01
US
Supplements
Vitamins, nutraceuticals, listed medicines and functional foods.
- Pathway: medicine, food or supplement
- Ingredient and dose permissibility
- Claims, label and packaging review
- Listing, notification or registration
USA Regulatory Affairs
FDA and DSHEA compliance for dietary supplements.
We are a dietary supplement regulatory consultant for brands entering or growing in the US. We check every ingredient against DSHEA, build the Supplement Facts label, write structure-function claims your evidence supports and, where an ingredient is new, prepare the NDI notification.
Markets
US
Timeline
From 8 weeks
You receive
A DSHEA-ready label and claims file
US
Map your US pathway.
Three questions. We show the services your product needs before it can be sold in the United States.
Starting from this service
Where will you sell?
Where is the product today?
What kind of product?
Your pathway
Your pathway
- Recommended services appear hereWritten output
Question 1 of 3
What this covers
What US supplement compliance covers
In the United States, dietary supplements are regulated by the FDA under the Dietary Supplement Health and Education Act of 1994 (DSHEA). The FDA does not approve supplements before they are sold. The brand is responsible for making sure every ingredient is lawful, every claim is truthful and substantiated, and the product is made under current good manufacturing practice.
That responsibility shows up in four places. The label must follow the Supplement Facts rules in 21 CFR 101. Structure-function claims must stop short of treating or preventing disease, carry the required disclaimer and be notified to the FDA within 30 days of first marketing. Manufacturing must meet 21 CFR 111. Advertising is also policed by the FTC, which expects competent and reliable scientific evidence for health claims.
Ingredients not marketed in the US before 15 October 1994 may need a new dietary ingredient notification before launch; we handle that as its own service. We also review Amazon listings and retailer requirements, because platform rules are often stricter than the FDA and are where many launches stall.
If an ingredient in your formula is new to the US market, see new dietary ingredient notification.
US
WRITTEN OUTPUTS
INGREDIENT STATUS REVIEW
US-01
DSHEA status for every ingredient, with NDI questions flagged.
SUPPLEMENT FACTS LABEL
US-02
Panel, statement of identity and required label copy, laid out for your designer.
STRUCTURE-FUNCTION CLAIMS FILE
US-03
Claims, substantiation and the 30-day FDA notification.
MARKETING AND AMAZON REVIEW
US-04
Website, ads and marketplace listings checked against FDA and FTC rules.
CGMP DOCUMENTATION CHECK
US-05
Supplier and manufacturer paperwork reviewed against 21 CFR 111.
INSPECTION READINESS NOTES
US-06
What an FDA inspector would ask for, and where it lives.
What we cover
Supplements, cosmetics and medical devices.
Regulatory affairs for all three product categories, in Australia, the United States and the UAE. One team, one point of contact, whichever market you start in.
- Australia
- United States
- UAE
02
US
Cosmetics
Skincare, personal care and the borderline products in between.
- Cosmetic or therapeutic: classification
- Ingredient and safety checks
- Claims, label and packaging review
- Notification or registration
03
US
Medical devices
Devices, accessories and software that make medical claims.
- Device classification
- Pathway: inclusion, clearance or registration
- Labelling and instructions for use
- Claims and marketing review
Not sure which category your product falls into? That is the first thing we work out.
How it works
Four stages, each one in writing.
Every USA Regulatory Affairs scope follows the same four stages. You receive a written output at the end of each, so nothing depends on memory or a phone call.
01
Discovery
We learn the product, where it is sold today and how you plan to sell it in the US.
Written output: Discovery notes
02
Validation
Each ingredient, dose and claim is checked against DSHEA, FDA labelling rules and FTC guidance.
Written output: Validation report
03
Scope
We set out exactly what will be prepared, by whom, and when you will have it.
Written output: Signed scope
04
Build
Label, claims file, notifications and marketing review, delivered to the scope.
Written output: Final compliance file
Who this is for
US pathways by category
Listed medicines, from single actives to complex multis.
Strain selection, stability and claim wording..
