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Ephedra Laws

KEYWORD
On January 3, 2007 Nutraceutical Corp. filed a petition for a writ of certiorari to appeal the US Tenth Circuit Court decision that affirmed the FDA's ban on ephedra. The following four entries were in response to that petition.
May 14, 2007 The US Supreme Court opted to not hear Nutraceutical Corp's appeal and let stand the lower court's order, so the petition was denied. Substances that conatin ephedrine alkaloids (including natural ephedra) remain banned in the United States.

The US Supreme Court considers only the most important cases for review. On this day, there were 283 other petitions that the US Supreme Court opted not to hear.

April 13, 2007 Reply of petitioners Nutraceutical Corporation, et al. filed.
April 6, 2007 Brief of respondents Andrew Von Eschenbach, Commissioner, Food and Drug Administration, et al. in opposition filed.
April 4, 2007 Brief amicus curiae of Natural Products Association filed.
 
January 3, 2007

Nutraceutical Corp. files a petition for a writ of certiorari.
Docketed January 5, 2007 as  No. 06-922.

August 17, 2006

US Federal Appeals Court reverses decision of ruling that had struck down the ban on ephedra - Case No. 05-4151

The US Tenth Circuit Court of Appeals overruled District Judge Tena Campbell's ruling and agreed with the FDA, saying there is no dosage level of ephedra dietary supplements acceptable for the market.

April 13, 2005 US Federal Court Overturns the Ban on Ephedra - Case No. 2:04CV409 TC

Plaintiffs Nutraceutical Corp. and Solaray, Inc.challenged the validity of the FDA's February 2004 regulation banning all ephedrine-alkaloid dietary supplements. 

District Judge Tena Campbell orders the FDA from taking any action against the Plaintiffs for selling dietary supplement containing 10 mg or less of ephedrine alkaloids per daily dose.

On April 12, 2004 the sale of ephedra for use as a weight loss supplement or as an energizer was prohibited in the United States.
However, the FDA's ban on ephedra specifically excludes uses of the herb in traditional Asian medicine. It states that "These products are beyond the scope of this rule because they are not marketed as dietary supplements." California and New York have made similar exceptions for herbal medicine. Illinois has not.

See the FDA on ephedra page for information on US ban on ephedra.

States that have banned ephedra:

Illinois    New York    California

Illinois:

Public Act 93-0008 SB1418 (Ephedra Prohibition Act)

Became law 05/28/2003

What's Defined?

What's Prohibited?

What are the Penalties?

Public Act 93-0008

SB1418 Enrolled                      LRB093 10881 MBS 11393 b

    AN ACT concerning public health.

    Be it enacted by the People of  the  State  of  Illinois,
represented in the General Assembly:

    Section  1.  Short  title.  This  Act may be cited as the
Ephedra Prohibition Act.

    Section 5.  Findings.  The  General  Assembly  finds  the
following:
         (1)  Over 3 billion servings of ephedra are consumed
    by Americans each year.
         (2)  Ephedra,  or ma huang, has been associated with
    a wide range of severe adverse events, including death.
         (3)  The  U.S.  Food  and  Drug  Administration  has
    received over 18,000  reports  of  adverse  reactions  by
    ephedra   users,   including   strokes,  seizures,  heart
    attacks, and deaths.
         (4)  The Inspector General of the U.S. Department of
    Health and Human Services noted in a  report  on  ephedra
    adverse  events  that  60%  of  those adverse events were
    experienced by people under the age of 40.
         (5)  A study reported  in  the  Annals  of  Internal
    Medicine  concluded  that,  compared  with  other  herbs,
    ephedra  is  associated with a greatly increased risk for
    adverse reactions and that the use of ephedra  should  be
    restricted.
         (6)  The   American   Medical  Association  and  the
    consumer  group,  Public  Citizen,  have  called  for   a
    nationwide ban on ephedra.
         (7)  The  National Collegiate Athletics Association,
    the  National  Football  League,  and  the  International
    Olympic Committee have all banned ephedra  use  by  their
    athletes  because  of  concerns  about the safety of this
    dietary supplement.
         (8)  The U.S. Army has banned the  sale  of  ephedra
    products  in  army  commissaries  worldwide after 33 army
    personnel died from consuming ephedra products.
         (9)  Canada, Britain, Germany,  and  Australia  have
    all taken steps to restrict the sale of ephedra products.

    Section  10.  Purpose.  The purpose of this Act is to ban
the sale of  all  dietary  supplements  containing  ephedrine
alkaloids  in  the State of Illinois regardless of the age of
the purchaser in order  to  protect  the  health  and  public
safety of Illinois residents.

