FD&C Act Section 502 - Misbranding

What it says

A drug is deemed misbranded if its labeling is false or misleading in any particular, if required information is not prominently and conspicuously displayed, or if it fails to bear adequate directions for use, among other specified labeling and marketing conditions.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Misbranding is a distinct legal concept from adulteration, focused on labeling, marketing claims and the information provided about a product, rather than on the physical or manufacturing quality of the product itself.
• A product can be misbranded even if it is manufactured to a perfectly compliant cGMP standard, if its labeling or promotional claims are false, misleading or omit required information.
• This provision is the statutory basis behind FDA enforcement actions related to false or misleading marketing claims, including many cases involving inadequate risk disclosure or overstated efficacy claims.

What FDA inspectors look for

• As with Section 501, this is a statutory legal provision rather than a specific manufacturing practice - the practical connection for quality and regulatory professionals is that labeling accuracy, covered operationally under provisions like 21 CFR 211.122 and 211.125, is what actually prevents a misbranding determination in practice.
• Promotional and marketing claims made about a product, separate from the physical label itself, also fall within the scope of what this provision addresses.

Related regulations