Compliance

Compliance Information

Last Updated: October 27, 2025

Our Commitment to Compliance

At Tiny Brander LLC, we are committed to manufacturing dietary supplements in full compliance with all applicable federal regulations. This page outlines our compliance standards, manufacturing practices, and the regulatory framework under which we operate.

Important Note: While Tiny Brander maintains strict compliance standards for our manufacturing operations, you (the brand owner) are ultimately responsible for ensuring that your business and products comply with all applicable laws and regulations. This page provides educational information to help you understand your compliance obligations.

FDA Registration and Compliance

FDA-Registered Facility

Tiny Brander operates an FDA-registered dietary supplement manufacturing facility in compliance with:

21 CFR Part 111 - Current Good Manufacturing Practice (cGMP) for Dietary Supplements

21 CFR Part 117 - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food

FDA Food Facility Registration requirements under the Bioterrorism Act

Our FDA Registration Number is available upon request for regulatory purposes.

Current Good Manufacturing Practices (cGMP)

Our facility follows strict cGMP standards, including:

Quality Control Systems - Comprehensive testing and verification of all ingredients and finished products Sanitation and Hygiene - Strict cleaning protocols and environmental monitoring Equipment Calibration - Regular calibration and maintenance of all manufacturing equipment  Personnel Training - Ongoing training for all manufacturing staff on cGMP requirements Documentation and Record-Keeping - Detailed batch records and quality documentation  Supplier Qualification - Verification of ingredient suppliers and certificate of analysis (COA) review

Product Safety and Quality

Ingredient Sourcing

All ingredients used in TinyBrander products are:

Sourced from qualified suppliers with current Certificates of Analysis (COAs) - Tested for identity, purity, strength, and composition - Verified to be free from contaminants (heavy metals, microbiological contamination, etc.) - Compliant with FDA dietary ingredient regulations - Non-GMO and allergen-controlled (where applicable)

Product Testing

Every batch of products manufactured by or for Tiny Brander undergoes:

Identity Testing - Verification that ingredients match label claims - Potency Testing - Confirmation of active ingredient levels  - Purity Testing - Screening for contaminants and adulterants - Microbiological Testing - Testing for harmful bacteria and pathogens - Heavy Metals Testing - Screening for lead, arsenic, cadmium, and mercury - Stability Testing - Verification of shelf life and expiration dating

Quality Assurance

Our quality assurance program includes:

Pre-production review of all formulations and labels

In-process quality checks during manufacturing

Final product inspection before release

Retention samples for every batch produced

Ongoing stability monitoring

Customer complaint tracking and investigation

Label Compliance

FDA Labeling Requirements

All Tiny Brander products are labeled in compliance with FDA regulations, including:

Principal Display Panel - Product name, net quantity, and brand identity - Supplement Facts Panel - Serving size, servings per container, and ingredient amounts - Ingredient List - All ingredients listed in descending order by weight - Allergen Declarations - Clear identification of major food allergens - Distributor Information - Name and address of distributor - Required Disclaimers - "This statement has not been evaluated by the FDA..." disclaimer

Structure/Function Claims

If your labels include structure/function claims (e.g., "supports immune health"), you must:

Ensure claims are truthful and not misleading

Have substantiation for all claims

Include the required FDA disclaimer: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."

Notify FDA within 30 days of first marketing (if required)

Tiny Brander provides compliant label templates, but you are responsible for ensuring your specific claims are substantiated and compliant.

Prohibited Claims

The following types of claims are prohibited on dietary supplement labels:

Disease Claims - Claims that the product can diagnose, treat, cure, or prevent a disease - Drug Claims - Claims that imply the product works like a pharmaceutical drug Unsubstantiated Claims - Any claim without adequate scientific support - False or Misleading Claims - Any statement that is deceptive or misleading

Making prohibited claims can result in FDA enforcement action, including warning letters, product seizures, and injunctions.

