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O-Selling Dietary Supplements on Amazon: Tips to Get Approved

May 30, 2024 · By Sneha Nisha, Lead Account Health Manager, VENDO

INTRODUCTION

Selling on Amazon has been a tumultuous experience for sellers this year, particularly for those in the vitamins and supplements category. While the supplement industry heavily depends on Amazon as a platform, it’s crucial to bear in mind that Amazon has strict quality assurance standards. The implementation of these new regulations has made the quality control process for supplements more stringent, applying to both existing and new products sold on Amazon.com. For those selling dietary supplements on Amazon who may be unsure about recent changes to approval policies, here is a summary of everything you need to know and how it could affect your brand.

WHICH PRODUCTS ARE CONSIDERED DIETARY SUPPLEMENTS?

Amazon acknowledges that dietary supplements are available in various forms, such as capsules, liquids, oral sprays, pills, powders, soft gels, and tablets. The testing requirements for dietary supplements on Amazon also adhere to the definition of a dietary ingredient by the US Food and Drug Administration (FDA), which includes vitamins, minerals, herbs, botanicals, amino acids, dietary substances for increasing dietary intake, concentrates, metabolites, constituents, extracts, or combinations thereof.

ARE THERE ANY SPECIFIC PRODUCTS OR INGREDIENTS THAT CANNOT BE PRESENT IN A DIETARY SUPPLEMENT SOLD ON AMAZON?

Yes, supplements cannot be listed on Amazon if they contain any of the following substances:

1. Sexual enhancement supplements: Sildenafil, Tadalafil, Vardenafil, Sulfoaildenafil, Desmethyl carbodenafil.

2. Weight loss supplements: SSibutramine, Desmethylsibutramine, Phenolphthalein, Fluoxetine.

1. Sports nutrition (bodybuilding) supplements: Ostarine, Ligandrol, 4-DHEA, Sibutramine and its analogs desmethylsibutramine and didesmethylsibutramine, DMAA.

As of December 6, 2021, Amazon prohibits the sale of sexual enhancement and weight loss dietary supplement products in single or double pill packs. Sellers must provide a new Certificate of Analysis (COA) every 12 months to prove the absence of prohibited substances in their listed dietary supplements, ensuring compliance with Amazon’s guidelines and product safety. Sellers should carefully review and adhere to Amazon’s requirements and guidelines for dietary supplements to avoid listing prohibited products and comply with relevant laws and regulations.

PRODUCTS THAT ARE OFTEN CLASSIFIED UNDER WEIGHT LOSS, SPORTS NUTRITION/BODYBUILDING, AND SEXUAL ENHANCEMENT SUPPLEMENTS CAN INCLUDE:

Yes, supplements cannot be listed on Amazon if they contain any of the following substances:

Weight Loss:

Appetite suppressants

Carb blockers

Fat burners

Herbal supplements for weight loss

Meal replacement products

Metabolism boosters

Sports Nutrition/Bodybuilding

Amino acid supplements

Creatine supplements

Performance enhancers for athletes

Pre-workout supplements

Post-workout supplements

Protein powders or shakes

Sexual Enhancement Supplements:

Erectile dysfunction supplements

Female libido enhancers

Herbal supplements for sexual health

Intimacy and arousal enhancers

Male enhancement supplements

Testosterone boosters

WHAT ARE THE REQUIREMENTS FOR SELLING DIETARY SUPPLEMENTS ON AMAZON?

You must have the following compliance documentation for dietary supplements (excluding sports nutrition and bodybuilding):

1.A valid good manufacturing practice (GMP) certificate from an accredited third-party certification body in compliance with 21 CFR 111 (for dietary supplements as defined at 21 U.S.C. 321(ff)), or 21 CFR Part 117 (for other human food products as defined at 21 U.S.C. 321(f)), or both. Amazon accepts GMP certificates from accredited third-party certification bodies such as NSF/ANSI 455-2, NSF/ANSI 173 Section 8, GRMA 455-2, UL GMP, USP GMP, Eurofins, SAI Global, SGS, Intertek, TGA, and SSCI.

2. A finished product Certificate of Analysis (COA) for declared dietary ingredients from an ISO/IEC 17025 accredited laboratory or in-house laboratory located in the above facility that complies with current GMPs (21 CFR Part 111 for dietary supplements as defined at 21 U.S.C. 321(ff)), or 21 CFR Part 117 (for other human food products as defined at 21 U.S.C. 321(f)), or both. (For more details on COA specifications, refer to “Requirements for the Certificate of Analysis” or “Frequently Asked Questions” below.)

OR

Evidence of product enrollment or participation in one of the following third-party quality certification programs: NSF/ANSI 173 Product Certification, NSF Certified for Sport®, BSCG Certified Drug Free®, Informed-Choice/Informed-Sport Program, USP Dietary Supplement Verification Program, or UL Brand Certification Program.

3. Product images that meet the following requirements:

Legible

Clearly show the entire product label (all sides), including facts panel, ingredients list, certification logos, identity statement, instructions for use, and product warnings

Contains the product name.

