Starting a supplement business is no easy endeavor. There is a lot involved in the process, including marketing, manufacturing, packaging, and distribution. You also need to ensure that the vitamins are in line with Food and Drug Administration (FDA) supplement regulations.

Soft Gel Technologies has been a contract manufacturer of soft gelatin capsules for the dietary supplement industry for more than 25 years. We meet and exceed FDA regulations to provide you with the highest quality of supplements for your business. Read on to learn more about dietary supplements and the FDA nutritional supplement regulations involved.

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What Is a Dietary Supplement?

A dietary supplement is one that is taken by mouth and contains ingredients such as vitamins, minerals, herbs, or botanicals. They come in various forms such as:

  • Softgels
  • Capsules
  • Tablets
  • Liquids
  • Energy bars
  • Powders

Are Supplements Regulated by the FDA?

In general, there are no FDA supplement regulations a company must follow before placing a product on the market. A manufacturer does not even have to prove a dietary supplement is safe before it is marketed. If the manufacturer makes claims, they do not have to be proven to be truthful or accurate.

The FDA’s job doesn’t begin until the supplements hit the marketplace. Once a supplement is on the market, the FDA has specific safety monitoring responsibilities. It must monitor adverse events caused by supplements and take action if they pose a significant risk of illness or injury. The FDA may also review product labels and promotional materials to ensure the supplement is not misbranded.

Responsibilities of Manufacturers

The Dietary Supplement Health and Education Act (DSHEA) outlines FDA nutritional supplement regulations for manufacturers. The main rule is that the manufacturer or distributor is required to inform the FDA if the supplement contains a “new dietary ingredient.” They also must prove that the ingredient is safe for use in the supplement.

While a supplement may benefit those suffering from certain medical conditions, it is illegal for a manufacturer to claim that a supplement can alleviate a disease’s symptoms. It is also illegal to claim that a supplement can treat or cure a specific disease. 

The FDA requires that manufacturers place certain information on the labels of these supplements. FDA supplement regulations require the following information:

  • Name of the product
  • Name and location of the manufacturer, distributor, or packer
  • Appropriate labeling stating that the product is a “dietary supplement,” “herbal supplement,” “calcium supplement,” or similar term
  • Complete list of ingredients (all ingredients must be listed on the label)
  • Net contents of the supplement (weight, volume, quantity, etc.)

Contact Us Today

As you can see, it’s essential that the softgels you sell meet FDA regulations for vitamins and supplements. Soft Gel Technologies, Inc. goes above and beyond through supplier qualification, extensive testing, and ingredient traceability. Contact us today to learn more about our stringent processes and how we can help you start your supplement business.