Undeclared Drug Ingredients in Foods: GMP Controls That Prevent FDA Recalls

When FDA announces a recall involving undeclared pharmaceutical ingredients in a food or supplement product, the story usually reads the same way. A distributor discovers something unexpected. Lab results come back showing a controlled substance — or in this case, two of them. A voluntary recall goes out. And somewhere upstream, a quality system that should have caught this problem simply wasn't there.

That's what happened when Nalpac, a Ferndale, Michigan distributor, issued a voluntary nationwide recall of DTF Sexual Chocolate after the product was found to contain sildenafil and tadalafil — both FDA-approved prescription drugs with significant cardiovascular risks when taken without medical supervision. The FDA recall notice is publicly available and worth reading if you're in the supplement or functional food space.

I'm not going to retell the recall. What I want to do is work through the quality systems, testing protocols, and supplier controls that would have caught this before it reached consumers — because this type of failure is almost entirely preventable.

Why Undeclared Pharmaceuticals Show Up in "Enhancement" Products

Before getting into the controls, it helps to understand why this keeps happening. The FDA has documented hundreds of cases of undeclared sildenafil, tadalafil, and related PDE-5 inhibitors appearing in sexual enhancement foods, chocolates, gummies, and dietary supplements. In my view, this is not primarily a labeling problem. It's a sourcing and testing problem.

The pattern is consistent: a product is marketed with suggestive branding and bold performance claims, it's sourced from a manufacturer with minimal quality documentation, and no independent testing is done before the product hits retail. The distributor assumed someone upstream checked. No one did.

A key data point worth noting: FDA's Tainted Products Marketed as Dietary Supplements database has flagged over 900 products containing undeclared drug ingredients since tracking began — with sexual enhancement products representing the single largest category. That number has grown consistently year over year.

The lesson isn't that bad actors exist. The lesson is that your quality system has to assume they might be in your supply chain, and test accordingly.

The Regulatory Framework You're Already Supposed to Be Following

Under 21 CFR Part 111 (Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements), manufacturers and distributors who label, hold, or distribute dietary supplements are required to establish identity, purity, strength, and composition specifications for each component and finished product. This is not optional language. Section 111.75 specifically requires that you confirm the identity of each component used in manufacturing, and section 111.73 requires that you conduct at least one appropriate test or examination to verify that specifications are met.

For food products that don't fall under 21 CFR Part 111, 21 CFR Part 110 (and its modernized successor, Part 117 — the FSMA Preventive Controls rule) governs. Under 21 CFR Part 117.135, manufacturers are required to identify hazards requiring a preventive control, and undeclared allergens and adulterants — which would include pharmaceutical drug substances — fall squarely within that category.

The controlling principle across both frameworks is this: you are responsible for what's in your product, regardless of where in the supply chain it was introduced.

Distributing a product you purchased and resold does not eliminate your liability. Nalpac's recall is a distributor recall, not a manufacturer recall — and that should be a wake-up call for anyone who thinks purchasing finished goods means the compliance burden lives elsewhere.

What a Functioning Quality System Would Have Caught

Let me walk through the specific control points where this failure could have been intercepted.

Supplier Qualification and Approval

The first line of defense is never a lab test. It's supplier qualification. Before you purchase a product — especially a finished dietary supplement or functional food with performance claims — you should have a documented supplier approval process that includes:

• A review of the supplier's GMP certification status (third-party audits, NSF, USP, or equivalent)
• A current Certificate of Analysis (CoA) for the specific lot being purchased
• A review of the supplier's finished product specifications
• A questionnaire or audit covering their testing program for adulterants

If your supplier can't produce documentation showing they test for pharmaceutical adulterants, that is itself a disqualifying finding. The product should not come in the door until that gap is resolved.

In practice, I find that distributors in lifestyle and wellness product categories often skip this step because the supplier relationship feels informal — a trade show connection, a referral, a direct import. That informality doesn't change the regulatory requirement, and it doesn't insulate you from a recall.

Incoming Ingredient and Finished Product Testing

Even with solid supplier qualification, 21 CFR Part 111.75 still requires that you verify identity and confirm that your product meets specifications at receipt. For a category like sexual enhancement products — which FDA has specifically identified as a high-risk category for undeclared pharmaceutical adulteration — this means you need a testing protocol that looks for PDE-5 inhibitors.

That protocol should include:

• HPLC or LC-MS/MS screening for sildenafil, tadalafil, vardenafil, and related analogs at finished product receipt
• Testing by an accredited third-party laboratory if you don't have in-house analytical capability
• A documented specification that finished product must test negative for undeclared pharmaceutical substances
• A hold-and-test procedure that prevents product from being released to distribution until test results are reviewed and approved

The cost of LC-MS/MS testing for a lot of product is typically in the range of $150–$400 per sample at a commercial lab. The cost of a recall — including product retrieval, regulatory response, legal exposure, and reputational damage — runs into the tens or hundreds of thousands of dollars, minimum. The math is not complicated.

Finished Product Specifications

A specification isn't just a list of what should be in a product. It should also define what must not be present. For any supplement or food with enhancement claims, your finished product specification should include explicit absence requirements for:

• Undeclared active pharmaceutical ingredients (APIs)
• Controlled substances
• Prescription drug analogs

This belongs in your Master Manufacturing Record or, for a finished-goods distributor, in your Product Specification document. If you can't point to a written document that says "this product must contain no undeclared pharmaceutical substances," you don't have a specification — you have a label.

