All Americans may lose their access to nutritional supplements.

[Guest guest]

http://www.doctoryourself.com/limitUSA.htm

 

 

All Americans may lose their access to nutritional supplements.

 

 

There is a bill in the Senate right now, the so-called " Dietary Supplement

Safety Act of 2003 (S. 722) " that will give one person in the FDA absolute power

to decide which food supplements you may or may not use.

 

Do you think this is right? The FDA has a history of hostility to vitamins. The

bill will give them total control over both the availability and dosage of all

supplements, including vitamins. The Secretary of the FDA will have the personal

power to make safety determinations for supplements based on just a single

" adverse report " about a supplement, a report that does not even have to be

proven to even be caused by the supplement!

 

You may find this hard to believe, so at the very bottom of this page you will

find the proposed bill in its entirety. But first, I have highlighted the worst

passages, which YOU should highlight when you write to your US Senator. Please

write today! You can get your senator's addresses right at

http://www.congress.org (or http://www.congress.org/congressorg/home). For

writing hints and a letter you can use, read on.

 

SUPPLEMENT RESTRICTION: AMERICA IS THE NEXT TARGET

 

Make no mistake about it: there is a movement afoot to take away your access to

vitamin supplements in the USA, as in Europe. If passed, Senate bill S. 722, the

so-called " Dietary Supplement Safety Act of 2003 " will insure that this happens.

 

For example, this proposed law contains the following words:

 

`SEC. 416. ADVERSE EXPERIENCES WITH DIETARY SUPPLEMENTS. (a) DEFINITIONS

 

" (1) ADVERSE DIETARY SUPPLEMENT EXPERIENCE-

 

The term `adverse dietary supplement experience' means an

 

adverse event that is associated with the use of a dietary supplement in a

human, without regard to whether the event is known to be causally related to

the dietary supplement. "

 

Think about that and re-read it. This is federal legislation based on hear-say.

Do you think that is a good idea?

 

How about this section:

 

`(d) SAFETY REVIEW FOR POSSIBLY DANGEROUS DIETARY SUPPLEMENTS

 

`(1) IN GENERAL- If a clinical evaluation by the Secretary (of the FDA) of 1 or

more serious adverse events indicates that a dietary supplement or a dietary

ingredient contained in a dietary supplement appears to present a significant or

unreasonable risk of illness, the Secretary may require the manufacturers of the

dietary supplement, or of a dietary ingredient contained in a dietary

supplement, to submit to the Secretary data demonstrating that the dietary

supplement containing the dietary ingredient is safe.

 

`(2) APPROVAL OR DISAPPROVAL OF CONTINUED MARKETING- As soon as practicable

after receiving data required under paragraph

 

(1), the Secretary shall review the data and issue a determination that--

 

`(A)(i) the dietary supplement is safe; and

 

`(ii) the continued marketing of the dietary supplement is approved; or

 

`(B)(i) the dietary supplement is not safe or has not been shown to be safe

under ordinary or frequent conditions of use; and

 

`(ii) the continued marketing of the dietary supplement is disapproved.'.

 

THIS WORDING GIVES THE SECRETARY OF THE U.S. FOOD AND DRUG ADMINISTRATION

ABSOLUTE POWER TO REGULATE EVERY SINGLE SUPPLEMENT.

 

Do you think that is right?

 

(To read the rest of this proposed law, scroll down to the bottom of this page.)

 

http://www.greatestherbsonearth.com/nsparticles/ama_dshea.htm contains a good

commentary article on S. 722, with a ready-to-print-and-use form letter provided

at http://www.greatestherbsonearth.com/nsparticles/s722_letter.htm so you can

write to your senator immediately. (I have no financial connection with this

website, and make no recommendation or endorsement of its products or other

commercial content.)

 

You can send your comments electronically, by email, for free, at

http://www.congress.org. I just cut-and-pasted the form letter into a plain text

format ( " Notepad " ) and then edited it a bit. You can, too, or if you prefer you

can just use my letter, below, which I have already to both my U.S. Senators.

