A supplement brand can outsource the making, not the responsibility

Key takeaways

• The FDA does not approve dietary supplements before they go on sale, so the company behind the label is the first and main safety check¹.
• A brand that hires another firm to make its products is still legally responsible for them, as the FDA told one such company in a 2017 warning letter⁵.
• You can search FDA warning letters and a health-fraud database for free, but a clean search proves less than most people assume⁹¹⁰.
• Every supplement label must list a U.S. address or phone number for reporting serious reactions, and companies must pass serious reports to the FDA within 15 business days¹²¹³.
• The scorecard below rates a brand on its record, manufacturing, paperwork and customer service before you spend a dollar.

In October 2022, the FDA sent warning letters to Amazon and Walmart. The products at issue were arthritis and joint-pain remedies sold under names like Artri and Ortiga².

FDA lab tests had found drugs in them that the labels never listed: the steroid dexamethasone, the anti-inflammatory diclofenac and the muscle relaxant methocarbamol². By July 2023, the FDA had learned of more than 30 more people with serious health effects, including stomach bleeding, adrenal problems and liver damage. The agency warned that some of these problems can be life-threatening or fatal².

The lesson is not that big stores are dangerous. It’s that a store is a shelf, not a screen. Nobody checked those bottles for the buyers before they were sold.

That job falls first to the company whose name is on the label, and then to you. The good news is that much of what you need to judge a supplement company is public, free and quick to find.

This guide shows you how to compare companies, not just bottles. If you already ask a farmer how the apples were grown, you have the right instinct. Here is how to point it at a supplement brand.

Nobody approves a supplement before you buy it

Under the 1994 law that governs supplements, the FDA has no authority to approve them before they reach the market¹. Companies must make sure their products are safe, truthfully labeled and made under federal manufacturing rules¹.

The FDA’s oversight mostly starts after a product is for sale. The agency inspects facilities, monitors the market, reviews complaints and adverse event reports, and acts when it finds a problem¹. It does not routinely test what’s inside supplements, and it doesn’t keep a complete list of the products sold in the U.S.¹.

The inspection math is sobering. In 2023, Cara Welch, then head of the FDA’s dietary supplement office, said the agency inspects roughly 500 to 600 supplement facilities a year, about 5% of the facilities it knows about, according to a trade-press report³. FDA records obtained by that publication showed 600 inspections in fiscal 2024: 510 in the U.S. and 90 abroad³.

At that pace, many facilities go years between visits. A brand’s name on a shelf tells you it is for sale. It does not tell you that anyone outside the company has looked inside the bottle.

The name on the bottle may not be the company that made it

Read the small print near the address. Federal labeling rules require the label to name the manufacturer, packer or distributor⁶. If the named company didn’t make the product, its name must come with a phrase such as “Manufactured for” or “Distributed by”⁶.

That arrangement is legal, and it is not a red flag by itself. A brand can design a formula and hire a contract manufacturer to make the capsules.

What matters is whether the brand still takes charge of quality. The FDA has been blunt about this. In a November 2017 warning letter to Ultra Perform, a company that had other firms make its products, the agency said a company can hire out the work but “cannot … contract out its ultimate responsibility” for making sure its products are not adulterated⁵.

That company had no written quality-control procedures for its contract-made products and no quality agreements with its manufacturers⁵. In other words, it was selling products it had no system to check.

So the useful question is not “Do you make it yourself?” It is “How do you check what your manufacturer sends you?”

What the manufacturing rules require, and what inspectors keep finding

The federal manufacturing rules for supplements are called current good manufacturing practices, or cGMPs. They sit in Part 111 of Title 21 of the Code of Federal Regulations⁷. Five requirements matter most to you as a buyer:

• Identity testing. Before using any dietary ingredient, a maker must run at least one suitable test to confirm the ingredient is what it claims to be, unless the FDA grants an exemption⁷.
• Supplier paperwork, with limits. For other components, a maker may rely on a supplier’s certificate of analysis, a lab report listing tests and results, only after confirming the supplier’s results are reliable. It must re-check them periodically⁷.
• Finished-product limits. Each product needs written specifications for identity, purity, strength and composition, plus limits on contaminants⁷.
• Complaint handling. A qualified person must review every product complaint, and quality-control staff must approve the decision on whether to investigate⁷.
• Records. Records must be kept for one year past the shelf-life date, or two years after the last batch ships, and be available to FDA inspectors⁷.

Inspections often find gaps. FDA data obtained by the same trade publication show 278 supplement inspections in fiscal 2021. Of those, 143, about half, ended with a Form 483, the written list of problems an inspector hands a company at the end of a visit⁴.

A January 2026 warning letter shows what those problems look like. Inspectors who visited CC Pollen Company, an Arizona maker of bee pollen and royal jelly products, found no specifications for its finished products and bee pollen used without identity testing⁸. The firm also lacked a written master manufacturing record for a formula and used a lot of silica that had failed its own identity test⁸.

