Συμπληρώματα περιέχουν στεροειδή είναι για ανυποψίαστους πελάτες

Τα συμπληρώματα διατροφής υπόκεινται σε ρύθμιση από την αμερικανική Υπηρεσία Τροφίμων και Φαρμάκων και την Ομοσπονδιακή Επιτροπή Εμπορίου. Η αρχή του FDA κωδικοποιήθηκε το 1994 από το νόμο για την υγεία και την εκπαίδευση του συμπληρώματος διατροφής (DSHEA), σύμφωνα με τον οποίο όσοι παρασκευάζουν και διανέμουν συμπληρώματα δεν μπορούν να πωλούν προϊόντα που είναι νοθευμένα ή ψευδώς επισημασμένα. Ωστόσο, το DSHEA έδωσε στους υπευθύνους συμπληρώματος την ευθύνη για την αστυνόμευση. Εκτός από τα προφανή προβλήματα που παρουσιάζουν, είναι σημαντικό να αναγνωρίσουμε ότι ακόμα και για τις εταιρείες με τις καλύτερες προθέσεις, η ανίχνευση αναβολικών στεροειδών είναι περίπλοκη και δαπανηρή υπόθεση, απαιτώντας εξελιγμένες προσεγγίσεις (όπως αέρια ή υγρή χρωματογραφία και  φασματομετρία μάζας ). Εν μέρει, αυτές οι προσεγγίσεις είναι δαπανηρές επειδή έχουν σχεδιαστεί για τον εντοπισμό γνωστών και συγκεκριμένων ενώσεων με χημικά δακτυλικά αποτυπώματα. Όπως είναι σημαντικό, κάθε νέο σχεδιαστικό φάρμακο είναι αρκετά διαφορετικό για να πορευτεί ξεφεύγοντας  κάτω από το ραντάρ.

Ενόψει αυτής της πρόκλησης, η υποεπιτροπή της Βουλής των Αντιπροσώπων για την υγεία ψήφισε ομόφωνα να διαβιβαστεί ένα νομοσχέδιο  το (HR 4771) το οποίο όχι μόνο θα προσέθετε 27 νέα φάρμακα σχεδιαστών στον υπό ρύθμιση κατάλογο  για τα αναβολικά στεροειδή αλλά θα διευκολύνε τον γενικό εισαγγελέα  να εντοπίσει τα νομίμως πωλούμενα εμπορικά προϊόντα που περιέχουν παράνομα αναβολικά στεροειδή. Το νομοσχέδιο ήταν σημαντικό για την παροχή της απαραίτητης ευελιξίας για την ομοσπονδιακή κυβέρνηση να βοηθήσει να ενισχυθεί η εποπτεία του περιεχομένου των συμπληρωμάτων διατροφής. Το νομοσχέδιο έλαβε ομόφωνη υποστήριξη από τα δύο μέρη στο Σώμα και από πέντε μεγάλες ενώσεις βιομηχανικών συμπληρωμάτων, όπως η United Natural Products Alliance και το Συμβούλιο για την υπεύθυνη διατροφή, ώστε να ξέρουν τι βρίσκεται στα σκευάσματα των εταιρειών. Παρά τους νέους ομοσπονδιακούς νόμους, τα τεστ για αναβολικά στεροειδή σε συμπληρώματα θα συνεχίσουν να είναι δαπανηρά και τα νέα και μη ανιχνεύσιμα σχεδιαστικά φάρμακα θα συνεχίσουν να αναπτύσσονται με ρυθμό που ξεπερνά την ικανότητα των επιστημόνων να τα εντοπίζουν. Με αυτό κατά νου, όταν παίρνετε αυτό το μπουκάλι πολυβιταμινών, οι καλύτερες συμβουλές εξακολουθούν να είναι προειδοποιητικές: μπορεί να περιέχει στανοζολόλη ! αναφέρει η  Leslie Henderson, Ph.D.,  κοσμήτορας και καθηγήτρια φυσιολογίας και νευροβιολογίας στο Geisel School of Medicine στο Dartmouth College.

[accordion title=”Εδώ το H.R.4771 – Designer Anabolic Steroid Control ” close=”0″]Public Law No: 113-260 (12/18/2014)
[113th Congress Public Law 260]
[From the U.S. Government Publishing Office]

[[Page 128 STAT. 2929]]

Public Law 113-260
113th Congress

An Act

To amend the Controlled Substances Act to more effectively regulate
anabolic steroids. <>

Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, < Anabolic Steroid Control Act of 2014.>>
SECTION 1. <> SHORT TITLE.

This Act may be cited as the “Designer Anabolic Steroid Control Act
of 2014”.
SEC. 2. AMENDMENTS TO THE CONTROLLED SUBSTANCES ACT.