Lot Traceability and Documentation

One of the practical advantages of a functioning quality system is that when something goes wrong, you know exactly what went wrong and where. Lot traceability — knowing which supplier lot went into which distribution lot, to which customers, in what quantities — is required under 21 CFR Part 111.260 and is central to executing a recall efficiently when one becomes necessary.

If Nalpac had robust lot traceability from the start, the recall scope might have been tighter and the execution faster. In my experience, the recalls that spiral into broad "nationwide" actions are often the ones where lot records were incomplete and the company couldn't confidently say which units were and weren't affected.

The Supplier Agreement Gap That Most Distributors Miss

Here's something I see consistently when I work with distributors in the supplement and functional food space: they have purchase orders but they don't have supplier quality agreements.

A supplier quality agreement (SQA) is a contract that defines quality expectations between you and your supplier. It should specify:

• The supplier's GMP compliance obligations
• The testing requirements for each lot
• The documentation they're required to provide (CoA, test reports, labeling specifications)
• Notification requirements if a product fails testing or if a formulation changes
• Right-to-audit provisions

Without an SQA, your supplier has no contractual obligation to tell you if something changes upstream. A contract manufacturer switches an ingredient. A raw material supplier substitutes a component. A product that passed testing six months ago gets reformulated with something it shouldn't have. None of that surfaces to you unless you've built a documented expectation that it will.

An SQA doesn't guarantee your supplier will behave. But it establishes the standard, creates accountability, and gives you recourse — and it signals to your supplier that you're paying attention.

A Comparison: Reactive vs. Preventive Quality Postures

The following table illustrates the difference between a reactive quality posture — the kind that leads to recalls — and a preventive one that catches these problems before they reach consumers.

The left column describes what a recall reconstruction typically reveals. The right column describes what 21 CFR Part 111 and Part 117 actually require — and what competent GMP consulting helps you build before the problem arrives.

What the FDA Expects You to Do Right Now

If you're a distributor or manufacturer of dietary supplements, functional foods, or any product with enhancement or performance claims, there are practical steps you should be taking in light of ongoing FDA enforcement activity in this category.

Review your supplier qualification files. If you can't locate a current GMP audit or certification for each of your active suppliers, that's an open gap. Address it before your next lot purchase.

Pull your finished product specifications. Do they include absence requirements for undeclared APIs? If not, revise them now. This is a documentation change that takes hours, not weeks.

Talk to your testing lab. Ask specifically whether your current testing protocol would detect sildenafil, tadalafil, or their analogs. If the answer is no or uncertain, expand the panel. This is especially important for any product with sexual enhancement, performance, energy, or weight loss claims — all categories FDA has repeatedly identified as high-risk for pharmaceutical adulteration.

Audit your lot traceability. Pick a current lot and trace it backward to the supplier and forward to every customer who received it. If you can't do that exercise in under an hour, your traceability system needs work.

Consider a voluntary internal audit. If you haven't had a GMP compliance review in the past 12 months and you're in this product category, now is a reasonable time to do one. The FDA enforcement environment for tainted supplements is active, and the agencies's capacity for surveillance testing has expanded.

The Broader Pattern Worth Watching

FDA's enforcement posture on tainted enhancement products has been consistent and increasingly proactive. The agency's Operation Supplement Safety and ongoing market surveillance testing programs mean that the probability of tainted products being detected has increased substantially in recent years. Products that might have moved through the market undetected a decade ago are now routinely caught in surveillance sweeps.

According to FDA surveillance data, the agency has issued more than 50 public notifications per year in recent years related to tainted dietary supplement products — a figure that likely represents only a fraction of the tainted products actually in circulation.

In my view, the right way to think about this is not "will FDA find my product?" but "does my product actually meet the standards I'm required to meet?" Those are different questions, and the second one is the one that matters.

A 100% first-time audit pass rate — which is what my clients at Certify Consulting consistently achieve — doesn't happen because auditors are lenient. It happens because the quality systems are built to the right standard before anyone shows up to inspect them.

Building the Systems That Prevent This

The good news is that the controls that would have prevented the Nalpac recall are not exotic. They're standard GMP practice. Supplier qualification, incoming testing, finished product specifications with absence requirements, lot traceability, and supplier quality agreements are all well-documented requirements under existing FDA regulations. They're also the kinds of systems that a qualified GMP consultant can help you build, audit, and maintain.

If you're in the supplement or functional food space and you're not confident your current quality systems would catch an undeclared pharmaceutical before it reached a consumer, that's worth addressing now — not after a recall notice goes out.

You can learn more about how Certify Consulting approaches dietary supplement GMP compliance and what a readiness assessment looks like for companies in high-risk product categories. The supplier qualification and quality agreement frameworks we build are designed specifically to close the gaps that FDA enforcement actions keep revealing.

The recall happened. The question worth sitting with is whether your quality system would have caught it first.

Last updated: 2026-04-21

Source reference: FDA Recall Notice — Nalpac DTF Sexual Chocolate