Uses and Limitations of Product Labeling for Public Safety

Purpose of Product Labeling

• Product labeling serves as the primary communication channel between manufacturers and product users.
• Consumers primarily rely on information provided on the product package.
• Labels provide information to:
  • Users: Directions for safe and effective product use.
  • Medical Personnel: Identification of toxicants for treatment in poisoning cases.
  • Federal Government: Means for control, ensuring standards are met and adequate information is provided to safeguard the public.
• Manufacturers use labeling to advertise and sell their products.
• If a product poses an unacceptable risk, its use can be restricted, or it can be removed from the market.
  • Examples: Pharmaceuticals recalled or banned, DDT and chlordane pesticides banned in the US.

Case Studies of Recalled Products

• Darvon & Darvocet (Propoxyphene)
  • Marketed for 55 years (1955-2010).
  • Use: Opioid pain reliever.
  • Manufacturer: Xanodyne.
  • Cause for recall: Serious toxicity to the heart; over 2,110 deaths reported between 1981 and 1999.
  • The UK banned Darvon and Darvocet in 2005. Public Citizen petitioned the FDA to ban the drug in 1978 and 2006.
• Accutane (Isotretinoin)
  • Marketed for 27 years (1982-2009).
  • Use: Acne treatment.
  • Manufacturer: Hoffman-La Roche.
  • Cause for recall: Increased risk of birth defects, miscarriages, and premature births when used by pregnant women; inflammatory bowel disease; suicidal tendencies.
  • Over 7,000 lawsuits were filed against the manufacturer over the side effects, including a 10.5 million verdict and two 9 million verdicts.

Consumer Use of Product Labels

• Consumers generally assume chemical products are safe if used according to label directions.
• Reasons for reading product labels:
  • When the product is new to them.
  • To understand directions for safe and effective use.
  • Presence of children or pets in the household.
  • Concern about potential hazards if used incorrectly.
  • After an accidental exposure.

Limitations of Product Labels

• Difficult to read (e.g., small print, fold-out labels).
• Failure to provide comprehensive ingredient information such as:
  • Full chemical names.
  • Chemical Abstracting Service (CAS) numbers.
  • Proprietary formulations.
• Misinterpreted or non-standard warnings.

Federal Requirements for Hazardous Substances

• A product or substance is hazardous when it exhibits one or more of the following properties:
  • Flammable.
  • Explosive/reactive.
  • Corrosive/caustic.
  • Toxic/poisonous/sensitizer.
  • Radioactive.

Federal Hazardous Substance Act (FHSA)

• Administered by the Consumer Product Safety Commission (CPSC) under 16 CFR Part 1500.
• Covers most products except foods, drugs, cosmetics, and tobacco products.
• Hazardous substance definition: any substance or mixture of substances that is toxic and may cause substantial personal injury or illness during customary or reasonably foreseeable handling or use, including reasonably foreseeable ingestion by children.
• Toxic definition: any substance that can produce personal injury or illness to humans through ingestion, inhalation, or absorption.

FHSA Label Requirements

• Brand or trade name.
• Common and/or chemical name (both may appear, e.g., bleach and sodium hypochlorite).
• Amount of contents (e.g., weight or volume).
• Description of hazard and precautionary statements:
  • Description of the principal hazard involved in using the product.
  • Examples:
    • Do not eat, drink, or smoke while using this product, and wash hands thoroughly when finished; may be harmful if swallowed.
    • Harmful vapor—work in a well-ventilated area.
    • Shortcoming: labels often do not specify adequate ventilation or required personal protective equipment.
    • Flammable—avoid excessive heat and open flames.
    • Avoid skin contact—can be absorbed through the skin—wear long sleeves and gloves.
    • Avoid eye contact—product is an “irritant” to the eyes; avoid splashing and wear protective goggles.
    • Avoid use if pregnant (indicates a concern that the product could injure the developing fetus).
    • Keep out of the reach of children.
• Signal word:
  • Informs the consumer about the level of the hazard.
    • Danger: extremely flammable, corrosive, or highly toxic (also includes the word "poison").
    • Warning: moderately hazardous.
    • Caution: slightly hazardous.
  • The word nontoxic lacks a regulatory definition but is used as a marketing tool.
  • Absence of a signal word implies a nonhazardous product.
• Name and address of manufacturer, distributor.
• Instructions for safe handling and use (e.g., warnings about where to avoid use, mixing instructions).
• First aid instructions (e.g., do not induce vomiting; if redness persists, see a physician; seek medical help immediately).

FIFRA and Pesticides

• The labeling of pesticides falls under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
• The EPA regulates pesticide sale and use in the United States.
  • Pesticides must be registered with the EPA for any use, whether residential or commercial, and regardless of the applicator.
• To obtain a registration number, a pesticide must undergo extensive testing and characterization of its chemical, physical, and toxicological properties.
  • Necessary data includes manufacturing production aspects, toxicology test results, and information on environmental fate.
• The EPA also conducts risk assessments for pesticides.
• FIFRA was amended in 1996 by the Food Quality Protection Act (FQPA) to account for prenatal, infant, and child exposures to pesticides.
  • Requires additional margins of safety (10-fold) for exposures due to unique potential health risks and vulnerabilities.
• Signal words associated with toxicity levels (based on laboratory studies and oral consumption):
  • Caution: Slightly toxic, more than 1 ounce can be fatal.
  • Warning: Moderately toxic, 1 teaspoon to 1 ounce can be fatal.
  • Danger or poison: Highly toxic, a few drops to 1 teaspoon can be fatal.