(a) Definitions.–Section 102(41) of the Controlled Substances Act
(21 U.S.C. 802(41)) is amended–
(1) in subparagraph (A)–
(A) in clause (xlix), by striking “and” at the
end;
(B) by redesignating clause (xlx) as clause (lxxv);
and
(C) by inserting after clause (xlix) the following:
“(l) 5a-Androstan-3,6,17-trione;
“(li) 6-bromo-androstan-3,17-dione;
“(lii) 6-bromo-androsta-1,4-diene-3,17-dione;
“(liii) 4-chloro-17a-methyl-androsta-1,4-diene-3,17b-diol;
“(liv) 4-chloro-17a-methyl-androst-4-ene-3b,17b-diol;
“(lv) 4-chloro-17a-methyl-17b-hydroxy-androst-4-en-3-one;
“(lvi) 4-chloro-17a-methyl-17b-hydroxy-androst-4-ene-3,11-
dione;
“(lvii) 4-chloro-17a-methyl-androsta-1,4-diene-3,17b-diol;
“(lviii) 2a,17a-dimethyl-17b-hydroxy-5a-androstan-3-one;
“(lix) 2a,17a-dimethyl-17b-hydroxy-5b-androstan-3-one;
“(lx) 2a,3a-epithio-17a-methyl-5a-androstan-17b-ol;
“(lxi) [3,2-c]-furazan-5a-androstan-17b-ol;
“(lxii) 3b-hydroxy-estra-4,9,11-trien-17-one;
“(lxiii) 17a-methyl-androst-2-ene-3,17b-diol;
“(lxiv) 17a-methyl-androsta-1,4-diene-3,17b-diol;
“(lxv) Estra-4,9,11-triene-3,17-dione;
“(lxvi) 18a-Homo-3-hydroxy-estra-2,5(10)-dien-17-one;
“(lxvii) 6a-Methyl-androst-4-ene-3,17-dione;
“(lxviii) 17a-Methyl-androstan-3-hydroxyimine-17b-ol;
“(lxix) 17a-Methyl-5a-androstan-17b-ol;
“(lxx) 17b-Hydroxy-androstano[2,3-d]isoxazole;
“(lxxi) 17b-Hydroxy-androstano[3,2-c]isoxazole;
“(lxxii) 4-Hydroxy-androst-4-ene-3,17-dione[3,2-c]pyrazole-
5a-androstan-17b-ol;
“(lxxiii) [3,2-c]pyrazole-androst-4-en-17b-ol;
“(lxxiv) [3,2-c]pyrazole-5a-androstan-17b-ol; and”; and
(2) by adding at the end the following:

[[Page 128 STAT. 2930]]

“(C)(i) Subject to clause (ii), a drug or hormonal substance (other
than estrogens, progestins, corticosteroids, and dehydroepiandrosterone)
that is not listed in subparagraph (A) and is derived from, or has a
chemical structure substantially similar to, 1 or more anabolic steroids
listed in subparagraph (A) shall be considered to be an anabolic steroid
for purposes of this Act if–
“(I) the drug or substance has been created or manufactured
with the intent of producing a drug or other substance that
either–
“(aa) promotes muscle growth; or
“(bb) otherwise causes a pharmacological effect
similar to that of testosterone; or
“(II) the drug or substance has been, or is intended to be,
marketed or otherwise promoted in any manner suggesting that
consuming it will promote muscle growth or any other
pharmacological effect similar to that of testosterone.

“(ii) A substance shall not be considered to be a drug or hormonal
substance for purposes of this subparagraph if it–
“(I) is–
“(aa) an herb or other botanical;
“(bb) a concentrate, metabolite, or extract of, or
a constituent isolated directly from, an herb or other
botanical; or
“(cc) a combination of 2 or more substances
described in item (aa) or (bb);
“(II) is a dietary ingredient for purposes of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); and
“(III) is not anabolic or androgenic.

“(iii) In accordance with section 515(a), any person claiming the
benefit of an exemption or exception under clause (ii) shall bear the
burden of going forward with the evidence with respect to such exemption
or exception.”.
(b) Classification Authority.–Section 201 of the Controlled
Substances Act (21 U.S.C. 811) is amended by adding at the end the
following:
“(i) <> Temporary and Permanent Scheduling of
Recently Emerged Anabolic Steroids.–
“(1) The Attorney General may issue a temporary order
adding a drug or other substance to the definition of anabolic
steroids if the Attorney General finds that–
“(A) the drug or other substance satisfies the
criteria for being considered an anabolic steroid under
section 102(41) but is not listed in that section or by
regulation of the Attorney General as being an anabolic
steroid; and
“(B) adding such drug or other substance to the
definition of anabolic steroids will assist in
preventing abuse or misuse of the drug or other
substance.
“(2) < publication.>> An order issued under paragraph (1) shall not
take effect until 30 days after the date of the publication by
the Attorney General of a notice in the Federal Register of the
intention to issue such order and the grounds upon which such
order is to be issued. <> The order
shall expire not later than 24 months after the date it becomes
effective, except that the Attorney General may, during the
pendency of proceedings under paragraph (6), extend the
temporary scheduling order for up to 6 months.