Contains the name and contact information of the brand owner or manufacturer

Direct image of the product or its packaging (computer-generated images or mock-ups not accepted)

Appear on the detail page of your product.

These documents may be requested by Amazon at any time, so it’s important to have them readily accessible.

FOR SUPPLEMENTS INTENDED FOR SEXUAL ENHANCEMENT OR WEIGHT LOSS/WEIGHT MANAGEMENT:

In addition to the above requirements, Amazon may ask you to submit a finished product Certificate of Analysis (COA) for the compounds listed in the table below for each dietary supplement product intended for sexual enhancement or weight loss and weight management. The COA must be issued by an ISO/IEC 17025 accredited laboratory. Amazon will not accept COAs from in-house labs for these compounds:

CategoryTest forFrequency of submissionSexual enhancementsSildenafil
Tadalafil
Vardenafi
Sulfoaildenafil
Desmethyl
carbodenafilAnnually

Weight loss and weight management

Sibutramine
Desmethylsibutramine
Phenolphthalein
Fluoxetine

Annually

Note:
Not all labs have the capabilities to test for these specific compounds. Depending on whether you sell sexual enhancement or weight loss and weight management supplements or both, you may need to use more than one lab. Amazon understands the following labs have broad capabilities: Covance; Eurofins; Silliker; BSCG; NSF; LGC; USP; and UL.

FOR SUPPLEMENTS INTENDED FOR BODYBUILDING AND SPORTS NUTRITION:

For each dietary supplement product intended for sports nutrition and bodybuilding, Amazon may ask you to submit the following:

1. A finished product Certificate of Analysis (COA) for the compounds listed in the table below for each dietary supplement product intended for sports nutrition (bodybuilding). The COA must be issued by an ISO/IEC 17025 or WADA accredited laboratory. Amazon will not accept COAs from in-house labs for these compounds.

CategoryTest forFrequency of submission

Sports nutrition	Selective androgen receptor modulators (SARMs): Ostarine (Enobosarm) Ligandrol (LGD-4033) Ostarine (Enobosarm) Ligandrol (LGD-4033) Anabolic steroids: Anabolic steroids: 4-DHEA (4-androstene-3α/β-ol-17-one) Stimulants: Sibutramine and its analogs desmethylsibutramine, and didesmethylsibutrmine DMAA	Annually

Sports nutrition

Selective androgen receptor modulators (SARMs):
Ostarine (Enobosarm) Ligandrol (LGD-4033)

- Ostarine (Enobosarm)
- Ligandrol (LGD-4033)
- Anabolic steroids:

Anabolic steroids:

- 4-DHEA (4-androstene-3α/β-ol-17-one)

Stimulants:
Sibutramine and its analogs desmethylsibutramine, and didesmethylsibutrmine
DMAA

Annually

Note:
Not all labs have the capabilities to test for these specific compounds. You may need to use more than one lab. Amazon understands the following labs have broad capabilities: Covance; Eurofins; Silliker; BSCG; NSF; LGC; USP; and UL.

OR

Evidence of product enrollment or participation in one of the following third-party quality certification programs: NSF/ANSI 173 Product Certification, NSF Certified for Sport®, BSCG Certified Drug Free®, Informed-Choice/Informed-Sport Program, USP Dietary Supplement Verification Program, or UL Brand Certification Program.

2. Product images that meet the following requirements:

Are legible.

Clearly show the entire product label (all sides), including the applicable facts panel, ingredients list, certification logos, identity statement, instructions for use, and any product warnings

Contains the product name.

Contains the name and contact information of the brand owner or manufacturer.

Are a direct image of the product or its packaging (a computer-generated image or mock-up will not be accepted)

Appear on the detail page of your product.

REQUIREMENTS FOR THE CERTIFICATE OF ANALYSIS

You need to provide a Certificate of Analysis (COA) in PDF format that supports the claimed amount per unit or per serving of each active or dietary ingredient on the applicable facts panel. The COA must have been issued within the past 12 months and contain the following information:

Complete product name

Batch number, lot number, or date code of the unexpired finished product sample that was tested

Name, address, and ISO accreditation number of the laboratory issuing the COA or the ISO/IEC 17025 accreditation certificate

The laboratory’s authorized representative’s signature, printed name, and title on the COA

Results from a laboratory assay performed to support the amount per unit or per serving of each active or dietary ingredient claimed on the applicable facts panel

A reference to the test method used for each dietary ingredient listed. If the test method is novel, not an Association of Official Analytical Chemists (AOAC) Official Method of Analysis, a modified version of these, or is in-house, the principle of the method should be stated (such as HPLC or GC). Actual data and observations should be recorded rather than non-specific “passes” or “conforms” statements.

The active or dietary ingredient name or names on the applicable facts panel must match the ingredient name or names on the COA

The unit of measure for each active or dietary ingredient on the applicable facts panel (such as g, mg, or mcg) must match the unit of measure on the COA

For sexual enhancement, weight loss and weight management supplements, as well as sports nutrition, the COA must include testing results for the specific compounds outlined in the tables above. The general COA requirements still apply.