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Not FDA-Approved: The Lung & Heart Disclaimer Explained

2026 guide  •  6 min read

Short answer: Statements on this website have not been evaluated by the Food and Drug Administration — a standard, legally required disclosure across the dietary supplement category.

Why this disclosure appears on essentially every dietary supplement

US regulations require this specific language on dietary supplement marketing — a category-wide legal standard, not a signal unique to PureLung + HemoPrime.

What "FDA Registered Facility" specifically means by contrast

PureLung and HemoPrime are manufactured in an FDA-registered facility following Good Manufacturing Practices; the FDA does not approve dietary supplements.

💡 Worth knowing: these products are dietary supplements and are not intended to diagnose, treat, cure or prevent any disease.

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