26 Dec How to Get Your Amazon Supplement Approved

Posted at 18:16h in Blog by Bronte Boyadzhyan

Selling dietary supplements on Amazon has become one of the fastest ways for new brands to launch nationally—but it’s also become one of the hardest product categories to get approved for. Amazon has dramatically tightened compliance requirements in the past few years. Brands now need third-party lab testing, compliant certificates, accurate labels, FDA-regulated claims, and proof their products are safe before listings go live.

If you don’t prepare your testing correctly, Amazon may reject your listing, remove it later, or suspend the entire account. The good news: with proper lab testing, documentation, and labeling, you can get approved smoothly and avoid constant compliance headaches.

This guide covers everything you need to know to get your supplement approved the first time, including:

What lab tests Amazon requires
How to obtain a compliant Certificate of Analysis (COA)
Required testing for identity, purity, potency, and microbes
Label requirements Amazon checks
Amazon claims you cannot make
How to choose the right lab
Common mistakes that get listings rejected
A step-by-step submission process

1. Why Amazon Requires Lab Testing for Supplements

Amazon is not the FDA, but Amazon must follow FDA laws for dietary supplements. To avoid liability, they require documentation proving:

The product is safe
The label is accurate
The supplement contains the ingredients you claim
No contaminants exceed allowable limits
The product is manufactured under GMP (Good Manufacturing Practices)

Amazon requires lab reports to demonstrate:

Identity (the ingredient is real)
Purity (no adulterants or contaminants)
Potency (the amount on label matches the formula)
Microbial safety
Heavy metal safety

If you’re new to selling supplements, think of Amazon’s testing rules as a “mini-FDA compliance check.”

2. Required Lab Tests for Amazon Supplement Approval

Below are the main tests Amazon almost always requires before approving a dietary supplement listing.

A. Identity Testing

This confirms the ingredient is what you claim on the label.

Common tests include:

HPTLC for botanicals
FTIR for protein powders
HPLC for active compounds
Microscopy (for herbal powders)

Amazon may request identity testing for:

Herbs
Botanicals
Extracts
Protein powders
Probiotics
Vitamins & minerals
Specialty compounds

If the ingredient identity is not verified, Amazon will automatically reject the listing.

B. Potency Testing

Amazon requires third-party verification that:

Ingredient levels match the Supplement Facts
The product is neither under-dosed nor over-dosed
Claims like “500 mg”, “10 billion CFU”, “2000 IU”, etc., are accurate

Examples of potency testing:

Vitamin C potency (mg)
Zinc potency (mg)
Curcumin potency (%)
Ashwagandha withanolide content
Probiotic CFU potency
Amino acid profile for protein powders
Caffeine content in energy supplements

C. Purity & Contaminants Testing

This includes tests for:

1. Microbial testing

Amazon typically requires:

Total Plate Count
Yeast & Mold
E. coli
Salmonella
Staphylococcus aureus

Some categories require Listeria.

2. Heavy Metals

Testing for:

Lead
Arsenic
Mercury
Cadmium

Amazon typically expects results below Prop 65 and FDA/USP limits.

3. Pesticide Screens

Required for botanicals, herbal extracts, and plant-based ingredients.

3. What a Compliant COA Must Include (Amazon Will Reject If Missing)

Amazon requires a third-party COA (Certificate of Analysis) with:

✔ Name & address of testing lab

✔ Name of product tested

✔ Lot number

✔ Test methods used

✔ Identity test results

✔ Potency test results

✔ Microbial safety results

✔ Heavy metals results

✔ Pass/Fail statement

✔ Signature of authorized lab personnel

✔ Date of analysis

Avoid COAs that are:

From the manufacturer only (not accepted)
Missing the lot number
Showing old dates (over 12 months for most products)
Missing test methods
Missing microbial testing

Amazon is strict. If even one field is incomplete, they will reject your submission.

4. Supplement Label Requirements Amazon Checks

Even if your lab testing is perfect, Amazon can still deny your listing due to label violations.

Here is what Amazon checks for:

A. Complete Supplement Facts Panel

Must include:

Serving size
Servings per container
Each ingredient amount
Percent Daily Values
Other ingredients
Allergen statements
Suggested use

B. Required FDA Statements

Amazon checks for:

The Dietary Supplement Disclaimer:
“These statements have not been evaluated by the Food and Drug Administration.”
The Not-A-Medicine Disclaimer:
“This product is not intended to diagnose, treat, cure, or prevent any disease.”

If missing, your listing will be flagged.

