Structure/Function Claims and FDA Notification: What You Need to Know When Launching Your Own Supplement Brand
When you launch your own supplement line, the claims you make on your labels and marketing materials become your responsibility. Structure/function claims are one of the most common — and most carefully regulated — types of statements used in the dietary supplement industry. Understanding the rules around them helps protect both your brand and your clients.
Here’s a clear overview of what structure/function claims are, what the FDA requires, and how the notification process works.
What Are Structure/Function Claims?
Structure/function claims describe the role of a nutrient or dietary ingredient in supporting the normal structure or function of the human body. They do not claim to diagnose, treat, cure, or prevent any disease.
Common examples include:
- “Calcium builds strong bones”
- “Supports immune function”
- “Helps maintain digestive regularity”
- “Promotes healthy energy levels”
These claims are allowed under the Dietary Supplement Health and Education Act of 1994 (DSHEA), provided they are truthful, not misleading, and properly substantiated.
The Required FDA Disclaimer
Every structure/function claim must be accompanied by this exact disclaimer:
This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
The disclaimer cannot be reworded. It is typically linked to the claim with an asterisk (*) and must appear prominently on the label.
Creatine Hydration Powder
This formula combines high-quality creatine monohydrate with essential electrolytes to support muscle energy, hydration, and workout performance. It’s designed to help you train harder, recover comfortably, and maintain proper mineral balance during activity. With a clean ingredient profile and refreshing taste, it fits easily into any daily routine. Ideal for anyone looking to support strength, endurance, and overall physical performance.*
Disclaimer: Please note that the actual product may slightly vary from the images shown on our website. Minor variations in packaging and content, such as color, design, or texture, may occur between production batches. These differences do not affect the quality or described functionality of the product.
Energy Strips
A strip power formulated with ingredients designed to support energy levels without the sugar crash commonly associated with energy drinks. It may assist with:
- Alleviating general tiredness*
- Reducing feelings of fatigue*
- Supporting wakefulness*
Disclaimer: Please note that the actual product may slightly vary from the images shown on our website. Minor variations in packaging and content, such as color, design, or texture, may occur between production batches. These differences do not affect the quality or described functionality of the product.
Focus Powder (Sour Grape)
Power up your mind with Focus Powder, a blend of nootropics, adaptogens, and essential vitamins designed to promote cognitive function, mental clarity, and sustained energy. With key ingredients like Alpha-GPC, L-Theanine, Natural Caffeine, and Asian Ginseng, this formula supports focus, memory, and alertness without the jitters. Whether you're studying, working, gaming, or training, Focus Powder helps you stay sharp and energized throughout the day.
Disclaimer: Please note that the actual product may slightly vary from the images shown on our website. Minor variations in packaging and content, such as color, design, or texture, may occur between production batches. These differences do not affect the quality or described functionality of the product.
Pure3 100% Whey Protein Isolate (Chocolate)
Our Chocolate Whey Protein Isolate is meticulously crafted to support muscle growth and recovery, providing an optimal blend of nutrients for athletes and fitness enthusiasts alike. This premium protein supplement is made with pure whey protein isolate, the purest form of whey available, ensuring maximum protein content with minimal fat and lactose.*
Disclaimer: Please note that the actual product may slightly vary from the images shown on our website. Minor variations in packaging and content, such as color, design, or texture, may occur between production batches. These differences do not affect the quality or described functionality of the product.
The 30-Day Notification Requirement
If your product carries a structure/function claim, you must notify the FDA within 30 days of first marketing the product with that claim.
Important points:
- This is a notification, not an approval process. The FDA does not pre-review or pre-approve structure/function claims.
- You are responsible for ensuring the claim is truthful and not misleading.
- You must have substantiation (competent and reliable scientific evidence) on file. You do not submit the evidence with the notification, but you must be able to provide it if requested.
Failing to notify the FDA on time can result in the product being considered misbranded under the Federal Food, Drug, and Cosmetic Act.
How to Submit the Notification
You can submit the notification either electronically or by mail.
Required information includes:
- Your company name and address (as the manufacturer, packer, or distributor)
- The exact text of the structure/function claim(s)
- The name of the dietary supplement (including brand name)
- The name of the dietary ingredient that is the subject of the claim
- A certification that the information is complete and accurate, and that you have substantiation that the claim is truthful and not misleading
Submission options:
- Electronic (preferred): Through the FDA’s Centralized Online Submission Module (COSM)
- By mail:
Food and Drug Administration
Center for Food Safety and Applied Nutrition (CFSAN)
Office of Dietary Supplement Programs (HFS-810)
5001 Campus Drive
College Park, MD 20740
Your Role as the Brand Owner
At Origin Well Nutrition, we handle formulation, manufacturing in cGMP-certified and FDA-registered U.S. facilities, label design, sampling, and fulfillment. We make the process of bringing your brand to life as straightforward as possible.
However, the selection of structure/function claims, the substantiation behind them, and the timely FDA notification remain the responsibility of the brand owner — you.
Getting this part right protects your professional reputation and builds long-term trust with the people you serve.
If you have questions about compliant claim language while developing your labels, our team is happy to guide you.
This page is for general informational purposes only and isn't legal advice. Regulatory requirements vary by product type, jurisdiction, and the specific claims you make — always confirm with a qualified regulatory or legal professional before finalizing your labels or marketing.
Want help figuring out which category fits your client base best? Get in touch with the Origin Well Nutrition team to start a discovery call.
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Focus Powder (Sour Candy)
Power up your mind with Focus Powder, a blend of nootropics, adaptogens, and essential vitamins designed to promote cognitive function, mental clarity, and sustained energy. With key ingredients like Alpha-GPC, L-Theanine, Natural Caffeine, and Asian Ginseng, this formula supports focus, memory, and alertness without the jitters. Whether you're studying, working, gaming, or training, Focus Powder helps you stay sharp and energized throughout the day.*
Disclaimer: Please note that the actual product may slightly vary from the images shown on our website. Minor variations in packaging and content, such as color, design, or texture, may occur between production batches. These differences do not affect the quality or described functionality of the product.
Oat Milk Honey Soap
Experience the pampering benefits of our Handmade Oat Milk Honey Soap, a natural skincare solution designed to nourish and gently exfoliate sensitive skin while offering a delightful summery fragrance.
Disclaimer: Please note that the actual product may slightly vary from the images shown on our website. Minor variations in packaging and content, such as color, design, or texture, may occur between production batches. These differences do not affect the quality or described functionality of the product.
Shilajit Gummies with Ashwagandha
Experience a dual-adaptogen formula that combines two highly concentrated botanical extracts in a clean, great-tasting gummy.
Disclaimer: Please note that the actual product may slightly vary from the images shown on our website. Minor variations in packaging and content, such as color, design, or texture, may occur between production batches. These differences do not affect the quality or described functionality of the product.
Gentle Balancing Toner
Revitalize your skin with our Gentle Balancing Toner, crafted with care for those with sensitive or blemish-prone skin. Harnessing the healing properties of green tea and the calming effects of chamomile, it gently supports your skin's natural balance. Ideal for daily use, this toner leaves your skin feeling refreshed and prepared for whatever comes next.
