To require manufacturers of dietary supplements to register dietary supplement products with the Food and Drug Administration.

SA 2127. Mr. DURBIN (for himself and Mr. Blumenthal) submitted an

[[Page S3430]]

amendment intended to be proposed by him to the bill S. 3187, to amend
the Federal Food, Drug, and Cosmetic Act to revise and extend the user-
fee programs for prescription drugs and medical devices, to establish
user-fee programs for generic drugs and biosimilars, and for other
purposes; which was ordered to lie on the table; as follows:

At the end of title XI, add the following:

SEC. 11__. REGISTRATION OF FACILITIES WITH RESPECT TO DIETARY
SUPPLEMENTS.

(a) In General.--Section 415(a) (21 U.S.C. 350d(a)) is
amended by adding at the end the following:
``(6) Requirements with respect to dietary supplements.--
``(A) In general.--A facility engaged in the manufacturing
processing, packing, or holding of dietary supplements that
is required to register under this section shall comply with
the requirements of this paragraph, in addition to the other
requirements of this section.
``(B) Additional information.--A facility described in
subparagraph (A) shall submit a registration under paragraph
(1) that includes, in addition to the information required
under paragraph (2)--
``(i) a description of each dietary supplement product
manufactured by such facility;
``(ii) a list of all ingredients in each such dietary
supplement product; and
``(iii) a copy of the label and labeling for each such
product.
``(C) Registration with respect to new, reformulated, and
discontinued dietary supplement products.--
``(i) In general.--Not later than the date described in
clause (ii), if a facility described in subparagraph (A)--

``(I) manufactures a dietary supplement product that the
facility previously did not manufacture and for which the
facility did not submit the information required under
clauses (i) through (iii) of subparagraph (B);
``(II) reformulates a dietary supplement product for which
the facility previously submitted the information required
under clauses (i) through (iii) of subparagraph (B); or
``(III) no longer manufactures a dietary supplement for
which the facility previously submitted the information
required under clauses (i) through (iii) of subparagraph (B),

such facility shall submit to the Secretary an updated
registration describing the change described in subclause
(I), (II), or (III) and, in the case of a facility described
in subclause (I) or (II), containing the information required
under clauses (i) through (iii) of subparagraph (B).
``(ii) Date described.--The date described in this clause
is--

``(I) in the case of a facility described in subclause (I)
of clause (i), 30 days after the date on which such facility
first markets the dietary supplement product described in
such subclause;
``(II) in the case of a facility described in subclause
(II) of clause (i), 30 days after the date on which such
facility first markets the reformulated dietary supplement
product described in such subclause; or
``(III) in the case of a facility described in subclause
(III) of clause (i), 30 days after the date on which such
facility removes the dietary supplement product described in
such subclause from the market.''.

(b) Enforcement.--Section 403 (21 U.S.C. 343) is amended by
adding at the end the following:
``(z) If it is a dietary supplement for which a facility is
required to submit the registration information required
under section 415(a)(6) and such facility has not complied
with the requirements of such section 415(a)(6) with respect
to such dietary supplement.''.
______