OTC labeling questions and answers

1. What is FDA announcing today?
   
   FDA has finalized its regulation that will require nonprescription drugs to carry clear, simple and readable labeling. This action also will make it easier for consumers to understand information about products, benefits and risks and how the drugs should be used most effectively. It will also help ensure that consumers select the right product to meet their needs. The new format will enable consumers to more readily and easily determine whether a product contains ingredients that they need or do not need or should not take. It will also make it easier to compare similar products to determine which ingredients are right for them based on their symptoms and personal health situation.
   
    
2. Specifically, in simple terms what will the new format look like?
   
   The new format will have standardized headings and subheadings using terms that will be more familiar to consumers. For example, the new label will refer to uses instead of indications, and it will no longer use the terms precautions or contraindications. It will also require the information to appear in a standardized order, described below:

   Drug Facts - title
   Active ingredient(s) - including amount in each dosage unit
   Purpose - pharmacologic class
   Use(s) - indications
   Warnings
   
   

   The final rule also requires certain graphical features, including:
   
   
   • Minimum type size

     Title = a type size larger than the largest type size
     Headings = at least 8 point or 2 points larger than text
     Text and subheadings = at least 6 point

   • A clear, easy-to-read type style, such as Helvetica or Universe, with no more than 39 characters per inch.
   • Left justified text
   • Leading - at least 0.5 point (minimum space between lines)
   • Kerning - letters cannot touch
   • Clearly marked sections with hairlines between sections
   • Bold line surrounding Drug Facts information
   • Upper and lower case letters only - no all caps
   • Bullets - solid square or circle, 5 point type
   • Directions table - if three or more categories
   • Other graphical highlights - contrast, white space, etc.
     
      
   There are also special provisions which allow modifications when the information does not fit on small or unusually shaped packages:
   
   
   • These exemptions may be used if 60% of available label space is insufficient to bear required labeling information.
   • If more than one bulleted statement is on a line, the second bullet may start on one line and continue to the next line. Also bulleted statements need not be vertically aligned.
   • Surrounding box may be omitted if information is offset using color contrast.
   • Less than 0.5 point leading may be used.
   • Headings may be presented using a 7-point minimum type size.
     
      
3. When will consumers start to see the new labels?
   
   For many products, the new labels will appear on products within the next 2 years. OTC drug products that have sales of less than $25,000 per year will receive a special one-year extension. Certain OTC drug products are not required to use the new format for 6 years, although manufacturers of these products are encouraged provide the new labeling sooner.
   
    
4. How many drugs will be affected by this new regulation?
   
   It is estimated that about 100,000 OTC drug products are on the market today. All OTC drug products are covered by this final rule.
   
    
5. How does this final rule affect homeopathic drugs and dietary supplements since they also are sold over the counter?
   
   Homeopathic drug products are subject to the same labeling provisions of the Food, Drug, and Cosmetic Act as other drug products. However, if these products are labeled in accordance to the existing Compliance Policy Guide for homeopathic products, they will not be recommended for regulatory action. Dietary supplements must be labeled in accordance with the dietary supplement regulations in 21 CFR Part 101.
   
    
6. Does the final rule include cosmetic products that contain drug ingredients, such as sunscreens?
   
   OTC Drug-cosmetic products are included in the final rule. These products contain drug ingredients and are marketed for both drug and cosmetic uses. Drug-cosmetics have specific warnings and directions that consumers need to know so they can use these products effectively and with less risk.
   
    
7. What about the elderly? Will they be able to read the new labels?
   
   It's quite true that the elderly have had difficulty reading OTC drug labels in the past. FDA reviewed several studies that included elderly consumers. One study showed that a 4.5-point minimum type size is not readable, and another study presented information that 6.7-point is a readability threshold for persons over age 60 years. Recognizing that factors other than type size can also enhance readability and that there are space constraints for labeling on drug packages, the agency chose to require a minimum type size of 6 point along with graphic labeling features.
   
    
8. Why didn't FDA require a larger type size on labels?
   
   FDA researched this issue very carefully, balancing the need for the required information to fit on various package sizes and the need to ensure that the required information is prominent and readable. FDA considered the comments received on the proposal and reviewed literature studies that demonstrated how important type size is in evaluating readability. Six point type size for the text is a minimum baseline. Manufacturers can use a larger type size and are encouraged to do so.
   
    
9. How much will this cost industry?
   
   The agency has calculated that this final rule will cost industry about $58 million. This cost estimate takes into account the two-year phase-in period and the additional one year extension for OTC drug products having sales of less than $25,000 per year. Some manufacturers may have to modify the label or package size to accommodate the new format. The agency also notes that the new rule will save consumers approximately 100 million dollars per year in health care costs.
   
    
10. Can manufacturers be exempted from this rule if their packages are very small?
    
    While an exemption process is available for unusual circumstances, FDA believes it has developed a rule that takes into account the needs of the variety of marketed OTC drug products and that it will be quite rare for a product to be unable to comply with the various modifications allowed in this regulation. Specifically, the rule provides for modifications of the provisions for packages that require a large amount of drug labeling in a small space.
    
     
11. Will consumers see an increased cost of OTC drugs as a result of this final rule?
    
    Since most OTC drug product labeling is routinely updated and reprinted every few years, the two-three year implementation period substantially reduces the overall cost impact. So, FDA does not expect this initiative to affect OTC retail drug prices. However, FDA also does not regulate OTC drug product pricing.
    
     
12. Did consumers and industry assist FDA in developing this final rule?
    
    FDA received substantial input from consumers, industry, health professionals, and other experts in developing the format and the provisions in this rule. The agency received over 1,800 comments to the proposed rule, held several public meetings, conducted consumer research, and met with many interested parties to obtain their input in this initiative.
    
     
13. Will drug companies need FDA approval of their new labeling prior to marketing?
    
    In most cases no prior approval will be necessary. The final rule contemplates many phrases and words that can be modified or deleted for the required information to fit in the new format. Manufacturers will be permitted to drop certain words or phrases without prior approval as long as such changes do not alter the meaning of the information. If there is a question, manufacturers are encouraged to discuss it with the agency.
    
     
14. How is FDA going to enforce this new final rule?
    
    A drug that requires, yet lacks, this new labeling after its required implementation period would be considered misbranded and subject to the same enforcement approach that FDA can take with other misbranded drugs, including warnings, product seizures, and injunctions. FDA, however, expects to work closely with the industry to ensure a cooperative, broad-based transition to the new labeling format.