Packaging and Label Compliance for Online Businesses

By Paul S. Rafelson, Founder, Rafelson Law PLLC

Why do several sets of rules apply to one package?

A package is a label, an advertisement and, often, a safety document at once. Different agencies regulate those functions. The Fair Packaging and Labeling Act sets general rules for consumer commodities. FDA has its own labeling requirements for food, drugs, cosmetics and medical devices. EPA regulates the labeling and packaging of pesticide products. The FTC polices claims printed on the package, including origin claims such as “Made in USA.” A product may be reached by one layer or several, and the layers do not always fit together neatly. A label that satisfies a general statute can still fall short of a product-specific rule, or can make a claim that creates a different regulatory category.

What does the general labeling statute care about?

As a general matter, the Fair Packaging and Labeling Act asks that a package of a consumer commodity state what the commodity is, identify the manufacturer, packer or distributor by name and place of business and state the net quantity of contents conspicuously on the principal display panel, in the units the statute calls for (15 U.S.C. § 1453(a)). The statute also addresses qualifying words that exaggerate the quantity. Cosmetics have a parallel FDA regulation on net quantity (21 C.F.R. § 701.13). The reasons are consumer protection and comparison: shoppers can see who is accountable and compare quantities across brands. The statute has exemptions and related regulations, and enforcement is split between agencies depending on the product, so whether and how it applies to a given product depends on the product and its category.

Why does the name on the package matter?

The name and place of business on a label is not only a formality. It can indicate who regulators and plaintiffs consider the responsible party. For cosmetics, the “responsible person” for FDA listing purposes is tied to the manufacturer, packer or distributor named on the label. In a private-label arrangement, a brand that places its name on a product made by someone else can take on responsibilities that a pure reseller does not. Contracts with manufacturers and fulfillment providers often try to allocate that risk, but a contract between businesses does not change what a regulator can ask of the party named on the box.

Why do claims on the package change the analysis?

The words and images on packaging can change what a product is. A claim that a product treats a condition may point toward drug or device status. A claim that a product kills germs or repels pests may point toward pesticide status under federal law. An unqualified “Made in USA” claim is subject to the FTC’s Made in USA Labeling Rule, which describes conditions about final assembly or processing, significant processing and the origin of components (16 C.F.R. § 323.2). Claims about environmental benefits, natural or organic content or testing are subject to the FTC Act’s prohibition on deceptive practices (15 U.S.C. § 45) and to other rules. See our pages on FTC reviews and claims and EPA pesticidal claims.

Where do product-specific rules come in?

• Medical devices, drugs, cosmetics and food. FDA rules can govern what a label says, what it leaves out and what it implies. See FDA registration and clearance.
• Pesticides and products that make pesticidal claims. EPA rules reach the label, the container and, in some cases, child-resistant packaging, and apply to the person who distributes or sells the product. See EPA pesticide packaging and labeling.
• Household products with safety packaging concerns. The CPSC enforces child-resistant packaging rules for certain household substances under the Poison Prevention Packaging Act (16 C.F.R. Part 1700). Ask us whether your product falls under them.
• State laws. States add their own warning, recycling and chemical-content rules, and a package sold nationally can be reached by many of them. Prop 65 is one example that shapes what a warning looks like on a product sold to California.

Why does the platform copy of the label matter?

On a marketplace, the listing is read alongside the package. Images of the package, the title and the bullet points can all be treated as labeling or advertising, and a platform may require label images or documentation for certain categories. Differences between the listing and the physical package, such as a quantity or origin claim that does not match, can create a problem on both. Platform requirements are set by the platform and change, and they are not the same as the law.

Why involve a lawyer before the packaging is printed?

Changes to a printed run or a stocked inventory are burdensome to make and, once a product is in distribution, can involve recalls, removals or relabeling. We identify which rules reach your package, where a claim pushes the product into a stricter category and which questions belong with a lab or a regulatory specialist rather than a lawyer.

How do I get started?

Contact us. Tell us the product, the claims on the package and where it is sold, and we will tell you whether we can help.

Frequently asked questions

Related pages

Sources and notes

• 15 U.S.C. § 1453(a) (Fair Packaging and Labeling Act, label content and net quantity).
• 21 C.F.R. § 701.13 (cosmetic net quantity of contents).
• 16 C.F.R. §§ 323.2 and 323.3 (Made in USA Labeling Rule, standard and scope). 15 U.S.C. § 45. FTC, Enforcement Policy Statement on U.S. Origin Claims (1997).
• FD&C Act §§ 604(4) and 607, as added by the Modernization of Cosmetics Regulation Act of 2022 (responsible person, facility registration and product listing).