Transcript Richards_CH21x

Chapter 21
Uses and Limitations of
Product Labeling for
Public Safety
Purpose of Product Labeling
• Labeling is the main method of
communication between a manufacturer
and the user of the product.
• The information attached to the product
package is what most consumers look at.
Product Labeling
• Labeling includes:
– all other information received from the
manufacturer about the product when it is
purchased
– pamphlets or brochures
– package inserts
Purpose of Product Labeling
• Labeling for the manufacturer is a way to
advertise and sell the product.
– To the user, it provides directions on how to use the
product safely and effectively. To medical personnel, it
is a source to identify toxicants for treatment in the
case of poisoning.
– To the federal government, it is a means for control
and assurance that standards are met and adequate
information is provided to safeguard the public.
Purpose of Product Labeling
• If a product is found to pose an
unacceptable risk to people or the
environment, it can be restricted in its use
or removed from the market.
– For example, the use of
dichlorodiphenyltrichloroethane (DDT),
chlordane, and other pesticides has been
banned in the United States.
Use of Product Labels by Consumers
• Consumers generally assume that chemical
products are safe if used according to the label
directions.
• They generally read product labels for the following
reasons:
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If the product is new to them
To understand the directions for safe and effective use
If there are children or pets in the household
If there is a concern for a potential hazard if used
incorrectly
– An accidental exposure has occurred
Limitations of Product Labels
• Difficult to read
• Fold-out
• Failure to provide comprehensive ingredient
information:
– full chemical names
– Chemical Abstracting Service (CAS) numbers
– proprietary formulations
• Misinterpreted or non-standard warnings
Federal Requirements
• A product or substance is hazardous when
it contains one or more of the following
properties:
– Flammable
– Explosive/reactive
– Corrosive/caustic
– Toxic/poisonous/sensitizer
– Radioactive
Federal Hazardous Substance Act
(FHSA)
• Brand or trade name.
• Common and/or chemical name: common
names of the chemical ingredients;
chemical name if there is no common
name; both chemical and common names
may appear on thelabel (e.g., bleach and
sodium hypochlorite).
• Amount of contents (e.g., weight or
volume).
FHSA, cont.
• Description of hazard and precautionary
statements: description of the principal
hazard involved in using the product, such as
– 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. (A
shortcoming of labels is that they do not specify
how much ventilation is adequate or (in many
cases) what personal protective equipment
should be used.)
FHSA
Description of hazard and
precautionary statements, cont:
– 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.
FHSA, cont.
• Signal word: informs the consumer about the
level of the hazard. The signal word danger
appears on products that are extremely
flammable, corrosive, or highly toxic (additionally
the word poison will appear on these products).
The signal words warning (moderately
hazardous) or caution (slightly hazardous) appear
on all other hazardous substances. The word
nontoxic lacks a regulatory definition, but it is
often used by the manufacturer as a marketing
tool. The absence of a signal word implies a
nonhazardous product.
FHSA, cont.
• Name and address of manufacturer,
distributor.
• Instructions for safe handling and use
(e.g., warnings about where to avoid the
use of the product; the amount to be
mixed with water; what not to mix with the
product).
• First aid instructions (e.g. do not induce
vomiting; if redness persists see a
physician; seek medical help immediately).
Caution, Warning and Danger
• The labeling of pesticides, even for
household use, falls under the Federal
Insecticide, Fungicide, and Rodenticide
Act (FIFRA). Here, signal words
associated with the level of toxicity (based
on laboratory studies and oral
consumption) include slightly toxic
(caution), moderately toxic (warning), and
highly toxic (danger)
Caution
Caution: slightly toxic, more than 1 ounce can
be fatal. Any product marketed as a pesticide
must at least bear the word caution on the
label.
Warning
Warning: moderately toxic, 1 teaspoon to 1
ounce can be fatal.
Danger
Danger or poison: Highly toxic, a few drops to
1 teaspoon can be fatal.
FIFRA and Pesticides
• Pesticides are an important public health
intervention to control vectors of disease and
increase the yields of agricultural products on a
global scale.
– Pesticide use protects the public and our property
from species that can produce physical injury to both.
– Concerns exist regarding the potential health risks to
the public and the environment because of the extent
of pesticide use.
– Special concern exists about exposures in more
susceptible individuals, including pregnant women,
the very young or elderly, and those with certain
disease states.
FIFRA and Pesticides, cont.
• This concern is reflected by the level of product
label detail for these chemicals.
– The U.S. Environmental Protection Agency (EPA)
under FIFRA regulates pesticide sale and use in the
United States.
– Pesticides must be registered with the EPA for use,
whether that use is residential or commercial and no
matter who is applying the pesticide.
– To obtain a registration number, a pesticide must
undergo extensive testing and characterization of its
chemical, physical, and toxicological properties.