The letter doesn’t say anyone was harmed. It says the system meant to catch a problem wasn’t fully in place. That is exactly what you want to know about a brand before you buy from it.

Five free records to search before you buy

Search the brand name. If the label says “Manufactured for,” also search the manufacturer’s name if the company will tell you what it is.

1. FDA warning letters. The FDA posts its warning letters in a searchable online list that shows the company, the subject and whether a response or close-out letter is attached⁹. Look for subjects that mention CGMP, adulteration or misbranding. The agency notes that a company’s status may have changed after a letter went out, so look for that follow-up paperwork⁹.
2. The health fraud product database. This FDA list collects products tied to health-fraud actions, many of them sold as supplements with hidden drug ingredients¹⁰. Entries include weight-loss pills with undeclared sibutramine, “improvement” honeys and coffees with sildenafil or tadalafil, and pre-workout powders with DMAA¹⁰. FDA says the list holds only a small fraction of risky products, so a clean search means little¹⁰.
3. The FTC’s 2023 notice list. In April 2023, the Federal Trade Commission sent notices to about 670 companies that sell supplements, functional foods, homeopathic and over-the-counter products¹¹. The notices warned that unsupported health claims could bring penalties of up to $50,120 per violation. The FTC posted the list and stressed that being on it does not mean a company broke the law¹¹.
4. The NIH dietary supplement label database. The NIH Office of Dietary Supplements launched it in 2013, and it now holds more than 200,000 labels, including products no longer sold¹⁴. Because it keeps older labels, you can sometimes see how a product’s formula or claims changed.
5. FDA’s recall list. Search the brand on the agency’s recalls page too. A recall handled quickly and openly is very different from a pattern of them.

Two habits make these searches more useful. Read the actual letter, not just the headline. And search the parent company if the brand belongs to a larger firm, since letters go to the legal entity, not the logo.

The 15-minute brand scorecard

Give one point for each “yes.” Score a company once, not every bottle, and redo it every year or two.

#	Check	Where to look	What a “yes” looks like
1	Label lists a full U.S. address or a phone number with area code	The bottle	A street or P.O. box address, or a working phone line, not just a website
2	You can learn who made the product	Label, email	“Manufactured by,” or a named manufacturer on request
3	No CGMP or adulteration warning letter in five years, or a posted close-out for an older one	FDA warning letters	Clean search or documented fix
4	No products in the Health Fraud Product Database	FDA database	Clean search
5	No disease claims on labels, website or social posts	Website, social media	Words like “supports,” never “cures,” “treats” or “prevents” a disease
6	Explains how it tests finished products	Website, email	Names identity, strength and contaminant tests, and who runs them
7	Shares a certificate of analysis for your lot	Email	Test methods, limits and actual results, matched to your lot number
8	Uses an independent verification program for at least some products	Label, then the certifier’s own website	The product appears on the certifier’s public list
9	Has a clear process for complaints and reactions	Website, phone	A named way to report problems that a person follows up on
10	Customer service answers a safety question within a few business days	Email or phone	Specific answers, not a sales script

How to read your score

• 8 to 10: The company is acting like it has nothing to hide.
• 5 to 7: Ask follow-up questions about the gaps before you buy.
• 0 to 4: Keep looking. Plenty of companies will score higher.

Three findings end the review on their own: a product in the Health Fraud database, a claim to cure or treat a disease, or no U.S. contact on the label. A supplement marketed to treat or cure a disease is legally a drug¹, and a label without the required contact is misbranded¹².

Three questions to ask the company, and what good answers sound like

Send these by email so you have the answers in writing.

“Who makes this product, and how do you check what they send you?”
A good answer names the manufacturer or describes the brand’s own testing and supplier audits. A weak answer is “It’s made in an FDA-registered facility.” Every facility that makes, packs or holds supplements for U.S. sale must register before it starts work¹. Registration is a listing, not an inspection or an approval.

“Can you send the certificate of analysis for lot number ___?”
Federal rules describe what a usable one includes: the test methods, the limits and the actual results⁷. Be wary of a generic sheet with no lot number, or one that says only “pass.” The rules require companies to keep records for FDA inspectors⁷, not to hand them to you. A brand that shares anyway is showing its work.

“If I have a bad reaction, what happens to my report?”
The law gives you leverage here. A company must send any serious adverse event report it receives to the FDA within 15 business days and keep records of every adverse event report for six years¹³. “Serious” includes death, hospitalization, a life-threatening event and lasting disability¹³.

Filing a report is not an admission that the product caused the problem¹³. So a company has no legal reason to dodge the question. One that does is telling you how it treats complaints.

Check the label while you’re at it. For these reports, it must show a domestic street or post office box address, or a domestic phone number with an area code¹². A website or email address can be added but doesn’t replace them¹².

