I

103D CONGRESS

1ST SESSION H. R. 1709

To amend the Federal Food, Drug, and Cosmetic Act to establish provisions

regarding the composition and labeling of dietary supplements.

IN THE HOUSE OF REPRESENTATIVES

APRIL 7, 1993

Mr. RICHARDSON (for himself, Mr. INHOFE, Mr. TOWNS, Mr. BOEHLERT, Mr.

SCHIFF, Mr. FROST, Ms. NORTON, Mr. BOUCHER, Mr. BOEHNER, Mr.

PETERSON of Minnesota, Ms. PELOSI, Mr. HALL of Texas, Mr. UPTON,

and Mr. PALLONE) introduced the following bill; which was referred to

the Committee on Energy and Commerce

JUNE 8, 1993

Additional sponsors: Mr. LAROCCO, Mr. OLVER, Mr. KREIDLER, Mr. INGLIS

of South Carolina, Mr. DOOLITTLE, Mr. PASTOR, Mr. BURTON of Indiana, Mr. HOCHBRUECKNER, Mr. PARKER, Mr. SENSENBRENNER, Mr.

SPENCE, Ms. VELA ́ZQUEZ, Mrs. UNSOELD, and Mr. INSLEE

JULY 28, 1993

Additional sponsors: Mr. SKAGGS, Mr. JEFFERSON, Mr. LEWIS of Florida, Mr.

COMBEST, Mr. HERGER, Mr. ORTON, Mr. MANZULLO, Mr. RANGEL, Mr.

SHAYS, Mr. DEFAZIO, Mr. BARCIA of Michigan, Mr. SWETT, Mr.

ZELIFF, Mr. CANADY, Mr. LIPINSKI, Mr. CALLAHAN, Mr. FRANK of Massachusetts, Mr. FARR of California, Mr. NEAL of Massachusetts, Mr.

TAUZIN, Mr. MEEHAN, Mr. BEVILL, and Mr. MCHALE

AUGUST 23, 1993

Additional sponsors: Mr. BLUTE, Mr. COX, Mr. YATES, Mr. HASTERT, and

Mr. KINGSTON

SEPTEMBER 9, 1993

Additional sponsors: Mr. REYNOLDS, Mr. APPLEGATE, Mr. LINDER, Mrs.

KENNELLY, Mr. STEARNS, Mr. MURPHY, Ms. FURSE, Mr.

KNOLLENBERG, Mr. MICA, Mr. SARPALIUS, Mrs. FOWLER, Mr. ROTH,

Mr. THOMAS of Wyoming, Mr. BONILLA, Ms. WOOLSEY, Mr. GREENWOOD, Mr. COYNE, Mr. DEAL, Mr. KING, Ms. SHEPHERD, Mr. BARLOW,

and Ms. ESHOO

OCTOBER 7, 1993

Additional sponsors: Mr. ALLARD, Mr. REGULA, Mr. GOODLATTE, Ms. MOL-
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INARI, Mr. CONDIT, Mr. SCHAEFER, Mr. HAMBURG, Mr. CAMP, Mr.

ARMEY, Mr. BAKER of California, Mr. DICKEY, Mr. BILBRAY, Mr.

MCCOLLUM, Mr. MCCRERY, Mr. TALENT, Mr. MACHTLEY, Mrs. VUCANOVICH, Mr. CLEMENT, Mr. JACOBS, Mr. LEWIS of Georgia, Mr. BROOKS,

Mr. KOPETSKI, Mr. GORDON, Mr. PORTMAN, Mr. BROWN of Ohio, Mr.

MILLER of Florida, Mr. BROWN of California, Mr. HALL of Ohio, Mr.

HINCHEY, Mr. DARDEN, Mr. KILDEE, Mr. KASICH, Mr. MCINNIS, Mr.

DORNAN, Mr. FRANKS of Connecticut, Ms. DANNER, Mr. FISH, Ms.

MCKINNEY, Mr. REED, Mr. DIAZ-BALART, Mr. DEUTSCH, Mr. ROYCE,

Ms. KAPTUR, Mr. GILMAN, Mr. EWING, Mr. SHARP, Ms. DUNN, Mr.

LEVY, Mr. GUTIERREZ, Mr. FAWELL, Mr. CALVERT, Mr. DE LA GARZA,

Mr. ANDREWS of New Jersey, Mr. GEJDENSON, Mr. HASTINGS, Mr. TAYLOR of Mississippi, Mr. QUILLEN, Ms. BYRNE, Mr. MONTGOMERY, Mr.

JOHNSON of Georgia, and Mr. WASHINGTON

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to

establish provisions regarding the composition and labeling of dietary supplements.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE AND REFERENCE.

