Understanding FDA regulations for dietary supplements can feel like jumping into the deep end without a life jacket. But I don’t want you to feel that way.
Whether you’re launching your first supplement or reviewing an existing product, this guide walks you through where to start, what to pay attention to, and the resources I return to again and again.
First, what does the FDA regulate?
The FDA oversees everything from what’s in your supplement to how you talk about it on your label. That includes:
- Ingredients and safety
- Label format and required statements
- Claims and how you word them
- Manufacturing standards (GMPs)
- Import requirements (if you’re producing outside the U.S.)
If your product is marketed as a dietary supplement in the U.S., it needs to follow specific federal regulations to stay on shelves and avoid red flags.
Who Else Regulates Dietary Supplements?
The FDA isn’t the only agency with eyes on your supplement. Depending on how and where you sell, you may also need to navigate:
- FTC (Federal Trade Commission)
They regulate your advertising. If you’re making claims online, in print, or in social media ads, the FTC wants those claims to be truthful, not misleading, and backed by solid evidence.
🔗 FTC Advertising Guide for Supplements - USDA
If your product includes agricultural ingredients and you’re labeling it organic, the USDA’s National Organic Program (NOP) gets involved.
🔗 USDA National Organic Program - State Regulators
Some states, like California and New York, have their own laws and enforcement teams. These can impact how you label, sell, or distribute your products in that state.
🔗 California Department of Public Health – Supplements - Customs and Import Authorities
If your supplement is made outside the U.S., it will be reviewed for compliance when entering the country. Even if your contract manufacturer handles this, your brand is still responsible.
🔗 U.S. Customs and Border Protection – Importing into the U.S.
Each of these groups has its own focus, but together they help keep the supplement space safe, accurate, and transparent. Knowing who does what helps you plan ahead and avoid surprises down the line.
Start Here: The Basics of Supplement Compliance
When I work with founders inside the program, we start simple. If you’re new to FDA compliance, this is where I recommend beginning:
1. Understand What a Supplement Is (Legally)
Make sure your product qualifies as a supplement and not a food or drug. The FDA defines a dietary supplement as a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet.
🔗 FDA Dietary Supplement Overview
2. Know the Required Elements of a Supplement Label
At minimum, every supplement label needs:
- A Supplement Facts panel
- Serving size and servings per container
- All active ingredients listed in the panel
- Other ingredients listed outside the panel
- The correct statement of identity and net quantity
- A domestic address or phone number for adverse event reporting
3. Understand What You Can (and Can’t) Say
You can make structure/function claims like “supports immune health”
You cannot say “prevents colds” or anything that sounds like you’re treating a disease.
4. Review Ingredient Safety and Compliance
If your supplement contains new dietary ingredients (NDIs), they may require FDA notification. You also need to be sure everything you’re using is safe and legal to include.
🔗 New Dietary Ingredient (NDI) Notification Guide
🔗 Dietary Supplement Ingredient Advisory List
5. Get Familiar with GMPs (Good Manufacturing Practices)
Even if you’re using a contract manufacturer, you are still responsible for compliance.
🔗 21 CFR 111 – Current Good Manufacturing Practice
Final Thoughts
If you feel overwhelmed, you’re not alone. The regulations are complex, but they’re there to protect consumers and your brand.
Start with the basics. Use trusted resources. And if you ever find yourself stuck in a gray area, don’t try to guess your way through it. That’s what I’m here for.
Need help with your supplement label?
Book a call and let’s make sure it’s done right the first time.
Happy labeling!
Lauren Rockteacher Consulting 
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