Protein, pre-workout and recovery, food or medicine.
Cognitive claims handled with care.
FSANZ standards for foods that do more.
Collagen, skin and hair from the inside.
A note from Amelia
“The FDA doesn’t approve your supplement. That makes your paperwork the only thing standing between you and a warning letter.”
Often scoped together
Related services
AU
AUS Regulatory Affairs
TGA and FSANZ pathways for supplements, nutraceuticals, cosmetics and medical devices.
- ✓ A signed-off label and claims file
From 6 weeks
AU · US · UAE
CONTACT MANUFACTURING
Which markets your formula can enter, and in what order.
- ✓ A written market entry order
From 2 weeks
AU · US
Clinical Strategy
Study design that supports the claims you want to make.
- ✓ A claims-to-evidence plan
From 4 weeks
Questions
What founders ask about USA Regulatory Affairs.
If your question isn’t here, send it with your enquiry. We reply within two business days.
Does the FDA approve dietary supplements?
No. Under DSHEA the FDA does not approve dietary supplements or their labels before they are sold. The brand is responsible for making sure the product is safe, the ingredients are lawful and the claims are truthful and substantiated. The FDA acts after the product is on the market, through inspections, warning letters and, in serious cases, removal from sale.
What is DSHEA compliance?
DSHEA compliance means your product meets the Dietary Supplement Health and Education Act and the FDA rules built on it. In practice: every ingredient is a lawful dietary ingredient, new ingredients have been notified where required, the label follows Supplement Facts rules, claims stay within structure-function limits and the product is made under cGMP.
What are the supplement labeling requirements in the USA?
A US supplement label needs a statement of identity, net quantity, a Supplement Facts panel, a full ingredient list, the name and place of business of the manufacturer, packer or distributor, and allergen information. Any structure-function claim must carry the FDA disclaimer. Layout, type size and order are all regulated, so we deliver the label as a finished specification for your designer.
What is a structure-function claim?
A structure-function claim describes how an ingredient affects the normal structure or function of the body, such as “supports restful sleep”. It cannot claim to diagnose, treat, cure or prevent a disease. It must be substantiated, carry the FDA disclaimer and be notified to the FDA within 30 days of first marketing.
Do I need an NDI notification?
You may, if your product contains an ingredient that was not marketed as a dietary supplement in the US before 15 October 1994 and has not been present in the food supply in an unaltered form. The notification is filed with the FDA at least 75 days before launch. We confirm whether you need one as part of the ingredient review.
Can you prepare us for an FDA inspection?
Yes. We review your specifications, supplier qualifications, batch records and complaint handling against 21 CFR 111, and set out what an inspector would ask to see and where it is kept. If you have received a warning letter or inspection observations, we help you prepare the written response.
Further reading
Reformulating a supplement for different populations and markets
October 17, 2026
No Comments
A formula that suits young adults in Sydney may not suit older adults in Los Angeles or families in Dubai. Nutrient needs, diets, cultural requirements, climate and local rules all shift from one population to the next. Here is how we approach reformulating a supplement so it fits the people who will take it.
Launching and scaling a supplement brand across markets
October 17, 2026
No Comments
Expanding a supplement brand into a second or third country is rarely a copy and paste job. Each market brings its own rules for ingredients, claims, labels and post-market duties. Here is how we help brands sequence their markets, build once and scale without losing control of compliance.
Amazon and Shopify listings need the same review as your label
October 14, 2026
No Comments
A compliant label does not make a compliant listing. Product pages on Amazon and Shopify carry claims, images and keywords that regulators and marketplaces treat just as seriously as your pack. Here is why your listings deserve the same review as your label, and what to check before you hit publish.
Collagen coffee: when your supplement is legally a food
October 14, 2026
No Comments
Add collagen to coffee and you might think you have made a supplement. In most cases, regulators see a food. That changes the label, the ingredients you can use and the claims you can make. Here is how classification works for functional foods in Australia and the US, and why it matters early.
Your scope
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