On March17th the Food and Drug Administration (FDA) issued, amidst great fanfare, a regulation governing labels for over-the-counter drug products (OTCs).1 These new provisions will ultimately apply to all OTC drugs, whether they were approved under a new drug application (NDA) or an abbreviated new drug application (ANDA covering generic drugs), are subject to a final monograph or are marketed during the pendency of the OTC review. In its resolve to mandate a uniform presentation of information, the FDA is drawing on its experience with the Nutrition Labeling and Education Act (NLEA). Through this effort, the agency hopes to make drug labels more user friendly so that consumers can locate and read the health and safety information for a product and compare it to other OTCs.
Label Information Content Requirements
Though the regulation does not include any new requirements for the principal display panel (PDP), on which basic product information such as name and manufacturer are listed, it does represent a major overhaul to drug product information panels, adding a standardized set of required information enclosed within a distinctive border. The FDA has specified not only the content but also the order in which information must appear. The agency believes that active ingredients and their purposes should appear first, followed by other information categories in the order of their perceived importance. According to the FDA, the following list will assist consumers when choosing OTCs:
- Drug Facts
- Uses
- Warnings
- Directions
- Other Information
- Inactive Ingredients
- Contact Information
On the redesigned label, "Drug Facts" will appear at the top of the information panel and will include each active ingredient, its concentration per unit dosage, and its purpose or pharmaceutical action. If the drug is subject to a monograph that contains a "statement of identity" requirement, that statement of identity must be listed as the active ingredient's purpose. (For example, drug products marketed under the Topical Antifungal Drug Products Monograph2 should list their active ingredient's purpose as "Antifungal."). Below the "Drug Facts" section, a "Uses" section will list the approved or monograph indications for the drug.
The next section of the label is "Warnings." In addition to specifying where warnings must appear, FDA has also prioritized the order in which warnings are presented.
The first warning, if applicable, is: "For external use only." Following that statement are any of seven specific warnings that may apply to the product, such as those related to allergy, Reye's Syndrome, alcohol and flammability. The contraindications of the drug appear next under the subheading "Do not use." Situations in which a doctor or other health care professional should be contacted follow the contraindications, and general warnings fall at the end of the section.
"Directions," as specified in the applicable OTC monograph or the product's approval application, follow the "Warnings" section. Other information that is required by the FDA in a monograph or product approval is listed below the directions. Promotional information may not appear in the "Other Information" section, or elsewhere within the "Drug Facts" portion of the label.
The last required information category is an alphabetical listing of "Inactive Ingredients." The new regulation implements a provision of the FDA Modernization Act (FDAMA) that requires OTC manufacturers to list each inactive ingredient on the outside container of a product's retail package. Although the FDAMA became effective in February 1998, the FDA had held off implementing that provision until now. Prior to the FDAMA, drug manufacturers had been required only to list active ingredients, except in cases of cosmetic drug products such as sunscreens and acne medications. Such combination drug/cosmetic products have been mandated to disclose their inactive ingredients in order of predominance, a requirement maintained by this rule.
The final section of the "Drug Facts" is labeled "Questions or Comments?" Under this section there is space where a manufacturer can provide a telephone number for consumers, should consumers wish to contact the manufacturer. Although the telephone number is not required by the regulation, FDA strongly encourages manufacturers to provide one. However, should a manufacturer provide one, it needn't be toll free. The FDA does, however, recommend that the company specify days and times during the week, when consumers would receive responses to their phone calls.
Label Information Format Requirements
Beyond its information content mandate, the FDA has set explicit labeling format requirements governing the alignment and punctuation of headings; type size; font characteristics; the use of bullets, dividing lines, and graphic images; and procedures for handling multiple panels. The FDA conducted two studies to evaluate the effects these parameters have on the drug label readability, and after evaluating the studies concluded that a minimum type size of 6.7point is required to ensure that people over the age of 60 can read the label. Recognizing the space constraints, however, the FDA chose to allow type size as small as 6.0 point. Unlike the net weight marking requirement for the PDP, the font size need not be increased as the package size increases.
If a package is too small to include all required labeling, the FDA is allowing manufacturers to make some modifications in the required label elements. These modifications, however, do not include reducing the type size below 6.0 point. To qualify for the modifications, a package must be considered "small"-that is, more than 60 percent of the total surface area available for labeling is needed to accommodate the FDA required labeling. The FDA interprets available surface area to include the entire container, except for flanges on the tops and bottoms of cans and the shoulders and necks of bottles and jars. Products that are unable to meet the normal or modified labeling format requirements must be reconfigured to comply with the rule. The FDA has stated that it will not routinely grant exemptions for products that claim to be too small to meet the rule's requirements.
Exemptions and Deferrals
The new labeling regulation allows manufacturers to request exemption from one or more of its requirements. The FDA may also grant exemptions or deferrals on its own initiative. For example, in its preamble to the final rule, FDA selected products such as lipsticks and lip balm that contain sunscreens as product types the FDA may identify as candidates for exemptions. Merely because an OTC is also a cosmetic, however, will not be sufficient reason to exempt the product from the new requirements. The FDA specifically stated that sunscreens, toothpaste and other cosmetic-drug products must comply with the new rule.
In response to a question about the status of homeopathic products, the FDA indicated that OTC homeopathic products are subject to the new regulation. However, the FDA stated that it intends to exercise its enforcement discretion and not take action against homeopathic products as long as they comply with the Compliance Policy Guide on "Conditions Under Which a Homeopathic Drug Product May Be Marketed."
Effective Date
The regulation takes effect immediately for products subject to approval through the premarket process (NDAs and ANDAs) and approved after April16, 1999. All other drug products have at least two years in which to come into compliance with the new labeling requirements. The outside date for compliance is six years, and applies to drug products that may be subject to an OTC monograph that is not yet final. While compliance with these rules has some preemptive effect over conflicting state law, it does not have any effect on product liability suits or existing state initiatives such as California's Proposition65.
164 Fed Reg. 13254 (Mar. 17, 1999).
221 C.FR. §§333.201-333.280.
If you have any questions or comments about any of the foregoing, please contact:
Donald E. Segal
202-452-7959
segalde@bipc.com
Edward John Allera
202-452-7985
alleraej@bipc.com