BILL NUMBER: AB 2294 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY APRIL 24, 2000
INTRODUCED BY Assembly Member Davis and Senator Speier
(Coauthor: Assembly Member Mazzoni)
FEBRUARY 24, 2000
An act to add Section 11100.02 Sections
11100.02 and 11100.03 to the Health and Safety Code, relating
to controlled substances.
LEGISLATIVE COUNSEL'S DIGEST
AB 2294, as amended, Davis. Ephedrine: dietary supplements.
Existing law provides for the reporting of certain transactions
involving ephedrine, pseudoephedrine, norpseudoephedrine, or
phenylpropanolamine; the issuance of state permits for the conduct of
business with respect to specified transactions involving ephedrine,
pseudoephedrine, norpseudoephedrine, or phenylpropanolamine; limits
on quantities of ephedrine, pseudoephedrine, norpseudoephedrine, or
phenylpropanolamine with regard to retail sale; and penalties for
violations of any requirement in these provisions.
This bill would, in addition, (1) prohibit the sale or
distribution of any dietary supplement product containing ephedrine,
as defined, unless the product meets specified requirements; (2)
impose requirements on product labels for dietary supplement products
containing ephedrine; and (3) impose requirements on companies that
engage in direct marketing of any dietary supplement product
containing ephedrine with respect to advertising and promotional
literature. A violation of any of these requirements would be a
misdemeanor. By creating new crimes, this bill would impose a
state-mandated local program upon local governments.
The California Constitution requires the state to reimburse local
agencies and school districts for certain costs mandated by the
state. Statutory provisions establish procedures for making that
reimbursement.
This bill would provide that no reimbursement is required by this
act for a specified reason.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: yes.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 11100.02 is added to the Health and Safety
Code, to read:
11100.02. (a) The sale or distribution of any dietary supplement
product containing ephedrine group alkaloids that are
characterized, labeled, or advertised as "all natural," "natural,"
"all herbal," or "herbal" is prohibited unless the product
complies with the following requirements:
(1) The product contains no chemically synthesized
synthetic ephedrine group alkaloids
.
(2) Each batch of the product shall be analyzed to ensure that it
contains the amount of total ephedrine alkaloids listed on the
product label.
(b) (1) The product label for any dietary supplement product
containing ephedrine group alkaloids shall include the following
statement:
"THIS PRODUCT HAS (INSERT THE AMOUNT OF PRODUCT) MILLIGRAMS OF
CONCENTRATED EPHEDRINE GROUP ALKALOIDS PER SERVING IN THE FORM OF
HERBAL EXTRACTS."
(2) The product label shall use standardized nomenclature for the
ephedrine ingredient in the product so that the term "ephedrine,"
"pseudoephedrine," or other ephedrine group alkaloid name is used
when referring to the active ingredients in the product instead of,
or in addition to, the botanical name of the ephedrine group
alkaloid.
(3) The product label shall state the amount in milligrams of
caffeine alkaloids and other ingredients per serving that have a
known stimulant effect (such as yohimbine).
(4) The product label shall include a warning statement for the
consumption of ephedrine group alkaloids that is conspicuously
displayed on the label information panel in distinct contrast to
other printing or graphics and in at least1/16 inch type.
(5) The warning on the product label shall contain at least the
following information at a minimum :
(A) WARNING: Not for use by individuals under the age of 18. Do
not use if pregnant or nursing. Consult a physician or licensed
qualified health care professional before using this product if you
have, or have a family history of, heart disease, thyroid disease,
diabetes, high blood pressure, recurrent headaches,
depression or other psychiatric condition, glaucoma,
difficulty in urinating, prostate enlargement, or seizure disorder,
or if you are using a monoamine oxidase inhibitor (MAOI) or any other
dietary supplement, prescription drug, or over-the-counter drug
containing ephedrine, pseudoephedrine, or phenylpropanolamine
(ingredients found in certain allergy, asthma, cough or cold, and
weight control products).
(B) Exceeding recommended serving may cause serious adverse health
effects, including heart attack and stroke.
(C) Discontinue use and call a physician or licensed qualified
health care professional immediately if you experience rapid
heartbeat, dizziness, severe headache, shortness of breath, or other
similar symptoms.
(D) Individuals who consume caffeine with this product may
experience serious adverse health effects.
(D) Individuals who are sensitive to the effects of caffeine
should consult a licensed health care professional before consuming
this product.
