Selling vitamin gummies without the right license risks legal penalties and damaged credibility. Stay compliant to protect your brand and ensure customer trust.
Yes, most countries require licenses or certifications to sell homemade vitamin gummies. This ensures product safety, accurate labeling, and compliance with local health regulations. Selling without proper approval may result in fines, recalls, or business closure.
Read on to learn the exact steps to legally sell your vitamin gummies. Proper licensing keeps your business safe and trustworthy.
Understanding the Licensing Requirements
The need for a license to sell homemade vitamin gummies depends on your location and target market. In the United States, dietary supplements are regulated by the Food and Drug Administration (FDA) under the Dietary Supplement Health and Education Act (DSHEA). While the FDA does not require pre-approval for supplements, it enforces strict labeling rules, Good Manufacturing Practices (GMP), and facility registration.
If you plan to sell internationally, requirements may include certifications such as HACCP, ISO, or GMP compliance. Certain countries, like Canada and Australia, require product registration before sale. Without these licenses, your gummies could be seized at customs or prohibited from being sold.
Why Licensing Matters
Licensing isn’t just about legal compliance—it’s about customer safety and brand reputation. Unlicensed supplements can pose health risks if ingredients are mislabeled or contaminated. A license demonstrates to buyers that your vitamin gummies are produced in a safe, controlled environment, using approved ingredients.
Moreover, having the right certifications allows you to sell through more channels, including major e-commerce platforms, pharmacies, and supermarkets, which often require proof of compliance before listing products.
Steps to Get Licensed
- Research Local Regulations – Check your country’s dietary supplement laws. Identify which government agencies oversee supplements and their specific requirements.
- Develop Your Formula – Ensure your ingredients comply with local and international standards. Document everything for regulatory purposes.
- Choose a Licensed Manufacturing Facility – Even if you create the formula, production should be in a GMP-certified facility to meet safety standards.
- Register Your Business – Obtain a business license and tax registration.
- Follow Labeling Rules – Include ingredient lists, nutritional information, and required disclaimers. Avoid unverified health claims.
- Product Testing – Have your gummies tested for purity, potency, and contaminants.
- Apply for Necessary Certifications – Depending on the market, this may include FDA facility registration, HACCP, or ISO certification.
Common Mistakes to Avoid
- Skipping GMP Manufacturing – Homemade products without certified production increase contamination risks.
- Making False Claims – Overstating benefits can lead to regulatory action.
- Ignoring Market Requirements – Each country’s rules differ; don’t assume your home country’s license is valid abroad.
Why Choose Us?
At ENZ Wellness, we make the licensing process easier for you. As a GMP-certified, FDA-registered gummy vitamin manufacturer with over 15 years of experience, we handle production, testing, and compliance from start to finish. Our facilities meet international quality standards, ensuring your gummies are safe, consistent, and ready for market.
We also offer custom formulations, private-label services, and global export support, helping you launch your brand quickly and confidently while meeting all regulatory requirements.
Start right, stay compliant, and grow with confidence.