Safety & Compliance
Regulatory & Compliance Information
Our Commitment to Quality and Compliance
Revival Nutrition and Revival Sprouts® products are dietary supplements regulated under the Federal Food, Drug, and Cosmetic Act, as amended by the Dietary Supplement Health and Education Act of 1994 (DSHEA).
We are committed to responsible formulation, transparent labeling, and compliance with applicable federal regulations governing dietary supplements in the United States.
Regulatory Classification
Our products are classified as dietary supplements. Dietary supplements are regulated differently than prescription and over-the-counter drugs.
They are not intended to diagnose, treat, cure, or prevent any disease.
FDA Oversight
Dietary supplements are not approved by the U.S. Food and Drug Administration prior to marketing. However, they are subject to FDA regulation regarding:
- Manufacturing standards
- Labeling requirements
- Ingredient safety
- Adverse event reporting
- Marketing claims
We comply with these applicable regulatory requirements.
Good Manufacturing Practices (cGMP)
Our products are manufactured in facilities that follow current Good Manufacturing Practices as outlined in 21 CFR Part 111.
These regulations establish standards for:
- Identity verification
- Purity
- Strength
- Composition
- Quality control
- Recordkeeping
- Packaging and labeling
Manufacturing facilities are subject to inspection by regulatory authorities.
Labeling Compliance
All product labels include:
- A Supplement Facts panel
- A complete ingredient list
- Serving size and suggested use
- Required warnings
- Manufacturer or distributor information
- Required FDA disclaimer for structure/function statements
Structure/function statements are used in accordance with federal regulations and are accompanied by the following statement:
“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.”
Structure/Function Claims
Revival Nutrition products may include statements describing the role of a nutrient intended to affect normal structure or function in the body.
We do not make drug claims. We do not represent our products as treatments or cures for medical conditions.
All claims are reviewed for compliance with DSHEA standards and applicable guidance.
Ingredient Standards
Ingredients are selected based on:
- Regulatory permissibility
- Safety considerations
- Supplier documentation
- Identity and purity specifications
We maintain documentation to support ingredient identity and formulation standards.
Quality Control & Testing
Quality control procedures include:
- Raw material verification
- Batch record documentation
- Identity and potency testing consistent with manufacturing standards
- Stability considerations where applicable
Testing protocols may vary depending on the ingredient and formulation.
Adverse Event Reporting
We monitor and document consumer-reported adverse events in accordance with federal requirements. Serious adverse events are reported to the FDA as required by law.
If you believe you have experienced an adverse event related to one of our products, please contact us immediately at:
marketing@revivalnutrition.com
Iron-Containing Products
Products containing iron include the federally required warning statement regarding accidental overdose, in accordance with applicable regulations.
Consumers should read and follow all label instructions carefully.
Responsible Marketing
We are committed to ethical marketing practices and compliance with:
- FDA dietary supplement regulations
- Federal Trade Commission advertising standards
- Applicable consumer protection laws
Our educational content is intended to provide general information and should not replace individualized medical advice.
Healthcare Consultation
Consumers are encouraged to consult with a qualified healthcare professional before starting any dietary supplement, especially if pregnant, nursing, taking medication, managing a medical condition, or purchasing for a child.
Disclaimer
Revival Nutrition products are dietary supplements. Statements on this website have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.
