NAD+ and glutathione are two of the most requested wellness products in the United States. Many wellness centers want to offer them because clients ask for support with energy, antioxidant activity, and general wellness. The problem is that the legal rules that apply to these compounds differ based on how the products are made and how they are used. The route of administration, the status of the ingredient, and the marketing claims all affect the legal category that applies.
At LumaLex Law, we help wellness centers, medical spas, supplement brands, and health businesses understand these rules so they can make safe decisions. This guide explains how centers can offer NAD+ and glutathione in a lawful way and how to reduce the risk of enforcement.
Why the Form of the Product Matters
Federal law generally treats oral products and injectable products under separate regulatory systems. The Food and Drug Administration regulates dietary supplements under the Dietary Supplement Health and Education Act, or DSHEA. FDA regulates injectable drugs under the Food, Drug, and Cosmetic Act, or FDCA. A product that qualifies as a dietary supplement follows one set of rules. A product that is an injectable drug follows a different set of rules.
Oral Products
Oral products include:
- Pills
- Capsules
- Tablets
- Powders
- Liquids that are swallowed
These products can qualify as dietary supplements if they meet the definition of a dietary ingredient and follow DSHEA. FDA does not treat oral NAD+ or oral glutathione as approved drugs when they are marketed as supplements with compliant labels and claims.
Injectable Products
Injectable products include:
- IV solutions
- Intramuscular injections
- Subcutaneous injections
Injectables bypass the digestive system and enter the body through sterile routes. FDA generally treats injectable products as drugs under the FDCA. Drugs must have FDA approval or must be compounded in compliance with federal and state rules and only for lawful medical use. FDA has stated that dietary supplements do not include products that are intended for injection.
Because of these distinctions, oral NAD+ and oral glutathione can qualify as dietary supplements. Injectable NAD+ and injectable glutathione do not qualify as dietary supplements and fall under drug rules.
Selling NAD+ and Glutathione as Dietary Supplements
Wellness centers can offer NAD+ and glutathione in oral form if the products meet DSHEA requirements. The regulatory path is clearer for oral products than for injectables.
Requirements for Dietary Supplements
A wellness center that sells NAD+ or glutathione supplements must follow dietary supplement rules. These include labeling, claims, manufacturing, and documentation.
1. Proper Labeling
A compliant supplement label must include:
- The correct statement of identity
- The net quantity of contents
- A Supplement Facts panel
- An ingredient list
- The name and address of the manufacturer, packer, or distributor
- The required DSHEA disclaimer when structure or function claims are used
FDA does not permit labels or marketing to state that a supplement can diagnose, treat, cure, or prevent disease. Statements that describe disease treatment turn a supplement into a drug. This applies even when the product is sold by a wellness center with a medical professional on staff.
2. Compliant Marketing
Marketing claims must stay within DSHEA limits. A wellness center cannot state or imply that oral NAD+ or oral glutathione can treat any disease. Prohibited claims include statements such as:
- Treats chronic fatigue
- Improves liver disease
- Reverses neurological disorders
Permitted structure or function claims include:
- Supports cellular energy
- Supports antioxidant activity
- Supports detoxification processes
These statements describe the function of the nutrient in the body. They do not describe disease treatment. Structure or function claims must include the required DSHEA disclaimer.
A wellness center should review all marketing materials before use. This includes print materials, website copy, social media content, and in-center education materials.
3. Ingredient Status
A product labeled as a dietary supplement must contain a lawful dietary ingredient. Some ingredients require a New Dietary Ingredient, or NDI, notification unless they were marketed as dietary supplements in the United States before 1994. Wellness centers should confirm that their suppliers have addressed any ingredient status questions and have handled NDI requirements if needed.
4. Good Manufacturing Practices
Manufacturers must follow Current Good Manufacturing Practices for dietary supplements. A wellness center should use reputable suppliers and keep documentation that shows compliance. Centers that private label products take on additional responsibilities as own-label distributors.
5. Serious Adverse Event Reporting
A seller of dietary supplements must maintain a process to collect and forward serious adverse event reports to FDA as required by law.
Why Oral Forms Have a Clearer Legal Path
Oral NAD+ and oral glutathione products can qualify as dietary supplements when they meet DSHEA requirements. This allows wellness centers to:
- Stock and sell the products
- Offer supplements as part of wellness programs
- Sell products online or in person
- Use private label programs if they meet all DSHEA rules
These activities do not require a medical professional when the center sells only lawful dietary supplements and stays within DSHEA claim limits.
Why Injectable NAD+ and Glutathione Are Not Dietary Supplements
Injectable products are not dietary supplements. FDA treats any injectable product as a drug. This applies even when the product contains the same ingredient as a dietary supplement.
Legal Status of Injectable NAD+
There is no FDA-approved NAD+ drug for IV or injectable use. FDA has issued safety communications about compounded NAD+ injections, including concerns about contamination and adverse events. FDA oversight of compounded NAD+ products continues through inspections, recalls, and compliance actions. A wellness center cannot lawfully buy raw NAD+ powder or a compounded NAD+ injectable for general use in clients.
