I 

108TH CONGRESS 

2D SESSION H. R. 4004

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

independent of the Food and Drug Administration for the review of 

health claims, to define health claims, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 18, 2004

Mr. PAUL introduced the following bill; which was referred to the Committee 

on Energy and Commerce 

A BILL

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

establish a system independent of the Food and Drug 

Administration for the review of health claims, to define 

health claims, and for other purposes.

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. 

4 This Act may be cited as the ‘‘Health Information 

5 Independence Act’’. 

6 SEC. 2. FINDINGS. 

7 The Congress finds as follows: 
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1 (1) Access to accurate information at the point 

2 of sale concerning the effect of nutrients on disease 

3 is indispensable to the exercise of informed con4 sumer choice in the marketplace and to the health 

5 and welfare of the American people. 

6 (2) In 1999, 2000, and 2001, Federal courts 

7 have held that Food and Drug Administration sup8 pression of nutrient-disease information is a viola9 tion of the First Amendment to the United States 

10 Constitution. 

11 (3) Despite those holdings and despite the 

12 courts’ orders, the Food and Drug Administration 

13 continues to suppress nutrient-disease information 

14 that could improve public health, reduce the costs of 

15 health care, and promote the welfare of the Amer16 ican people. 

17 (4) The history of the Food and Drug Adminis18 tration review of nutrient-disease relationships re19 veals a strong and unscientific bias against food and 

20 dietary supplement health claims in direct violation 

21 of the constitutional mandates of Federal courts and 

22 the intent of Congress. 

23 (5) The Food and Drug Administration favors 

24 suppression of health claims over disclosure, despite 
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1 court imposed constitutional requirements to the 

2 contrary. 

3 (6) To ensure that health claims are evaluated 

4 rationally, fairly, and in compliance with constitu5 tional requirements and the intent of Congress, the 

6 federal government must be denied authority to deny 

7 the public access to health information absent prob8 able cause that the claims are untrue, misleading or 

9 pose a danger to human health and jurisdiction over 

10 health claims evaluation must be removed from the 

11 Food and Drug Administration and placed in the 

12 hands of Independent Scientific Reviewers who do 

13 not harbor a bias against food and dietary supple14 ment health claims. 

15 SEC. 3. AUTHORITY FOR MAKING HEALTH CLAIMS. 

16 (a) LIMITATION ON AGENCY AUTHORITY TO RE17 STRICT DISTRIBUTION.—Notwithstanding any other pro18 vision of Federal law, the Federal Government shall have 

19 no authority to restrict the distribution of any dietary sup20 plement or other nutritional food on the basis that the 

21 manufacturer is making health claims unapproved by the 

22 Food and Drug Administration if—

23 (1) the product has a label clearly stating that 

24 its health claims are not FDA approved; and 
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1 (2) such Administration lacks evidence estab2 lishing probable cause that the claims contain mis3 leading information posing a threat to the safety and 

4 well-being of those who use such product. 

5 (b) INDEPENDENT REVIEW OF AGENCY DETERMINA6 TION OF EXISTENCE OF PROBABLE CAUSE.—In the event 

7 that the Food and Drug Administration determines that 

8 there is probable cause that the claims for a dietary sup9 plement or other nutritional food contain misleading infor10 mation posing a threat to the safety and well-being of 

11 those who use such product, such Administration shall, be12 fore acting against the product carrying the allegedly of13 fensive claims, submit the claims to review before an inde14 pendent review board as described in the following sections 

15 of this Act. 

16 SEC. 4. DEFINITIONS. 

17 Section 201 of the Federal Food, Drug, and Cosmetic 

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

19 following: 

20 ‘‘(nn) The term ‘Independent Scientific Reviewer’ 

21 means a person who—

22 ‘‘(1) holds a Ph.D., an M.D., or both, and has 

23 been employed full-time for at least the past 5 con24 secutive years as a professor or assistant or asso25 ciate professor in a department of medicine, bio-
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1 chemistry, epidemiology, pharmacology, pharmacog2 nosy, or nutrition at a university that is accredited 

3 by an organization recognized by the Department of 

4 Education of the United States; 

5 ‘‘(2) has never been employed by, and has never 

6 been contracted to do work for, the Food and Drug 

7 Administration or any other agency or office of the 

8 Department of Health and Human Services (except 

9 to review health claim petitions under section 

10 403D); 

11 ‘‘(3) has never been employed by, and has never 

12 been contracted to do work for, the health claim pe13 titioner; 

14 ‘‘(4) signs an oath pledging to evaluate the 

15 health claim petition provided to him or her by the 

16 Secretary in strict accordance with the criteria speci17 fied in section 403D; 

18 ‘‘(5) signs an oath pledging not to discuss with 

19 any person the fact that he or she is reviewing the 

20 health claim petition or the substance of the petition 

21 or the substance of the evaluation before the results 

22 of the scientific review are supplied in a complete 

23 written evaluation to the Secretary; 

24 ‘‘(6) signs an oath pledging to supply complete 

25 copies of all publicly available scientific evidence re-
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1 viewed along with a complete written evaluation of 

2 the health claim to the Secretary no later than 180 

3 days after receipt of the health claim petition from 

4 the Secretary; and 

5 ‘‘(7) signs an oath pledging to exercise inde6 pendent professional judgment, free of any external 

7 influence and any unscientific bias that might inter8 fere with the objective evaluation of the health 

9 claim.’’. 