 

Here it is:

 

Dear Senator:

 

I respectfully urge you to do all in your power to kill S-722 (the " Dietary

Supplement Safety Act of 2003, " introduced March 26th, 2003 by Senator Richard

J. Durbin (D-IL). The bill's intent is to overturn the main provisions of the

Dietary Supplement Health and Education Act of 1994 (DSHEA).

 

I think S-722 and its congressional backers will be very unpopular with the

American people. I can say this because more citizen letters were sent to

Congress in 1992-1994 in support of DSHEA than over any other issue in American

history. If you have a hand in overturning the freedoms that DSHEA provides,

voters will strongly disapprove.

 

DSHEA was enacted after years of debate in Congress. During the process, it

became very clear that there was overwhelming public support for ensuring free

access to dietary supplements.

 

S-722 would give the FDA the potential power to remove thousands of herbs and

other dietary supplements from the marketplace, as it has tried to do many times

already, literally for decades. S-722 would give FDA complete discretion to make

such a determination. That is wrong. It was the will of the people and of

Congress, as stated in DSHEA, that supplement availability in America is not to

be regulated or restricted.

 

S-722 would require premarket approval for caffeine in herbs and dietary

supplements but would specifically exempt manufacturers of drugs and foods like

coffee, tea, and soft drinks from that requirement. Do you really think that is

right?

 

You are almost certainly most concerned with the safety of your constituents,

but you may not be aware of this: There is not even one death per year from

vitamins. S. 722 gives FDA power to control access to vitamins, and not just

other, more questionable products. And as for unsafe products, you should be

fully aware that DSHEA already provides FDA with very ample authority to remove

any dangerous product at any time. FDA has always had this authority. They still

have it. S. 722 is essentially a power grab that undermines DSHEA and the rights

of your constituents.

 

Please oppose S. 722, and please write back to me on this subject.

 

Respectfully yours,

 

Andrew W. Saul

 

My Senator's office tells me that we can check and see to what extent this bill

is making progress at http://thomas.loc.gov

 

There is more information, and important links, concerning attempts to restrict

access to vitamin supplements at

 

http://www.doctoryourself.com/news/v3n21.txt and

 

http://www.doctoryourself.com/supplement_limit.html.

 

Abram Hoffer, M.D., offers this comment on Europe's recently approved,

continent-wide ban on consumer access to vitamin supplements:

 

" Your recent newsletter http://www.doctoryourself.com/news/v3n21.txt)proves very

clearly that modern medicine is not scientific, that it is full of prejudice,

illogic and susceptible to advertising. Doctors are not taught to reason. They

are programmed to believe in whatever their medical schools teach them and the

leading doctors tell them. And over the past 20 years the drug companies with

their enormous wealth have taken medicine over and now control its research,

what is taught and the information released to the public. Very important

information in your newsletter. If the European Union has its way, all consumer

access to nutrients throughout Europe will be prohibited, while the massive drug

companies will still be permitted to experiment all they like with their

dangerous potions. "

 

Please write to both your Senators today. And how about sending a letter to your

local newspaper? My easy how-to hints to help you are at

 

http://www.doctoryourself.com/write_now.html

 

" When I feel the heat, I see the light. " (Senator Everett Dirksen)

 

 

 

WRITE TO OPPOSE S. 722 (AND SUPPORT S. 1538 INSTEAD!)

Senators Tom Harkin and Orrin Hatch have introduced an excellent alternative to

the draconian S. 722, a bill that would give the Secretary of the FDA absolute

power to personally decide which supplements will or will not be available to

you. (Details on this are at

http://www.doctoryourself.com/news/Extra%20092603.txt)

 

The alternative, far better bill is the " DSHEA Full Implementation and

Enforcement Act of 2003 (S. 1538). " This bill will help the Food and Drug

Administration enforce the current and fully adequate safety law, the " Dietary

Supplement Health and Education Act of 1994 " (DSHEA).

 

From the letters page at http://www.congress.org:

 

" Even though the two most recent FDA commissioners have said that they (already)

have the power to ensure dietary supplements are safe for American consumers,

the agency has also expressed concern that it doesn't have enough funding to

enforce the current law. S. 1538 will provide funding that is consistent with

FDA's needs and will also require the agency to file annual reports to Congress

about how DSHEA is being implemented and enforced. "

 

We should support Senators Harkin and Hatch in their efforts to pass this bill.

