Botox and dermal fillers: what the FDA says

Dermal fillers and botulinum toxin injections are offered at many med spas. This page summarizes what the U.S. Food and Drug Administration says about both, based on its consumer pages and safety alerts. This page is not medical advice.

What dermal fillers are and where they are approved

The FDA describes dermal fillers as medical device implants approved to help create a smoother or fuller appearance. The approved areas include the folds beside the nose and mouth, the cheeks, the chin, the lips and the back of the hands. Some fillers are absorbed by the body over time, so a patient may need repeat treatments. How long a result lasts depends on the filler material and the injection site.

The FDA lists approved uses for adults age 22 and older. Absorbable fillers are approved for moderate to severe facial wrinkles and skin folds, and for adding volume to the lips, cheeks, chin and hands. Non-absorbable fillers are approved only for the folds beside the nose and mouth and for cheek acne scars.

Uses the FDA advises against

The FDA advises against using fillers for body contouring, such as breast or buttock enhancement. It also advises against injecting fillers into the bone or muscle, or into the area between the eyebrows, the nose, the area around the eyes, the forehead or the neck. According to the FDA, injectable silicone is not approved for any aesthetic procedure.

If a provider suggests one of these uses, the FDA position is a reason to ask more questions before you agree.

Risks of fillers

The FDA names injection into a blood vessel as the most serious concern. It can cause tissue death, vision problems including blindness, and stroke. Common effects are bruising, redness, swelling, pain, itching and rash. Less common effects include infection, lumps under the skin, open wounds and allergic reactions.

The FDA also lists rare effects: a severe allergic reaction, filler that moves or ruptures, permanent hard lumps, and death. It says removal may be difficult or impossible, especially for permanent fillers.

Counterfeit and unapproved botulinum toxin

In an alert, the FDA said counterfeit Botox was found in several states and was injected into consumers for cosmetic reasons. The agency received reports of hospitalizations. Symptoms included blurred or double vision, difficulty swallowing, dry mouth and constipation. The FDA lists signs of the fake product: a specific lot number, an ingredient printed as "Botulinum Toxin Type A" instead of "OnabotulinumtoxinA", 150-unit doses that its maker does not produce, and in some cases non-English text on the carton.

In a later action, the FDA sent 18 warning letters to website operators that sell unapproved and misbranded botulinum toxin products. The FDA says these products carry serious health risks. Approved botulinum toxin products already carry a boxed warning about botulism-like effects, which can include muscle weakness, trouble breathing and death.

Who should give the injection

The FDA says a filler procedure should be considered a medical procedure, not a cosmetic treatment. It tells patients to select a provider who is trained to perform the injection and to ask about that provider's training and experience. Its guidance for providers says they should know the anatomy of the injection site. For botulinum toxin, the FDA tells patients to receive it only from a provider who is licensed and trained, and to confirm the product comes from an authorized source.

The FDA also warns against buying fillers online, because they may be counterfeit or not approved for use in the United States. It says not to inject yourself.

Questions to ask before treatment

The FDA suggests asking the provider about training and experience, the injection sites and their risks, and the product's patient labeling. The questions below build on that advice and on the FDA's safety information. The same ideas apply to botulinum toxin.

What training and experience do you have with fillers in this part of the face or body?
What are the risks at each injection site?
Is the product FDA-approved for this area, and can I see its patient labeling?
Does my history raise any concern, such as inflamed or infected skin, allergies, a bleeding disorder or a past severe allergic reaction?
What is your plan if a product is injected into a blood vessel?
Can you confirm the product came from an authorized source, and that you are licensed and trained to inject it?

When to get care and how to report a problem

The FDA says to seek immediate care for unusual pain, vision changes, white, gray or blue skin near the injection site, or signs of a stroke such as a drooping face, trouble speaking, or numbness or weakness in the face, arms or legs. After a botulinum toxin injection, trouble swallowing or breathing needs urgent care.

Problems with fillers or botulinum toxin can be reported to the FDA through its MedWatch program. Suspected counterfeit Botox can be reported to the FDA at 800-551-3989.

Also on this site: Questions to ask a med spa before treatment · all med spas by state.

Sources

Read on November 9, 2026. Rules and advice change. If something here is out of date, the contact page is at the bottom.