C. Manufacturer Information

Must include:

Company name
Address or “Distributed by”
Contact info

D. No disease claims

Amazon prohibits:

❌ Treats anxiety
❌ Cures depression
❌ Reduces blood pressure
❌ Treats diabetes
❌ Helps ADHD
❌ Solves insomnia
❌ Cures inflammation

You can say:

✔ Supports calm
✔ Supports healthy blood sugar
✔ Supports immune function
✔ Promotes relaxation

5. Amazon’s GMP (Good Manufacturing Practices) Requirement

Amazon requires proof your product was manufactured in a GMP-certified facility.

Accepted GMP documentation:

NSF GMP certificate
USP GMP certificate
State/FDA inspection documents
Third-party GMP audit paperwork
Manufacturer GMP registration

Amazon may ask for:

Batch manufacturing records
Ingredient spec sheets
Supplier verification documents

6. How to Choose the Right Lab for Amazon Testing

To avoid rejections, choose a lab that:

✔ Specializes in dietary supplement testing

✔ Uses HPLC, LC/MS, GC/MS, ICP-MS, HPTLC

✔ Issues Amazon-acceptable COAs

✔ Performs identity, potency, microbial, and heavy metals in-house

✔ Understands dietary supplement FDA/USP limits

✔ Has a quick turnaround time

Supplement categories requiring specialized labs:

Botanicals → need HPTLC
Herbal extracts → need active compound verification
Protein powders → need amino acid profile
Probiotics → need CFU potency and viability
Greens powders → need pesticides + heavy metals
Pre-workouts → need caffeine verification

7. Step-by-Step Submission Process to Get Approved

Follow this process to avoid delays:

STEP 1 — Get your supplement tested by a third-party lab

Tests needed:

Identity
Potency
Microbial safety
Heavy metals

STEP 2 — Review your COA for accuracy

Before submitting, verify:

Lot number matches your batch
Methods listed
Every ingredient accounted for
Microbial limits within USP ranges
No missing fields
COA is less than 12 months old

STEP 3 — Prepare your supplement label

Check for:

Correct Supplement Facts
Allergen labeling
FDA disclaimers
No disease claims
Contact info

STEP 4 — Upload COA + label to Amazon Seller Central

Under:

Compliance → Product Documentation → Dietary Supplements

STEP 5 — Wait for Amazon approval

Times vary:

Standard review: 24–72 hours
Complex formulas: 3–7 days
If rejected: resubmit with corrected documents

STEP 6 — Maintain updated COAs

Amazon may request:

New COAs every 6–12 months
COA per batch
Additional documents if policies change

8. The Most Common Reasons Amazon Rejects Supplement Listings

Below are the top issues that cause delays or rejections.

1. COA not from a third-party lab

Amazon rejects COAs provided by:

Your manufacturer
Your contract packager
Internal testing only

2. Identity test missing

Most common issue with herbs.

3. Missing microbial panel

Brands often only test potency—Amazon requires more.

4. Heavy metals missing for botanical or plant-based products

Amazon expects full metals testing.

5. Supplement label has disease claims

Amazon bots scan for banned phrases.

6. COA older than 12 months

Needs recent testing.

7. Missing lot number on the COA

Huge rejection trigger.

8. No GMP documentation

Amazon may request proof of compliance.

9. Advanced Tips to Increase Approval Success

A. Add QR codes on your label to your COA

Amazon loves transparency.

B. Include your lab results in your A+ Content

Boosts conversion.

C. Build a “Testing & Quality Assurance” page on your website

Amazon reviewers often check your website to verify legitimacy.

D. Use consistent terminology

Example:

“Turmeric Extract” on your label
Must match “Turmeric Extract” on your COA

Even small differences can trigger rejections.

10. Working With a Lab That Specializes in Amazon Compliance

Because Amazon’s rules shift constantly, many supplement labs now offer:

Amazon-ready COAs
Combined potency + microbial panels
Preformatted PDF reports
Guidance on label compliance
Support emails if Amazon requests clarification

If you want Amazon listing approval without back-and-forth headaches, working with a lab familiar with Amazon requirements makes the process seamless.

Getting your supplement approved on Amazon isn’t difficult—if you understand what Amazon requires. By preparing the correct lab testing, using a compliant certificate of analysis, ensuring your label follows FDA rules, and avoiding disease claims, you can get approved quickly and prevent listing removals or suspensions later.

Quality testing not only meets Amazon requirements — it gives customers the trust they need to choose your product over competitors.

Print page

How to Get Your Amazon Supplement Approved