4 (a) SHORT TITLE.—This Act may be cited as the

5 ‘‘Dietary Supplement Health and Education Act of 1993’’.

6 (b) REFERENCE.—Whenever in this Act (other than

7 section 7) an amendment or repeal is expressed in terms

8 of an amendment to, or repeal of, a section or other provi9 sion, the reference shall be considered to be made to a

10 section or other provision of the Federal Food, Drug, and

11 Cosmetic Act.
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1 SEC. 2. DEFINITIONS.

2 (a) DIETARY SUPPLEMENT.—Section 201 (21 U.S.C.

3 321) is amended by adding at the end the following new

4 paragraph:

5 ‘‘(gg) The term ‘dietary supplement’ means a food

6 for special dietary use, as defined in section 411(c)(3),

7 that—

8 ‘‘(1) includes one or more—

9 ‘‘(A) vitamins;

10 ‘‘(B) minerals;

11 ‘‘(C) herbs;

12 ‘‘(D) amino acids; or

13 ‘‘(E) other ingredients for use by man to

14 supplement the diet by increasing the total die15 tary intake, including a concentrate or extract

16 of any article listed in this paragraph; and

17 ‘‘(2) is intended for use in tablet, capsule, pow18 der, softgel, or any other form (including liquid

19 form) that is not represented for use as conventional

20 food or as a sole item of a meal or of the diet.’’.

21 (b) FOOD ADDITIVE.—Section 201(s) (21 U.S.C.

22 321(s)) is amended—

23 (1) by striking out the period at the end of sub24 paragraph (5) and inserting in lieu thereof ‘‘; or’’;

25 and
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1 (2) by adding after subparagraph (5) the fol2 lowing:

3 ‘‘(6) any dietary ingredients of the kind speci4 fied in paragraph (gg)(1) in, or intended for use in,

5 a dietary supplement.

6 For purposes of subparagraph (6) the term ‘dietary ingre7 dient’ means an ingredient that is in, or intended for use

8 in, a dietary supplement.’’.

9 SEC. 3. DIETARY SUPPLEMENT LABELING AND COMPOSI10 TION.

11 (a) ADULTERATION.—Section 402 (21 U.S.C. 342)

12 is amended by adding at the end the following:

13 ‘‘(f) If it is a dietary supplement and—

14 ‘‘(1) it contains an unsafe dietary ingredient

15 which is a substance that is intended to be

16 consumed for its dietary properties but which the

17 Secretary has found through rulemaking to present

18 a substantial and unreasonable risk of illness or in19 jury; or

20 ‘‘(2) it contains a dietary ingredient that has

21 not been adequately substantiated for safety by the

22 person identified under section 403(e)(1) or by the

23 raw material manufacturer through—

24 ‘‘(A) evidence of a history of safe use (as

25 part of any prior intended use) and the absence
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1 of substantial information that brings the safety

2 of the ingredient into question; or

3 ‘‘(B) by well-designed scientific studies

4 conducted in a manner that is consistent with

5 generally recognized scientific procedures and

6 principles; or

7 ‘‘(C) by other appropriate means.

8 A dietary ingredient that is found to be safe for use in

9 a dietary supplement or as a nutrient by the Secretary

10 or by the National Academy of Sciences through the estab11 lishment of a recommended dietary allowance or an esti12 mated safe and adequate dietary intake shall be deemed

13 to have met the requirements of this paragraph within the

14 scope of the determination by the Secretary or the Na15 tional Academy of Sciences.

16 ‘‘(g)(1) If it is a dietary supplement and the Sec17 retary was not notified, in accordance with regulations is18 sued under subparagraph (2), about a significant change

19 in the manufacturing practice which produced the supple20 ment or of potential problems of safety or contamination

21 affecting such practice.

22 ‘‘(2) The Secretary shall promulgate regulations

23 within 18 months of the date of the enactment of this sub24 paragraph to require notification to the Secretary by man25 ufacturers of raw materials utilized in dietary supplements
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1 of significant changes in manufacturing practices of such

2 materials or of any potential problems of safety or con3 tamination arising from any such changes to ensure the

4 safety of such materials.

5 ‘‘(3) Subparagraphs (1) and (2) apply only to manu6 facturing changes that are substantial and have been

7 shown to present adverse safety consequences. These sec8 tions do not apply to routine changes in the formulating

9 and manufacturing of dietary supplements by dietary sup10 plement manufacturers that utilize good manufacturing

11 practices.’’.

