In March 2026, FDA analysis confirmed that Kian Pee Wan capsules — sold through Buy-herbal.com and an eBay storefront — contained two undeclared drug ingredients: dexamethasone, a corticosteroid, and cyproheptadine, an antihistamine with appetite-stimulating effects. A voluntary nationwide recall followed. You can read the FDA's official recall notice here.
What I want to talk about is not the recall. The recall is just evidence of what can go wrong when the right systems are not in place. What I want to talk about is what would have stopped it — and what you can do right now to make sure you are not next.
The dietary supplement industry is not short on cautionary tales. The FDA's Tainted Products Marketed as Dietary Supplements database lists hundreds of products found to contain undeclared active pharmaceutical ingredients (APIs). According to a 2023 analysis published in JAMA Network Open, nearly 776 dietary supplements were identified as containing undeclared drug ingredients between 2007 and 2022 — and that number almost certainly undercounts what is actually on the market. The Kian Pee Wan recall is not an anomaly. It is a recurring pattern, and it is almost always preventable.
Why Undeclared Drug Ingredients Show Up in Supplements
Before we get to the controls, it helps to understand how this happens in the first place. There are a few common pathways, and knowing which one applies to your supply chain changes what you need to prioritize.
The supplier problem. A raw material or finished product arrives from an overseas manufacturer with undeclared APIs already present — sometimes deliberately added to make the product "work," sometimes as cross-contamination from a shared production line. The importer or reseller either does not test or relies entirely on the supplier's certificate of analysis (COA). The COA is clean. The product is not.
The formulation knowledge gap. Some traditional herbal formulas have been used in combination with pharmaceutical compounds in their country of origin for decades. The manufacturer may not understand — or may not disclose — that this is the case. The U.S. distributor assumes they are selling an herbal product. They are selling a drug.
The labeling disconnect. A product is reformulated at the manufacturing level, an ingredient is swapped, and the change never makes it back to the label or the distributor's quality file. What is on the label no longer matches what is in the capsule.
In the case of dexamethasone and cyproheptadine specifically, both drugs are associated with appetite stimulation and weight gain — effects that would make an herbal "weight support" or "appetite" product appear to work remarkably well. That is not a coincidence. It is a pattern the FDA has documented repeatedly in this product category.
The Regulatory Framework You Are Working Inside
If you are importing, distributing, or selling dietary supplements in the United States, you are operating under 21 CFR Part 111 — Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. This has been in effect since 2010, and the FDA's enforcement posture has grown steadily more aggressive in the years since.
Here is what Part 111 actually requires that is directly relevant to undeclared ingredient situations:
21 CFR §111.70 — Component and Product Specifications. You must establish specifications for every component you use, including identity, purity, and the absence of contaminants. "The supplier said it was fine" does not satisfy this requirement.
21 CFR §111.75 — Testing and Examination. You must verify that your specifications are met before use. For finished products, you must confirm the identity of components and verify that finished product specifications are met. This means testing — not just reviewing a COA.
21 CFR §111.95 — Batch Production Records. You must maintain records sufficient to trace every lot through your manufacturing process. If an FDA investigator walks in and asks you to demonstrate that your finished product matches your label, you need to be able to show that.
21 CFR §111.465 — Required Testing. The regulation requires testing that provides statistical confidence in your results. A single point-in-time test on one sample from one lot does not accomplish that.
The practical consequence of non-compliance with these provisions is not just a recall. It is potential seizure, injunction, and criminal referral. The FDA has used all three in the supplement space within the last five years.
| Regulatory Requirement | What It Demands | Common Gap |
|---|---|---|
| 21 CFR §111.70 | Written component specifications including purity limits | Specs exist for identity only; no contaminant limits defined |
| 21 CFR §111.75 | Verification testing before use | Relying solely on supplier COA without independent testing |
| 21 CFR §111.95 | Complete batch production records | Records exist but cannot demonstrate label accuracy |
| 21 CFR §111.465 | Statistically valid finished product testing | Single-sample testing with no statistical basis |
| 21 CFR §111.140 | Master manufacturing records | Outdated records that don't reflect current formulation |
| FD&C Act §403(a) | No false or misleading label statements | Label doesn't reflect actual product composition |
What a Functioning Quality System Looks Like
I have worked with supplement companies at every stage of maturity, from startups sourcing their first contract manufacturer to established brands managing complex international supply chains. The ones that do not end up on the FDA's recall list generally share a few things in common.
