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 The FDA Modernization Act of 1997 (FDAMA) repealed the restriction in Section 301(l) of the Federal Food, Drug and Cosmetic (FFD&C) Act, which prohibited reference to FDA approval in the labeling or advertising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.
False or Misleading Labeling
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."
Permissible Promotional Labeling
The Modernization Act sets forth conditions under which firms may promote devices that have an approved IDE or PMA. Manufacturers may disseminate written information concerning the safety, effectiveness, or benefit of a use not described in a device’s approved labeling to health care practitioners, pharmacy benefit managers, health insurance issuers, group health plans, or Federal or State agencies provided the following requirements are satisfied:
- the device is a legally marketed device;
- the information is not derived from clinical research conducted by another manufacturer, unless the manufacturer disseminating the information has permission to use the information;
- sixty (60) days prior to disseminating the information, the manufacturer submits to FDA a copy of the information and any clinical trial information the manufacturer has relating to the safety or effectiveness of the new use, any reports of clinical experience that pertain to safety of the new use, and a summary of such information;
- the manufacturer has complied with the requirements (discussed below) relating to a supplemental application for such use; and
- information on the new use is not false or misleading, does not pose a significant risk to public health, and is in the form of:
1) unabridged reprints or copies of peer-reviewed, scientifically sound articles published in scientific or medical journals about clinical investigations involving the device; or
2) reference publications that include information about clinical investigations.
- The manufacturer includes with the information to be disseminated a prominently displayed statement disclosing:
1) that the use is not approved or cleared by FDA;
2) if applicable, that the information is being disseminated at the expense of the manufacturer;
3) if applicable, the names of any authors of the information who are employees or consultants to the manufacturer or have received compensation or have a financial interest in the manufacturer;
4) the official labeling and all updates;
5) if applicable, a statement that there are products or treatments that have been approved or cleared for the use that is the subject of the information; and
6) the identification of any person that has provided funding for the study related to the new use.
- the manufacturer includes a bibliography of other articles from scientific reference publications or journals relating to the use that is the subject of the information.
if FDA determines that the manufacturer fails to provide data, analyses or other written matter that is objective and balanced, FDA may require the manufacturer to disseminate additional objective and scientifically sound information that pertains to the safety and effectiveness of the use that is the subject of the information and an objective statement of FDA that bears on the safety or effectiveness of the new use.
- the manufacturer has submitted a supplemental application for such use;
in the case of a completed study, the manufacturer submits to FDA an application containing a certification that the studies needed for a supplemental application for the new use are completed and the supplemental application will be submitted within 6 months after the initial dissemination of information on the new use;
in the case of a planned study, the manufacturer submits an application to FDA containing a proposed protocol and schedule for conducting the studies needed for the supplemental application for the new use and a certification that the supplemental application will be submitted not later than 36 months after the initial dissemination of information on the new use;
- the manufacturer submits to FDA an application for an exemption from submission of a supplemental application, and such exemption is granted.
Manufacturers have an ongoing responsibility to provide FDA with new information about the new use and if this new information indicates that the use may present a significant risk to public health, FDA may order cessation of the dissemination of information about the use.
FDA may also order cessation of dissemination if the manufacturer fails to comply with the requirements for dissemination, including the requirements relating to the submission of a supplemental application. The Agency can, except in limited circumstances, also require the manufacturer to take corrective action when it orders the cessation of dissemination.
Manufacturers are required to prepare and submit to FDA lists of titles of articles and publications that have been disseminated and the categories of providers that have received the materials. In addition, manufacturers must keep records which can be used by the manufacturer or FDA to take corrective action.
It is a prohibited act to disseminate information in violation of the requirements of this section.