12 (b) MISBRANDING.—Section 403 (21 U.S.C. 343) is

13 amended by adding at the end the following:

14 ‘‘(s) If it is a dietary supplement and—

15 ‘‘(1) its label fails to list the name and quantity

16 or proportion of each dietary ingredient included in

17 section 201(gg), except that proprietary blends of in18 gredients may declare the quantity of the total

19 blend;

20 ‘‘(2) its label fails to identify the product as a

21 supplement, as a supplement modified with the

22 name of the ingredient of the kind specified in sec23 tion 201(gg)(1), or as a dietary supplement;

24 ‘‘(3) it contains an ingredient of the kind speci25 fied in section 201(gg)(1)(C) and the labeling fails
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1 to identify the part of the plant from which the in2 gredient is derived;

3 ‘‘(4) if it purports to be or is represented as a

4 dietary supplement the name of which is listed in a

5 compendium for foods recognized in regulations is6 sued by the Secretary and its composition or

7 strength differs from, or its quality or purity (in8 cluding tablet or capsule disintegration or dissolu9 tion) falls below, the standards set forth in such

10 compendium unless such difference in composition,

11 strength, quality, or purity from the applicable com12 pendium standards is plainly stated on the label; or

13 ‘‘(5) it is not subject to subparagraph (4) and

14 its composition or strength differs from, or its purity

15 or quality (including tablet or capsule disintegration

16 or dissolution) falls below, that which it purports or

17 is represented to have.

18 Subparagraph (4) is not to be construed as prohibiting

19 a dietary supplement from representing that it meets U.S.

20 Pharmacopeia standards for dietary supplements if it

21 meets such standards. Such a supplement shall not be

22 deemed a drug because of such a representation.’’.

23 (c) COMPOSITIONAL LIMITS.—Section 411 (21

24 U.S.C. 350) is amended by adding at the end the follow25 ing:
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1 ‘‘(d)(1) Except as provided in paragraph (2), the Sec2 retary may not—

3 ‘‘(A) establish under section 201(n), 401, or

4 403 maximum limits on the potency of any dietary

5 supplement or any dietary ingredient of the kind

6 specified in section 201(gg);

7 ‘‘(B) classify any dietary supplement or any in8 gredient of the kind specified in section 201(gg) as

9 a drug solely because it exceeds the level of potency

10 that the Secretary determines is nutritionally ration11 al or useful; or

12 ‘‘(C) limit, under section 201(n), 401, or 403,

13 in a dietary supplement the combination or number

14 of ingredients of the kind specified in section

15 201(gg).

16 ‘‘(2) Paragraph (1) does not apply in the case of a

17 dietary supplement represented (other than in conformity

18 with section 403(r)(5)(D)) for use by individuals in the

19 treatment or management of specific diseases or disorders,

20 by children, or by pregnant or lactating women. For pur21 poses of this paragraph, the term ‘children’ means individ22 uals who are under the age of 12 years.’’.

23 SEC. 4. CLAIMS.

24 Section 403(r)(5)(D) (21 U.S.C. 343(r)(5)(D)) is

25 amended to read as follows:
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1 ‘‘(D)(i) A subparagraph (1)(B) claim made with re2 spect to a dietary supplement shall not be subject to sub3 paragraph (3).

4 ‘‘(ii) Labeling of a dietary supplement may character5 ize the relationship between the supplement and a disease

6 or other condition of the body if—

7 ‘‘(I) the supplement contains one or more nutri8 ents for which a claim of the type described in sub9 paragraph (1)(B) has been authorized by the Sec10 retary pursuant to subparagraph (3)(B) and such

11 characterization is consistent with the claim author12 ized by the Secretary, unless the Secretary deter13 mines, through rulemaking based upon the totality

14 of publicly available scientific evidence, that con15 sumption of the nutrient in a dietary supplement

16 would not tend to reduce the risk of disease or other

17 health-related condition in a manner similar to the

18 consumption of such nutrient in conventional foods;

19 or

20 ‘‘(II) such characterization accurately rep21 resents the current state of scientific evidence con22 cerning the relationship between the supplement or

23 dietary ingredient of the supplement and a disease

24 or other health-related condition, taking into account

25 the totality of scientific evidence (including evidence
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1 from well-designed studies conducted in a manner

2 consistent with generally recognized scientific prin3 ciples).

4 This clause does not prohibit the labeling of a dietary sup5 plement from providing truthful and non-misleading infor6 mation, measured by the standard set forth in subclause

7 (II), concerning its vitamin, mineral, or other dietary

8 properties, including nutritional information about the

9 manner in which those dietary properties affect physio10 logical processes of the body or prevent or repair damage

11 caused by diet or other environmental factors and does

12 not authorize the Secretary to establish a prior restraint

13 on the use of any labeling that is subject to subclause (II).