– Manufacturing production aspects, toxicology test
results, and information on environmental fate are
examples of the necessary data requirements to
apply for registration.
FIFRA and Pesticides, cont.
• The EPA also conducts risk assessments
for pesticides. FIFRA was amended in
1996 by the Food Quality Protection Act
(FQPA) to take into account prenatal,
infant, and child exposures to pesticides,
recognizing that they require additional
margins of safety (10-fold) for exposures
because of their unique potential health
risks and vulnerabilities associated with
toxicant insults.
Pesticide Product Labeling
• To comply with EPA guidelines, mandatory
statements must appear on pesticide
product labels.
• These mandatory statements include the
actions that are necessary to ensure the
proper use of the product and to help
prevent adverse effects on the applicator,
bystanders, and the environment.
Pesticide Product Labeling
• Examples of mandatory statements include
directions for the use of the pesticide and
precautions needed for the user to take or to
avoid specific actions. Examples of mandatory
statements may include the following:
– 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.
Pesticide Product Labeling
• In addition to mandatory statements,
advisory statements must be provided on
the labeling as well.
• The statements must not conflict with the
mandatory statements and must not be
misleading or false or violate any
regulatory provisions.
Pesticide Product Labeling
• Advisory statements include the following:
– 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.
Pesticide Product Labeling:
Required Information
• The required information on pesticide
product labeling is as follows:
– The name and address of the manufacturer or
registrant must appear on the label
– A “restricted use” statement (not applicable to
the consumer) must appear where a product
should only be applied commercially or has a
high level of restrictions on its use.
Pesticide Product Labeling:
Required Information, cont
– The product name, brand, or trademark must
be plainly visible on the front label of the
product container.
– A statement of ingredients must be on the
product label and include the percentage of
active and “inert” ingredients.
– The EPA registration number and EPA
establishment number appear on the front of
the label.
Pesticide Product Labeling:
Required Information, cont
– An appropriate signal word must appear on
the front label of the pesticide container.
– All pesticide labels must have a misuse
statement on the label that generally reads
“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 is a labeling requirement as well.
Example of Typical Labeling of a
Restricted Use Pesticide
Product Labels Are Not Material
Safety Data Sheets
• The product label is not a material safety data
sheet (MSDS). The manufacturers of pesticides
and other consumer products can provide an
MSDS upon request.
• MSDSs are not generic and may vary with
respect to the accuracy and amount of information
contained within them.
• They should essentially be viewed as documents
that contain additional product information that
could not be contained within the confines of a
typical container label.
An MSDS contains information on:
– Product identification
– Composition information and/or ingredients
– Hazardous identifications
– First aid
– Fire-fighting measures
– Accidental release measures
– Handling and storage
An MSDS contains information on:
(cont.)
– Exposure controls and personal protection
– Physical and chemical properties
– Stability/reactivity
– Toxicological information
– Ecological information
– Disposal
– Transport
– Regulatory information
– Other
Federal Drug Administration
Requirements for Labeling
• We have seen a great increase in use of both
prescription and over-the-counter (OTC)
drugs in the United States and worldwide,
due in part to an aging population.
– People frequently rely on OTC preparations to
“self-medicate” themselves or their children.
– Many OTC preparations were once available by
prescription only and thus today are relied on to
treat many conditions (e.g., pain, allergy, acid
reflux, colds, and bronchial asthma).
– Thousands of generic preparations are available.
Federal Drug Administration
Requirements for Labeling
• The enormous market of OTC drugs has
been associated with medicine misuse, in
part because of failure to recognize the
potential risks associated with their use.
Part of the blame attributed to:
– Difficulty associated with reading and
understanding product labels
– Failing eyesight accompanying old age
– Language barriers
Federal Drug Administration
Requirements for Labeling
• In its review of the readability of OTC drug
labels, the Food and Drug Administration
(FDA) found studies in which a significant
number of people 60 and older could not
read the print on some labels and some
labels even required eyesight much better
than normal.
Label Enclosures
• These inserts typically contain:
– 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
“Americans are overwhelmed with the
complexity of health information. We have hit
a point of information overload and the public
health message is being diluted,”
says former Surgeon General
Richard H. Carmona, MD,
“This is of great concern when it comes to
making sure a patient knows how to use
prescription drugs safely and effectively. This
problem is compounded by prescription
medication information that reads more like
legal disclaimers than useful or actionable
health information.”
Example
of OTC
Product
Label
Websites
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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/FDNews_Fd-LABEL2_CRL_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/
Websites
• 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. National Library of Medicine, National Institutes of Health,
Environmental Health, and Toxicology Specialized Information
Services (SIS). (2005). Toxicology tutorial I.
http://www.sis.nlm.nih.gov/enviro/toxtutor.html