Please write to both your U.S. Senators and ask them to oppose S. 722, and

instead co-sponsor S. 1538.

 

This is serious. If we do not act now, we can expect to lose our access to

nutrition supplements just as has already happened in Europe.

(http://www.doctoryourself.com/news/v3n21.txt)

 

 

 

It can happen here. Don't let it! Get your Senators' addresses, and write to

them both today. Their addresses are easy to find at http://www.congress.org (or

http://congress.org/congressorg/home). You can send an email letter to them

directly from that website, but remember this: A HANDWRITTEN, PLAIN-OLD U.S.

POSTAL SERVICE 37-CENT LETTER **ALWAYS** HAS MORE IMPACT. When you write, be

sure to ask for a response from your senators. . . and please share those

responses with me at drsaul, would you?

 

 

 

Here is the proposed bill that we do NOT want, in its entirety:

 

108th CONGRESS

 

1st Session

 

S. 722

 

To amend the Federal Food, Drug, and Cosmetic Act to require that manufacturers

of dietary supplements submit to the Food and Drug Administration reports on

adverse experiences with dietary supplements, and for other purposes.

 

IN THE SENATE OF THE UNITED STATES

 

March 26, 2003

 

Mr. DURBIN introduced the following bill; which was read twice and referred to

the Committee on Health, Education, Labor, and Pensions

 

 

 

A BILL

 

To amend the Federal Food, Drug, and Cosmetic Act to require that manufacturers

of dietary supplements submit to the Food and Drug Administration reports on

adverse experiences with dietary supplements, and for other purposes.

 

Be it enacted by the Senate and House of Representatives of the United States of

America in Congress assembled,

 

SECTION 1. SHORT TITLE.

 

This Act may be cited as the `Dietary Supplement Safety Act of 2003'.

 

SEC. 2. ADVERSE EXPERIENCES WITH DIETARY SUPPLEMENTS.

 

(a) IN GENERAL- Chapter IV of the Federal Food, Drug, and Cosmetic Act (21

U.S.C. 341 et seq.) is amended by adding at the end the following:

 

`SEC. 416. ADVERSE EXPERIENCES WITH DIETARY SUPPLEMENTS.

 

`(a) DEFINITIONS- In this section:

 

`(1) ADVERSE DIETARY SUPPLEMENT EXPERIENCE- The term `adverse dietary supplement

experience' means an adverse event that is associated with the use of a dietary

supplement in a human, without regard to whether the event is known to be

causally related to the dietary supplement.

 

`(2) SERIOUS ADVERSE DIETARY SUPPLEMENT EXPERIENCE- The term `serious adverse

dietary supplement experience' means an adverse dietary supplement experience

that--

 

`(A) results in--

 

`(i) death;

 

`(ii) a life-threatening condition;

 

`(iii) inpatient hospitalization or prolongation of hospitalization;

 

`(iv) a persistent or significant disability or incapacity; or

 

`(v) a congenital anomaly, birth defect, or other effect regarding pregnancy,

including premature labor or low birth weight; or

 

`(B) requires medical or surgical intervention to prevent 1 of the outcomes

described in subparagraph (A).

 

`(b) REPORTING AND REVIEW-

 

`(1) SERIOUS ADVERSE DIETARY SUPPLEMENT EXPERIENCES-

 

`(A) IN GENERAL- Each manufacturer of a dietary supplement, and each packer or

distributor of a dietary supplement the name of which appears on the labeling of

the dietary supplement--

 

`(i) shall develop written procedures for--

 

`(I) surveillance, receipt, and evaluation of information on adverse dietary

supplement experiences associated with use of the dietary supplement; and

 

`(II) submission to the Secretary of reports under this subsection;

 

`(ii) as soon as practicable after, but in no event later than 15 calendar days

after, initial receipt of information with respect to a serious adverse dietary

supplement experience, shall submit to the Secretary--

 

`(I) the information; and

 

`(II) a copy of the current labeling for the dietary supplement;

 

`(iii)(I) shall promptly investigate the adverse dietary supplement experience;

and

 

`(II)(aa) if additional information is obtained, shall submit to the Secretary a

report describing the information--

 

`(AA) not later than 15 days after obtaining the information; or

 

`(BB) at the request of the Secretary; or

 

`(bb) if no additional information is obtained, shall maintain records of the

steps taken to seek additional information.

