The short answer: no. Under the Dietary Supplement Health and Education Act of 1994, usually shortened to DSHEA, the FDA has no authority to approve dietary supplements before they are sold, and it generally does not approve supplement claims or labeling before use either. Supplements are regulated, but the regulation is mostly post-market, which means the agency acts after a product is already on the shelf rather than before.
This matters to a lot of people right now. A Pew Research Center survey published September 10, 2026 found that 78 percent of US adults are currently taking at least one supplement, and The New York Times reported on the findings the following day in a piece by Alice Callahan on why experts doubt many of these products deliver a benefit. Below is what the law actually requires, taken from the FDA's own guidance and the Code of Federal Regulations, so you can judge a bottle for yourself.
What "Not FDA Approved" Does and Does Not Mean
The phrase gets used as an accusation and as a shrug, and it is neither. It describes which regulatory pathway a product travels, and supplements travel a different one from drugs.
| Claim | Accurate? | Detail |
|---|---|---|
| The FDA approves supplements before sale | No | DSHEA removed that authority. The FDA states it cannot approve supplements before marketing |
| The FDA reviews supplement claims before you see them | Generally no | The agency generally does not approve supplement claims or other labeling before use |
| Supplements are unregulated | No | Manufacturing, labeling, facility registration and claim substantiation are all governed by federal rules |
| A supplement without FDA approval is illegal | No | Approval is not available to seek. Most supplements are sold lawfully |
| Conventional foods are FDA approved before sale | No | Neither are they. Pre-market approval is the drug pathway, not the food or supplement pathway |
That last row is the one most articles leave out, and it is worth holding onto. Pre-market approval is what distinguishes a prescription drug. It is not the standard groceries meet either.
What the Law Does Require, and When
The useful question is not whether an agency signed off, it is which obligations exist and at what point they bite. Almost all of them land after a product is already for sale.
| Requirement | What it means | Before or after sale |
|---|---|---|
| Facility registration | Facilities that manufacture, process, pack or hold supplements must register with the FDA before beginning operations | Before |
| Current good manufacturing practice | 21 CFR Part 111 governs identity, purity, quality, strength and composition, so the bottle contains what it says in the amount it says | Ongoing |
| New dietary ingredient notification | Applies only to ingredients not marketed in the US before October 15, 1994. The firm files safety information with the FDA at least 75 days before the product enters commerce | Before, but only for new ingredients |
| Claim substantiation | A firm making a structure/function claim must hold substantiation that it is truthful and not misleading. It is generally not required to file that evidence with the FDA | Held by the company, not reviewed |
| Structure/function claim notification | The firm must notify the FDA of the claim no later than 30 days after first marketing the product, per 21 CFR 101.93(a)(1) | After |
| Labeling | Supplement Facts panel, the term dietary supplement, manufacturer details, other ingredients, net quantity, and a domestic contact for reporting serious adverse events | Before |
| Enforcement | Inspections, marketplace monitoring, import examinations, review of notifications, and investigation of adverse event reports | After |
Read the fifth row again, because it is the single most surprising line in the rulebook. When a supplement company puts a structure/function claim on a label, the deadline to tell the FDA is thirty days after the product goes on sale. The notification is a record of what was said, not permission to say it.
The Place the Burden of Proof Flips
For a drug, a company must demonstrate to the FDA that the product is safe and effective before anyone can buy it. For a supplement, the arrangement runs the other way. A firm generally does not have to give the FDA the evidence it relies on for safety before or after marketing, and if the agency wants to restrict or remove a product that is already selling, the work of establishing the problem falls to the agency.
This is not a loophole somebody found. It is the deliberate design Congress chose in 1994, and it is why the practical safeguards that matter to a shopper are the ones that sit outside the federal process: who made it, whether an independent lab tested the finished batch, and whether the claim on the front is the kind of claim anyone is allowed to make.
What a Supplement Is Allowed to Claim
There is a hard line in the regulations, and it explains most of the strange phrasing you see on labels. Under 21 CFR 101.93, a supplement may describe the role of a nutrient in maintaining normal structure or function of the body. It may not claim to diagnose, mitigate, treat, cure or prevent a disease. If a label crosses that line, the regulation says the product becomes subject to regulation as a drug, unless the claim happens to be an authorized health claim the product qualifies for.
| Type of statement | Example shape | Allowed on a supplement label? |
|---|---|---|
| Structure/function | Describes a nutrient's role in supporting normal function | Yes, with substantiation and the required disclaimer |
| Classical nutrient deficiency | States a benefit related to a deficiency disease, and says how common that deficiency is in the US | Yes, with substantiation and the disclaimer |
| General well-being | Describes general well-being from consuming the ingredient | Yes, with substantiation and the disclaimer |
| Disease claim | Says or implies the product treats, prevents or mitigates a disease | No. The product would be regulated as a drug |
| Authorized health claim | Uses wording the FDA has specifically authorized, where the product meets every condition | Only in the exact authorized wording, and only if it qualifies |
The regulation even defines the word disease for this purpose: damage to an organ, part, structure or system of the body such that it does not function properly, or a state of health leading to that, with diseases caused by essential nutrient deficiencies such as scurvy carved out. This is why supplement marketing so often gestures at a condition without naming it. Naming it would change what the product legally is.
