How are Dietary Supplements 

Regulated?

Under the Dietary Supplement Health and 

Education Act (DSHEA), companies are 

responsible for ensuring that the dietary 

supplements they sell are safe and properly 

labeled. Unlike drugs, FDA does not have the 

authority to approve dietary supplements or 

their labeling before they are sold to the 

public. In fact, companies can often introduce 

a dietary supplement to the market without 

notifying FDA. FDA’s role in regulating dietary 

supplements primarily begins after products 

enter the marketplace. If a product is found to 

be unsafe or not otherwise in compliance with 

the law, FDA can work with the company to 

bring the product into compliance or possibly 

remove it from the market.

What are Dietary Supplements?

Dietary supplements are products that 

are ingested and are intended to add to or 

“supplement” the diet. Supplements can 

come in a variety of forms, including tablets, 

capsules, softgels, gel caps, liquids, 

gummies, powders, and bars. 

Common dietary supplements include:

• Vitamins (such as multivitamins 

or individual vitamins like vitamin 

D and biotin) 

• Minerals (such as calcium, 

magnesium, and iron)

• Botanicals or herbs (such as 

echinacea and ginger)

• Botanical compounds (such as caffeine 

and curcumin) 

• Amino acids (such as tryptophan 

and glutamine)

• Live microbials (commonly referred 

to as “probiotics”)

Dietary supplements can be beneficial 

to your health, but they can also involve 

health risks. Before deciding whether 

to take a supplement, it is important to 

know the facts.

How are Dietary Supplements Labeled?

Dietary Supplements are required to have a 

Supplement Facts label that lists the serving 

size, the number of servings per container, each 

dietary ingredient in the product, and the amount 

of certain ingredients per serving. They are also 

required to have a statement on the front of the 

product identifying it as a “dietary supplement” or 

similar term (for example, “vitamin supplement”). 

Understanding 

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How Can You Be an Informed 

Consumer?

Read product labels, be cautious, and always 

talk to your healthcare professional—doctor, 

nurse, registered dietitian, or pharmacist—

before purchasing or taking any dietary 

supplement. They can help you decide which 

supplements, if any, might be right for you.

What Should You Do if You Experience 

an Adverse Event?

If you think that a dietary supplement may 

have caused you to experience an adverse 

event, you should:

1: STOP taking the supplement immediately

2: SEEK medical care

3: REPORT the adverse event to FDA

• Online via the Safety Reporting Portal

at www.safetyreporting.hhs.gov.

• Call an FDA Consumer Complaint

Coordinator. Contact information for

your local Consumer Complaint

Coordinator can be found at

www.fda.gov/consumer-complaintcoordinators or by calling FDA’s

SAFEFOOD Information Line at

1-888-SAFEFOOD (1-888-723-3366).

Any information you provide can help FDA 

identify unsafe products on the market and 

take action to protect the public.

Are There Any Risks in Taking Dietary 

Supplements?

Dietary supplements may contain ingredients 

that can have strong effects in the body, 

so always be alert to the possibility of a 

bad reaction or side effect (also known as 

an adverse event). Problems can occur 

especially if you:

• Take too much of some supplements

• Combine supplements

• Use supplements with medications

(prescription or over-the-counter)

• Take supplements instead

of medications

Adverse events can range from less serious 

to life-threatening and can include rash, 

fatigue, severe and persistent vomiting or 

diarrhea, difficulty urinating, severe joint 

and muscle pain, chest pain, or stroke. 

For more possible reactions, see 

www.fda.gov/dietarysupplements.

What are the Benefits of Dietary 

Supplements?

Dietary supplements can help you improve 

or maintain your overall health, and some 

supplements can also help you meet your 

daily requirements of essential nutrients. 

For example, calcium and vitamin D can 

help build strong bones. Even though dietary 

supplements can be beneficial, they should 

not take the place of the variety of foods that 

are important for a healthy diet. 

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