Your Compliance Responsibilities as a Brand Owner

Federal Regulations

As a brand owner using TinyBrander, you are responsible for compliance with:

1. FDA Dietary Supplement Regulations

Label Compliance - Ensuring your labels meet all FDA requirements

Claims Substantiation - Having adequate scientific support for any health claims

Adverse Event Reporting - Reporting serious adverse events to FDA within 15 days

Product Recalls - Initiating recalls if products are found to be adulterated or misbranded

2. FTC Advertising and Marketing Regulations

Truthful Advertising - All marketing claims must be truthful and not misleading

Substantiation - You must have competent and reliable scientific evidence for all claims

Endorsements and Testimonials - Disclosures required for paid endorsements

Social Media Marketing - Compliance with FTC guidelines for social media advertising

3. State Regulations

Some states have additional requirements for dietary supplement sellers, including:

Business licensing and registration

State-specific labeling requirements

Sales tax collection and remittance

Product registration (in certain states)

You are responsible for researching and complying with regulations in all states where you sell products.

Business Compliance

Sales Tax

You are responsible for:

Determining where you have sales tax nexus

Registering for sales tax permits in applicable states

Collecting sales tax from customers

Filing sales tax returns and remitting taxes to state authorities

Tiny Brander does not collect or remit sales tax on your behalf.

Business Licensing

You may need to obtain:

Federal Employer Identification Number (EIN)

State business license

Local business permits

Seller's permit or resale certificate

Professional licenses (if required in your state)

Insurance

We strongly recommend obtaining:

Product Liability Insurance - Protects against claims related to product defects or injuries

General Liability Insurance - Protects against general business risks

Professional Liability Insurance - If you provide health or fitness coaching

Adverse Event Reporting

Your Obligation to Report

Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act, you must report serious adverse events to FDA within 15 business days.

A serious adverse event includes:

Death

Life-threatening experience

Inpatient hospitalization

Persistent or significant disability or incapacity

Congenital anomaly or birth defect

Medical or surgical intervention to prevent one of the above outcomes

How to Report

Submit reports through the FDA Safety Reporting Portal (https://www.safetyreporting.hhs.gov)

Maintain records of all adverse event reports for at least 6 years

Notify Tiny Brander immediately if you receive reports of serious adverse events

Failure to report serious adverse events can result in significant penalties.

International Compliance

Selling Outside the United States

If you plan to sell products internationally, you must comply with the regulations of each country where you sell, including:

Product registration requirements

Import/export regulations

Country-specific labeling requirements

Health claims regulations

Customs and duties

Intellectual Property Compliance

Trademark Compliance

Before launching your brand, you should:

Conduct a trademark search to ensure your brand name is available

Consider registering your trademark with the U.S. Patent and Trademark Office (USPTO)

Ensure you're not infringing on existing trademarks

Tiny Brander is not responsible for trademark infringement claims related to your brand name or logo.

You must ensure that all content you use (images, text, designs) is either:

Original content you created

Licensed content you have permission to use

Public domain or royalty-free content

Using copyrighted material without permission can result in legal action.

Data Privacy and Security

Customer Data Protection

If you collect customer data (names, emails, payment information), you must comply with:

GDPR (if you have customers in the European Union)

CCPA (California Consumer Privacy Act)

Other state privacy laws

Payment Card Industry Data Security Standard (PCI DSS) (if you process credit cards)

You must have a privacy policy on your website that discloses:

What data you collect

How you use customer data

Who you share data with

How customers can access or delete their data

Your data security measures

Enforcement and Penalties

FDA Enforcement Actions

FDA can take enforcement action for violations, including:

Warning Letters - Formal notification of violations

Product Seizures - Physical removal of non-compliant products from the market

Injunctions - Court orders to stop manufacturing or selling products

Criminal Prosecution - For serious or intentional violations

Civil Penalties - Fines up to $100,000+ per violation

FTC Enforcement Actions

FTC can take action for false or misleading advertising, including:

Cease and Desist Orders

Civil Penalties - Fines up to $43,280 per violation

Consumer Redress - Requirement to refund customers

Corrective Advertising - Requirement to run ads correcting false claims

State Enforcement

State attorneys general can also take enforcement action for violations of state consumer protection laws.

