Our healthcare and business law firm works with many providers and other allied health professionals who are beginning their journeys of opening a Medical Spa. Medical Spas have been growing in popularity across the country. They are unique practices in that they involve many medical and non-medical procedures. There are many factors to consider in opening a medical spa and/or IV hydration clinic, and this medical spa series focuses on key factors to consider when opening a medical spa in Georgia. Although our healthcare law firm has assisted numerous clients in establishing a medical spa from the ground up, each client continues to present unique issues requiring our firm to research and analyze the nuances of each client’s intended setup. This Georgia Medical Spa Series is intended to provide spas.
This post in the Georgia Medical Spa Series focuses on a newer treatment, nicotinamide adenine dinucleotide (“NAD+”), which is a newer treatment our clients have inquired about. If you have questions regarding this blog post or would like to speak with counsel regarding opening your medical spa practice, you may contact us at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, firstname.lastname@example.org. You may also learn more about our law firm by visiting www.hamillittle.com.
- NAD+ is a dietary supplement.
NAD+ is currently a dietary supplement (not an “approved drug” by the Food and Drug Administration (“FDA”)). “The FDA generally does not approve dietary supplement claims or other labeling before use.” Questions and Answers on Dietary Supplements, FDA.gov. As such, it is on the manufacturer and distributor to “ensur[e] that the dietary supplements it manufactures or distributes are not adultered, misbranded, or otherwise in violation of federal law.” Id.
- NAD+ does not require a prescription in Georgia.
NAD+ is also not a prescription-requiring “dangerous drug” in Georgia. See O.C.G.A. § 16-13-71. So a preliminary review of intravenous injections of NAD+ shows that it is a dietary supplement and does not require a prescription.
- Nevertheless, the FDA is testing NMN as a “drug.”
Despite the above, given some recent FDA pronouncements regarding NMN, there may be a “best practices” to consider. NMN is a precursor to NAD+ meaning it is needed in the body to produce NAD+; NMN can be orally ingested. In late 2022, the FDA stated that NMN can no longer be sold/distributed as a dietary supplement, and it is undergoing FDA testing as a “drug.” See FDA NMN Letters, available here. Thus, it is foreseeable that NAD+ may come under increased scrutiny in the future.
Because IV hydration therapy in Georgia requires physician or mid-level evaluation already, the best practice to consider is to ensure the evaluating-provider determines how to incorporate NAD+ into a patient’s IV therapy plan and specifies that clearly within a written order.
This subject appears to be a developing area. If you have questions regarding this blog post or would like to speak with counsel regarding structuring your medical spa practice, you may contact us at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, email@example.com. You may also learn more about our law firm by visiting www.hamillittle.com.
*Disclaimer: Thoughts shared here do not constitute legal advice.