I 

110TH CONGRESS 

1ST SESSION H. R. 2117 

To amend the Federal Food, Drug, and Cosmetic Act concerning foods 

and dietary supplements, to amend the Federal Trade Commission Act 

concerning the burden of proof in false advertising cases, and for other 

purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 2, 2007 

Mr. PAUL (for himself, Mr. BURTON of Indiana, Mr. SHAYS, Mr. BARTLETT

of Maryland, and Mr. DUNCAN) 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 concerning foods and dietary supplements, to amend the 

Federal Trade Commission Act concerning the burden 

of proof in false advertising cases, 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 Freedom Pro5 tection Act’’. 


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1 SEC. 2. DEFINITIONS. 

2 The second sentence of subparagraph (1) of section 

3 201(g) of the Federal Food, Drug, and Cosmetic Act (21 

4 U.S.C. 321(g)) is amended by inserting ‘‘including a claim 

5 to cure, mitigate, treat, or prevent disease,’’ after ‘‘for 

6 which a claim,’’. 

7 SEC. 3. MISBRANDED FOOD. 

8 Section 403(r) of the Federal Food, Drug, and Cos9 metic Act (21 U.S.C. 343(r)) is amended— 

10 (1) in subparagraph (1)(B), by striking ‘‘to a 

11 disease or a health-related condition’’ and inserting 

12 ‘‘to the cure, mitigation, treatment, or prevention of 

13 any disease or any health-related condition’’; 

14 (2) in subparagraph (2)— 

15 (A) by amending clause (G) to read as fol16 lows: 

17 ‘‘(G) Publications of the United States 

18 Government shall not be subject to this sub19 paragraph, subparagraph (3), or subparagraph 

20 5(D). The Secretary shall take no action under 

21 this Act to restrict, limit, or impede the reprint22 ing and distribution or sale of any publication 

23 of the United States Government (including 

24 ones published by or at the request of any de25 partment, agency, institute, center, or academy 

26 and including content characterizing the relaVerDate Aug 31 2005 03:55 May 04, 2007 Jkt 059200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2117.IH H2117

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1 tionship of any nutrient to the cure, mitigation, 

2 treatment, or prevention of any disease). The 

3 Secretary shall not construe the distribution or 

4 sale of a publication of the United States Gov5 ernment in connection with the sale of a food 

6 or dietary supplement as evidence of an intent 

7 to sell that food or dietary supplement as a 

8 drug.’’; and 

9 (B) by amending clause (H) to read as fol10 lows: 

11 ‘‘(H) Accurate quotations from a publica12 tion of the United States Government referred 

13 to in clause (G) shall not be subject to this sub14 paragraph, subparagraph (3), or subparagraph 

15 5(D). The Secretary shall take no action under 

16 this Act to restrict, limit, or impede the use of 

17 accurate quotations from a United States Gov18 ernment publication that characterize the rela19 tionship of any nutrient to the cure, mitigation, 

20 treatment, or prevention of any disease. The 

21 Secretary shall not construe accurate quotations 

22 from a United States Government publication 

23 used in connection with the sale of a food or di24 etary supplement as evidence of an intent to 


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1 sell that food or dietary supplement as a 

2 drug.’’; 

3 (3) in subparagraph (3), by adding at the end 

4 the following: 

5 ‘‘(E) The Secretary shall allow with rea6 sonable and concise disclaimers not to exceed 

7 three sentences claims of the type described in 

8 subparagraph (1)(B) not authorized under this 

9 subparagraph or subparagraph (5)(D) unless 

10 the Secretary determines that— 

11 ‘‘(i) there is no scientific evidence that 

12 supports the claim; and 

13 ‘‘(ii) the claim is inherently mis14 leading and incapable of being rendered 

15 nonmisleading through the addition of a 

16 disclaimer. 

17 The Secretary shall not use tests of consumer 

18 perception of product health benefits as a basis 

19 for a determination under subclause (ii). The 

20 Secretary shall bear the burden of proof by 

21 clear and convincing evidence on each element 

22 of this clause. 

