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Bucked Up Pre Workout – Regulatory and Scientific Review

by Curtis

An Overview of Product Composition and Formulation

Ingredient List and Functional Roles

Caffeine Anhydrous – 200 mg per serving

Blocks adenosine receptors, thereby increasing alertness and cognitive acuity; at the same time, it activates the central nervous system. Its use is within FDA limits.

Beta-Alanine-Single Serving (3.2 g)

 Acts as the precursor in carnosine formation, which buffers intracellular pH during anaerobic contraction. Paresthesia at therapeutic levels is acknowledged. 

Citrulline Malate (6 g)

 Precursor to NO synthesis, inducing vasodilation and substrate delivery. Cited in multiple RCTs for ingestion pre-exercise.

ElevATP® (150 mg)

A proprietary blend made from ancient peat and apple extracts that have been proven in human studies to aid endogenous ATP production. It has GRAS status. 

Manufacturing Standards and Quality Systems

Manufactured in cGMP-compliant facilities

Implemented allergen controls and sanitation protocols

Batch integrity during production is maintained with in-process audits, while COAs further guarantee integrity post-production

Regulatory Framework and Label Claims

21 CFR 101- Dietary Supplements Act

Nutrition Labeling and Education Act provisions followed

Preparation of the Supplement Facts Panel in the format required by FDA

Standardized in font size, placement, and disclosure

Claims Substantiation Principles

Scientific evidence- Human clinical studies and systematic review

Structure/function claims submitted to FDA within the regulatory time period

Claims do not contain any implication of therapeutic, curing, or preventing disease

Adverse Event Reporting and Compliance

Adherence to Section 8 of DSHEA protocol

MedWatch for reporting serious adverse events

Recall documented in the FDA Enforcement Reports

Evidence and Efficacy Ergogenic Effect of the Active Ingredients

Caffeine: mental processing and alertness enhancement

Beta-alanine: buffering capacity enhancement and fatigue onset delay

Citrulline malate: vasodilation and enhanced nutrient transport

Human Clinical Studies

elevATP® found to increase peak power output

Trials with adequate blinding and controls

Indexed by PubMed and referenced in regulatory documents

Comparative Analysis Versus Competitors

Dosing transparency, exceeds industry minimums 

No artificial colors, no undisclosed proprietary blends

In an elevated position against competitor labels and dosages

Safety, Tolerability, and Contraindications Known Adverse Reactions and Risk Mitigation

Reported effects: paresthesia, aggravation of anxiety, thermogenesis

Label warnings include stacking advisory relevant to stimulants

Contraindications and Cautions

Excluded populations are pregnant/lactating individuals or those with cardiovascular risk

Interactions with antihypertensives and CNS stimulants have been reported

Label Warning Statements and Consumer Guidance

Disclosure of caffeine is mandatory at 200 mg

Usage limits are presented in boldface

Production Integrity and Quality Assurance

Endorsed cGMP facility

FDA Registration and Annual Third-Party Audit

SOPs for Sanitation and Validation Documentation

Third-Party Certifications

NSF Certified for Sport®

Drug-Free Verification of Informed Choice®

Stability Testing and Shelf-Life Estimation

Accelerated and real-time testing for 24 months

Keeping Moisture and Oxidation at Bay Through Packaging

Directions for Use and Practical Application

Serving Size and Time

Take about 1 scoop with water about 15 to 30 minutes before exercise

Not to be taken together with other sources of caffeine

Cycling Parameters

Four-week periods of usage followed by rest times

Compatibility with Dietary Paradigms

Non-GMO, gluten-free, and artificial-sweetener-free

May or may not be vegan owing to the handling of the plant in the same facility

Packaging, label design, and consumer information

FDA Format Compliance

Nutrient quantification compliant with SFP guidelines

Claim Disclaimers & Legal Copy

Includes disclaimers stipulated by DSHEA

Transparency via QR or Batch Lookup

On-pack QR codes provide the public with access to lab COAs

Market Positioning and Brand Authority

Brand History and Reputation

DAS Labs distributing in 10,000+ retail points

There are no historical regulatory enforcement actions

Expert Endorsements and Advisory Board

Reviewed by experts such as certified sport nutritionists and physiologists

Consumer Trust and User Reviews

Verified reviews claim it’s always effective

Rarely do any adverse effects get reported

Gap Coverage (Commonly Overlooked Areas)

Long-Term Safety Monitoring

Post-market surveillance procedures with ultimate QA review

Interaction with Other Supplements or Medications

Data concerning interaction with beta-blockers and NO-enhancers referenced

Environmental and Sustainability Clauses

PET packaging and eco-label inks

FAQs

What is the distinction between elevATP® and regular ATP supplements?

elevATP® is a patented complex that has clinical support for endogenous ATP stimulation unlike plain ATP which is generally bioavailable. 

Are they FDA compliant statements?

Claims are in accordance with DSHEA and were made based on peer reviewed data. There are no therapeutic claims.

How long is the usage cycle? 

One serving before a workout.  You use it for 8 weeks and can then take 4 weeks off to it tolerant. 

Do I stack this product with other nitric oxide supplements?

Stacking other nitric oxide supplements could create an overload to the vasodilatory effects.  It is very wise to check with a health care provider before doing so. 

How do I view COAs?

COA’s will be linked through a QR code on the product label with corresponding batches.

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