What They Cover and Where They Stop
"Is this a medical device?" sounds like a question a packaging EPR program should be able to answer. It cannot. The seven state packaging laws do not define a medical device or a pesticide on their own terms. They borrow the category from other law, so the first answer has to come from there.
That is the first thing to understand about the exclusions written for regulated products. Many of them begin outside EPR law. Whether a package qualifies can depend on how the product inside it is defined or regulated under the Food, Drug, and Cosmetic Act, the federal pesticide statute or another federal regime. How far the exclusion then reaches through the packaging around that product is a separate question, and each state draws that boundary in its own place.
This article walks outward from the product. It starts with the product's legal identity, then moves to the container that holds it, the carton around the container, and the shipper around the carton. At the end it returns inside the box. At each step the question is the same: is this component still excluded?
Read the exclusion lists side by side and the vocabulary is not EPR vocabulary. The state laws do not test the product themselves. Each one points to a status the product already has under another regime, and attaches a packaging consequence to it. That status might be a definition in the Federal Food, Drug, and Cosmetic Act, regulation under the federal pesticide statute, or a classification under OSHA's hazard communication rules. Even the one drug exclusion that does not borrow from FDA borrows from somewhere else: Oregon defines it through the state pharmacy code.
The lists overlap heavily, but they are not the same list. Dietary supplements are a clean example. Colorado and Washington exclude packaging for a product regulated as a dietary supplement by FDA. California, Oregon, Minnesota and Maryland do not name dietary supplements in their exclusion lists at all.
So the first step in any exclusion analysis happens outside EPR law. A federal regime identifies the relevant product status. State EPR law decides what that status does.
Even where states borrow the same federal category, they do not ask the same question about it.
California's regulation excludes:
"Packaging used for 'devices,' as defined in subsection (h) of section 321 of Title 21 of the United States Code."— 14 CCR §18980.2(a)(4)
The test is the definition. Does the product fall within the federal statutory meaning of a device?
Colorado, Washington, Minnesota and Maryland phrase it differently. Colorado's version is typical: packaging "used to contain a product that is regulated as a drug, medical device, or dietary supplement by the federal food and drug administration." The test there is regulatory status. Is FDA in fact regulating the product as a device?
Most of the time the two answers coincide. They come apart at the low-risk end of the market, and federal policy is what pulls them apart. Consider a low-risk wellness product that may fall within the federal statutory definition of a device. FDA's January 2026 CDRH guidance on general wellness products, which is non-binding, sets out the agency's approach to that class:
"CDRH does not intend to examine low risk general wellness products to determine whether they are devices within the meaning of the FD&C Act …"— FDA, General Wellness: Policy for Low Risk Devices (January 6, 2026)
The same sentence goes on to say that, where such products are devices, CDRH does not intend to examine whether they comply with device requirements, including registration and listing.
The same guidance notes that some general wellness products do not meet the device definition at all. Both possibilities have to stay open. So the question for that product is not whether it is "a medical device". The question each state asks is narrower. Does the state exclude packaging for something defined as a device, or only for something regulated as one? That distinction can matter because the states are not asking the same legal question. One "medical device" label is not enough for a multi-state exclusion analysis.
Oregon asks a third, narrower question. Its statute does not exclude device packaging at all. The exclusion comes from a rule, and it is drawn by FDA class: packaging of Class II devices "sold labeled as sterile" with a cleared 510(k) premarket notification, and packaging of Class III devices (OAR 340-090-0840(2)(b)). A Class I device does not qualify in Oregon, whatever its status elsewhere.
California asks one kind of federal-status question. Several other states ask another. Oregon uses a narrower device-specific test. Maine does something different again. The federal product category can trigger regulatory review without itself creating an exclusion.
Maine's statute lists four groups of federally regulated products: drugs; medical devices and biological products; over-the-counter drugs that require tamper-evident packaging; and products that require special packaging under the Poison Prevention Packaging Act. It directs the Department of Environmental Protection to review their packaging and, if warranted, to exclude it by rule. The test is whether federal content or construction standards may preclude or significantly diminish the producer's ability to make that packaging more recyclable or reduce its volume. Any such rule is a major substantive rule, which in Maine goes before the Legislature.
The review has not produced an exclusion. In its February 2026 report to the Legislature, the department wrote that it "did not identify any such standards during its initial review." It invited exclusion requests, received eleven, and "continues to evaluate these requests." It also told the Legislature that "if it is the Legislature's intent for this packaging to be excluded from regulation under 38 M.R.S. § 2146, the statute should be amended to exempt those product categories." Maine's packaging rule, as amended in March 2026, contains no such exclusion. In Maine, the same federal category that excludes packaging in California or Colorado has so far opened a review, and nothing more.
Qualifying for an exclusion is only the first question. The next is what, physically, the exclusion removes.
Walk outward from the product. The container directly holding the product is the clearest case: where an exclusion reaches primary or immediate packaging, this is the first ring it removes. The disagreement starts one ring further out.