Pesticide Product Labeling Requirements

• Mandatory statements must appear on pesticide product labels to ensure proper use and prevent adverse effects on the applicator, bystanders, and the environment.
  • Examples:
    • Directions for the use of the pesticide.
    • Precautions needed for the user to take or avoid:
      • Wear chemical-resistant gloves when applying this product.
      • Do not apply in windy conditions.
      • Keep away from open flames, sparks, and heat.
      • Do not induce vomiting.
      • Do not use indoors.
• Advisory statements must also be provided, which must not conflict with mandatory statements or be misleading or false.
  • Examples:
    • This product is best applied within 2 hours of mixing.
    • Spray around the baseboards for optimum coverage.
    • For best results, apply the granules at the base of the ant mound.
    • Common household latex gloves provide adequate protection.
    • This product may discolor carpet.
• Required information:
  • The name and address of the manufacturer or registrant.
  • A “restricted use” statement (not applicable to the consumer) for products that should only be applied commercially or have high restrictions.
  • The product name, brand, or trademark must be plainly visible on the front label.
  • A statement of ingredients, including the percentage of active and “inert” ingredients.
  • The EPA registration number and EPA establishment number on the front of the label.
  • An appropriate signal word (Caution, Danger, Warning) on the front label.
  • “Keep Out Of Reach Of Children”.
  • A misuse statement: “use of this product in any manner inconsistent with its labeling is a violation of federal law”.
  • A statement for the storage and disposal of pesticides.

Federal Drug Administration (FDA) Requirements for Labeling

• Increased use of both prescription and over-the-counter (OTC) drugs in the United States and worldwide due to an aging population.
• OTC preparations are often used for self-medication.
• Many OTC preparations were once prescription-only and are relied on to treat conditions such as pain, allergy, acid reflux, colds, and bronchial asthma.
• Thousands of generic preparations are available.
• The large OTC drug market has been associated with medicine misuse, partly due to difficulty in reading and understanding product labels.
• Factors contributing to misuse:
  • Failing eyesight with age.
  • FDA studies found many people over 60 could not read the print on some labels which required better than normal eyesight.
  • Language barriers.
• Label Enclosures:
  • Ingredient name
  • Common uses
  • Things to do before using this medicine
  • Instructions on how to use this medicine
  • Cautions
  • Possible side effects
  • Overdose
  • Additional information

Safety Data Sheet (SDS)

• The product label is not a safety data sheet (SDS).
• Manufacturers of pesticides and other consumer products can provide an SDS upon request.
• SDSs are not generic and may vary in accuracy and amount of information.
• SDSs contain additional product information that could not be contained within the label.
• It is a legal requirement that chemical products used at home must have labels.
• Occupational Safety and Health Administration (OSHA) HazCom requires employers to have SDSs available for any chemical a worker may contact.
• If you use bleach on the job, your employer must have the SDS available.

SDS Contents

• Product identification
• Composition information and/or ingredients
• Hazardous identifications
• First aid
• Fire-fighting measures
• Accidental release measures
• Handling and storage
• Exposure controls and personal protection
• Physical and chemical properties
• Stability/reactivity
• Toxicological information
• Ecological information
• Disposal
• Transport
• Regulatory information
• Other

Websites

• American National Standards Institute: http://www.ansi.org/
• California Department of Health Services Food and Drug Branch: http://www.dhs.ca.gov/ps/fdb/PDF/FDNewsFd-LABEL2CRL_030201.PDF
• Clinical Data Interchange Standards Consortium: http://www.cdisc.org/
• Gateway to Government Food Safety Information: http://www.foodsafety.gov/
• HL7: http://www.hl7.org/
• U.S. EPA Regulating Pesticides: http://www.epa.gov/oppfead1/labeling/lrm/
• U.S. FDA: http://www.fda.gov/default.htm
• U.S. FDA Center for Drug Evaluation and Research: www.fda.gov/cder/regulatory/physLabel/
• U.S. FDA Center for Food Safety and Applied Nutrition: http://www.cfsan.fda.gov/list.html
• U.S. FDA Data Standards Council: http://www.fda.gov/oc/datacouncil/
• U.S. FDA Structured Product Labeling Resources: http://www.fda.gov/oc/datacouncil/spl.html
• U.S. HHS Office of the National Coordinator for Health Information Technology (ONC): http://www.hhs.gov/healthit/chiinitiative.html
• U.S. NLM, NIH, Environmental Health, and Toxicology Specialized Information Services (SIS). (2005). Toxicology tutorial I. http://www.sis.nlm.nih.gov/enviro/toxtutor.html