 

`(B) ELIMINATION OF DUPLICATIVE REPORTING-

 

`(i) IN GENERAL- To avoid duplicative reporting under this subsection, the

Secretary may establish a procedure under which--

 

`(I) a packer or distributor of a dietary supplement may submit a report to the

manufacturer of the dietary supplement; and

 

`(II) the manufacturer shall transmit the report to the Secretary.

 

`(ii) REQUIREMENT- A procedure under clause (i) shall ensure that the Secretary

receives reports within the applicable period of time specified in subparagraph

(A).

 

`© CLINICAL EVALUATIONS BY THE SECRETARY-

 

`(i) IN GENERAL- The Secretary shall conduct a clinical evaluation of each

serious adverse dietary supplement experience with a patient that is reported to

the Secretary under subparagraph (A).

 

`(ii) UNWILLING PATIENT- The Secretary is not required to conduct a clinical

evaluation under clause (i) to the extent that any unwillingness of the patient

(or the next of kin for the patient, as the case may be) to cooperate with the

evaluation makes it impracticable to conduct the evaluation.

 

`(2) PERIODIC ADVERSE DIETARY SUPPLEMENT EXPERIENCE REPORTING- A manufacturer of

a dietary supplement shall annually (or at such shorter intervals as the

Secretary may require), in accordance with such requirements as the Secretary

may establish, submit to the Secretary a report that discloses all information

received with respect to adverse dietary supplement experiences not previously

reported under paragraph (1).

 

`(3) REVIEW REGARDING ADVERSE DIETARY SUPPLEMENT EXPERIENCES-

 

`(A) IN GENERAL- Promptly after a manufacturer of a dietary supplement receives

from a consumer, or obtains by any other means, any information on an adverse

dietary supplement experience, the manufacturer shall review the information.

 

`(B) APPLICABILITY- Subparagraph (A)--

 

`(i) applies to information without regard to the source of the information,

foreign or domestic; and

 

`(ii) includes information derived from sources such as--

 

`(I) commercial marketing experience;

 

`(II) postmarketing investigations;

 

`(III) postmarketing surveillance;

 

`(IV) studies;

 

`(V) reports in the scientific literature; and

 

`(VI) unpublished scientific papers.

 

`(4) ADDITIONAL REPORTING REQUIREMENTS- In addition to the requirements of

paragraphs (1) and (2), the Secretary may establish such requirements regarding

the reporting of information on adverse dietary supplement experiences as the

Secretary determines to be appropriate to protect the public health.

 

`(5) WAIVERS- The Secretary may grant a waiver from the requirement of paragraph

(1), (2), or (3) with respect to a dietary supplement if the Secretary

determines that compliance with the requirement is not necessary to protect the

public health.

 

`(6) SYSTEM FOR COORDINATION OF REPORTS RECEIVED BY THE SECRETARY- With respect

to reports of adverse dietary supplement experiences submitted to the Secretary

(whether required under this subsection or otherwise), the Secretary shall

establish a system to--

 

`(A) receive the reports;

 

`(B) refer the reports to the appropriate officials within the Food and Drug

Administration;

 

`© store and retrieve the reports;

 

`(D) store and retrieve records of activities carried out in response to the

reports; and

 

`(E) carry out such other administrative functions regarding the reports as the

Secretary determines to be appropriate.

 

`(7) DATA COLLECTION BY SECRETARY-

 

`(A) IN GENERAL- The Secretary shall carry out a program to collect data on

serious adverse dietary supplement experiences, in addition to receiving reports

required in this subsection.

 

`(B) COOPERATION- In carrying out the program, the Secretary shall seek the

cooperation of appropriate public and private entities, including entities that

respond to medical emergencies.

 

`(8) AUTHORIZATION OF APPROPRIATIONS- There is authorized to be appropriated to

carry out this subsection $10,000,000 for fiscal year 2003 and each fiscal year

thereafter.