Maryland draws the line at primary packaging. The Maryland statute excludes "packaging" for a product regulated as a drug or medical device, with no qualifier. Maryland's implementing regulation, in force since May 25, 2026, narrows the exclusion. Its list of statutorily exempt materials begins every item with the same two words:
"Primary packaging for a product regulated as a drug or medical device by the U.S. Food and Drug Administration, including associated components and consumable medical equipment;"— COMAR 26.04.14.05(B)(1)(d)
Colorado's statute has no such word. Colorado's regulator, however, reads its exclusion the same way. In its published FAQ, CDPHE answers whether all packaging for drugs, devices and dietary supplements is exempt: "No, only the immediate packaging 'used to contain' … is exempt", and "Secondary or grouped packaging, which includes boxes or cartons, film or wrap, used to protect, handle, bundle, sell in bulk, brand, or display the product is not exempt." That is the agency's published reading, not a rule.
The shipper is where California goes further than anyone. Its regulation states that, for these product exclusions, packaging used for a good "includes primary, secondary, and tertiary packaging." It then closes the obvious gap: "tertiary packaging used for goods not identified in those subparagraphs is covered material regardless of whether the packaging also contains goods identified in those subparagraphs." A shipping case that carries only excluded products is excluded. A mixed case is covered.
For Washington and Minnesota, the verified public authorities do not currently establish how far these exclusions extend through multiple packaging levels. As of October 2026, both statutes exclude "packaging for" the listed products without saying which levels that means. Washington's implementing rulemaking is at its earliest stage, and Minnesota has not yet proposed program rules. That is a finding in its own right. The answer does not exist yet in verified public authority, and it should not be filled in by borrowing another state's.
The same excluded product can therefore leave the reporting universe at the container in one state, at the carton in another, and at the shipping case in a third.
By now the walk has reached the outside of the shipping case. There is one more component to check, and it is back inside the box: the paper.
A device comes with instructions for use. A drug comes with a leaflet. Almost every boxed product carries something printed: a manual, a warranty card, a quick-start sheet, a promotional insert. None of it is packaging in the sense these exclusions use. In Colorado, Oregon, Washington, Minnesota and Maryland, paper products are covered materials under a separate definition. Colorado's, for example, reaches "paper and other cellulosic fibers, whether or not they are used as a medium for text or images." The exclusions in those five states are written for packaging, and nothing in their text extends to the paper that travels with the product.
In those five states, the exclusion stops at the package. The paper in the box stays.
That changes the question a producer of regulated products should be asking. It is not "is our product exempt?" It is "which physical components actually leave the reporting universe?" For a boxed device sold into a paper-product state, the honest answer can be: the container and possibly the carton leave, and the manual stays.
California is the exception, for a structural reason. Its program covers packaging and plastic food service ware, with no separate paper-products category. The five-state point does not carry over to it. (Which states cover paper products, and what that means for brands outside regulated categories, is covered in Am I Required to Register for EPR?)
After the "defined as" and "regulated as" distinction, it is tempting to draw the opposite conclusion: anything FDA regulates is excluded somewhere. The texts do not support that either.
California's exclusion for non-prescription drugs carries its own carve-out. A non-prescription drug qualifies only if it is not a cosmetic or soap, or if it is a drug for some reason other than containing a sunscreen active ingredient (14 CCR §18980.2(a)(6)). The only product that fails both tests is a cosmetic or soap that counts as a drug solely because of its sunscreen. For example, FDA treats "moisturizers and makeup marketed with sun-protection claims" as cosmetic/drug products. Where that status comes only from the sunscreen, the packaging stays covered in California, even though FDA regulates the product as a drug.
Dietary supplements show the same thing from the other side. Supplements are regulated by FDA, and in Colorado and Washington their packaging is excluded. In California, Oregon, Minnesota and Maryland it is not, because the lists there do not include them.
A borrowed federal category settles the question only for the products the state wrote into its list. Products in adjacent federal categories stay covered.
An exclusion can be categorical without being administratively automatic.
California lists its product exclusions as "not covered material." There is no application to file for them. That is the opposite of California's small-producer exemption, which has to be applied for and approved. Maryland treats the claim differently:
"Should the producer identify they are exempt or excluded from specific covered materials, they must provide supporting documents and records to explain the exemption to the Department for approval …"— COMAR 26.04.14.09D(4)
Whether a product qualifies and what a producer must do to claim that it qualifies are separate questions. They are answered state by state. How the supporting record should be built is covered in Why Packaging EPR Is Creating a New Evidence Burden for Producers and The EPR Exemption Trap.
The exclusions for regulated products are among the most valuable provisions in packaging EPR for the companies they fit. They are also among the easiest to over-apply. The mistake is treating a federal category as the answer, when it opens three separate questions.
Does the product qualify? That depends on the federal status the state actually asks about: the federal definition, FDA's regulation of the product, an FDA class, or, in Maine, only a pending review.
How far does the exclusion reach? To the container, the carton or the shipping case, depending on the state, and in two states the answer has not yet been established.
What has to be done to claim it? Sometimes nothing, sometimes a submission for approval.
Answer only the first, and the reporting program gets built around the wrong scope. Which brings the walk back to where it ended: in five of the seven states, a fully excluded regulated product can still ship with reportable paper inside the box.
We work through these questions product by product with brands in regulated categories before any reporting gets built. Classification comes first; operations follow from it.
A Status Check determines where your products fall under current state packaging EPR rules before you build the reporting program around the wrong scope.
Start a Free Compliance Status CheckThis article is for informational purposes only and does not constitute legal advice. Regulatory timelines and program requirements are subject to change. Always verify current obligations with state authorities, PROs, and qualified legal counsel directly. Orbitlex is not a law firm.