23 ‘‘(F) The Secretary shall not exclude stud24 ies concerning the treatment effects of nutrients 

25 on disease from the evaluation of any health 


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1 claims under this subparagraph or subpara2 graph (1)(B) or (5)(D). 

3 ‘‘(G) Notwithstanding any other provision 

4 of law, a member of an advisory committee 

5 under this Act may not, with respect to service 

6 on a committee evaluating a claim of the type 

7 described in subparagraph (1)(B), be granted 

8 an exemption under section 208(b) of title 18, 

9 United States Code (relating to personal finan10 cial interests). 

11 ‘‘(H) Notwithstanding any prior decisions 

12 of the Secretary concerning the relationship of 

13 saw palmetto to benign prostatic hyperplasia, 

14 the relationship of omega-3 fatty acids and cor15 onary heart disease, the relationship of omega16 3 fatty acids and sudden death heart attack, 

17 the relationship of glucosamine or chondroitin 

18 sulfate and osteoarthritis, or the relationship of 

19 calcium and bone fractures, the following health 

20 claims are authorized for use on labels and in 

21 the labeling of all foods and dietary supple22 ments containing those nutrients: 

23 ‘‘(i) Saw Palmetto may improve urine 

24 flow, reduce nocturia and reduce voiding 


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1 urgency associated with mild benign pros2 tatic hyperplasia (an enlarged prostate). 

3 ‘‘(ii) Omega-3 Fatty Acids may re4 duce the risk of coronary heart disease. 

5 ‘‘(iii) Omega-3 Fatty Acids may re6 duce the risk of sudden death heart attack. 

7 ‘‘(iv) Glucosamine may reduce joint 

8 stiffness and pain associated with osteo9 arthritis. 

10 ‘‘(v) Chondroitin Sulfate may reduce 

11 joint stiffness and pain associated with os12 teoarthritis. 

13 ‘‘(vi) Glucosamine and Chondroitin 

14 Sulfate may reduce joint stiffness and pain 

15 associated with osteoarthritis. 

16 ‘‘(vii) Calcium may reduce the risk of 

17 bone fractures.’’; 

18 (4) in subclause (i) of subparagraph (4)(A)— 

19 (A) in the first sentence, by striking ‘‘or 

20 (3)(B)’’ and inserting ‘‘, (3)(B), or (3)(E)’’; 

21 and 

22 (B) by striking ‘‘Not later than 100 days’’ 

23 and all that follows through the end of sub24 clause (i) and inserting ‘‘The Secretary shall 

25 promulgate regulations authorizing or denying 


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1 claims under subparagraph (3)(B), shall publish 

2 notice of claims allowed or disallowed under 

3 subparagraph (3)(C) or (3)(E) no later than 

4 100 days after the petition for such claims is 

5 received by the Secretary, and shall not seek or 

6 grant any extensions of that deadline. Any fail7 ure by the Secretary to act within the 100-day 

8 period described in the preceding sentence shall 

9 result in authorization or allowance, as applica10 ble, of the petitioned claim by operation of 

11 law.’’; and 

12 (5) in the matter following clause (C) in sub13 paragraph (6), by adding at the end the following 

14 ‘‘A statement for a dietary supplement under this 

15 subparagraph may include words that are recognized 

16 as signs or symptoms of disease or that among their 

17 commonly understood meanings imply the cure, miti18 gation, treatment, or prevention of disease so long as 

19 the statement does not include the name of a spe20 cific disease and is made in compliance with the re21 quirements of clause (C). A statement for a dietary 

22 supplement under this subparagraph may in support 

23 of the statement refer to or cite a scientific publica24 tion that has a title or contents that include the 


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1 name of a specific disease or a sign or symptom of 

2 a specific disease.’’. 

3 SEC. 4. DIETARY SUPPLEMENT LABELING EXEMPTIONS. 

4 Section 403B of the Federal Food, Drug, and Cos5 metic Act (21 U.S.C. 343–2) is amended to read as fol6 lows: 

7 ‘‘FOOD AND DIETARY SUPPLEMENT LABELING

8 EXEMPTION

9 ‘‘SEC. 403B. A truthful and nonmisleading scientific 

10 publication reprinted in its entirety and used in connection 

11 with the sale of a food or dietary supplement to consumers 

12 shall not be defined as labeling and shall not be deemed 

13 evidence of an intent to sell a drug. The Secretary shall 

14 not restrict in any way whatsoever the distribution of any 

15 publication exempt from labeling under this section.’’. 

