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FDA Supplement & Vitamin Regulation: Do Your Supplements Need Approval?

The FDA regulates both supplements and vitamins, but the process for approval can be confusing. This article will help entrepreneurs understand what is required for their business to sell supplements and vitamins, as well as advise on determining if a new supplement or vitamin needs FDA approval.


Are Supplements FDA Approved? What You Need to Know

To get started, it’s important to know that the FDA regulates two types of products: dietary supplements and conventional foods. Dietary supplements are regulated under the Dietary Supplement Health and Education Act (DSHEA) of 1994, while conventional foods are regulated under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Dietary supplements are defined as products that:

  • Are intended to supplement the diet
  • Contain one or more dietary ingredients (including vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandular, and metabolites)
  • Are intended to be taken by mouth as a pill, capsule, tablet, or liquid
  • Are labeled as a supplement

Vitamins are a type of dietary supplement regulated like all other supplements. This means that they do not need FDA approval before they are sold. However, the FDA has the authority to take action against a vitamin product if it is found unsafe.

To determine if your supplement or vitamin business needs FDA approval, you will need to answer the following questions:

  • What are the ingredients in your product?
  • How are the ingredients processed?
  • Are the ingredients from a natural source, or are they synthetic?
  • What are the intended uses for your product?
  • How will your product be labeled?

If you are unsure about any of these questions, it’s best to consult with a lawyer who specializes in FDA regulations.

Remember that even if your supplement or vitamin does not need FDA approval, you are still responsible for ensuring that your product is safe and accurately labeled. To learn more about how to do this, check out our other article on FDA regulation of supplements and vitamins.


Next Steps

Now that you know more about FDA supplements and vitamin regulation, it’s time to start planning your business. Starting your business off on the right foot will save you a lot of time and money in the long run.

The following resources can also help you get started:

  • Dietary Supplement Labeling Guide
  • Small Business Regulatory Enforcement Fairness Act
  • Federal Food, Drug, and Cosmetic Act
  • Code of Federal Regulations (CFR) – Title 21 – Part 111 – Good Manufacturing Practices for Dietary Supplements

If you have any questions about FDA supplements and vitamin regulation, feel free to reach out to us for help. We are here to support you every step of the way!


Did You Know?

The FDA does not need to approve vitamins or supplements before you sell them, but they can take action if a product is unsafe. Therefore, your product must be safe and accurately labeled.



The FDA regulates both supplements and vitamins, and the approval process can be confusing. Regardless, your product must be safe and accurately labeled. You can consult with a lawyer to determine if your product needs FDA approval.

Finally, remember to stay up-to-date on FDA regulations to avoid any issues in the future. As new regulations roll out, adjust your process accordingly.