FDA & Regulatory Disclaimer

Purpose of this page

Our goal is to explain, in plain language, how U.S. Food & Drug Administration (FDA) regulation relates to medical services and technologies that may be discussed in consultation. We avoid absolute claims, and we present evidence in cautious, conditional terms (e.g., “may help,” “has shown potential in studies”).

About FDA Status

• The FDA evaluates certain medical products (such as devices, drugs, and biologics) for specific intended uses. FDA authorization, clearance, or approval applies only to those specific uses and labeling.
• Some services or techniques discussed during consultation may involve applications that are not specifically reviewed by the FDA for that use. In such cases, they are considered off-label or investigational in nature.
• Off-label use is a recognized part of medical practice in the United States and relies on clinician judgment, available evidence, and patient preferences. Results vary; not all patients benefit.

How We Discuss Evidence

• Educational materials may reference peer-reviewed literature, consensus statements, or clinical experience. Such summaries are not comprehensive, and new data may emerge over time.
• Any potential benefits are described using conservative, non-promissory language. Individual outcomes depend on many factors, and there is no guarantee of benefit.
• All medical decisions should be made in consultation with a qualified clinician who can consider your personal history, goals, risks, alternatives, and preferences.

Informed-Consent Process

• Before any procedure or program begins, we review the goals, logistics, expected course, and alternatives—including doing nothing.
• We discuss known and reasonably foreseeable risks as well as the uncertainties that may exist when evidence is limited.
• Participation is always voluntary, and you may withdraw consent at any time prior to treatment.

Safety & Contraindications (General)

• Screening may include medical history, medication review, and evaluation of any factors that could increase risk or reduce suitability.
• Certain conditions or implanted devices may represent a contraindication to specific interventions; your clinician will advise you accordingly.
• If a treatment is not clinically indicated or a better option is available elsewhere, we will discuss referral options.

Next Steps

If you’d like to discuss whether an approach may be appropriate for your situation, please request a consultation. This discussion is informational and does not obligate you to pursue care.

You can also review our Medical Disclaimer for details about limitations of evidence, risks, and alternatives.