Comprehensive Regulatory Compliance Summary
Regarding the FDA General Wellness Policy and GRAS Status of Molecular Hydrogen
1. Introduction
This document provides a consolidated analysis of The H2 Therapy Company’s products and claims in light of the U.S. Food and Drug Administration (FDA) regulations, specifically:
- The FDA’s “General Wellness: Policy for Low Risk Devices” (Guidance, September 27, 2019), which outlines the regulatory framework for wellness products making general health claims without disease treatment claims.
- The FDA’s GRAS (Generally Recognised As Safe) Notification No. 520 (ucm409796-1.pdf) addresses the safety of molecular hydrogen dissolved in beverages.
This summary clarifies how The H2 Therapy Company’s products, including hydrogen inhalation devices and hydrogenated water preparation machines, align with FDA policies.
2. FDA General Wellness Policy for Low Risk Devices
2.1 Scope and Intended Use
The FDA defines general wellness products as those intended to:
- Maintain or encourage a general state of health or a healthy activity, without reference to diseases or medical conditions, or
- Support healthy lifestyle choices that may reduce the risk or impact of certain chronic diseases, where the association is well understood and accepted.
Examples of acceptable wellness claims include:
- Relaxation or stress management
- Antioxidant support
- Physical fitness
- Energy enhancement
- Sleep management
Unacceptable claims include:
- Diagnosing, treating, curing, or preventing any disease or medical condition.
2.2 Low Risk Requirement
General wellness products must be low risk, meaning:
- Non-invasive
- Not implanted
- Not involving hazardous technologies (e.g., lasers, radiation)
- Safe for general consumer use
2.3 Enforcement Discretion
The FDA does not intend to enforce device regulatory requirements (such as premarket review) for low-risk general wellness products that comply with these criteria.
2.4 Application to The H2 Therapy Products
- The H2 Therapy Company’s products are marketed with claims related to general wellness (e.g., relaxation, antioxidant support, energy enhancement) and do not claim to treat or cure diseases.
- The products are non-invasive hydrogen inhalation devices and hydrogen water preparation machines, meeting the low risk criteria.
- The company shares scientific research on hydrogen’s potential health benefits for educational purposes only, without making disease treatment claims.
Supporting FDA Guidance Quotes:“The first category of general wellness intended uses involve claims about sustaining or offering general improvement to functions associated with a general state of health that do not make any reference to diseases or conditions.”
(FDA Guidance, Section III, p. 3)“CDRH does not intend to examine low risk general wellness products to determine whether they are devices within the meaning of the FD&C Act or… whether they comply with the premarket review and post-market regulatory requirements.”
(FDA Guidance, Section II, p. 2)“A product’s inclusion under the general wellness policy in this guidance does not establish that it has been shown to be safe and/or effective for its intended use.”
(FDA Guidance, Section II, p. 2)
3. FDA GRAS Notification on Molecular Hydrogen in Beverages
3.1 Overview of GRAS Notice No. 520
- The FDA acknowledges that molecular hydrogen (H₂) dissolved in water up to 2.14% by volume is generally recognized as safe (GRAS) for use in beverages, including pure drinking water, flavored drinks, and sodas.
- This includes hydrogenated water produced with food-grade hydrogen gas (≥99.995% purity) under good manufacturing practices.
3.2 Safety and Exposure
- Hydrogen gas is non-toxic, non-carcinogenic, and chemically stable at proposed concentrations.
- Typical consumption of up to 2 liters of hydrogen-enriched water per day (approximately 3.2 mg hydrogen) is safe, with no adverse effects reported in scientific studies.
- Hydrogen is naturally present in the environment and some foods.
3.3 Application to The H2 Therapy Company’s Machines
- The H2 Therapy Company’s hydrogen machines can be used to prepare hydrogenated water consistent with these FDA GRAS guidelines.
- When operated to produce hydrogen-enriched water within the specified concentration and purity parameters, the product aligns with FDA-recognized safety standards.
- This supports marketing the machine for general wellness purposes such as antioxidant support and hydration enhancement.
Important Compliance Note:
While the GRAS status supports safety for consumption, no claims may be made that hydrogenated water cures, treats, or prevents diseases without FDA approval.
4. Regulatory Position on Disease Claims and FDA Approval
- The FDA requires rigorous premarket review and approval for any product claiming to diagnose, treat, cure, or prevent diseases.
- The H2 Therapy Company does not make such disease claims for its products.
- Any company claiming their hydrogen products are “FDA approved” for disease treatment without formal approval is making false or misleading claims.
Supporting FDA Quotes:“If the product’s intended uses are not limited to the above general wellness intended uses, this guidance does not apply.”
(FDA Guidance, Section III, p. 3)“Section 520(o)(1)(B) of the FD&C Act excludes software functions intended for maintaining or encouraging a healthy lifestyle and unrelated to diagnosis, cure, mitigation, prevention, or treatment of disease from the device definition.”
(FDA Guidance, Section I, p. 1)
5. Summary and Recommendations
| Aspect | The H2 Therapy Company’s Position | FDA Guidance Alignment |
|---|
| Product Claims | General wellness: relaxation, antioxidant support, energy | Allowed under general wellness policy |
| Disease Claims | None | Prohibited without FDA approval |
| Product Risk | Non-invasive hydrogen inhalation and water preparation devices | Low risk as per FDA criteria |
| Hydrogenated Water | Prepared using food-grade hydrogen, within GRAS limits | Recognized as GRAS for beverage use |
| Sharing Research | Educational only, no marketing as treatment | Allowed, provided no disease claims |
| FDA Approval Claims | No claims of FDA approval for disease treatment | Only valid if FDA formally approves product for such use |
6. References
