FDA Regulations for Dietary Supplements

Stephanie Stiavetti
How were your supplements approved by the FDA?

If you have questions about dietary supplement regulation, you've come to the right place. Learn all about the process the FDA uses to decide which nutitional supplements are safe for you to take.

The Facts Behind Dietary Supplement Regulation

Dietary supplements are regulated by the Food and Drug Administration, also known as the FDA.

What Is the Food and Drug Administration?

The FDA is the federal agency responsible for making sure that health products are safe for public use. In addition to dietary supplements, the FDA also regulates foods, drugs, cosmetics, veterinary products and medical devices and equipment. Beyond simply approving products for use, the FDA also makes sure that manufacturers market these products honestly and accurately to the public.

When it comes to nutritional supplements, the FDA governs three particularly important areas:

  • Approving products for public use
  • Regulating labeling practices for accuracy and honesty
  • Setting manufacturing standards to guarantee product quality and safety (called Good Manufacturing Practice, or GMP, regulations)

How the FDA Regulates Supplements

In order for manufacturers to sell a new dietary supplement or ingredient, they must submit information to the FDA on how they determined that it is safe for consumption and that it performs to their claims. Any product or ingredient sold before October 15, 1994 is not required to have such documentation on file, as its safety is assumed based on the product's historical use.In order to remove a supplement from the market, the FDA must prove that a product is truly unsafe for public consumption. The FDA can also restrict a product if the information on its label is untruthful or misleading.

Companies cannot sell unsafe, ineffective supplements and must provide the FDA with documentation that their product will not hurt or injure anyone who takes it. Manufacturers must also provide convincing evidence that the product does what it claims, at least to some degree.

What a Label Can and Can't Say

There are specific regulations when it comes to what can and can't appear on a supplement's label. The first requirement is general information, which includes:

  • The supplement's name
  • Quantity of the supplement contained in the package
  • Name and location of manufacturer
  • Clear direction for the product's use

The label must also include:

  • Serving size
  • Dosage of product per serving
  • A list of all contained dietary ingredients
  • Percentage of daily nutritional value, as established by the National Institute of Health
  • Specific information regarding the accuracy of any health claims
  • The scientific name of all contained plants or botanicals
  • A list of all fillers, binders, and inactive ingredients

You should know that the FDA does not require manufactures to print a cautionary statement about any adverse effects that a supplement may cause. This means that despite what a product says on its label, you may have a bad reaction to it. It is very important for you to talk with a doctor or other qualified healthcare professional before taking any new nutritional supplements. Let your doctor know what medications and supplements you are already taking so that they can help you decide if it is safe to try something new.

The Involvement of Politics

As with other government agencies, there exists speculation of the involvement of politics when it comes to food and drug regulation practices. Many factors can affect the FDA approval process, and there is no proof either way to indicate that the FDA calls upon non-scientific data in its decision making. That said, being a federal entity, it makes sense to consider the fact that the administration will be affected by the country's political climate at any given time. Large pharmaceutical businesses do indeed fund large-scale health research, the implications of which are unclear at this point.

More Information

If you're interested in finding out more about dietary supplement regulation, there is a great deal of information available on the Internet:

FDA Regulations for Dietary Supplements