10 SEC. 5. HEALTH CLAIMS. 

11 Section 403(r) of the Federal Food, Drug, and Cos12 metic Act (21 U.S.C. 343(r)) is amended—

13 (1) in subparagraph (1)—

14 (A) in the matter preceding clause (A)—

15 (i) by striking ‘‘food intended’’ and in16 serting ‘‘food or dietary supplement in17 tended’’; and 

18 (ii) by striking ‘‘food which’’ and in19 serting ‘‘food or dietary supplement 

20 which’’; and 

21 (B) in clause (B)—

22 (i) by inserting after ‘‘health-related 

23 condition’’ the following: ‘‘(including any 

24 statement that the nutrient prevents, 

25 treats, or cures a disease)’’; and 
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1 (ii) by striking ‘‘or (5)(D)’’; 

2 (2) in subparagraph (3), by amending clause 

3 (B) to read as follows: 

4 ‘‘(B)(i) The Secretary shall promulgate no later than 

5 30 days after receiving an evaluation from an Independent 

6 Scientific Reviewer regulations that authorize use on la7 bels and in labeling of all claims of the type described in 

8 subparagraph (1)(B) recommended for approval by the 

9 Independent Scientific Reviewer together with such dis10 claimer or disclaimers as the Independent Scientific Re11 viewer may also recommend. 

12 ‘‘(ii) The duties of the Secretary described in sub13 clause (i) are nondelegable and may be discharged only 

14 by the Secretary.’’; 

15 (3) by striking subparagraph (4) and redesig16 nating subparagraph (5) as subparagraph (4); and 

17 (4) in subparagraph (4) (as so redesignated), 

18 by striking clause (D). 

19 SEC. 6. INDEPENDENT SCIENTIFIC REVIEW. 

20 Chapter IV of the Federal Food, Drug, and Cosmetic 

21 Act (21 U.S.C. 341 et seq.) is amended by inserting after 

22 section 403C the following new section: 

23 ‘‘SEC. 403D. INDEPENDENT SCIENTIFIC REVIEW. 

24 ‘‘(a) INVITATIONS TO PARTICIPATE.—No later than 

25 30 days after the date of the enactment of the Health In-
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1 formation Independence Act, and every 180-days there2 after, the Secretary shall send to every department of 

3 medicine, biochemistry, epidemiology, pharmacology, 

4 pharmacognosy, and nutrition at every university that is 

5 accredited by an organization recognized by the Secretary 

6 of Education a notice and invitation to participate, stating 

7 the following: 

8 ‘‘(1) Scientists employed by the university in its 

9 departments of medicine, biochemistry, epidemiology, 

10 pharmacology, pharmacognosy, or nutrition who pos11 sess a Ph.D. or an M.D., or both, and have been ei12 ther a full-time professor or a full-time assistant or 

13 associate professor for at least the past 5 consecu14 tive years are invited to apply to the Secretary to be 

15 Independent Scientific Reviewers in assessing health 

16 claims made without a label clearing stating its 

17 health claims are not approved by the Food and 

18 Drug Administration or such Administration has 

19 evidence establishing probable cause that the claims 

20 contain misleading information posing a threat to 

21 the safety and well-being of those who use the prod22 uct. Health claims are statements of nutrient-disease 

23 association. 

24 ‘‘(2) Scientists who qualify to be Independent 

25 Scientific Reviewers will be selected at random by 
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1 the Secretary to review all publicly available sci2 entific evidence on a particular nutrient-disease as3 sociation, must supply copies of all evidence reviewed 

4 to the Secretary, and must supply a written evalua5 tion of that evidence and the health claim to the 

6 Secretary no later than 180 days after receipt of the 

7 health claim petition. The Independent Scientific Re8 viewer shall state whether the claim is supported by 

9 scientific evidence and is, therefore, recommended 

10 for approval. The Independent Scientific Reviewer 

11 should only conclude that the health claim is not 

12 supported by scientific evidence, and, therefore, not 

13 recommended for approval, if the reviewer finds—

14 ‘‘(A) no credible scientific evidence sup15 porting the claim; and 

16 ‘‘(B) no disclaimer that could accompany 

17 the claim that could eliminate any potentially 

18 misleading connotation conveyed by the claim. 