Resources for Compliance

FDA Resources

FDA Dietary Supplement Website: https://www.fda.gov/food/dietary-supplements

Small Business Nutrition Labeling Exemption: https://www.fda.gov/food/nutrition-facts-label/small-business-nutrition-labeling-exemption

Dietary Supplement Labeling Guide: https://www.fda.gov/food/dietary-supplements-guidance-documents-regulatory-information/dietary-supplement-labeling-guide

FTC Resources

FTC Advertising and Marketing Basics: https://www.ftc.gov/business-guidance/resources/advertising-marketing-internet-rules-road

Dietary Supplements: An Advertising Guide for Industry: https://www.ftc.gov/business-guidance/resources/dietary-supplements-advertising-guide-industry

Industry Associations

Council for Responsible Nutrition (CRN): https://www.crnusa.org

Natural Products Association (NPA): https://www.npanational.org

American Herbal Products Association (AHPA): https://www.ahpa.org

Recommended Compliance Partners

While Tiny Brander handles manufacturing compliance, we recommend working with qualified professionals for your business compliance needs:

Regulatory Consultants

Consider hiring a regulatory consultant to:

Review your labels for FDA compliance

Advise on permissible health claims

Help with adverse event reporting

Assist with FDA inspections or warning letters

Legal Counsel

Consider hiring an attorney who specializes in:

FDA and FTC regulations

Dietary supplement law

Intellectual property (trademarks and copyrights)

Business formation and contracts

Accountants/CPAs

Work with an accountant to:

Set up proper business accounting

Handle sales tax compliance

Manage tax filings and deductions

Advise on business structure (LLC, S-Corp, etc.)

TinyBrander's Compliance Support

What We Provide

Compliant Manufacturing - All products manufactured in our FDA-registered, cGMP facility - Label Templates - Pre-formatted templates that meet FDA labeling requirements - Ingredient Documentation - COAs and specifications for all ingredients - Batch Records - Complete documentation for every batch produced - Educational Resources - Guides and information about supplement regulations

What You Are Responsible For

Your Label Content - Ensuring your specific claims and statements are compliant  - Your Marketing Claims - Substantiating and complying with FTC requirements - Business Licensing - Obtaining necessary permits and licenses - Sales Tax - Collecting and remitting sales tax - Adverse Event Reporting - Reporting serious adverse events to FDA - Legal and Regulatory Advice - Consulting with qualified professionals

Compliance Checklist for Brand Owners

Before launching your supplement brand, ensure you have:

Pre-Launch Compliance

☐Conducted trademark search for your brand name

☐Reviewed labels with regulatory consultant (recommended)

☐Ensured all health claims are substantiated

☐Obtained business license and EIN

☐Registered for sales tax in applicable states

☐Obtained product liability insurance

☐Created privacy policy and terms of service for your website

☐Set up adverse event reporting system

Ongoing Compliance

☐Monitor customer complaints and adverse events

☐Keep records of all claims substantiation

☐Update labels when regulations change

☐File sales tax returns on time

☐Maintain business licenses and permits

☐Review marketing materials for compliance

☐Stay informed about FDA and FTC enforcement actions

Updates to Compliance Standards

Dietary supplement regulations are subject to change. We will notify you of any significant regulatory changes that may affect your business. However, you are ultimately responsible for staying informed about regulatory changes and ensuring ongoing compliance.

Questions About Compliance?

If you have questions about TinyBrander's manufacturing compliance, please contact us:

TinyBrander LLC PO Box 917 Acton, ME 04001

Email: support@tinybrander.com Website: https://tinybrander.com

For questions about your specific compliance obligations, please consult with qualified legal and regulatory professionals.

Disclaimer

This Compliance Information page is provided for educational purposes only and does not constitute legal or regulatory advice. You should consult with qualified legal counsel and regulatory consultants regarding your specific compliance obligations.

Tiny Brander LLC is not responsible for your compliance with applicable laws and regulations. You are solely responsible for ensuring that your business and products comply with all federal, state, and local requirements.

Last Updated: October 27, 2025