Launching your supplement brand is exciting, but navigating the maze of licensing and compliance can feel overwhelming. Generally, you do not need a license to sell vitamins and supplements in the EU or U. S. However, you still must follow certain laws and regulations in your target market and platform. Let’s break it down.
Do you need a license to sell vitamins and supplements in the EU?
In the EU, no central license is required. As a seller, you need to ensure your products comply with Directive 2002/46/EC for food supplements. For instance, your supplement labeling must provide the required information in the official language of the country where you market the product.
On a national level, you are mostly required to notify authorities in individual member states before marketing your products. For instance, in France, notification to the General Directorate for Competition Policy, Consumer Affairs, and Fraud Control (DGCCRF) is required.
The European Commission provides a list of competent authorities with contact information for each member state.
If you are marketing supplements that contain ingredients categorized as novel foods, you are responsible for ensuring that any such ingredient in your products has received the necessary authorization and that the products comply with all applicable EU regulations.
Compliance with Good Manufacturing Practices (GMP) is required at the manufacturing level, so you only need to ensure that your supplement manufacturer holds the corresponding certification.
Do you need a license to sell vitamins and supplements in the U. S.?
There is no federal licensing requirement specifically for selling supplements. However, meeting the Food and Drug Administration’s requirements is crucial. The FDA regulates dietary supplements under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
For example, it prohibits manufacturers and distributors from marketing supplements that are misbranded. Such products do not, among other things, list the name of each ingredient or do not identify the product by using the term ‘dietary supplement’.
Compliance with Current Good Manufacturing Practices (CGMPs) is mandatory to ensure product quality and safety, and failure to do so may result in enforcement actions. Always partner with a GMP-certified manufacturer only.
If the supplement contains a new dietary ingredient (NDI), you must ensure that the NDI has been properly notified to the FDA. NDIs require a pre-market notification with safety evidence at least 75 days prior to marketing the product.
Businesses must register their facilities with the FDA if they manufacture, process, pack, or store supplements. It means that the manufacturer must fulfill this requirement. If you only sell private label supplements or hire contract manufacturers to produce unique products for your brand, this does not apply to you.
Local and state governments may require business licenses or permits, depending on the jurisdiction.
Do you need a license to sell vitamins and supplements online?
While a special license may not be explicitly required to sell dietary supplements online, you must comply with a range of federal, state, and local regulations as we specified earlier in this blog post.
When you sell your products on platforms like Amazon, eBay, and Shopify, it is necessary to adhere to specific regulations and platform-specific policies. By doing so, you will ensure product safety and compliance. Below is an overview of the requirements for each platform:
1. Amazon
Your products must adhere to FDA labeling requirements, including accurate ingredient lists and avoidance of unapproved health claims. Moreover, Amazon requires adherence to specific regulatory standards and platform policies.
As a seller, you must provide a valid GMP certificate issued by an accredited third-party certification body, ensuring compliance with 21 CFR Part 111 (CGMP for dietary supplements) or 21 CFR Part 117 (CGMP for human food).
On April 2, 2024, changes to dietary supplements policy became effective. Now, you need a verification of your products through a third-party Testing, Inspection, and Certification (TIC) organization. You initiate testing via Amazon’s Manage Your Compliance dashboard and work directly with the TIC organization to complete product testing.
A finished product COA, issued by an ISO/IEC 17025 accredited laboratory, must support the amount per unit or per serving of each dietary ingredient claimed on the product label.
2. eBay
Sellers are responsible for ensuring that their dietary supplements comply with all applicable federal, state, and local laws, including FDA regulations.
eBay prohibits the sale of certain supplements, especially those containing banned substances or making unverified health claims. According to the Prescription and over-the-counter drugs policy, supplements must be new and their packaging original, unopened, and undamaged.
English must be used for all necessary labeling information. Listings must accurately describe the product, including its condition, ingredients, and any relevant warnings.
3. Shopify
This platform allows the sale of dietary supplements. As a merchant, however, you are responsible for ensuring your products comply with all relevant laws and regulations, including FDA guidelines.
Shopify’s Acceptable Use Policy prohibits the sale of products that are illegal, including certain controlled substances that may be present in some supplements.
Some payment gateways may have restrictions on processing payments for dietary supplements, especially those containing specific ingredients. Therefore, pay special attention to selecting the appropriate solution, such as Authorize.net or Merchant e-Solutions.
H2: To sum it up
Licensing and compliance are essential to running a successful supplement brand, whether you’re selling in the U.S., the EU, or online. By partnering with a GMP-certified manufacturer and staying informed on platform-specific requirements, you can ensure your business remains compliant. Ready to take the next step? Contact us to learn how we can support your brand.