14 ‘‘(iii) At least 30 days before the introduction into

15 interstate commerce of any label, consumer package, or

16 literature in the package containing a claim described in

17 subclause (ii), or before the making of such a claim

18 through any other means, a person responsible for market19 ing the dietary supplement to which such claim refers shall

20 provide notification to the Secretary of the wording of

21 such claim if such claim has not previously been made for

22 such dietary supplement by such person. Documentation

23 that is intended to support such claim may be submitted

24 with such notice. The Secretary may not impose any addi-
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1 tional pre-market requirement, including requirements or

2 requests for further documentation.’’.

3 SEC. 5. DIETARY INTAKE STANDARDS.

4 (a) NUTRITION INFORMATION.—Section 403(q)(1)

5 (21 U.S.C. 343(q)(1)) is amended by striking the period

6 at the end of subparagraph (E) and inserting in lieu there7 of ‘‘, or’’ and by adding after that subparagraph the fol8 lowing:

9 ‘‘(F) a declaration of the percent of a daily ref10 erence amount for each nutrient specified in sub11 paragraphs (D) and (E), stated as a ‘Percent Daily

12 Value’ provided by a serving of that food.’’.

13 (b) REGULATIONS.—

14 (1) IN GENERAL.—

15 (A) DAILY VALUE.—Subject to subpara16 graph (B), the Secretary of Health and Human

17 Services shall, by regulation, determine, based

18 on the dietary guidance provided by the Depart19 ment of Agriculture, the Department of Health

20 and Human Services, the Centers for Disease

21 Control, the National Institutes of Health, and

22 other authoritative public health organizations,

23 a daily value for each nutrient specified in sub24 paragraphs (1)(D) and (1)(E) of section 403(q)

25 of the Federal Food, Drug, and Cosmetic Act
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1 which shall reflect the daily intake of each such

2 nutrient that will promote optimal health and

3 minimize the risk of disease or other health-re4 lated condition.

5 (B) LIMITATION.—The daily value deter6 mined by the Secretary under subparagraph (A)

7 shall be no less than the Recommended Daily

8 Allowances established by the Food and Nutri9 tion Board of the National Academy of Sciences

10 for the age and sex group most at risk of nutri11 tional deficiencies of any particular nutrient.

12 (2) TIMING.—Except as provided in paragraph

13 (4), the Secretary of Health and Human Services

14 shall issue proposed regulations under paragraph (1)

15 no later than 12 months from the date of the enact16 ment of this Act and shall issue final regulations no

17 later than 24 months from such date.

18 (3) PENDING DAILY VALUES.—Pending the is19 suance of final regulations under paragraph (1), the

20 daily values for the nutrients declared under section

21 403(q)(1)(F) of the Federal Food, Drug, and Cos22 metic Act (21 U.S.C. 343(q)(1)(F)) shall be those

23 specified in sections 101.9(8) and 101.9(9) of regu24 lations published in title 21 of the Code of Federal
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1 Regulations, as in effect on the date of the enact2 ment of this Act.

3 (4) ASSISTANCE.—To assist the Secretary of

4 Health and Human Services in issuing regulations

5 under paragraph (1), the Director of the Congres6 sional Research Office, in consultation with the Di7 rector of the Office of Technology Assessment, shall

8 arrange for that office to review existing scientific

9 data and conduct one or more studies, if necessary,

10 to be completed no later than 9 months from the

11 date of the enactment of this Act, to determine what

12 amount of each nutrient specified in subparagraphs

13 (1)(D) and (1)(E) of section 403(q) of the Federal

14 Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)

15 would be provided by the diets recommended by the

16 Department of Agriculture, the Department of

17 Health and Human Services, the Centers for Dis18 ease Control, the National Institutes of Health, and

19 other authoritative public health organizations to

20 minimize the risk of disease and other health-related

21 conditions and to promote optimal health. If the Of22 fice of Technology Assessment does not complete the

23 studies determined to be necessary within 9 months

24 from the date of the enactment of this Act, the time

25 prescribed by paragraph (2) for the issuance of pro-
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1 posed and final regulations shall be extended by a

2 period equal to the additional time required by such

3 Office to complete such studies.

4 SEC. 6. APPEAL.

5 Section 411 (21 U.S.C. 350), as amended by section

6 3(c), is amended by adding at the end the following:

7 ‘‘(e)(1) If the Secretary asserts that a dietary supple8 ment is in violation of any provision of this Act, whether

9 the assertion is made in a warning letter issued by an offi10 cer or employee of the Department of Health and Human

