CDRH’s compliancy policy for general wellness products.

READ MORE

FDA Verbiage Reference Sheet
Learn the types of things we can and can not say in regards to complying with our designation as a General Wellness Product.

READ MORE

SELECT YOUR SUBJECT OF INTEREST FROM THE PROVIDED LIST BELOW.

ACADEMIC PERFORMANCE

STATEMENT:

NeurOptimal® helps promote sleep management, which as part of a healthy lifestyle, may help academic performance.

Links:

The relationship between sleep and wake habits and academic performance in medical students: a cross-sectional study By Ahmed S BaHammam, Abdulrahman M Alaseem, Abdulmajeed A Alzakri, Aljohara S Almeneessier, and Munir M Sharif.

Direct Link | PDF

Sleep Insufficiency, Sleep Health Problems and Performance in High School Students By Xue Ming, Rebecca Koransky, Victor Kang, Sarah Buchman, Christina E. Sarris, and George C. Wagner.

Direct Link | PDF

The Link Between Sleep Quantity and Academic Performance for the College Student By Megan Lowry, Kayla Dean, and Keith Manders.

PDF

ACHIEVE PEAK PERFORMANCE

STATEMENT:

NeurOptimal® helps promote self confidence, sleep management and stress management which as part of a healthy lifestyle, may help achieve peak performance.

Links:

Priming for self-esteem influences the monitoring of one’s own performance By Sara L. Bengtsson, Raymond J. Dolan, and Richard E. Passingham.

Direct Link | PDF

The Effects of Total Sleep Deprivation on Cerebral Responses to Cognitive Performance By Sean P.A. Drummond, Ph.D., and Gregory G. Brown, Ph.D.

PDF

The Effects of Sleep Extension on the Athletic Performance of Collegiate Basketball Players By Cheri D. Mah, MS, Kenneth E. Mah, MD, MS, Eric J. Kezirian, MD, MPH, and William C. Dement, MD, PhD.

Direct Link | PDF

Sleep and athletic performance: the effects of sleep loss on exercise performance, and physiological and cognitive responses to exercise By Fullagar HH, Skorski S, Duffield R, Hammes D, Coutts AJ, Meyer T.

Direct Link

ADDICTION

STATEMENT:

NeurOptimal® helps promote stress management, which as part of a healthy lifestyle, may help manage addiction in particular during times of stress.

Links:

The Relationship between Stress and Addiction By Afsaneh Hassanbeigi, Jafar Askari, Dordaneh Hassanbeigi, Zahra Pourmovahed

Direct Link | PDF

Chronic stress may facilitate the recruitment of habit- and addiction-related neurocircuitries through neuronal restructuring of the striatum By S.B. Taylor, J.M. Anglin, P.R. Paode, A.G. Riggert, M.F. Olive, and C.D. Conrad

Direct Link | PDF

Chronic Stress, Drug Use, and Vulnerability to Addiction By Rajita Sinha

Direct Link | PDF

ADD/ADHD

STATEMENT:

NeurOptimal® helps promote sleep management, which as part of a healthy lifestyle, may help living with ADD/ADHD.

Links:

Sleep disturbances in children with attention-deficit/hyperactivity disorder By Karen Spruyt and David Gozal1.

Direct Link | PDF

A Clinical Overview of Sleep and Attention-Deficit/Hyperactivity Disorder in Children and Adolescents By Judith A. Owens, MD, MPH.

Direct Link | PDF

STATEMENT:

NeurOptimal® helps promote stress management, which as part of a healthy lifestyle, may help families living well with ADHD in particular during times of stress.

Links:

Parent stress management training for attention-deficit/hyperactivity disorder By Lee Treacy, GailTripp, Amanda Baird.

Direct Link

Attention Deficit Hyper Activity Disorder (ADHD) and Stress: A Mutual Relationship between Children and Mothers By Mercedeh Samiei, Reza Daneshmand, Rasul Keramatfar, Katayoon Khooshabi, Nasrin Amiri, Yadollah Farhadi, Seyedeh Zeinab Farzadfard, Hamid Kachooi, and Roya Samadi.

Direct Link

ALZHEIMERS

STATEMENT:

NeurOptimal® helps promote sleep management, which as part of a healthy lifestyle, may help living with alzheimers.