(6) The product label shall include a toll-free telephone number
to permit consumers to report adverse effects to the State Department
of Health Services.
(7) All labeling, except that affixed to the product container,
all prerecorded or scripted radio and television advertising, and all
promotional literature shall include the following warning:
"This product" (optional: may use any specific reference to the
product) "has ephedrine group alkaloids in the form of herbal
extracts" (optional: from ma huang or other named herb) "and may
cause serious adverse health effects. Read the label and follow
directions."
(c) (1) All advertising and promotional literature shall be
reviewed and approved by the company responsible for the manufacture
of the dietary supplement product containing ephedrine group
alkaloids and a copy shall be submitted to the State
Department of Health Services.
(2) Companies that engage in direct marketing of dietary
supplement products containing ephedrine shall incorporate into
contracts with distributors, franchisees, or independent contractors
the following conditions:
(A) No claims about the product which have not been approved in
writing by the company may be made.
(B) No medical claims may be made.
(C) Distributors, franchisees, or independent contractors shall be
required to direct consumers to read the product label prior to
purchase or consumption.
(D) Distributors, franchisees, or independent contractors shall be
required to advise consumers under the care of a physician or with a
chronic condition to consult with a physician prior to purchasing
the product.
(E)
(D) Distributors, franchisees, or independent contractors
shall be required to refer any person who makes a complaint about
side effects to a physician or licensed qualified health care
professional.
(3) Companies that engage in direct marketing of dietary
supplement products containing ephedrine shall effectively respond to
distributors, franchisees, or independent contractors to prevent the
distribution of unauthorized literature.
(4) Distributors, franchisees, or independent contractors shall be
trained by companies that engage in direct marketing of dietary
supplement products containing ephedrine to refer medical questions
to a physician and shall not be authorized to give medical advice.
(5) (A) No claims shall be made for the use of dietary supplement
products containing ephedrine, as a "legal" alternative to illicit
drugs, in order to achieve an alteration of consciousness or
euphoria, or for the use of dietary supplement products containing
ephedrine as a drug for the diagnosis, cure, mitigation, treatment,
or prevention of any disease.
(B) To determine compliance with this requirement, the State
Department of Health Services may consider the following factors:
(i) The product packaging.
(ii) The name and container labeling of the product.
(iii) Advertising and promotional materials created by the company
responsible for the manufacture or distribution of the product.
(6) Prior to Within 60 days of the
distribution by a company of any dietary supplement product
containing ephedrine, the company shall submit a copy of
the product label to the State Department of Health Services.
(d) For the purposes of this section, "ephedra," "ephedra extract,"
or "ephedrine" means a source of any ephedrine alkaloid, including,
but not limited to, ephedrine, pseudoephedrine, norephedrine,
norpseudoephedrine, N-methylephedrine, or N-methylpseudoephedrine,
that is either derived from natural sources such as the herb Ephedra
sinica, Ma-Huang, or Chinese Ephedra, or is synthetically produced.
(e) A violation of this section is a misdemeanor.
SEC. 2. Section 11100.03 is added to the Health and Safety
Code, to read:
11100.03. (a) The sale or distribution of any dietary supplement
product containing ephedrine group alkaloids is prohibited unless the
product complies with the following requirement:
(1) Each batch of the product shall be analyzed to ensure that it
contains the amount of total ephedrine alkaloids listed on the
product label.
(b) (1) The product label for any dietary supplement product
containing ephedrine group alkaloids shall include the following
statement:
"THIS PRODUCT HAS (INSERT THE AMOUNT OF PRODUCT) MILLIGRAMS OF
SYNTHETIC EPHEDRINE (IF ANY) AND (INSERT THE AMOUNT OF PRODUCT)
MILLIGRAMS OF CONCENTRATED GROUP ALKALOIDS PER SERVING IN THE FORM OF
HERBAL EXTRACTS."
(2) The product label shall use standardized nomenclature for the
ephedrine ingredient in the product so that the term "ephedrine,"
"pseudoephedrine," or other ephedrine group alkaloid name is used
when referring to the active ingredients in the product instead of,
or in addition to, the botanical name of the ephedrine group
alkaloid.
(3) The product label shall state the amount in milligrams of
caffeine alkaloids and other ingredients per serving that have a
known stimulant effect (such as yohimbine).