19 Recommended disclaimers must be accurate and 

20 concise. Disclaimers should reveal the extent of sup21 port for the claim by stating whether evidence in 

22 support of the claim is less than conclusive, e.g., 

23 that evidence in support of the claim is preliminary 

24 and inconclusive, suggestive but not conclusive, or 
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1 generally accepted but not yet proven to a conclusive 

2 degree. 

3 ‘‘(3) Independent Scientific Reviewers must 

4 complete their reviews within 180 days of receipt of 

5 a health claim petition from the Secretary. 

6 ‘‘(4) To qualify to be an Independent Scientific 

7 Reviewer you must certify in writing under penalty 

8 of perjury that—

9 ‘‘(A) you hold a Ph.D., an M.D., or both, 

10 and have been employed full-time for at least 

11 the past 5 consecutive years as a professor, as12 sistant professor, or associate professor in a de13 partment of medicine, biochemistry, epidemi14 ology, pharmacology, pharmacognosy, or nutri15 tion at a university that is accredited by an or16 ganization recognized by the Department of 

17 Education of the United States; 

18 ‘‘(B) you have never been employed by, 

19 and have never been contracted to do work for, 

20 the Food and Drug Administration or any other 

21 agency or office of the Department of Health 

22 and Human Services (except to review health 

23 claim petitions) or for the health claim peti24 tioner; 
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1 ‘‘(C) you will evaluate any health claim pe2 tition submitted to you in strict accordance with 

3 the criteria specified in section 403D; 

4 ‘‘(D) you will not discuss with any person 

5 the fact that you are reviewing the health claim 

6 petition or the substance of the petition or the 

7 substance of the evaluation before you submit a 

8 complete written evaluation of the health claim 

9 to the Secretary; 

10 ‘‘(E) you will complete your review of the 

11 health claim petition and will supply your com12 plete written evaluation of it along with all sci13 entific evidence reviewed to the Secretary no 

14 later than 180 days after receipt of the health 

15 claim petition from the Secretary; and 

16 ‘‘(F) you will exercise independent profes17 sional judgment, free of any external influence 

18 and any unscientific bias that might interfere 

19 with the objective evaluation of the health 

20 claim. 

21 ‘‘(5) Failure to abide by the above rules will re22 sult in disbarment from the Independent Scientific 

23 Review program and disallowance of all compensa24 tion for any review undertaken. 
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1 ‘‘(b) CONFIRMATION OF INDEPENDENT SCIENTIFIC

2 REVIEWER STATUS.—No later than 30 days after the Sec3 retary determines that a health claim meets the criteria 

4 established in section 3 of the Health Information Inde5 pendence Act for government approval, including the cer6 tifications required under subsection (a)(4) of this section, 

7 from a person who seeks to serve as an Independent Sci8 entific Reviewer, the Secretary shall notify that person 

9 whether he or she satisfies the qualification criteria speci10 fied in such subsection and is, thereby, eligible to be se11 lected to serve as an Independent Scientific Reviewer. 

12 ‘‘(c) RANDOM SELECTION OF INDEPENDENT SCI13 ENTIFIC REVIEWER TO EVALUATE HEALTH CLAIM.—Not 

14 later than 15 days after the Secretary determines that a 

15 health claim meets the criteria established in section 3 of 

16 the Health Information Independence Act for government 

17 approval, the Secretary shall select an Independent Sci18 entific Reviewer at random and shall provide that person 

19 with a complete copy of the health claim petition for eval20 uation. The Secretary shall not reveal the name of the 

21 Independent Scientific Reviewer to the public or to the 

22 health claim petitioner until after the Secretary receives 

23 from the Independent Scientific Reviewer all publicly 

24 available scientific evidence reviewed and a complete eval25 uation of the health claim. 
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1 ‘‘(d) ALL PUBLICLY AVAILABLE SCIENTIFIC EVI2 DENCE SHALL BE REVIEWED.—Upon receipt of a health 

3 claim petition, the Independent Scientific Reviewer shall 

4 acquire and evaluate all publicly available scientific evi5 dence relevant to the claim. The Independent Scientific 

6 Reviewer shall determine whether credible scientific evi7 dence supports the health claim. 

8 ‘‘(e) EVERY HEALTH CLAIM SHALL BE REC9 OMMENDED FOR APPROVAL THAT IS SUPPORTED BY

10 CREDIBLE SCIENTIFIC EVIDENCE.—If the Independent 

11 Scientific Reviewer finds that credible scientific evidence 

12 supports the health claim, the Independent Scientific Re13 viewer shall recommend to the Secretary that the health 

14 claim be approved. If the Independent Scientific Reviewer 

15 finds the scientific evidence in support of the claim less 

16 than conclusive, suggestive but not conclusive, preliminary 

17 and inconclusive, or generally accepted but not yet proven 

18 to a conclusive degree, or if the Independent Scientific Re19 viewer finds the claim to convey a potentially misleading 

20 connotation, the Independent Scientific Reviewer shall 

21 also recommend that the health claim be approved accom22 panied by a concise disclaimer carefully worded to render 

23 the claim nonmisleading. 

