Labeling Requirements - Misbranding
Section 502 of the FFDCA contains provisions on misbranding and false or misleading labeling. A device is misbranded if:
- Its labeling is false or misleading in any particular:
- It is in package form and its label fails to contain the name and place of business of the manufacturer, packer, or distributor; and an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count;
- Any required wording is not prominently displayed as compared with other wording on the device, or is not clearly stated;
- Its label does not bear adequate directions for use; including warnings against use in certain pathological conditions; or by children where its use may be dangerous in health; or against unsafe dosage, or methods, or duration of administration or application;
- It is dangerous to health when used in the dosage or manner or with the frequency or duration prescribed, recommended or suggested in the labeling; or
- It does not comply with the color additives provisions listed under Section 706 of the Act.
- If the device's established name (if it has one) its name in an official compendium, or any common or usual name is not prominently printed in type at least half as large as that used for any proprietary name;
- If the establishment is not registered with FDA as per Section 510, has not device listed as per section 510(j), or obtained applicable premarket notification clearance as per Section 510(k);
- If the device is subject to a performance standard and it does not bear the labeling prescribed in that standard;
- If there is a failure or refusal to comply with any requirement prescribed under the FFDCA, Section 518 on notification and other remedies, or failure to furnish any materials or information requested by or under Section 519 on reports and records or under Section 522; or
- If there is any representation that created an impression of official approval because of the possession by the firm of an FDA registration number.
Note: Previously, it was considered misbranding to have the premarket approval application (PMA) number on the device labeling. The FDA Modernization Act of 1997 (FDAMA) repealed the restriction in Section 301(l) of the Federal Food, Drug and Cosmetic (FFD&C) Act, which prohibited reference to FDA approval in the labeling or advertising of medical devices that have an approved PMA or IDE.
Section 502(a) declares that a drug or device is misbranded if its labeling proves false or misleading in any particular. This phrase "false or misleading" is not confined in meaning to untrue, forged, fraudulent, or deceptive. In fact, the word, statement, or illustration may be true in the strict sense of the word; however, the labeling can be deemed by the FDA to be in violation of the law if it proves deceptive to the customer. It is not a necessary condition that the labeling should be flatly and baldly false; the work "misleading" in the Act means that labeling is deceptive if it is such as to create or lead to a false impression in the mind of the reader. A "false impression" may result not only from a false deceptive statement, but may also be instilled in the mind of the purchaser by ambiguity or misdirection. It may also be caused by failure to inform the consumer of facts that are relevant to those statements actually made. In other words, the label that remains silent as to certain consequences may be as deceptive as the label that contains extravagant claims.
A device can be misbranded by making reference to a medical device registration number assigned by FDA in response to a firm's filing requirements under the FFDCA. Section 807.39 of 21 CFR, misbranding by reference to establishment registration or registration number states that the assigned numbers do not constitute official FDA approval of the device.
Examples of false labeling include:
- incorrect, inadequate or incomplete identification;
- unsubstantiated claims of therapeutic value;
- inaccuracies concerning condition, state, treatment, size, shape or style; and
- substitution of parts or material;
Examples of misleading labeling include:
- ambiguity, half-truths, and trade puffery;
- expressions of opinion or subjective statements; and
- failure to reveal material facts, consequences that may result from use, or the existence of difference of opinion.
Examples of other objectionable labeling practices include:
- deceptive pictorial matter;
- misleading testimonials;
- misleading list of parts or components; and
- use of brand or trade names instead of "established names."