Navigating the FDA approval process for shilajit can be challenging, especially if you’re new to the regulatory landscape. As shilajit gains popularity in the U.S. for its health benefits, it’s crucial to ensure your product meets FDA requirements before introducing it to the market. Understanding these steps from the beginning can help you streamline the process and avoid delays.
In this blog, we’ll walk you through the key steps you need to follow to successfully navigate the shilajit FDA approval process for. From labeling to shipping regulations, we’ll cover everything you need to know to ensure your product is compliant. Keep reading to learn how to bring your shilajit supplement to the U.S. market with confidence.
1. FDA Compliant Dietary Supplement Labeling
The first step in the FDA approval process for shilajit is ensuring that your dietary supplement label complies with FDA guidelines. This means using structure-function claims, which are statements that describe the role of a nutrient or ingredient intended to affect the structure or function of the body. The label must include only these types of claims. Health claims or claims suggesting a therapeutic benefit are not allowed unless they have FDA approval.
2. Submit a 30-Day Pre-Market Notification
If your dietary supplement contains at least one structure-function claim, you must submit a 30-day pre-market notification to the FDA. This notification informs the agency of your intent to market the product and provides necessary details about the supplement’s composition and claims. This step is essential for ensuring that the product meets regulatory standards before it enters the U.S. market.
3. Ensure FDA Registration for Foreign Manufacturers
If your shilajit supplement is manufactured overseas, your foreign manufacturer must be FDA registered. Additionally, the manufacturer must have a U.S. agent who can act as the liaison with the FDA. This step ensures that the FDA can reach the manufacturer if necessary and verifies that the product complies with U.S. regulations.
4. Work with an FSVP Agent Who is PCQI Certified
An FSVP (Foreign Supplier Verification Program) agent is required for all dietary supplements that are imported into the U.S. The FSVP agent must be PCQI (Preventive Controls Qualified Individual) certified. This certification ensures that the foreign supplier is in compliance with the FDA’s food safety standards and that the shilajit supplement will be safe for consumption.
5. No License Required, but Shipping Time Must Be Considered
One of the key benefits of selling shilajit in the U.S. is that you do not need a license for distribution. However, it’s important to factor in transit shipping time from the overseas manufacturer to the U.S. The entire process can take anywhere from 1-2 months on average, depending on shipping logistics. While this is a relatively quick timeline for international trade, it’s important to plan accordingly to avoid delays.
Ready to Navigate the FDA Approval Process for Shilajit?
Navigating the FDA approval process for shilajit can seem overwhelming, but by following these five key steps, you can ensure that your product complies with FDA regulations and reaches the U.S. market smoothly. From labeling compliance to shipping logistics, each step plays a critical role in ensuring your shilajit supplement is safe and legal for consumers.
To learn more about how Quality Smart Solutions can help you navigate FDA regulations and other compliance processes, contact us today. For more detailed guidance on dietary supplement labeling, visit the official FDA page on dietary supplements.