24 ‘‘(f) HEALTH CLAIMS NOT RECOMMENDED FOR AP25 PROVAL.—If the Independent Scientific Reviewer finds 
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1 that no credible scientific evidence supports the health 

2 claim and that no disclaimer can eliminate a misleading 

3 connotation conveyed by the claim, then the Independent 

4 Scientific Reviewer shall recommend that the Secretary 

5 not approve the health claim. 

6 ‘‘(g) COMPENSATION FOR INDEPENDENT SCIENTIFIC

7 REVIEWERS AND SANCTIONS FOR NONCOMPLIANCE.—

8 The Secretary shall pay each Independent Scientific Re9 viewer the sum of $40,000 no later than 60 days after 

10 the Secretary receives all publicly available scientific evi11 dence reviewed and a complete evaluation of the health 

12 claim. If the Secretary finds that the Independent Sci13 entific Reviewer has submitted a false certification under 

14 subsection (a)(4), the Secretary may debar the Inde15 pendent Scientific Reviewer from the Independent Sci16 entific Review program and shall refrain from paying the 

17 $40,000 fee.’’. 

18 SEC. 7. LEGAL EFFECT OF HEALTH CLAIM RECOMMENDA19 TION BY INDEPENDENT SCIENTIFIC REVIEW20 ERS. 

21 Chapter IV of the Federal Food, Drug, and Cosmetic 

22 Act (21 U.S.C. 341 et seq.), as amended by section 6 of 

23 this Act, is amended by inserting after section 403D the 

24 following new section: 
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1 ‘‘SEC. 403E. LEGAL EFFECT OF HEALTH CLAIM REC2 OMMENDATIONS. 

3 ‘‘(a) SECRETARY’S RESPONSE TO HEALTH CLAIM

4 EVALUATIONS BY INDEPENDENT SCIENTIFIC REVIEW5 ERS.—No later than 30 days after the Secretary receives 

6 from an Independent Scientific Reviewer copies of all pub7 licly available scientific evidence reviewed and a complete 

8 written evaluation of a health claim, the Secretary shall—

9 ‘‘(1) make the evaluation and all scientific evi10 dence reviewed publicly available; and 

11 ‘‘(2) publish in the Federal Register as a final 

12 and binding order of the Department of Health and 

13 Human Services the recommendation of the Inde14 pendent Scientific Reviewer verbatim and without 

15 any alteration in content whatsoever, including the 

16 claim, whether the claim is approved or disapproved, 

17 the reasons therefor, and whether the claim must be 

18 accompanied by a disclaimer and the content of the 

19 disclaimer, and the reasons therefor. 

20 ‘‘(b) ORDER ON HEALTH CLAIMS RECOMMENDA21 TIONS OF INDEPENDENT SCIENTIFIC REVIEWERS IMME22 DIATELY APPEALABLE TO THE UNITED STATES COURT

23 OF APPEALS FOR THE D.C. CIRCUIT.—Any health claim 

24 petitioner, or any other aggrieved party, may file an ap25 peal for review of an order of the Secretary pursuant to 

26 subsection (a) directly to the United States Court of Ap-
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1 peals for the District of Columbia Circuit within 90 days 

2 of the date of publication of the order in the Federal Reg3 ister.’’. 

4 SEC. 8. DEPARTMENT OF HEALTH AND HUMAN SERVICES 

5 BUDGET ALLOCATION FOR INDEPENDENT 

6 SCIENTIFIC REVIEWS. 

7 (a) COSTS OF IMPLEMENTATION.—All costs associ8 ated with implementing this Act shall be borne by the De9 partment of Health and Human Services from its existing 

10 budget. 

11 (b) OFFSETS.—This Act eliminates the need for the 

12 Food and Drug Administration to review health claim pe13 titions for foods and dietary supplements. No later than 

14 six months after the date of the enactment of this Act, 

15 the Secretary of Health and Human Services shall elimi16 nate staff, reduce operating expenses, and maximize cost 

17 savings in the Food and Drug Administration’s Center for 

18 Food Safety and Applied Nutrition to offset the costs of 

19 implementing this Act. 

20 SEC. 9. DEFINITION REGARDING DISTINCTION BETWEEN 

21 FOOD AND DRUGS. 

22 Section 201(g)(1) of the Federal Food, Drug, and 

23 Cosmetic Act (21 U.S.C. 321(g)(1)) is amended in clause 
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1 (B) by inserting ‘‘(other than food, including dietary sup2 plements)’’ after ‘‘articles’’.

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