16 SEC. 5. HEALTH INFORMATION. 

17 Section 5 of the Federal Trade Commission Act (15 

18 U.S.C. 45) is amended by adding at the end the following: 

19 ‘‘(o) ADVERTISING OF DIETARY SUPPLEMENTS AND

20 DIETARY INGREDIENTS.— 

21 ‘‘(1) DEFINITIONS.—In this subsection: 

22 ‘‘(A) DIETARY SUPPLEMENT.—The term 

23 ‘dietary supplement’ has the meaning given to 

24 that term in section 201(ff) of the Federal 

25 Food, Drug, and Cosmetic Act. 


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1 ‘‘(B) DIETARY INGREDIENT.—The term 

2 ‘dietary ingredient’ means an ingredient listed 

3 in clause (A) through (F) of section 201(ff)(1) 

4 of the Federal Food, Drug, and Cosmetic Act 

5 that is included in, or that is intended to be in6 cluded in, a dietary supplement. 

7 ‘‘(2) EXEMPTIONS FROM REGULATION AS AD8 VERTISING.— 

9 ‘‘(A) Insofar as a publication is exempt 

10 pursuant to Section 403B of the Federal Food, 

11 Drug, and Cosmetic Act, the publication is also 

12 exempt from regulation as ‘advertising’ under 

13 this Act. 

14 ‘‘(B) A truthful and accurate summary of 

15 the findings of a peer-reviewed medical, nutri16 tional, or other scientific publication shall not 

17 be subject to regulation as ‘advertising’ under 

18 this Act. 

19 ‘‘(3) NO IMPLIED CLAIMS.—In any investiga20 tion commenced by the Commission and in any adju21 dicative proceeding in which the Commission is a 

22 party, the Commission shall not attribute to an ad23 vertiser accused of false advertisement any adver24 tising statement not actually made by that adver25 tiser. 


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1 ‘‘(4) NOTICE, OPPORTUNITY TO CURE, AND

2 BURDEN OF PROOF FOR INVESTIGATION.— 

3 ‘‘(A) Before the Commission authorizes an 

4 investigation of false advertisement by an ad5 vertiser of a dietary supplement or a dietary in6 gredient, the Commission shall send the adver7 tiser a written ‘Notice of Suspected Violation 

8 and Opportunity to Cure’ informing the adver9 tiser of— 

10 ‘‘(i) the precise advertising statement 

11 that the Commission suspects may be false 

12 or misleading; 

13 ‘‘(ii) the scientific basis for the Com14 mission’s view that any statement of health 

15 benefit may be false or misleading; and 

16 ‘‘(iii) a date certain, not less than 30 

17 days after the date of the advertiser’s re18 ceipt of the notice, by which the advertiser 

19 may voluntarily discontinue further use of 

20 the statement the Commission suspects 

21 may be false or misleading and, upon so 

22 doing, the advertiser shall not be subject to 

23 an investigation of false advertisement by 

24 the Commission for the statement. 


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1 ‘‘(B) The Commission shall not commence 

2 any investigation of an advertiser of a dietary 

3 supplement or a dietary ingredient to determine 

4 whether the advertiser has disseminated a false 

5 advertisement unless it possesses before the 

6 commencement of such investigation proof by a 

7 preponderance of the evidence that the adver8 tisement is false and misleading. 

9 ‘‘(5) BURDEN OF PROOF FOR FALSE ADVER10 TISEMENT CASES.—In any proceeding before a 

11 Court or the Commission in which an advertiser of 

12 a dietary supplement or a dietary ingredient is 

13 charged with deceptive advertising, the burden of 

14 proof shall be on the Commission to establish that 

15 the advertisement is false and misleading and that 

16 the advertisement actually causes consumers to be 

17 misled into believing to be true that which is demon18 strably false. No order adverse to the advertiser 

19 shall be entered except upon the Commission satis20 fying that burden of proof.’’. 

Æ 


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