11 Services or in any other manner, the manufacturer, proc12 essor, packer, distributor, or retailer of the dietary supple13 ment or any other person to whom the assertion is ad14 dressed may, within 60 days, appeal to the Secretary or

15 to an officer or employee of the Department of Health and

16 Human Services assigned by the Secretary to hear such

17 an appeal showing that the assertion is incorrect and

18 should be withdrawn. During the 60-day period after such

19 assertion is made by the Secretary and during pendency

20 of such an appeal, the United States shall not initiate liti21 gation on the matter unless the Secretary concludes that

22 such litigation is required because of an imminent hazard

23 to health. If such an appeal is not resolved to the satisfac24 tion of the appellant, the appellant may—
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1 ‘‘(A) bring an action in a United States district

2 court in any appropriate judicial district under sec3 tion 1391 of title 28, United States Code, to secure

4 a declaratory judgment in which all factual deter5 minations regarding the validity of the assertion in

6 question shall be made de novo; or

7 ‘‘(B) obtain any other means of judicial review

8 authorized by law.

9 The absence of an action described in subparagraph (A)

10 or (B) shall not establish any inference that an assertion

11 is valid.

12 ‘‘(2) The institution by the United States of a libel

13 of information to condemn a dietary supplement shall con14 stitute final agency action on the part of the Secretary.’’.

15 SEC. 7. OFFICE FOR DIETARY SUPPLEMENTS.

16 (a) IN GENERAL.—Title IV of the Public Health

17 Service Act is amended by inserting after section 486 (42

18 U.S.C. 287c–3) the following:

19 ‘‘Subpart 4—Office for Dietary Supplements

20 ‘‘SEC. 486E. OFFICE OF DIETARY SUPPLEMENTS.

21 ‘‘(a) ESTABLISHMENT.—The Secretary shall estab22 lish an Office of Dietary Supplements within the National

23 Institutes of Health.

24 ‘‘(b) DUTIES.—The Office for Dietary Supplements

25 shall—
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1 ‘‘(1) conduct and coordinate scientific research

2 within the National Institutes of Health relating to

3 dietary supplements and the extent to which the use

4 of dietary supplements can limit or reduce the risk

5 of diseases such as heart disease, cancer, birth de6 fects, osteoporosis, cataracts, or prostatism;

7 ‘‘(2) collect and compile the results of scientific

8 research relating to dietary supplements, including

9 scientific data from foreign sources or the Office of

10 Alternative Medical Practice;

11 ‘‘(3) serve as the principal advisor to the Sec12 retary and to the Assistant Secretary for Health,

13 and to provide advice to the Director of the National

14 Institutes of Health, the Director of the Centers for

15 Disease Control and Prevention, and the Commis16 sioner of Food and Drugs, on issues relating to die17 tary supplements including—

18 ‘‘(A) dietary intake regulations;

19 ‘‘(B) the safety of dietary supplements;

20 ‘‘(C) claims characterizing the relationship

21 between—

22 ‘‘(i) dietary supplements; and

23 ‘‘(ii)(I) prevention of disease or other

24 health-related conditions; and

25 ‘‘(II) maintenance of health; and
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1 ‘‘(D) scientific issues arising in connection

2 with the labeling and composition of dietary

3 supplements;

4 ‘‘(4) compile a database of scientific research

5 on dietary supplements and individual nutrients;

6 ‘‘(5) coordinate funding relating to dietary sup7 plements for the National Institutes of Health;

8 ‘‘(6) explore more fully the potential role of die9 tary supplements as a significant part of the efforts

10 of the United States to improve health care; and

11 ‘‘(7) promote scientific study of the benefits of

12 dietary supplements in maintaining health and pre13 venting chronic disease and other health-related con14 ditions.

15 ‘‘(c) DEFINITION.—As used in this section, the term

16 ‘dietary supplement’ has the meaning given the term in

17 section 201(gg) of the Federal Food, Drug, and Cosmetic

18 Act (21 U.S.C. 321(gg)).

19 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There

20 are authorized to be appropriated to carry out this section

21 $5,000,000 for fiscal year 1994 and such sums as may

22 be necessary for each subsequent fiscal year.’’.

23 (b) CONFORMING AMENDMENT.—Section 401(b)(2)

24 of the Public Health Service Act (42 U.S.C. 281(b)(2))

25 is amended by adding at the end the following:
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1 ‘‘(E) The Office for Dietary Supplements.’’.

2 SEC. 8. EFFECTIVE DATE.

3 The amendments made by this Act shall take effect

4 on the date of the enactment of this Act, except that the

5 amendments made by section 3 shall take effect 18

6 months after such date with respect to products labeled

7 after such date.

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