Supplier Qualification That Actually Has Teeth
Most companies have a supplier qualification process on paper. Fewer have one that actually protects them. The difference is usually whether the process requires independent verification or just documentation review.
A functional supplier qualification program for dietary supplement components — especially anything sourced from overseas — includes:
- A current, completed supplier questionnaire with documentation of the supplier's own quality system
- At minimum one on-site or third-party audit before initial approval, and periodic re-audits (annually for high-risk ingredients)
- Independent laboratory testing of incoming materials, separate from the supplier's COA
- A risk-tiering system that assigns higher scrutiny to ingredients with a documented history of adulteration
For traditional herbal products, I would add a specific requirement: documentation from the supplier confirming the product has been screened for pharmaceutical adulterants. Not a general statement. A specific test, performed by an accredited laboratory, with results you can review.
Incoming Material Testing That Goes Beyond Identity
The most common gap I see is companies that confirm ingredient identity — they know they received what they ordered — but do not screen for what should not be there. Those are two different tests.
For higher-risk ingredients, including traditional herbal preparations and products sourced from regions where pharmaceutical adulteration is common, incoming material testing should include:
- Pharmaceutical adulterant screening by HPLC or LC-MS/MS — methods capable of detecting compounds like dexamethasone and cyproheptadine at low concentrations
- Heavy metals testing (USP <2232> or equivalent) for botanical ingredients
- Pesticide residue screening where applicable
The cost of this testing is real. So is the cost of a recall, and I mean that in a much broader sense than just the direct expenses. The reputational damage that follows an FDA recall announcement is not easily recovered from, especially for a small distributor.
Finished Product Testing as a Control, Not a Formality
Many companies test finished products to confirm potency claims and verify that labeled ingredients are present at stated levels. That is the right instinct. But the same testing program also needs to address what should not be present.
A complete finished product testing protocol for supplements should include:
- Confirmation that all labeled ingredients are present at claimed levels
- Screening for undeclared pharmaceutical compounds, particularly for product categories with documented adulteration history (weight loss, sexual enhancement, pain relief, appetite stimulation)
- Microbiological testing per 21 CFR §111.70(e)
- Retention of reserve samples from each lot for at least one year beyond the product's shelf life or expiration date
The FDA has published guidance on testing for pharmaceutical adulterants in supplements, and the methodology is well-established. There is no technical barrier here. The barrier is usually cost prioritization.
A Labeling Review Process That Keeps Up With Formulation Changes
One of the most overlooked failure modes is the gap between formulation and label. A product changes — a supplier changes, an ingredient is substituted, a concentration shifts — and the label does not update to match. Over time, what is in the bottle and what is on the label diverge.
A functional labeling control process includes:
- A documented change control procedure that links any formulation change to a mandatory label review
- A periodic label accuracy audit — at minimum annually — that compares the current label against the current batch production record
- A requirement that no formulation change goes into production without sign-off from both the quality function and a regulatory reviewer
This sounds like table stakes, and it is. But I have reviewed quality systems at companies that had been in business for a decade with no formal change control process connecting their manufacturing side to their labeling side. The risk that creates is exactly the kind of risk that produces an FDA recall.
The Import Dimension: A Separate Layer of Risk
The Kian Pee Wan recall involves a product being sold through an eBay storefront and a direct website — which tells you something about the distribution model. Products sourced overseas and sold through e-commerce channels represent a specific compliance profile that deserves its own attention.
Under 21 CFR Part 1, Section 1.83, importers of food and dietary supplement products are responsible for verifying that the foreign supplier has adequate preventive controls in place. This is not a courtesy — it is a legal obligation that has been in effect since the Foreign Supplier Verification Program (FSVP) rule was finalized in 2015.