Links:

Clinical management of sleep disturbances in Alzheimer’s disease: current and emerging strategies By Elena Urrestarazu and Jorge Iriarte.

Direct Link | PDF

The brain may clean out Alzheimer’s plaques during sleep By Laura Beil.

Direct Link

STATEMENT:

NeurOptimal® helps promote stress management, which as part of a healthy lifestyle, may help living with alzheimers.

Links:

‘Making the best you can of it’: living with early‐stage Alzheimer’s disease By Hazel MacRae.

Direct Link | PDF

The relationship between stress and Alzheimer’s disease By Nicholas J. Justice.

Direct Link | PDF

ANXIETY

STATEMENT:

NeurOptimal® helps promote stress management, which as part of a healthy lifestyle, may help living well with anxiety in particular during times of stress.

Links:

Mindfulness-Based Stress Reduction for Stress Management in Healthy People: A Review and Meta-Analysis By Alberto Chiesa, Alessandro Serretti

Direct Link

Self-confidence and anxiety interpretation: A qualitative investigation By Sheldon Hanton, Stephen D.Mellalieu, and Ross Hall

Direct Link

Mental And Emotional Impact Of Stress By Harry Mills, Ph.D., Natalie Reiss, Ph.D. and Mark Dombeck, Ph.D

Direct Link

Effects of Relaxation Therapy on Anxiety Disorders: A Systematic Review and Meta-analysis By Hyeun-sil Kim, Eun Joo Kim

Direct Link

STRESS AND HEALTH: Psychological, Behavioral, and Biological Determinants By Neil Schneiderman, Gail Ironson, and Scott D. Siegel. (Reference #55)

Direct Link | PDF

STATEMENT:

NeurOptimal® helps promote self confidence, sleep management, stress management and relaxation which as part of a healthy lifestyle, may help manage anxiety.

Links:

Relationship Between Self-Concept, Self-esteem, Anxiety, Depression and Academic Achievement in Adolescents By Ali Fathi-Ashtiani, Javad Ejei, Mohammad-Karim Khodapanahi and Hamid Tarkhorani

Direct Link | PDF

How Do You Feel? Self-esteem Predicts Affect, Stress, Social Interaction, and Symptom Severity during Daily Life in Patients with Chronic Illness By VANESSA JUTH, JOSHUA M. SMYTH, and ALECIA M. SANTUZZI

Direct Link | PDF

ATHLETIC PERFORMANCE

STATEMENT:

NeurOptimal® helps promote sleep management, which as part of a healthy lifestyle, may help athletic performance.

Links:

Sleep Medication and Athletic Performance—The Evidence for Practitioners and Future Research Directions By Lee Taylor, Bryna C. R. Chrismas, Ben Dascombe, Karim Chamari, and Peter M. Fowler.

Direct Link | PDF

Role of sleep in performance and recovery of athletes: A review article By Rachel Venter.

Direct Link | PDF

Correlational study of psychological variables self-confidence and anxiety By Gloria González Campos, Javier Cachón Zagalaz, and Santiago Romero Granados.

Direct Link | PDF

BETTER MOOD

STATEMENT:

NeurOptimal® helps promote sleep management, which as part of a healthy lifestyle, may help maintain a better mood.

Links:

Sleep and Mood By the Division of Sleep Medicine at Harvard Medical School

Direct Link

The human emotional brain without sleep — a prefrontal amygdala disconnect By Seung-Schik Yoo, Ninad Gujar, PeterHu, Ferenc A.Joles, and Matthew P.Walker.

Direct Link | PDF

BRAIN INJURY

STATEMENT:

NeurOptimal® helps promote stress management, which as part of a healthy lifestyle, may help living well during recovery of a Traumatic Brain Injury.

Links:

Stress and Traumatic Brain Injury: A Behavioral, Proteomics, and Histological Study By Sook-Kyung C. Kwon, Erzsebet Kovesdi, Andrea B. Gyorgy, Daniel Wingo, Alaa Kamnaksh, John Walker, Joseph B. Long, and Denes V. Agoston.

Direct Link | PDF

Traumatic Brain Injury: What Counselors Need to Know Larry Maucieri, Ph.D.

PDF

The partner’s experience of traumatic brain injury and its recovery By Gerard A Riley.

Direct Link | PDF

Traumatic Brain Injury: Unmet Support Needs of Caregivers and Families in Florida By Christina Dillahunt-Aspillaga, Tammy Jorgensen-Smith, Sarah Ehlke, Melanie Sosinski, Douglas Monroe, and Jennifer Thor.

