Amazon Requirements
Learn More About the Certificate of Analysis (COA) Requirements for Supplement Testing
In recent years, there have been many studies conducted that demonstrate that many of the supplements sold on the Amazon platform do not contain the concentrations of active ingredients as listed on the label.
Unfortunately, this means that the supplements in question do not provide the therapeutic benefits being promised to the consumer, which has led to an erosion of public trust in the entire dietary supplements industry. In response to these ongoing issues, Amazon has come out with a number of requirements that sellers of dietary supplements must meet in order to have their products listed on the site. Labofine is here to help break down these requirements and answer any questions you may have. Reach out to our team for additional information or to schedule an appointment with us!
What's Considered a Dietary Supplement by These guidelines?
If you list dietary supplements on Amazon, you must comply with federal, state, and local laws, as well as Amazon policies applicable to those specific products and their listings. The FDA defies dietary ingredients as minerals, vitamins, herbs, and other botanical, amino acid, dietary substances for people to supplement within their diets in an effort to increase total dietary intake or a specific concentrate. These supplements come in many different forms, including powders, pills, liquids, and oral sprays.
Amazon's Policy
If the product you wish to list on Amazon has a Supplement Facts panel, you will be required to submit proper compliance documentation. If the product has a Nutrition Facts panel, then this policy does not apply to you. If you wish to sell on Amazon, you’ll be required to provide documentation that states that any dietary supplement you’re selling on the store meets and complies with applicable regulations or standard requirements. These include, but are not limited to:
- 21 CFR 101.36 - Nutritional Labeling of Dietary Supplements
- 21 CFR 111 - Current Good Manufacturing Practice (cGMP) in manufacturing, packaging, labeling, or holding operations for dietary supplements
- 21 CFR 117 - Current Good Manufacturing Practice (cGMP), Hazard Analysis, and Risk Based Preventative Controls (HARPC) for Human Food
Required Documentation
Each dietary supplement requires the submission of one the following documents:
A finished copy of the Certificate of Analysis (COA) — This certificate must be issued by an ISO or IEC 17025 accredited lab (either in-house or third-party). The valid ISO certificate must also show the name of the accreditation body and the accreditation number must be submitted as well.
or
A finished copy of the Certificate of Analysis (COA) issued by an in-house laboratory that is compliant with proper manufacturing practices per 21 CFR 111 and 117. A valid GMP certificate of the manufacturing facility must also be submitted. Amazon does accept GMP certificates from third-party programs including: NSF (NSF/ANSI 173 Section 8), GRMA (GRMA 455-2), UL GMP, USP GMP, Eurofins, SAI Global, SGS, Intertek, TGA, and SSCI.
or
Evidence of Product or ASIN 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.
Along with one of the above documents, product images are also required.
To learn more about the specific requirements for the Certificate of Analysis (COA) and product images, please visit Amazon Seller Central or contact our team at Labofine.
Benefits of Supplement Testing From Labofine
Here at Labofine, we offer a wide range of services to help ensure that your dietary supplements meet all of Amazon’s requirements. The benefits of working with our team at Labofine include:
- We are ISO 17025 accredited
- We have a Certificate of Analysis that meets Amazon’s requirements
- We perform assay testing of finished products and raw materials in order to demonstrate the concentration of specific ingredients that match the claims made on the Supplement Facts panel
- Our team offers input testing of both herbal blends and proprietary ingredients
- We offer competitive pricing and quick turnaround times, including rush testing which is available for some tests and offers results within 24 to 72 hours.
Professional Supplement Testing
Before you decide to list your dietary supplements on Amazon, it’s important to ensure that your products meet all of the necessary requirements. In order to do that, you need professional testing from an analytical laboratory. Luckily for you, our team at Labofine is here to help!
We use state-of-the-art testing procedures and equipment to ensure that your dietary supplements not only meet Amazon’s requirements but that they also exceed those of your competitors.
In addition, Amazon recently imposed new testing requirements for supplements that treat erectile dysfunction. Before you can become a vendor who is allowed to sell sexual enhancement drugs on the site, you first must pass testing. As a result, we’ve added erectile dysfunction pills to the list of products we can test and examine.
In our testing, we will check to ensure that your product does not contain specific adulterants such as Tadalafil, Vardenafil, Sulfoaildenafil, and Desmethyl carbodenafil.
Here is a closer look at these potentially harmful ingredients:
Tadalafil
Tadalafil is a PDE5 inhibitor that is used to treat erectile dysfunction. It’s also sold under the brand names Adcirca and Cialis. While it is generally considered to be safe, there have been some reports of adverse effects when taking this drug. To be specific, Tadalafil can interact with some prescription medications and lower blood pressure to dangerous levels. This has been closely traced back to taking nitrates for heart disease or alpha-blockers for high blood pressure.
Vardenafil
Vardenafil is another PDE5 inhibitor that is used to treat erectile dysfunction. It’s sold under the brand names Levitra and Staxyn. Like Tadalafil, Vardenafil can interact with some medications and lower blood pressure to dangerous levels. The most common side effects of Vardenafil are headache, flushing, stuffy or runny nose, and upset stomach. In rare cases, Vardenafil can cause more serious side effects, such as sudden vision loss or hearing loss.
Sulfoaildenafil
Sulfoaildenafil is a synthetic version of sildenafil, the active ingredient in Viagra. It’s not approved for use in the United States, but it is sold as a dietary supplement. Sulfoaildenafil can interact with some prescription medications and lower blood pressure which can deprive the patient’s brain of both blood and oxygen.
Desmethyl Carbodenafil
Desmethyl carbodenafil is another synthetic version of sildenafil. Like sulfoaildenafil, desmethyl carbodenafil is not approved for use in the United States. And like all the other adulterants listed, it can seriously lower blood pressure when mixed with other prescription medications.
When you choose Labofine as your supplement testing partner, you can rest assured knowing that your products are in good hands. We will provide you with a Certificate of Analysis (COA) that meets all of Amazon’s requirements. To learn more about our supplement testing or to schedule an appointment with our team, reach out to Labofine today!
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