    Section 15. Definitions:
    "Ephedra"  means  herbs  and herbal products that contain
ephedrine alkaloids, including  ma  huang,  Chinese  ephedra,
ephedra sinica, ephedra herb powder, epitonin, or any extract
of  those  substances,  but  does  not  include any drug that
contains ephedrine and  is  lawfully  sold,  transferred,  or
furnished  over  the  counter  with or without a prescription
pursuant to the federal Food,  Drug,  and  Cosmetic  Act  (21
U.S.C.  301  and following) or regulations adopted under that
Act.
    "Person"   means   any   natural   person,    individual,
corporation,   unincorporated   association,  proprietorship,
firm, partnership, joint venture, joint stock association, or
any other business organization or entity.

    Section 20. Prohibition.
    (a)  No person may sell or offer  for  sale  any  dietary
supplement  containing  any  quantity of ephedra or ephedrine
alkaloids to any person located within the State  or  to  any
person making the purchase from within the State.
    (b)  The  prohibition  in  subsection (a) of this Section
does not apply to the  sale  of  any  product  that  receives
explicit  approval as safe and effective for its intended use
under the federal Food, Drug, and  Cosmetic  Act  (21  U.S.C.
355)  or  is  lawfully  marketed  under  an  over-the-counter
monograph issued by the U.S. Food and Drug Administration.

    Section 25. Penalties.
    (a) Any person who violates this Act is guilty of a Class
A misdemeanor.  The penalty is imprisonment for less than one
year  or  a  fine of not more than $5,000 or both for a first
offense.
    (b)  For a subsequent violation of this Act, a person  is
guilty  of  a Class 3 felony, and the penalty is imprisonment
for less than 5 years or a fine of not more than  $20,000  or
both.

    Section  99.  Effective  date. This Act shall take effect
upon becoming law.
Effective Date: 05/28/2003

New York:

Laws of New York, 2003   -   Chapter 385 (full text)

Became law 10-19-03 (if the above is busy, go to http://public.leginfo.state.ny.us/menugetf.cgi and enter 'ephedra' into the search box)

What's Prohibited?

What's Excluded?

What are the Penalties?

AN ACT to amend the general business law, in relation to banning the sale of dietary supplements containing ephedra to persons in New York State became a law August 19, 2003, with the approval of the Governor. Passed by a majority vote, three-fifths being present.

The People of the State of New York, represented in Senate and Assembly, do enact as follows:

Section 1. The general business law is amended by adding a new section 391-o to read as follows:

391-o. Sale or promotional distribution of dietary supplements containing ephedra.

1. No person, firm, corporation, partnership, association, limited liability company, or other entity shall sell or offer to sell or give away, as either a retail or wholesale promotion, a dietary supplement containing any quantity of ephedrine alkaloids within New York state, except as authorized by subdivision three of this section.

2. For purposes of this section, the following terms have the following meanings:

(a) "dietary supplement" means 

(1) a product (other than tobacco) that is intended to supplement the diet and that bears or contain some or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for the use by a person to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients;

(2) intended for ingestion in pill, capsule, tablet, or liquid form; and 

(3) labeled as a "dietary supplement" pursuant to the federal Dietary Supplement Health and Education Act, 21 U.S.C.321, as amended.

(b) "ephedra" means any natural or synthetic form of ephedrine and ephedrine alkaloids.

3. (a) Nothing in this section shall apply to nonprescription over-the-counter drugs approved or regulated by the Food and Drug Administration.

    (b) This section shall not apply to ma huang (ephedra sinica) sold or dispensed by any practitioner of acupuncture or oriental medicine, whose qualification to use ma huang and other herbs is explicitly
established via evidence of an active certification issued to such individual from an entity accredited by the National Commission of Certifying Agencies (NCCA), or any physician or any practitioner of acupuncture licensed by the state of New York as long as it is not sold or dispensed as a dietary supplement for weight loss, for body building, or as an "energy food".


4. Any person, firm, corporation, partnership, association, limited liability company, or other entity that violates the provisions of this section by selling, offering to sell, or giving away as either a retail or wholesale promotion, a dietary supplement containing any quantity of ephedrine alkaloids shall be subject to a civil penalty of not more than five hundred dollars per violation, recoverable in an action by any enforcement authority designated by any municipality or political subdivision.

5. It shall be a defense that any person, firm, corporation, partnership, association, limited liability company, or other entity that sold, offered for sale, or gave away as either a retail or wholesale promotion a dietary supplement, did not have knowledge that the supplement contained any quantity of ephedrine alkaloids, if such knowledge was not reasonably discoverable.