Direct Link | PDF

STATEMENT:

NeurOptimal® helps promote sleep management, which as part of a healthy lifestyle, may help living well during recovery of a Traumatic Brain Injury.

Links:

Chronic Stress and Fatigue-Related Quality of Life after Mild-to-Moderate Traumatic Brain Injury (TBI) By Esther Bay, PhD ACNS BC, Assistant Professor and Marita B. de-Leon, PhD, Post-doctoral research fellow.

Direct Link | PDF

CHOLESTEROL LEVELS

STATEMENT:

NeurOptimal® helps promote sleep management, which as part of a healthy lifestyle, may help improve cholesterol levels.

Links:

Associations of Usual Sleep Duration with Serum Lipid and Lipoprotein Levels By Yoshitaka Kaneita, MD, Makoto Uchiyama, MD, Nobuo Yoshiike, MD, and Takashi Ohida, MD.

Direct Link | PDF

How Lack of Sleep Affects Cholesterol By Rachael Herman.

Direct Link

Lack of Sleep Affects Cholesterol Metabolism and Inflammation By Lila Abassi.

Direct Link

The efficacy of relaxation training in treating anxiety By Pagnini Francesco MS, Manzoni Gian Mauro Psy.D, Castelnuovo Gianluca Ph.D, Molinari Enrico Ph.D.

Direct Link | PDF

Effectiveness of a music therapy intervention on relaxation and anxiety for patients receiving ventilatory assistance By Linda Chlan, PhD, RN

Direct Link

CONCUSSION REHABILITATION

STATEMENT:

NeurOptimal® helps promote stress management, which as part of a healthy lifestyle, may help living well during times of concussion rehabilitation.

Links:

Relationship Between Stress, Coping, and Postconcussion Symptoms in a Healthy Adult Population
Author links open overlay panel By Mary M. Machulda, Thomas F. Bergquist, Valerie Ito, Stephen Chew.

Direct Link

Stress after a concussion By Fraser Health.

Direct Link

Case Study – Complex Concussion Patients in the MVA System By Canadian Physiotherapy Association.

Direct Link

CREATIVITY

STATEMENT:

NeurOptimal® helps promote sleep management, which as part of a healthy lifestyle, may help improve creativity.

Links:

Sleep and Creativity: A Literature Review By Rui Marguilho, Saul Neves de Jesus, João Nuno Viseu, Rita B Domingues, Brandolim Nathália, Nathália Brandolim Becker, Rafaela Dias Matavelli, Raul Quevedo, and Gualberto Buela-Casal.

Direct Link | PDF

REM, not incubation, improves creativity by priming associative networks By Denise J. Cai, Sarnoff A. Mednick, Elizabeth M. Harrison, Jennifer C. Kanady, and Sara C. Mednick

Direct Link | PDF

Short- and long-term health consequences of sleep disruption By Goran Medic, Micheline Wille, and Michiel EH Hemels

Direct Link | PDF

DECISION MAKING SKILLS

STATEMENT:

NeurOptimal® helps promote healthy sleep habits, which as part of a healthy lifestyle, may help decision making skills.

Links:

Productivity and Sleep By Tuck.com

Direct Link

The Impact of Sleep Deprivation on Decision Making: A Review By Yvonne Harrison and James A. Home

PDF

DEPRESSION

STATEMENT:

NeurOptimal® helps promote stress management, which as part of a healthy lifestyle, may help living well with depression in particular during times of stress.*

Links:

STRESS AND HEALTH: Psychological, Behavioral, and Biological Determinants By Neil Schneiderman, Gail Ironson, and Scott D. Siegel. (Reference #55)

Direct Link | PDF

Surprising Ways Sleep Can Improve Your Health and Life By Susan Biali Haas M.D.

Direct Link

STATEMENT:

NeurOptimal® helps promote sleep management, which as part of a healthy lifestyle, may help living well with depression.*

Links:

Sleep disorders as core symptoms of depression By David Nutt, DM, FRCP, FRCPsych, FMedSci, Sue Wilson, PhD, and Louise Paterson, PhD

Direct Link | PDF

HEADACHES (MIGRAINES)

STATEMENT:

NeurOptimal® helps promote stress management, which as part of a healthy lifestyle, may help living well with headaches (migraines) in particular during times of stress.