Legal Status of Injectable Glutathione
Injectable glutathione is also an unapproved drug. FDA has evaluated glutathione for potential compounding but has not approved it as a finished drug product. Glutathione appears on a list of bulk substances that FDA places under enforcement discretion for 503A compounding in limited settings. This does not make the product FDA-approved and does not remove the need for medical supervision and patient-specific prescriptions. FDA has issued warnings about injectable glutathione after contamination events.
Requirements for Lawful Injectable Use
Injectables must follow drug rules. A wellness center may only offer injectable NAD+ or injectable glutathione through a lawful medical structure. This requires:
- A licensed prescriber
- A valid patient-provider relationship
- A patient-specific prescription for 503A compounded products
- Use of an FDA-approved drug or a lawfully compounded drug
- Proper medical oversight of administration
- Compliance with state medical practice and pharmacy laws
Wellness centers cannot buy bulk injectable ingredients or buy pre-made injectables for general administration. They cannot claim that a non-medical staff member may prepare or administer injectables. They cannot hold compounded injectables for office stock unless they come from a 503B outsourcing facility that is permitted to compound the substance for office use.
Risks of Noncompliance
A wellness center that offers injectable NAD+ or glutathione without meeting drug requirements can face:
- FDA warning letters
- State medical board actions
- State pharmacy board actions
- Product seizure
- Civil penalties
FDA has issued recalls of injectable NAD+ products for contamination. This shows the risk that centers face when they handle unapproved and non-sterile injectable compounds.
Understanding Compounded Injectables
Some centers attempt to offer injectables through compounding pharmacies. Compounding is lawful only within the limits set by federal and state law.
503A Compounding Pharmacies
A 503A pharmacy prepares drugs pursuant to prescriptions for identified patients. A 503A pharmacy cannot compound NAD+ or glutathione for general office use. A 503A pharmacy cannot supply bulk injectable products for stock. A wellness center that uses a 503A pharmacy must obtain a valid prescription for each patient before compounding occurs.
503B Outsourcing Facilities
A 503B outsourcing facility may compound drugs for office use, but only if the bulk substance appears on a list that FDA has reviewed and determined may be used. FDA places many substances, including glutathione, under enforcement discretion for patient-specific compounding but has not approved them for broad office-stock use. NAD+ is not on the 503B bulks list.
Because of these restrictions, centers often cannot hold injectable NAD+ or glutathione on hand unless they do so under a compliant medical structure with a licensed provider, patient-specific prescriptions, and proper documentation.
Why the Distinction Matters for Wellness Centers
Injectable services have higher demand and higher margins than oral supplements. They also carry higher legal risk. A wellness center must understand the distinction to avoid enforcement.
Oral Supplements
Oral supplements:
- Do not require medical staff
- Can be sold online or in person
- Fall under DSHEA
- Carry lower legal risk when labeled and marketed correctly
Injectable Products
Injectable products:
- Are drugs under the FDCA
- Require licensed medical oversight
- Must come from approved or lawfully compounded sources
- Carry medical and regulatory risk
A center that offers injectable NAD+ or glutathione without meeting these requirements exposes itself to FDA and state enforcement.
Best Practices for Wellness Centers
A wellness center should use a clear compliance plan.
If You Sell Oral Supplements
- Use reputable suppliers that follow cGMP
- Review labels and marketing materials
- Use compliant structure or function claims
- Keep documentation of sourcing and testing
- Follow serious adverse event reporting rules
If You Offer Injectables Through Medical Providers
- Contract with licensed physicians or nurse practitioners
- Use FDA-approved or lawfully compounded drugs from permitted pharmacies
- Ensure that each patient has a proper prescription
- Follow state medical practice and pharmacy laws
- Maintain clear protocols for storage and administration
If You Want to Offer Both
Many centers use a hybrid approach. They sell oral supplements as dietary supplements. They offer injectable services through a separate medical entity that employs or contracts with licensed medical professionals. This structure reduces corporate practice of medicine concerns and separates supplement sales from drug administration.
How LumaLex Law Helps Wellness Centers
LumaLex Law helps wellness centers that want to offer NAD+, glutathione, and other wellness products. We advise on:
- Dietary supplement labeling
- Marketing compliance
- Ingredient status reviews
- Medical director and prescriber agreements
- Compounding pharmacy relationships
- Corporate practice of medicine rules
- Protocols and forms for injectable services
We help centers understand the law so they can reduce risk and offer services in a clear and compliant way.
Understanding the Distinction
Wellness centers can legally sell NAD+ and glutathione when the products qualify as oral dietary supplements under DSHEA. Oral products have a clear regulatory path when they follow labeling, claim, and manufacturing rules. Injectable NAD+ and glutathione do not fall under DSHEA. FDA treats injectables as drugs that require medical oversight, lawful compounding, and strict compliance with federal and state law.
A wellness center that understands this distinction can build programs that meet client demand while staying within the limits of the law.
Work With LumaLex Law
If your wellness center wants to sell NAD+, glutathione, or other supplements, or if you plan to expand into injectable services, LumaLex Law can guide you through the legal requirements. We help wellness operators understand the rules, structure compliant programs, and avoid regulatory mistakes that could damage the business.
Contact LumaLex Law today to schedule a consultation and learn how to expand your supplement and wellness offerings safely and legally.
