FDA Finalizes OTC Labeling Format
Changes are intended to make labels easier to read and understand.
More than two years after FDA proposed to change over-the-counter (OTC) drug labels, the agency has finalized a rule standardizing their format. The final rule was published in the March 17, 1999, Federal Register (64 FR:13253—13303).
Labeling information must be printed in at least six-point type and in an easy-to-read typestyle such as Helvetica or Univers. Headings must be underlined and printed in at least eight-point type, or two points larger than the subheadings and text, whichever is greater. The leading (space between lines) must be at least one-half point. The text must be left justified. The type must be all black or another solid color, and the background must be white or light enough to provide a contrast with the type. Bullet points must be a solid circle or square and must be the same shape and color throughout. They should be vertically aligned.
The information is to be boxed and is not to be interrupted by logos, graphics, or bar codes. It can, however, spread to more than one panel. The format is specified as follows:
- At the top of the box, in at least eight-point bold and italic type, is the title "Drug Facts." An FDA study showed that consumers found such a title to indicate that important information was to follow and that they found the information to be more credible and reliable as a result. If the information spreads to another panel, there must be another title, "Drug Facts (continued)."
- Next is a list of active ingredients and the purpose of each, listed by established name and quantity per dosage unit. If the product does not have discrete dosage units, then the active ingredients are to be listed by proportion.
- After the ingredients is a list of the drug's intended uses.
- Warnings are listed next. This section should explain whether the drug is for external, rectal, or vaginal use only. Ingredient-specific warnings also should be indicated. The subheading "Ask a Doctor Before Use" should be used regarding certain symptoms or preexisting conditions. Another subheading, "Ask a Doctor or Pharmacist Before Use," should be used regarding food-and-drug or drug-and-drug interactions. Warnings about the drug's use during pregnancy or breast-feeding may include the term health professional, because the practitioner often consulted is a nurse or midwife.
The subheading "When Using This Product" should be used to list side effects and substances or activities to avoid. "Stop Use and Ask a Doctor If" is the subheading for the section that explains signs of toxicity or other serious reactions. Following these subheadings should be other warnings not previously listed. The section ends with a referral to a poison control center.
- The next section is "Directions," which should be written and organized concisely. If there are different dosing requirements for three or more age groups, a table is required.
- Other information regarding proper storage and tamper evidency is included next. Priority in this section is given to required information about certain inactive ingredients: sodium, potassium, calcium, magnesium, and aspartame. Logos or seals of approval are not allowed in this section.
- Next, inactive ingredients are listed in alphabetical order.
- The final section, which is not required but highly encouraged, should be titled "Questions?" or "Questions or Comments?" and should list a telephone number in six-point or larger bold type. The number does not have to be toll free, but its hours of operation should be listed.
One of industry's biggest concerns about the anticipated OTC drug label formats was that many packages would be too small to accommodate the new rules. While FDA did not write a blanket exemption for small packages, it did build some flexibility into the rules. If more than 60% of the surface area available to bear labeling would be used for the new format, the label could feature seven-point headings, no minimum leading (other than such that ensures the lines of text don't touch), and no vertically aligned bullet points.
The rule took effect April 16, 1999, and most packages will have to comply in two to six years.
Products under an existing drug approval or final monograph must comply by April 16, 2001. An extra year is permitted for products with less than $25,000 in annual sales. Products that receive FDA approval on or after April 16, 1999, must comply immediately upon approval. Products under a monograph effective after April 16, 1999, must comply by the date the monograph becomes effective, at the next major revision of the label, or by April 18, 2005, whichever is earliest.
For more information, contact Debra L. Bowen, FDA, Center for Drug Evaluation and Research (HFD-560), 5600 Fishers Ln., Rockville, MD 20852. 301/827-2222; or e-mail email@example.com.