BILL ANALYSIS
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Elaine K. Alquist, Chair
BILL NO: SB 400
S
AUTHOR: Corbett
B
AMENDED: September 2, 2009
HEARING DATE: September 10, 2009
4
CONSULTANT:
0
Dunstan/sh
0
PURSUANT TO SENATE RULE 29.10
SUBJECT
Electronic cigarettes
SUMMARY
This bill provides that electronic cigarettes are drugs
under state law, making them subject to the Sherman Food,
Drug, and Cosmetic Law. Allows the Department of Public
Health (DPH) to halt the sale, distribution, or offering of
electronic cigarettes as part of its enforcement of the
Stop Tobacco Access to Kids Enforcement (STAKE) Act.
CHANGES TO EXISTING LAW
Existing state law:
Requires DPH, under the Sherman Food, Drug, and Cosmetic
Law, to regulate the manufacture, sale, labeling, and
advertising activities related to food, drugs, devices, and
cosmetics in conformity with the federal Food, Drug, and
Cosmetic Act. Provides that a violation of these
provisions is a crime. Requires federal or state approval
before a drug can be sold, delivered or given away.
Continued---
STAFF ANALYSIS OF SENATE BILL SB 400 (Corbett)Page 2
Requires DPH to take primary responsibility for enforcement
of the Stop Tobacco Access to Kids Enforcement Act (STAKE
Act). Requires, under the Stop Tobacco Access to Kids
Enforcement (STAKE) Act a retailer from selling cigarettes
and tobacco products to minors under the age of 18 and
requires that retailers check identification of individuals
trying to buy cigarettes and tobacco products who appear to
be under the age of 18. Makes certain violations of the
STAKE Act a criminal offense. Requires DPH to take primary
responsibility for enforcement of the STAKE Act and
requires DPH to conduct random, onsite inspections of
retail sites.
This bill:
Authorizes DPH, while conducting STAKE Act enforcement
activities, to halt the sale, distribution or offering for
sale electronic cigarettes that have not been approved or
cleared by the U.S. Food and Drug Administration (FDA).
States that any article that can provide inhaled doses of
nicotine, including electronic cigarettes, shall be deemed
to be a drug under the Sherman Food, Drug, and Cosmetic
Law.
FISCAL IMPACT
According to the Assembly Appropriations Committee, there
are minor, if any, nonreimbursable local incarceration
costs as this bill changes the definition of an existing
crime.
BACKGROUND AND DISCUSSION
According to the author, SB 400 provides the Department of
Public Health with the tools to stop the illegal sale of
this product in California by updating the Stop Tobacco
Access to Kids Enforcement (STAKE) Act and the Health and
Safety Code to halt the sale of electronic cigarettes until
they are approved by the United States Food and Drug
Administration (FDA). The author notes that producers of
electronic cigarettes have not sought approval by the FDA
which has jurisdiction over nicotine products and drug
delivery devices. As a result, the author argues,
STAFF ANALYSIS OF SENATE BILL SB 400 (Corbett)Page 3
electronic cigarettes are completely unregulated, illegal
and until the FDA has the opportunity to comprehensively
study the effects of this product - unsafe. Despite this,
electronic cigarettes are readily available to adult and
minors alike at mall kiosks across the state and retailers
have used methods that flagrantly appeal to minors such as
offering flavored nicotine cartridges, according to the
author. The author points out that an initial study
commissioned by the FDA found that the product contains
carcinogens and misrepresentations in nicotine content.
Nicotine
Nicotine is highly addictive. It is both a stimulant and a
sedative to the central nervous system. The ingestion of
nicotine results in an almost immediate kick because it
causes a discharge of epinephrine from the adrenal cortex.
This stimulates the central nervous system, and other
endocrine glands, which causes a sudden release of glucose.
Stimulation is then followed by depression and fatigue,
leading the abuser to seek more nicotine. Nicotine is
absorbed readily from tobacco smoke in the lungs, and it
does not matter whether the tobacco smoke is from
cigarettes, cigars, or pipes.
Nicotine also is absorbed readily when tobacco is chewed.
With regular use of tobacco, levels of nicotine accumulate
in the body during the day and persist overnight. Thus,
daily smokers or chewers are exposed to the effects of
nicotine for 24 hours each day. Nicotine taken in by
cigarette or cigar smoking takes only seconds to reach the
brain but has a direct effect on the body for up to 30
minutes.
Nicotine is one of the most heavily used addictive drugs in
the United States. Cigarette smoking has been the most
popular method of taking nicotine since the beginning of
the 20th century. In 1989, the U.S. Surgeon General issued
a report that concluded that cigarettes and other forms of
tobacco, such as cigars, pipe tobacco, and chewing tobacco,
are addictive and that nicotine is the drug in tobacco that
causes addiction. In addition, the report determined that
smoking was a major cause of stroke and the third leading
cause of death in the United States.