(4) The product label shall include a warning statement for the
consumption of ephedrine group alkaloids that is conspicuously
displayed on the label information panel in distinct contrast to
other printing or graphics and in at least 1/16 inch type.
(5) The warning on the product label shall contain at least the
following information:
(A) WARNING: Not for use by individuals under the age of 18. Do
not use if pregnant or nursing. Consult a physician or licensed
qualified health care professional before using this product if you
have, or have a family history of, heart disease, thyroid disease,
diabetes, high blood pressure, depression or other psychiatric
condition, glaucoma, difficulty in urinating, prostate enlargement,
or seizure disorder, or if you are using a monoamine oxidase
inhibitor (MAOI) or any other dietary supplement, prescription drug,
or over-the-counter drug containing ephedrine, pseudoephedrine, or
phenylpropanolamine (ingredients found in certain allergy, asthma,
cough or cold, and weight control products).
(B) Exceeding recommended serving may cause serious adverse health
effects, including heart attack and stroke.
(C) Discontinue use and call a physician or licensed qualified
health care professional immediately if you experience rapid heart
beat, dizziness, severe headache, shortness of breath, or other
similar symptoms.
(D) Individuals who are sensitive to the effects of caffeine
should consult a licensed health care professional before consuming
this product.
(6) The product label shall include a toll-free telephone number
to permit consumers to report adverse effects to the State Department
of Health Services.
(7) All labeling, except that affixed to the product container,
all prerecorded or scripted radio and television advertising, and all
promotional literature shall include the following warning:
"This product" (optional: may use any specific reference to the
product) "has ephedrine group alkaloids and may cause serious adverse
health effects. Read the label and follow directions."
(c) (1) All advertising and promotional literature shall be
reviewed and approved by the company responsible for the manufacture
of the dietary supplement product containing ephedrine group
alkaloids and a copy shall be submitted to the State Department of
Health Services.
(2) Companies that engage in direct marketing of dietary
supplement products containing ephedrine group alkaloids shall
incorporate into contracts with distributors, franchisees, or
independent contractors the following conditions:
(A) No claims about the product which have not been approved in
writing by the company may be made.
(B) No medical claims may be made.
(C) Distributors, franchisees, or independent contractors shall be
required to direct consumers to read the product label prior to
purchase or consumption.
(D) Distributors, franchisees, or independent contractors shall be
required to refer any person who makes a complaint about side
effects to a physician or licensed qualified health care
professional.
(3) Companies that engage in direct marketing of dietary
supplements products containing ephedrine shall effectively respond
to distributors, franchisees, or independent contractors to prevent
the distribution of unauthorized literature.
(4) Distributors, franchisees, or independent contractors shall be
trained by companies that engage in direct marketing of dietary
supplement products containing ephedrine to refer medical questions
to a physician and shall not be authorized to give medical advice.
(5) (A) No claims shall be made for the use of dietary supplement
products containing ephedrine, as a "legal" alternative to illicit
drugs, in order to achieve an alteration of consciousness or
euphoria, or for the use of dietary supplement products containing
ephedrine as a drug for the diagnosis, cure, mitigation, treatment,
or prevention of any disease.
(B) To determine compliance with this requirement, the State
Department of Health Services may consider the following factors:
(i) The product packaging.
(ii) The name and container labeling of the product.
(iii) Advertising and promotional materials created by the company
responsible for the manufacture or the distribution of the product.
(6) Within 60 days of the distribution by a company of any dietary
supplement product containing ephedrine, the company shall submit a
copy of the product label to the State Department of Health Services.
(d) For the purposes of this section, "ephedra," "ephedra extract,"
or "ephedrine" means a source of any ephedrine alkaloid, including,
but not limited to, ephedrine, pseudoephedrine, norephedrine,
norpseudoephedrine, N-methylephedrine, or N-methylpseudoephedrine,
that is either derived from natural sources such as the herb Ephedra
sinica, Ma-Huang, or Chinese Ephedra, or is synthetically produced.
(e) A violation of this section is a misdemeanor.
SEC. 3. No reimbursement is required by this act pursuant to
Section 6 of Article XIIIB of the California Constitution because
the only costs that may be incurred by a local agency or school
district will be incurred because this act creates a new crime or
infraction, eliminates a crime or infraction, or changes the penalty
for a crime or infraction, within the meaning of Section 17556 of the
Government Code, or changes the definition of a crime within the
meaning of Section 6 of Article XIIIB of the California Constitution.