Links:

Stress symptoms: Effects on your body and behavior By Mayo Clinic Staff.

Direct Link

Headaches: Reduce stress to prevent the pain By Mayo Clinic Staff.

Direct Link

Stress and migraine By Francoise Radat.

Direct Link

Perceived stress in patients with migraine: a case-control study By Hye-Jin Moon, Jong-Geun Seo, and Sung-Pa Park.

Direct Link | PDF

The association between stress and headache: A longitudinal population-based study By Sara H Schramm, Susanne Moebus, Nils Lehmann, Ursula Galli, Mark Obermann, Eva Bock, Min-Suk Yoon, Hans-Christoph Diener, and Zaza Katsarava.

Direct Link

The Effects of Stress on Your Body By WebMD.

Direct Link

HEALTHY WEIGHT

STATEMENT:

NeurOptimal® helps promote sleep management, which as part of a healthy lifestyle, may help maintain a healthy weight.

Links:

The Relationship Between Sleep and Weight in a Sample of Adolescents By Leslie A. Lytle, Keryn E. Pasch, and Kian Farbakhsh

Direct Link | PDF

HIGH BLOOD PRESSURE

STATEMENT:

NeurOptimal® helps promote stress management, which as part of a healthy lifestyle, may help living well with high blood pressure in particular during times of stress.

Links:

Stress and high blood pressure: What’s the connection? By Mayo Clinic Staff.

Direct Link

Managing Stress to Control High Blood Pressure By American Heart Association

Direct Link

Stress and Hypertension: Symptoms and Treatment By The American Institute of Stress

Direct Link

HYPERACTIVITY

STATEMENT:

NeurOptimal® helps promote sleep management, which as part of a healthy lifestyle, may help lower hyperactivity, inattentiveness and impulsivity in children.

Links:

Sleep and children: the impact of lack of sleep on daily life By Reut Gruber, PhD.

Direct Link

INFLAMMATION

STATEMENT:

NeurOptimal® helps promote sleep management, which as part of a healthy lifestyle, may help curb inflammation.

Links:

The relevance of sleep abnormalities to chronic inflammatory conditions By Z. Ranjbaran, L. Keefer, E. Stepanski, A. Farhadi, and A. Keshavarzian.

Direct Link

Sleep Loss and Inflammation By
Janet M. Mullington, Ph.D., Norah S. Simpson, Ph.D., Hans K. Meier-Ewert, M.D., and Monika Haack, Ph.D.

Direct Link | PDF

Investigating the Relationship Between Inflammation and Sleep Quality By Roger McIntyre, MD.

Direct Link

Lack of Sleep Affects Cholesterol Metabolism and Inflammation By Lila Abassi.

Direct Link

INSOMNIA

STATEMENT:

NeurOptimal® helps promote stress management, which as part of a healthy lifestyle, may help living well with insomnia in particular during times of stress.

Links:

Stress and Sleep Disorder By Kuem Sun Han, Lin Kim, and Insop Shim

Direct Link | PDF

On the nature of burnout–insomnia relationships: A prospective study of employed adults By Galit Armon, Arie Shirom, Itzhak Shapira, and Samuel Melamed

Direct Link

MAINTAIN BETTER RELATIONSHIPS

STATEMENT:

NeurOptimal® helps promote sleep management, which as part of a healthy lifestyle, may help maintain better relationships.

Links:

Sleep deprivation impairs recognition of specific emotions By William D.S.Killgore, Thomas J.Balkin, Angela M.Yarnell, Vincent F.Capaldi II.

Direct Link | PDF

SOCIAL RELATIONSHIPS AND SLEEP QUALITY By Robert G. Kent, Bert N. Uchino, Matthew R. Cribbet, Kimberly Bowen, and Timothy W. Smith.

Direct Link | PDF

Family Relationships and Troubled Sleep among U.S. Adults: Examining the Influences of Contact Frequency and Relationship Quality By Jennifer A. Ailshire and Sarah A. Burgard.

Direct Link | PDF

The human emotional brain without sleep — a prefrontal amygdala disconnect By Seung-Schik Yoo, Ninad Gujar, Peter Hu, Ferenc A.Jolesz, Matthew P.Walker.

