Physician's Choice
Is Physician's Choice FDA Approved? What the FDA Does and Does Not Do
The FDA does not approve dietary supplements before they are sold, but it does regulate their safety, manufacturing, and labeling. Like all dietary supplements, Physician's Choice products are subject to these requirements, not FDA approval. The same rules cover probiotic supplements: under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the FDA's role mostly begins after a supplement goes on sale.
- What the FDA does not do: approve supplements, their labels or their structure/function claims before sale, or test them before they are sold.
- What the FDA does: sets manufacturing and labeling rules, requires facilities to register, inspects them, tracks reports of side effects, and can act against unsafe products.
- Our manufacturers: All of our manufacturers are required to operate in FDA-registered facilities that comply with FDA's current good manufacturing practice (cGMP) requirements. Registered is not the same as approved.
- Our testing: We test every lot of our products, including for four heavy metals.
By the Physician's Choice Team. Updated October 9, 2026. FDA facts are from the FDA's own pages, linked below.
What the FDA does and does not do for supplements
The FDA's role, step by step, from FDA 101: Dietary Supplements and the FDA's Questions and Answers on Dietary Supplements.
| Step | Does the FDA do it? | Details, from the FDA |
|---|---|---|
| Approve a supplement before it is sold | No | Under DSHEA, the FDA has no authority to approve supplements before they are marketed. |
| Approve the label or claims before use | Generally no | Some claim types, such as health claims, need FDA review and authorization first. |
| Test products before they are sold | No | The FDA does not test supplements before they are sold to consumers. |
| Set manufacturing rules | Yes | Current good manufacturing practices, in 21 CFR Part 111. |
| Require facilities to register | Yes | Before a facility begins operating, renewed every other year. |
| Inspect facilities | Yes | Periodic inspections of supplement manufacturing facilities. |
| Review new dietary ingredients | Yes, by notification | A safety notification at least 75 days before sale, with some exceptions. |
| Track reports of side effects | Yes | Companies must send serious adverse event reports they receive to the FDA within 15 days. |
| Act against unsafe products | Yes, after sale | Ask for a voluntary recall, or act to remove a dangerous product from the market. |
What the FDA does oversee
Under federal law, companies that manufacture or sell dietary supplements are responsible for ensuring their products are safe and properly labeled. FDA regulations require supplement manufacturers to follow current good manufacturing practices (cGMPs) to help ensure their products meet standards for identity, purity, quality, strength, and composition. For supplements, those rules are in 21 CFR Part 111.
Labels have rules too. A supplement must be labeled as a dietary supplement, carry a Supplement Facts panel, and give a U.S. address or phone number for reporting serious reactions to the company.
Once a product is on sale, the FDA also reviews labels and other labeling, including websites. If a product is unsafe or breaks the law, the FDA can work with the company to bring it into compliance, ask for a voluntary recall, or act to remove a dangerous product from the market. Advertising is generally the Federal Trade Commission's job.
Our help center gives the short version in Are your products regulated and approved by the FDA?
Why supplements are not approved like drugs
A drug must be proven safe and effective for its intended use before it is sold. The law has no matching approval step for supplements, so the FDA's enforcement mostly comes after a product reaches shoppers. It also means the FDA keeps no complete list of the supplements sold in the U.S.
One step does come before sale for some products. A new dietary ingredient is one not sold in the U.S. before October 15, 1994. Unless it is already in the food supply in a form that has not been chemically altered, the maker or distributor must send the FDA a safety notification at least 75 days before the supplement goes on sale.
A product sold as a supplement but meant to treat, cure or prevent a disease is a drug under the law, and the drug rules apply.
FDA-registered is not FDA approved
All of our manufacturers are required to operate in FDA-registered facilities that comply with FDA's current good manufacturing practice (cGMP) requirements.
Facilities that manufacture, process, pack or hold dietary supplements for people in the U.S. must register with the FDA before they begin. Registration includes an assurance that the FDA may inspect the facility, and it must be renewed every other year.
The FDA is direct about what registration means. In its food facility registration guidance, it says a registration number means the facility is registered, and that it does not in any way convey FDA approval or endorsement of the facility or its products. The FDA also does not issue certificates of registration, and does not recognize ones issued by private businesses. So "FDA-registered" describes a facility. It does not mean a product made there is FDA approved.
What the label statement means
Our product pages include the FDA-required disclaimer alongside claims about how a supplement supports the body: "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."
The law requires this disclaimer when supplement labeling makes a structure/function claim: a claim about how a nutrient or ingredient affects the normal structure or function of the body, such as the FDA's example "calcium builds strong bones."
These claims are not pre-approved by the FDA. The company must have substantiation that a claim is truthful and not misleading, and must notify the FDA of the claim no later than 30 days after it starts selling the product with it. The second half of the statement is there because only a drug can legally claim to diagnose, treat, cure or prevent a disease. You can see the statement on the 60 Billion Probiotic product page.
How we test each lot
The FDA does not test dietary supplements before they are sold to consumers. Here is how we test ours.
We test every lot of our products, including for four heavy metals. Testing is performed by our contract manufacturers' in-house ISO/IEC 17025-accredited labs and, for select testing, independent third-party labs, primarily Eurofins.
For what the tests cover, see Is Physician's Choice Third-Party Tested?
If you have a reaction
If you experience an adverse event, stop using the product and contact your healthcare provider immediately. Please also notify us at support@physicianschoice.com or 1-877-395-2707.
Before you start a supplement
The FDA advises talking with your doctor, pharmacist or other health care professional before you buy or use a supplement, because some supplements can interact with medicines or other supplements. Our How to Take page covers directions, storage, and who should check with a doctor first.
Questions shoppers ask
Is Physician's Choice probiotic FDA approved?
The FDA does not approve dietary supplements before they are sold, but it does regulate their safety, manufacturing, and labeling. Like all dietary supplements, Physician's Choice products are subject to these requirements, not FDA approval. That includes 60 Billion Probiotic and our other probiotics.
Are probiotics FDA approved?
Probiotics sold as dietary supplements are not approved by the FDA before they are sold. The FDA counts live microbials, commonly called probiotics, as dietary ingredients, so the supplement rules apply.
Does the FDA regulate supplements?
Yes, mostly after they go on sale. The FDA sets manufacturing and labeling rules, requires facilities to register, inspects them, tracks reports of side effects, and can act against unsafe products. It does not approve supplements before they are sold.
What does "FDA-registered facility" mean?
It means the facility is registered with the FDA, as the law requires of facilities that make, pack or hold supplements for the U.S. The FDA says a registration number does not convey its approval or endorsement of a facility or its products. All of our manufacturers are required to operate in FDA-registered facilities that comply with FDA's current good manufacturing practice (cGMP) requirements.
Why does a supplement label say "These statements have not been evaluated by the Food and Drug Administration"?
The law requires it when a supplement makes a claim about how it affects the structure or function of the body. The FDA does not pre-approve those claims, and only a drug can legally claim to diagnose, treat, cure, or prevent a disease.
Does the FDA test supplements before they are sold?
No. The FDA says it does not test dietary supplements before they are sold to consumers. We test every lot of our products, including for four heavy metals.
Sources: U.S. Food and Drug Administration pages linked above, chiefly FDA 101: Dietary Supplements, Questions and Answers on Dietary Supplements and Questions and Answers Regarding Food Facility Registration. Product facts: Physician's Choice product pages and help center.