2. This act shall take effect on the sixtieth day after it shall have become a law.

The Legislature of the STATE OF NEW YORK ss:
Pursuant to the authority vested in us by section 70-b of the Public Officers Law, we here by jointly certify that this slip copy of this session law was printed under our direction and, in accordance with such section, is entitled to be read into evidence.

JOSEPH L. BRUNO - Temporary President of the Senate
SHELDON SILVER - Speaker of the Assembly

November 3, 2003 News Release: GOVERNOR PATAKI SIGNS LAW BANNING SALE OF EPHEDRA PRODUCTS
MAY 23, 1996 News Release: GOVERNOR PROTECTS CONSUMERS FROM PRODUCTS CONTAINING DANGEROUS HERB
Westchester County, New York: Restrictions on The Sale of Dietary Supplements Containing Ephedra

California:

California Senate Bill No.582 - Ephedrine group alkaloids.

Became Law 1-1-04

What's Prohibited?

What's Excluded?

Summary - The act prohibits the sale of dietary supplements containing ephedrine group alkaloids unless a California licensed health care practitioner who is practicing within his or her scope of practice and who prescribes or dispenses, or both, dietary supplement products containing ephedrine group alkaloids in the course of the treatment of a patient under the direct care of that licensed health care practitioner,
except that a licensed health care practitioner shall not prescribe or dispense dietary supplements containing ephedrine group alkaloids for purposes of weight loss, body building, or athletic performance enhancement.
INTRODUCED BY   Senator Speier

                        FEBRUARY 20, 2003

   An act to add Article 4.5 (commencing with Section 110423.100) to
Chapter 4 of Part 5 of Division 104 of the Health and Safety Code,
relating to public health.

	LEGISLATIVE COUNSEL'S DIGEST

   SB 582, Speier.  Ephedrine group alkaloids.
   The Sherman Food, Drug, and Cosmetic Law contains various
provisions regarding the packaging, labeling, and advertising of
food, drugs, and cosmetics.  Violation of any of these provisions is
a crime.  The act prohibits the sale of dietary supplements
containing ephedrine group alkaloids or steroid hormone precursors
unless the product label of these products includes specified
information.  Existing law makes it a misdemeanor for any
manufacturer, wholesaler, retailer, or other person to sell,
transfer, or otherwise furnish a dietary supplement containing
ephedrine group alkaloids or steroid hormone precursors to a person
under 18 years of age.
   This bill would prohibit the sale or distribution of any dietary
supplement product containing ephedrine group alkaloids,
notwithstanding the provisions of existing law described above
relating to the sale and distribution of these supplements.  Because
the bill would create a new crime, it would impose a state-mandated
local program.
   This bill would provide that its provisions do not apply in
specified circumstances.
  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.

THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:

  SECTION 1.  Article 4.5 (commencing with Section 110423.100) is
added to Chapter 4 of Part 5 of Division 104 of the Health and Safety
Code, to read:

      Article 4.5.  Ephedrine Group Alkaloids

   110423.100.  Notwithstanding Article 4 (commencing with Section
110423), the sale or distribution of any dietary supplement products
containing ephedrine group alkaloids is prohibited.
   110423.101.  This article shall not apply, but Article 4
(commencing with Section 110423) shall apply, to any of the
following:
   (a) A California licensed health care practitioner who is
practicing within his or her scope of practice and who prescribes or
dispenses, or both, dietary supplement products containing ephedrine
group alkaloids in the course of the treatment of a patient under the
direct care of that licensed health care practitioner, except that a
licensed health care practitioner shall not prescribe or dispense
dietary supplements containing ephedrine group alkaloids for purposes
of weight loss, body building, or athletic performance enhancement.

   (b) Dietary supplement products containing ephedrine group
alkaloids that are sold or distributed directly to a licensed health
care practitioner when the dietary supplement product containing
ephedrine group alkaloids is used solely for the purpose of the
treatment of patients under the direct care of the health care
practitioner.
   (c) Dietary supplement products containing ephedrine group
alkaloids that are sold or distributed directly to a licensed
pharmacist for resale to a patient for whom the products have been
prescribed pursuant to subdivision (a).
   (d) Dietary supplement products containing ephedrine group
alkaloids that are not for resale in California and that are sold or
distributed directly to businesses not located in California.
  SEC. 2.  No reimbursement is required by this act pursuant to
Section 6 of Article XIII B 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 XIII B of the California
Constitution. 


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