Navigating Complexity

Launching a supplement in the United States is a challenging and complex task that demands a deep understanding of FDA regulations. Failing to navigate this process correctly can cost you significantly and delay your product launch by months.

Our team of regulatory experts is here to guide you through this process, using their extensive experience to ensure that there are no delays or issues with your product registration.

To launch a product in the USA, the following documents are required

  • Free Sale Certificate
  • Product Specification
  • Technical Certificate of Analysis
  • Certificate of Manufacturing (NSF Certificate)
  • 20 + Samples
  • Full Artwork and Labels
  • Certificate of Origin
  • Stability study (only on select cases)

The full registration process

  • Formulation Compliance.

    The supplement formulation will be reviewed and ensured to comply with US dietary supplement regulations.

  • Manufacturer Check.

    The supplement manufacturer must be registered and approved by the FDA. Without this approval, your supplement cannot be sold in the US.

  • Compliance checks.

    Option 1 - A full compliance report, which takes between 15-20 days to complete. This is a fully signed report by the FDA that confirms the legality of your entire product.

    Option 2 - Label check report. This involves an FDA review of the label to ensure it is formatted correctly and the health claims are accurate. Please note, this check does not cover other aspects of your supplement product, which may still be non-compliant with FDA regulations.

  • Samples for FDA label matching.

    You must send 20 packaged samples to the FDA. These will be cross-referenced with your initial compliance checks, and the FDA will conduct random ad hoc inspections of your finished products to verify that what you are selling matches the stored samples.

  • Prior notice shipment.

    Five days prior to shipping your supplement, you must submit the full product specification, a copy of the label, a declaration of origin, a free sale certificate, and a certificate of analysis to the FDA.

  • Best Before Date or Date of Manufacture.

    Depending on the chosen sales channel, you will either need to have Best Before Date or Date of manufacturer on your packaging. Please see below for more information.

  • Vet Certification.

    If your product contains ingredients of animal origin, you must obtain a full veterinary health certificate. A qualified veterinarian will need to inspect your shipment, approve it, and then seal it.

Where will you be selling your supplement?

Retail & Amazon

If you plan to sell your products in retail outlets or on Amazon, you are required to include a Best Before Date (BBE) on all packaging. Furthermore, a full stability test must be underway on your supplement at the time of shipment. It is important to note that accelerated stability tests are not permitted.

D2C

If you are planning to sell your supplement online (not on amazon), then you will not need to put a BBE on your packaging. Instead, you will need to place the date of manufacture on your supplement.

Important information

  • To sell your product in the USA, you must use a manufacturer approved by the FDA.
  • When storing your product in the USA, it must be kept in an FDA-approved warehouse.
  • Your label must include either a USA registered office address or the address of a US distributor.

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