 

`© POSTMARKET SURVEILLANCE-

 

`(1) AUTHORITY TO REQUIRE SURVEILLANCE- The Secretary may by order require a

manufacturer of a dietary supplement to conduct postmarket surveillance for the

dietary supplement if the Secretary determines that there is a reasonable

possibility that a use or expected use of the dietary supplement by a

significant number of consumers may result in serious adverse experiences.

 

`(2) SURVEILLANCE PLAN-

 

`(A) IN GENERAL- Not later than 30 days after receiving from the Secretary an

order under paragraph (1) to conduct surveillance for a dietary supplement, a

manufacturer shall submit to the Secretary, for the approval of the Secretary, a

plan for the required surveillance.

 

`(B) QUALIFICATIONS REGARDING SURVEILLANCE; DATA REGARDING ADVERSE DIETARY

SUPPLEMENT EXPERIENCES- Not later than 60 days after a plan is submitted to the

Secretary under subparagraph (A), the Secretary shall determine whether--

 

`(i) the person designated to conduct the surveillance has appropriate

qualifications and experience to conduct the surveillance; and

 

`(ii) the plan will result in the collection of useful data that will disclose

adverse dietary supplement experiences or other information necessary to protect

the public health.

 

`(3) SURVEILLANCE PERIOD- In consultation with a manufacturer of a dietary

supplement that is required to conduct surveillance under paragraph (1), the

Secretary may by order require a prospective surveillance period for the

manufacturer of not more than--

 

`(A) 3 years; or

 

`(B) such longer period as may be determined--

 

`(i) by agreement between the Secretary and the manufacturer; or

 

`(ii) if the Secretary and the manufacturer cannot agree, through a dispute

resolution process established by the Secretary by regulation.

 

`(d) SAFETY REVIEW FOR POSSIBLY DANGEROUS DIETARY SUPPLEMENTS-

 

`(1) IN GENERAL- If a clinical evaluation by the Secretary of 1 or more serious

adverse events indicates that a dietary supplement or a dietary ingredient

contained in a dietary supplement appears to present a significant or

unreasonable risk of illness, the Secretary may require the manufacturers of the

dietary supplement, or of a dietary ingredient contained in a dietary

supplement, to submit to the Secretary data demonstrating that the dietary

supplement containing the dietary ingredient is safe.

 

`(2) APPROVAL OR DISAPPROVAL OF CONTINUED MARKETING- As soon as practicable

after receiving data required under paragraph (1), the Secretary shall review

the data and issue a determination that--

 

`(A)(i) the dietary supplement is safe; and

 

`(ii) the continued marketing of the dietary supplement is approved; or

 

`(B)(i) the dietary supplement is not safe or has not been shown to be safe

under ordinary or frequent conditions of use; and

 

`(ii) the continued marketing of the dietary supplement is disapproved.'.

 

(b) PROHIBITED ACTS- Section 301 of the Federal Food, Drug, and Cosmetic Act (21

U.S.C. 331) is amended by adding at the end the following:

 

`(hh) ADVERSE DIETARY SUPPLEMENT EXPERIENCES-

 

`(1) FAILURE TO COMPLY- The failure of a person to submit a report or comply

with any other requirement under section 416.

 

`(2) DISAPPROVAL OF CONTINUED MARKETING- The continued marketing of a dietary

supplement by any person after the Secretary issues a determination under

section 416(d)(2)(B) that--

 

`(A) the dietary supplement is not safe or has not been shown to be safe under

ordinary conditions of use; and

 

`(B) the continued marketing of the dietary supplement is disapproved.'.

 

SEC. 3. STIMULANTS.

 

(a) DEFINITION OF STIMULANT- Section 201 of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 321) is amended by adding at the end the following:

 

`(nn) STIMULANT- The term `stimulant' means a dietary ingredient that has a

stimulant effect on the cardiovascular system or the central nervous system of a

human by any means, including--

 

`(1) speeding metabolism;

 

`(2) increasing heart rate;

 

`(3) constricting blood vessels; or

 

`(4) causing the body to release adrenaline.'.