What the common shortcuts are worth

Most people judge supplement companies by habit. Here is how those habits hold up, using our four-level evidence scale.

Shortcut	What the record shows	Rating
“A big retailer sells it, so someone vetted it.”	The FDA sent warning letters to Amazon and Walmart over joint products with hidden drugs2.	Evidence says no
“A clean FDA record proves a company is careful.”	The FDA inspects about 5% of known facilities a year and says its fraud list holds only a small fraction of risky products, so a clean search can’t prove much310.	Evidence says no
“A brand that makes its own pills beats one that outsources.”	The law holds the brand responsible either way5. We found no study comparing the two.	Not enough evidence
“Weight-loss, sexual-improvement and bodybuilding products carry extra risk.”	FDA’s health-fraud database lists many such products with hidden prescription drugs10.	Strong evidence, from repeated FDA findings
“A detailed certificate of analysis signals a careful company.”	The rules spell out what a real one shows7, but no study links sharing one with better products.	Not enough evidence

The pattern is clear. Public records are good at flagging bad actors. They are poor at proving a company is good. That is why the scorecard mixes records with direct questions.

How to report a problem

If you think a supplement made you sick, stop taking it and get medical care if you need it. Then report it to the FDA through its online Safety Reporting Portal at safetyreporting.hhs.gov¹⁵. The FDA’s general phone line is 1-888-INFO-FDA (1-888-463-6332)¹⁵.

Also report it to the company, using the address or phone number on the label. That contact exists so serious reports reach the FDA¹²¹³.

For misleading ads or sales tactics, file a report with the FTC at ReportFraud.ftc.gov. Your state attorney general’s consumer protection office also takes complaints.

If someone has swallowed too much of a product or seems to be poisoned, call Poison Control at 1-800-222-1222. Call 911 for trouble breathing, chest pain or collapse.

Questions readers ask

The bottom line

The FDA doesn’t screen supplements before they’re sold, and it inspects only a small share of facilities each year. That leaves the brand as the main quality check, whether it makes the product or hires someone else to.

Fifteen minutes with free FDA and FTC records, a careful look at the label and three emailed questions will tell you a lot about who you’re buying from. You won’t learn whether a product works that way. You will learn whether the company behaves like it has something to protect besides its sales.

Related reading

• Third-party tested says what’s in the bottle, not that it works
• A supplement is a series of batches, not one product
• What gets into supplements that isn’t on the label
• How to compare two supplements that look identical
• Why supplement labels say ‘supports’ and never say ‘cures’

Sources

1. U.S. Food and Drug Administration. “Questions and Answers on Dietary Supplements.” FDA, 2026. fda.gov
2. U.S. Food and Drug Administration. “FDA Warns Consumers Not to Purchase or Use Artri and Ortiga Products, Which May Contain Hidden Drug Ingredients.” FDA, updated 2023. fda.gov
3. Long, Josh. “FDA Increases Annual Domestic, Foreign Dietary Supplement Inspections.” SupplySide Supplement Journal, December 13, 2024. supplysidesj.com
4. Long, Josh. “FDA Inspections of Dietary Supplement Facilities Fall—Again.” SupplySide Supplement Journal, December 13, 2021. supplysidesj.com
5. U.S. Food and Drug Administration. Warning Letter to Ultra Perform, Inc. FDA, November 22, 2017. fda.gov
6. Electronic Code of Federal Regulations. “21 CFR 101.5: Food; Name and Place of Business of Manufacturer, Packer, or Distributor.” National Archives, 2026. ecfr.gov
7. Electronic Code of Federal Regulations. “21 CFR Part 111, Subparts E, O and P: Production Controls, Product Complaints and Records.” National Archives, 2026. ecfr.gov (also subpart-O and subpart-P)
8. U.S. Food and Drug Administration. Warning Letter to CC Pollen Company. FDA, January 9, 2026. fda.gov
9. U.S. Food and Drug Administration. “Warning Letters.” FDA, 2026. fda.gov
10. U.S. Food and Drug Administration. “Health Fraud Product Database.” FDA, 2026. fda.gov
11. Federal Trade Commission. “FTC Warns Almost 700 Marketing Companies That They Could Face Civil Penalties if They Can’t Back Up Their Product Claims.” FTC, April 13, 2023. ftc.gov
12. U.S. Food and Drug Administration. “Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.” FDA, September 2009. fda.gov
13. Legal Information Institute, Cornell Law School. “21 U.S. Code 379aa-1: Serious Adverse Event Reporting for Dietary Supplements.” law.cornell.edu
14. NIH Office of Dietary Supplements. “Dietary Supplement Label Database (DSLD).” National Institutes of Health. ods.od.nih.gov
15. U.S. Food and Drug Administration. “How to Report a Problem with Dietary Supplements.” FDA, 2025. fda.gov