The disclaimer attached to those permitted claims has its own rules and its own two versions. We took that apart separately in why labels say "these statements have not been evaluated by the Food and Drug Administration".
The Proprietary Blend Gap
One detail deserves its own heading because it changes how you read a panel. The Supplement Facts panel must declare each dietary ingredient and, depending on the ingredient, the amount per serving by weight, as a percentage of the Daily Value, or both. The exception is ingredients that are part of a proprietary blend. Those can be listed without individual amounts.
So a label can name fifteen impressive botanicals inside one blend and disclose only the total weight of the blend. The order of the list still tells you something, since ingredients run from most to least, but a blend can be almost entirely its cheapest component and the panel will look the same. If you are comparing two products and one of them hides its doses this way, you are not actually comparing them.
How This Compares to a Conventional Food
Supplements and conventional foods are two different regulatory categories with two different panels. A dietary supplement must be labeled as one and carries a Supplement Facts panel. A conventional food carries a Nutrition Facts panel and is not permitted to present itself as a supplement.
| Dietary supplement | Conventional food | |
|---|---|---|
| Panel on the label | Supplement Facts | Nutrition Facts |
| Pre-market FDA approval | No | No |
| Per-ingredient amounts always disclosed | No, proprietary blends are exempt | Ingredients listed by weight, with the panel's declared nutrients quantified |
| Governing manufacturing rules | 21 CFR Part 111 | Food current good manufacturing practice rules |
Neither column is a seal of quality. What the comparison gives you is a way to know which set of rules you are reading a label under.
Where SaladPower Sits
SaladPower is a conventional food, not a dietary supplement. It carries a Nutrition Facts panel, and the ingredient list is six whole organic ingredients: spinach, kale, carrot, broccoli, apple and lemon, blended whole and sealed in a shelf-stable 8 oz pouch. There is no proprietary blend, because there is nothing to blend into one. What is in the pouch is the food itself.
That is a description of a category, not a claim of superiority. A conventional food is not pre-approved by the FDA either, and being a food is not evidence that any particular product is good for you. If you want the specific nutrient numbers rather than the category, what SaladPower is good for lists them against the FDA claim thresholds, including the ones we fall below. For how a pouch compares with the formats this article describes, see SaladPower vs. a multivitamin, SaladPower vs. gummies and SaladPower vs. greens powders. And because processing is the other thing people ask about, is SaladPower ultra-processed works through the classification line by line.
Frequently Asked Questions
Are dietary supplements approved by the FDA?
No. Under the Dietary Supplement Health and Education Act of 1994, the FDA does not have the authority to approve dietary supplements before they are marketed. The FDA says so directly: it does not approve supplements, and it generally does not approve supplement claims or labeling before use either. Its role is largely post-market, which means acting after a product is already on shelves.
Does the FDA test supplements before they are sold?
Generally no. A company does not have to give the FDA the evidence it relies on for safety, either before or after it starts selling, with one exception: a supplement containing a new dietary ingredient, meaning one not marketed in the United States before October 15, 1994, requires a safety notification to the FDA at least 75 days before it enters commerce. Everything else reaches the shelf without an FDA safety review.
Who is responsible for making sure a supplement is safe?
The company selling it. Under the FD&C Act a firm is responsible for ensuring its supplements are not adulterated or misbranded, and manufacturers must follow current good manufacturing practices under 21 CFR Part 111, which cover identity, purity, quality, strength and composition. If the FDA wants to restrict or remove a supplement already on sale, the burden is on the agency to establish there is a problem.
Does 'not FDA approved' mean a supplement is unsafe or illegal?
No. It is a statement about a regulatory process, not a verdict on a product. Most supplements are sold lawfully, and no conventional food is FDA approved before sale either. What it does mean is that no government agency checked that specific product's safety, dosage or claims before you were able to buy it, so third-party testing and the quality of the manufacturer carry more weight than they would for a drug.
What does the FDA actually check on a supplement label?
The label must carry a Supplement Facts panel, the words dietary supplement or an equivalent such as iron supplement, the name and place of business of the manufacturer, packer or distributor, a list of other ingredients, the net quantity, and a domestic address or phone number for reporting serious adverse events. One gap is worth knowing: ingredients disclosed as part of a proprietary blend do not have to show the amount of each individual ingredient.
Sources
- Pew Research Center. Kikuchi, E. and Kennedy, B. "About 8 in 10 Americans take supplements, and many see them as important to their health," September 10, 2026. Read the original article
- Callahan, A. "Americans Love Supplements, but Experts Doubt Their Benefits." The New York Times, September 11, 2026. Read the original article
- U.S. Food and Drug Administration. "Questions and Answers on Dietary Supplements." fda.gov
- 21 CFR 101.93, Certain types of statements for dietary supplements. ecfr.gov
- 21 CFR Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. ecfr.gov
- Dietary Supplement Health and Education Act of 1994 (DSHEA), amending the Federal Food, Drug, and Cosmetic Act.
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.