Direct Link | PDF

MULTIPLE SCLEROSIS

STATEMENT:

NeurOptimal® helps promote stress management, which as part of a healthy lifestyle, may help living well with Multiple Sclerosis.

Links:

Stress and multiple sclerosis: A systematic review considering potential moderating and mediating factors and methods of assessing stress By Laia Briones-Buixassa, Raimon Milà, Josep M. Aragonès, Enric Bufill, Beatriz Olaya, and Francesc Xavier Arrufat.

Direct Link | PDF

Stress and multiple sclerosis: A systematic review considering potential moderating and mediating factors and methods of assessing stress By Laia Briones-Buixassa, Raimon Milà, Josep M. Aragonès, Enric Bufill, Beatriz Olaya, and Francesc Xavier Arrufat.

PDF

STATEMENT:

NeurOptimal® helps promote sleep management, which as part of a healthy lifestyle, may help living well with Multiple Sclerosis.

Links:

Relationship between Sleep Quality and Quality of Life in Patients with Multiple Sclerosis By Payam Sarraf, Sepeher Azizi, Abdorreza Naser Moghaddasi, Mohammad Ali Sahraian, Abbas Tafakhori, and Mahsa Ghajarzadeh.

Direct Link

The impact of disability, fatigue and sleep quality on the quality of life in multiple sclerosis By Haleh Ghaem and Afshin Borhani Haghighi.

Direct Link

OCD

STATEMENT:

NeurOptimal® helps promote stress management, which as part of a healthy lifestyle, may help living well with OCD in particular during times of stress.

Links:

The Importance of Managing Stress When You Have OCD By Owen Kelly, PhD.

Direct Link

The Role of Stress in the Pathogenesis and Maintenance of Obsessive-Compulsive Disorder By Thomas G. Adams, Benjamin Kelmendi, C. Alex Brake, Patricia Gruner, Christal L. Badour, Christopher Pittenger.

Direct Link | PDF

PARKINSONS

STATEMENT:

NeurOptimal® helps promote stress management, which as part of a healthy lifestyle, may help living well with Parkinsons.

Links:

Coping processes and health-related quality of life in Parkinson’s disease By R. S. Bucks, K. E. Cruise, T. C. Skinner, A. M. Loftus, R. A. Barker, and M. G. Thomas

PDF

STATEMENT:

NeurOptimal® helps promote sleep management, which as part of a healthy lifestyle, may help living well with Parkinsons.

Links:

Exacerbated physical fatigue and mental fatigue in Parkinson’s disease By Jau‐Shin Lou MD, PhD, Greg Kearns, BS, Barry Oken, MD, Gary Sexton, PhD, John Nutt, MD.

Direct Link

Sleep Dysfunction and its Management in Parkinson’s Disease By Scott J. Kutscher, MD, Siavash Farshidpanah, MD, and Daniel O. Claassen, MD.

Direct Link | PDF

Quality of Sleep in Patients with Parkinson’s Disease By Mohammad Reza Najafi, Ahmad Chitsaz, Zahra Askarian, and Mohammad Amin Najafi.

Direct Link

QUALITY OF LIFE

STATEMENT:

NeurOptimal® helps promote self confidence, which as part of a healthy lifestyle, may help significantly improved quality of life.

Links:

A study of the relationship between quality of life, self-esteem and health By Stephen Kermode and Doug MacLean.

PDF

Self-esteem and life satisfaction in adolescents-gender and age as potential moderators By Unni Karin Moksnes and Geir Arild Espnes.

Direct Link | PDF

TINNITUS

STATEMENT:

NeurOptimal® helps promote stress management, which as part of a healthy lifestyle, may help living well with tinnitus in particular during times of stress.

Links:

Stress and tinnitus—from bedside to bench and back By Birgit Mazurek, Heidemarie Haupt, Heidi Olze, and Agnieszka J. Szczepek.

Direct Link | PDF

STATEMENT:

NeurOptimal® helps promote sleep management, which as part of a healthy lifestyle, may help living well with tinnitus.

Links:

Stress and tinnitus—from bedside to bench and back By Birgit Mazurek, Heidemarie Haupt, Heidi Olze, and Agnieszka J. Szczepek.

Direct Link | PDF

Please Note: The Zengar® Main Office, Order Desk, and ZenConnect will be closed on Monday, October 14th, for the Thanksgiving Day Holiday (Canadian). Thank you!