Electronic cigarettes
Electronic cigarettes are not cigarettes. They are
STAFF ANALYSIS OF SENATE BILL SB 400 (Corbett)Page 4
electronic devices that are manufactured to look like
cigarettes that cost between $40 and $70. They are battery
powered and provide the person who uses them a vaporized
liquid to inhale, which delivers nicotine to the user.
They also come in a variety of flavors, including
chocolate, mint and apple, which make them appealing to
children and adolescents.
Since electronic cigarettes are not cigarettes they fall
outside of the tobacco regulatory scheme at the state and
federal levels. As an unregulated product, there is no age
limit for purchasing them. Electronic cigarettes do not
contain warnings, which are required on nicotine
replacement therapies and tobacco products.
These products have not been subject to an analysis to
determine the possible impact on consumer health. The
amount of nicotine they deliver is unknown. The existence
and possible levels of other compounds that may be
contained is uncertain, although the FDA has researched
some samples and announced that they contain toxic and
carcinogenic chemicals. Because electronic cigarettes are
a means of delivering nicotine, there is a concern that the
use of them may lead to nicotine addiction, including among
youths. Concerns have been raised that this nicotine
addiction could lead to increased underage smoking.
The U.S. FDA is investigating electronic cigarettes. The
FDA has opined that nicotine is a drug and subject to
agency regulation and that electronic cigarettes are
devices used to deliver drugs, hence they must be approved
by the FDA before being marketed within the United States.
Before approval could be gained, the manufacturers would
have to show that electronic cigarettes are safe and
effective.
The FDA has been examining and detaining shipments of
e-cigarettes at the border and the products it has examined
thus far meet the definition of a combination drug-device
product under the Federal Food, Drug and Cosmetic Act.
However, the FDA has not taken any steps to remove them
from the U.S. market. The FDA has been challenged
regarding its jurisdiction over e-cigarettes in a case
currently pending in federal district court (Smoking
Everywhere, Inc. v. FDA). The basis of the challenge is
that electronic cigarettes are nontherapeutic alternatives
STAFF ANALYSIS OF SENATE BILL SB 400 (Corbett)Page 5
to cigarettes; hence they do not fall under FDA regulation.
Stop Tobacco Access to Kids Enforcement (STAKE) Act
In response to the federal law, in 1994, the state began to
track minors' access to cigarettes and tobacco products.
The state conducted a survey, using over 400 youths, 13-17
years of age, who attempted to buy cigarettes at more than
1,800 retail stores. Fifty-two percent of the retailers
sold to minors. The poor compliance with the law was a
factor in the September 1994 enactment of the STAKE Act,
which sought to more effectively police tobacco sales to
minors and fulfilled the federal mandate.
The STAKE Act requires DPH to:
Implement an enforcement program to reduce the illegal
sale of tobacco products to minors and to conduct sting
operations using 15 and 16 year olds;
Operate a toll-free number for the public to report
illegal tobacco sales to minors;
Assure that tobacco retailers post warning signs which
include the toll-free number to report violations;
Assure that clerks check the identification of youthful
appearing persons prior to a sale; and,
Assess civil penalties ranging from $200 to $6,000
against the store owner for violations.
Related Bills
SJR 8 (Corbett), requests that the federal Food and Drug
Administration prohibit all sales of electronic cigarettes
until they have been found by the Food and Drug
Administration to be safe. This resolution is in Assembly
Governmental Organization Committee.
Arguments in support
According to the supporters, SB 400 halts the sale of
electronic cigarettes to minors in California by amending
the California Stop Tobacco Access to Kids Enforcement
(STAKE) Act and keeps the addictive and harmful drug
nicotine away from minors.. They argue that this is
necessary because, in recent years, industries have been
innovative in their marketing of tobacco and nicotine
products to children. A new product called electronic
cigarettes has hit the market without any regulation or
STAFF ANALYSIS OF SENATE BILL SB 400 (Corbett)Page 6
studies. Producers of electronic cigarettes have refused
to apply for approval from the U.S. FDA. Furthermore, they
argue that electronic cigarette companies are currently
marketing their product to minors by selling flavored
nicotine cartridges and utilizing shopping mall kiosks and
other locations frequented by minors.
PRIOR ACTIONS
Assembly Floor: 51-24
Assembly Appropriations: 17-0
Assembly Governmental Organization:18-0
POSITIONS
Support: Breathe California
California Medical Association
California Tobacco Control Alliance
Community Advocate Teens of Today Coalition
Oppose: None received