[[Page 128 STAT. 2931]]

<> “(3) The Attorney General shall
transmit notice of an order proposed to be issued under
paragraph (1) to the Secretary of Health and Human Services. In
issuing an order under paragraph (1), the Attorney General shall
take into consideration any comments submitted by the Secretary
in response to a notice transmitted pursuant to this paragraph.
“(4) A temporary scheduling order issued under paragraph
(1) shall be vacated upon the issuance of a permanent scheduling
order under paragraph (6).
“(5) An order issued under paragraph (1) is not subject to
judicial review.
“(6) The Attorney General may, by rule, issue a permanent
order adding a drug or other substance to the definition of
anabolic steroids if such drug or other substance satisfies the
criteria for being considered an anabolic steroid under section
102(41). Such rulemaking may be commenced simultaneously with
the issuance of the temporary order issued under paragraph
(1).”.
SEC. 3. LABELING REQUIREMENTS.

(a) In General.–Section 305 of the Controlled Substances Act (21
U.S.C. 825) is amended by adding at the end the following:
“(e) False Labeling of Anabolic Steroids.–
“(1) It shall be unlawful to import, export, manufacture,
distribute, dispense, or possess with intent to manufacture,
distribute, or dispense, an anabolic steroid or product
containing an anabolic steroid, unless the steroid or product
bears a label clearly identifying an anabolic steroid or product
containing an anabolic steroid by the nomenclature used by the
International Union of Pure and Applied Chemistry (IUPAC).
“(2)(A) A product described in subparagraph (B) is exempt
from the International Union of Pure and Applied Chemistry
nomenclature requirement of this subsection if such product is
labeled in the manner required under the Federal Food, Drug, and
Cosmetic Act.
“(B) A product is described in this subparagraph if the
product–
“(i) is the subject of an approved application as
described in section 505(b) or (j) of the Federal Food,
Drug, and Cosmetic Act; or
“(ii) is exempt from the provisions of section 505
of such Act relating to new drugs because–
“(I) it is intended solely for
investigational use as described in section 505(i)
of such Act; and
“(II) such product is being used exclusively
for purposes of a clinical trial that is the
subject of an effective investigational new drug
application.”.

(b) Clarification to Import and Export Statute.–Section 1010 of the
Controlled Substances Import and Export Act (21 U.S.C. 960) is amended,
in subsection (a)(1), by inserting “305,” before “1002”.
(c) Civil Penalties.–Section 402 of the Controlled Substances Act
(21 U.S.C. 842) is amended–
(1) in subsection (a)–
(A) in paragraph (14), by striking “or” at the
end;
(B) in paragraph (15), by striking the period at the
end and inserting “; or”; and

[[Page 128 STAT. 2932]]

(C) by inserting, after paragraph (15), the
following:
“(16) to violate subsection (e) of section 825 of this
title.”; and
(2) in subsection (c)(1)–
(A) by inserting, in subparagraph (A), after
“subparagraph (B)” the following: “, (C), or (D)”;
and
(B) <> by inserting after
subparagraph (B) the following:

“(C) In the case of a violation of paragraph (16) of subsection (a)
of this section by an importer, exporter, manufacturer, or distributor
(other than as provided in subparagraph (D)), up to $500,000 per
violation. For purposes of this subparagraph, a violation is defined as
each instance of importation, exportation, manufacturing, distribution,
or possession with intent to manufacture or distribute, in violation of
paragraph (16) of subsection (a).
“(D) In the case of a distribution, dispensing, or possession with
intent to distribute or dispense in violation of paragraph (16) of
subsection (a) of this section at the retail level, up to $1000 per
violation. For purposes of this paragraph, the term `at the retail
level’ refers to products sold, or held for sale, directly to the
consumer for personal use. Each package, container or other separate
unit containing an anabolic steroid that is distributed, dispensed, or
possessed with intent to distribute or dispense at the retail level in
violation of such paragraph (16) of subsection (a) shall be considered a
separate violation.”.
SEC. 4. <> IDENTIFICATION AND PUBLICATION
OF LIST OF PRODUCTS CONTAINING ANABOLIC
STEROIDS.

(a) In General.– < publication. Web posting.>> The Attorney General may, in the Attorney
General’s discretion, collect data and analyze products to determine
whether they contain anabolic steroids and are properly labeled in
accordance with this Act and the amendments made by this Act. The
Attorney General may publish in the Federal Register or on the website
of the Drug Enforcement Administration a list of products which the
Attorney General has determined, based on substantial evidence, contain
an anabolic steroid and are not labeled in accordance with this Act and
the amendments made by this Act.

[[Page 128 STAT. 2933]]

(b) Absence From List.–The absence of a product from the list
referred to in subsection (a) shall not constitute evidence that the
product does not contain an anabolic steroid.

Approved December 18, 2014.

LEGISLATIVE HISTORY–H.R. 4771:
—————————————————————————

HOUSE REPORTS: No. 113-587, Pt. 1 (Comm. on Energy and Commerce) and
Pt. 2 (Comm. on the Judiciary).
CONGRESSIONAL RECORD, Vol. 160 (2014):
Sept. 15, considered and passed House.
Dec. 11, considered and passed Senate.[/accordion]