 

(b) PREMARKET APPROVAL- Chapter IV of the Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 341 et seq.) (as amended by section 2(a)) is amended by adding at the

end the following:

 

`SEC. 417. STIMULANTS.

 

`(a) IN GENERAL- No person shall introduce or deliver for introduction into

interstate commerce a dietary supplement containing a stimulant unless an

approval of the dietary supplement under this section is in effect.

 

`(b) APPROVAL- The Secretary shall approve an application for premarket approval

of a dietary supplement containing a stimulant if the manufacturer of the

stimulant demonstrates that the dietary supplement is safe under ordinary or

frequent conditions of use.

 

`© COMBINATIONS OF STIMULANTS- In the case of a dietary supplement that

contains a combination of stimulants, the Secretary, in determining the safety

of the dietary supplement, shall consider the interaction of the various

stimulants contained in the dietary supplement.

 

`(d) ACTION ON APPLICATION- The Secretary shall approve or disapprove an

application for premarket approval of a dietary supplement containing a

stimulant not later than 180 days after receiving the application.'.

 

© ADULTERATED FOOD- Section 402 of the Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 342) is amended by adding at the end the following:

 

`(i) DIETARY SUPPLEMENTS CONTAINING A STIMULANT- If the food is a dietary

supplement containing a stimulant for which the Secretary has not granted

premarket approval under section 417.

 

`(j) EFFECT OF SECTION- Nothing in this section affects any other law (including

a regulation) applicable to caffeine used as a food or drug.'.

 

(d) REGULATIONS- Not later than 1 year after the date of enactment of this Act,

the Secretary of Health and Human Services shall issue guidance for implementing

the amendments made by this section.

 

(e) EFFECTIVE DATE-

 

(1) IN GENERAL- Except as provided in paragraph (2), the amendments made by this

section--

 

(A) apply to dietary supplements manufactured before, on, or after the date of

enactment of this Act; and

 

(B) take effect on the date that is 180 days after the date of enactment of this

Act.

 

(2) ALREADY-MARKETED DIETARY SUPPLEMENTS- The amendments made by this section do

not apply to a dietary supplement that has been marketed before the date of

enactment of this Act until the date that is 2 years after the date of enactment

of this Act.

 

SEC. 4. STEROID PRECURSORS.

 

(a) FEDERAL FOOD, DRUG, AND COSMETIC ACT- Section 201(ff)(1) of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 321(ff)(1)) is amended by striking

`(other than tobacco)' and inserting `(other than tobacco or a product that

bears or contains an anabolic steroid (including a substance that is chemically

and pharmacologically related to testosterone but not including an estrogen,

progestin, or corticosteroid))'.

 

(b) CONTROLLED SUBSTANCES ACT-

 

(1) DEFINITION OF ANABOLIC STEROID- Section 102(41)(A) of the Controlled

Substances Act (21 U.S.C. 802(41)(A)) is amended--

 

(A) by striking `that promotes muscle growth, and includes--' and inserting

`that promotes muscle growth or is advertised or used to promote muscle growth.

 

`(B) The term `anabolic steroid' includes--'; and

 

(B) by striking `(B)(i)' and inserting `©(i)'.

 

(2) EXCLUSION FROM SCHEDULE- Section 201(g)(1) of the Controlled Substances Act

(21 U.S.C. 811(g)(1)) is amended by striking `if such substance' and all that

follows and inserting `if the substance--

 

`(A) is approved as being safe and effective for its intended use under section

505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355); or

 

`(B) is lawfully marketed under an over-the-counter monograph issued by the Food

and Drug Administration.'.

 

SEC. 5. AGENCY EXPERTISE AND AUTHORITY.

 

Section 402(f)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

342(f)(1)) is amended by striking the matter following subparagraph (D).

 

(end of proposed Senate bill)

 

For additional information, please go to John Hammell's website, International

Advocates for Health Freedom http://www.iahf.com.

 

 

 

 

 

 

AN IMPORTANT NOTE: This page is not in any way offered as prescription,

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condition. Any form of self-treatment or alternative health program necessarily

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Consult your doctor before making any health decision.

 

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