“Flag the Label”

Manufacturers of over-the-counter (OTC) medicines often make changes in their products to improve safety or increase effectiveness, either as a result of the development and recognition of new scientific data or by providing more detailed labeling information. Additionally, OTC manufacturers often introduce, under an existing brand name, new products which may contain different single ingredients or new combinations of ingredients, in order to provide a broader range of available self-care options. The advent in 1972 of the Food and Drug Administration's massive, unprecedented and still-ongoing review of all categories of OTC medicines has acted as a catalyst for these changes which still occur at a frequent rate.

A noteworthy program — "Flag the Label" — has been adopted by members of the Consumer Healthcare Products Association to aid in alerting consumers to significant changes in nonprescription medicines. The "Flag the Label" campaign is a consumer information program approved by the Consumer Healthcare Products Association in 1977 and amended in 1993 and 1995. ("Flag" is a term used by industry to designate an attention-getting label signal which alerts consumers to read the label carefully because of significant new information.) Members of the Association have agreed to implement the flagging program as they make significant changes in their nonprescription medicines or introduce new products under an existing brand name.

Flag the Label for Significant Changes in a Currently Marketed Nonprescription Medicine

Manufacturers of nonprescription medicines should flag the label when significant changes are made in currently marketed (i.e., not new) products or labels. "Significant Changes" are defined as:

1. Expansion or limitation of indications (claims);
2. Material modification of dosage level;
3. Change in active ingredients or in directions for use;
4. New warnings or new contraindications; and
5. Any other significant new information.

This guideline is met by using phrases such as the following (or words of similar meaning), with the goal of being as specific as possible in relation to the significant change that is being undertaken:

• "See new directions"
• "See new label directions"
• "New information: Read entire label"
• "See label for new ingredients"
• "See new warnings"
• "Read label for current directions and warnings"
• "See new uses"
• "See new use"
• "See new dosage"
• “See new Drug Facts”

To ensure that consumers are alerted to these changes, the language of the flag should:

• appear on the principal display panel;
• be prominent and conspicuous; and
• be carried for at least six months after such a change is made.

Manufacturers should select appropriate means to make the flag conspicuous consistent with their trade dress.

Flag the Label for New Products Introduced Under Existing Brand Names

Manufacturers of nonprescription medicines should flag the labels of all new products introduced under an existing brand name.

The statement in the flag should be an accurate representation of the unique/new product feature(s). For example, if the brand name line extension is the addition of a second (or third or fourth) ingredient to a single ingredient brand name product, then such phrases as the following (or similar applicable phrases) should be used to meet this guideline:

• "Added new ingredient"
• "Added new ingredients"
• “See label for new ingredients”
• “Added [insert pharmacological class – e.g., Decongestant]

If, for example, the brand name line extension is a change in the single ingredient that is (or had been) in the brand name product, then the guideline could be met with the following phrase (or phrase of similar applicable meaning):

• "Contains no (insert type of ingredient that is in the brand name product, such as 'antihistamine')" - i.e., "Contains no antihistamine"
• "(insert name of new ingredient, such as 'decongestant'), no (insert name of ingredient that is in the brand name product, such as 'antihistamine')" - i.e., "decongestant, no antihistamine"

If, for example, the brand name line extension is an extension of a line of products into new pharmacologic categories (e.g., an antacid product now expanded to relief of constipation, gas, or diarrhea), then this guideline could be met by the use of the following phrases (or phrases of similar meaning):

"For (insert new indication category, such as 'constipation', or 'diarrhea')" - i.e., "For constipation"

If, for example, the brand name line extension is a new dosage or dosage form, then the use of the following phrases (or phrases of similar applicable meaning) would meet this guideline:

• "New dosage"
• "New timed release formula"
• "New dosage form"

The above examples are not meant to cover all possible examples of line extensions, but rather to provide known examples as models in helping companies to address other possible situations, such that specificity is added to the words/phrases used in the flag to describe the new brand name line extensions.

To ensure that consumers are alerted to these changes, the language of the flag should:

• appear on the principal display panel;
• be prominent and conspicuous; and
• and be carried for at least six months after such a change is made.

The indication(s)/purpose(s) for which the brand name line extension is intended should be displayed prominently and conspicuously, and be clearly distinguishable from other labeling on the principal display panel.

Additional Considerations

Note: Current requirements for the statement of identity are: "The statement of identity shall be presented in bold face type on the principal display panel, shall be in a size reasonably related to the most prominent printed material on such panel, and shall be in lines generally parallel to the base on which the package rests as it is designed to be displayed." [See Code of Federal Regulations, 21 CFR 201.61 (c).]