The FSVP requires, at minimum: - A hazard analysis of the food being imported - An evaluation of the foreign supplier's performance and the risk posed by the product - Verification activities adequate to provide assurance that identified hazards are controlled - Corrective actions when verification activities reveal problems - Importer of record identification on every entry line
If you are importing dietary supplements and you have not formally documented your FSVP compliance, that is a gap that needs to close before your next shipment, not after your first warning letter. FSVP inspections have increased meaningfully since 2022, and the FDA's Center for Food Safety and Applied Nutrition (CFSAN) has made import compliance a stated enforcement priority for 2025–2026.
What a Pre-Market Compliance Review Should Include
If you are bringing a new supplement product to market — or reviewing an existing one that has not had formal compliance scrutiny — here is the minimum scope I would recommend:
- Label review against 21 CFR Part 101 and 21 CFR Part 111 — confirm that all required elements are present, that structure/function claims are properly substantiated, and that the label accurately reflects the product composition as manufactured
- Supply chain documentation review — confirm that supplier qualification records exist for all components, that COAs are on file for each lot, and that independent testing records exist
- Finished product specification review — confirm that specifications exist, that they are science-based, and that testing records demonstrate the product meets them
- Adulteration risk assessment — based on product category, ingredient source, and supply chain complexity, assess the probability that undeclared compounds could be present and document the controls in place to address that risk
- FSVP documentation review — for imported products, confirm that the importer of record has a documented FSVP on file that has been reviewed within the past year
This is not a comprehensive quality audit. It is a targeted risk review focused on the failure modes that show up in FDA enforcement actions. In my experience, this kind of focused review catches the majority of high-priority gaps in a fraction of the time a full audit would require.
The Practical Timeline for Getting Controls in Place
If your company does not currently have pharmaceutical adulterant screening in your testing program, the question is not whether you need it — it is how quickly you can get it running. Here is a realistic timeline:
- Weeks 1–2: Identify an accredited contract laboratory with LC-MS/MS capability and relevant method validation for pharmaceutical adulterants. NSF International, Eurofins, and ChromaDex are among the labs with established supplement testing programs.
- Weeks 2–4: Define your screening panel based on your product category. Work with the laboratory to confirm which analytes will be included and what the detection limits are.
- Weeks 4–6: Pilot the testing protocol on your current inventory. If you find anything unexpected, you want to find it before FDA does.
- Weeks 6–8: Integrate the protocol into your standard batch release procedure and document it in your quality plan.
That is roughly two months from decision to implementation. Given the current FDA enforcement environment, that is a timeline worth moving on.
Working With a Compliance Consultant
I will be direct: many of the companies I work with come to Certify Consulting after they have already received a warning letter or been through a recall. The work we do together after the fact is real and valuable, but it is considerably harder — and more expensive — than the work we could have done before.
If you are selling dietary supplements and you have not had a formal compliance review in the last two years, that is the place to start. Not because the FDA is necessarily looking at your product today, but because the regulatory framework has teeth and the enforcement environment in 2026 is meaningfully different from what it was five years ago.
The Kian Pee Wan recall is a clean example of what happens when the quality infrastructure does not match the regulatory obligation. The product apparently worked — which is exactly why it was a problem. Consumers were getting pharmaceutical drug effects from a product labeled as an herbal supplement, without any of the dosing guidance, contraindications, drug interaction warnings, or physician oversight that a prescription corticosteroid like dexamethasone requires.
That is not a technicality. That is a genuine public health risk. And it is the kind of risk that a functioning quality system, at any of several points in the supply chain, would have caught.
If you want to talk through where your quality system stands, reach out to Certify Consulting — we have helped more than 200 clients build the kind of compliance infrastructure that keeps them off the FDA's recall list.
You might also find our overview of dietary supplement CGMP compliance useful as a starting point for understanding where the regulatory obligations begin and end.
Last updated: 2026-04-23
Jared Clark
Principal Consultant, Certify Consulting
Jared Clark is the founder of Certify Consulting, helping organizations achieve and maintain compliance with international standards and regulatory requirements.