|
|
FDA to Reevaluate Scientific Basis for Previously Authorized Soy
Health Claims
Federal Register -- December 21, 2007
The Food and Drug Administration (FDA) is announcing an opportunity
for public comment on its intent to reevaluate the scientific evidence
for two previously authorized health claims (dietary lipids (fat) and
cancer; soy protein and risk of coronary heart disease) and two
qualified health claims that were the subject of letters of enforcement
discretion (antioxidant vitamins and risk of certain cancers; selenium
and certain cancers). The agency is undertaking a reevaluation of the
scientific basis for these authorized health claims and qualified
health claims because of new scientific evidence that has emerged for
these substance-disease relationships. The new scientific evidence may
have the effect of weakening the substance-disease relationship for
these authorized health claims and either strengthening or weakening
the scientific support for the substance-disease relationship for these
qualified health claims.
DATES: Submit written or electronic comments by February 19,
2008.
ADDRESSES: You may submit comments, identified by Docket No.
2007N-0464, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following ways:
* Federal eRulemaking Portal: http://www.regulations.gov. Follow the
instructions for submitting comments.
* Agency Web site: http://www.fda.gov/dockets/ecomments. Follow the
instructions for submitting comments on the agency Web site.
Written Submissions
Submit written submissions in the following ways:
* FAX: 301-827-6870.
* Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal or the agency Web site, as described previously, in
the ADDRESSES portion of this document under Electronic Submissions.
Instructions: All submissions received must include
the agency name and docket number for this notice. All comments
received may be posted without change to
http://www.fda.gov/ohrms/dockets/default.htm, including any personal
information provided. For additional information on submitting
comments, see the "How to Submit Comments" heading of the SUPPLEMENTARY
INFORMATION section of this document.
Docket: For access to the docket to read background
documents or comments received, go to
http://www.fda.gov/ohrms/dockets/default.htm and insert the docket
number, found in brackets in the heading of this document, into the
"Search" box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852.
FOR FURTHER INFORMATION CONTACT: Claudine Kavanaugh, Center for Food
Safety and Applied Nutrition (HFS-830), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1450,
FAX: 301-436-2636.
SUPPLEMENTARY INFORMATION: The Nutrition Labeling and Education Act
of 1990 (NLEA) (Public Law 101-553) was designed to give consumers more
scientifically valid information about foods they eat. Among other
provisions, the NLEA directed FDA to issue regulations providing for
the use of statements that describe the relationship between a
substance and a disease (health claims) in the labeling of foods,
including dietary supplements, after such statements have been reviewed
and authorized by FDA. /1/ For these health claims, that is, statements
about substance-disease relationships, FDA has defined the term
"substance" by regulation as a specific food or food component ( SEC
101.14(a)(2) (21 CFR 101.14(a)(2))). An authorized health claim may be
used on both conventional foods and dietary supplements, provided that
the substance in the product and the product itself meet the
appropriate standards in the authorizing regulation. Health claims are
directed to the general population or designated subgroups (e.g., the
elderly) and are intended to assist the consumer in maintaining
healthful dietary practices.
FOOTNOTE 1 In 1997, Congress enacted the Food and Drug
Administration Modernization Act, which established an alternative
authorization procedure for health claims based on authoritative
statements of certain federal scientific bodies or the National Academy
of Sciences. This notice does not address that alternative procedure.
END FOOTNOTE
Under section 403(r)(4)(A)(i) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 343(r)(4)(A)(i)), any person may
petition FDA to issue a health claim regulation. In evaluating the
petition, FDA considers whether there is "significant scientific
agreement" (SSA) based on the totality of publicly available scientific
evidence concerning the relationship that is the subject of the claim.
This standard derives from section 403(r)(3)(B)(i) of the act (21
U.S.C. 343(r)(3)(B)(i)), which provides that FDA shall authorize a
health claim to be used on conventional foods if the agency "determines
based on the totality of the publicly available scientific evidence
(including evidence from well-designed studies conducted in a manner
which is consistent with generally recognized scientific procedures and
principles), that there is significant scientific agreement, among
experts qualified by scientific training and experience to evaluate
such claims, that the claim is supported by such evidence." This
scientific standard was prescribed by statute for conventional food
health claims; by regulation, FDA adopted the same standard for dietary
supplements health claims (see SEC 101.14(c)).
In evaluating a petition for an authorized health claim, if FDA
concludes that the evidence supporting the relationship that is the
subject of the claim does not meet the SSA standard, the agency
considers whether there is credible evidence to support a qualified
health claim. FDA may issue a letter of enforcement discretion for a
qualified health claim where the totality of scientific evidence
supporting the relationship that is the subject of the claim is
credible but does not meet the SSA standard. Qualified health claims
contain qualifying language about the level of scientific evidence to
ensure consumers receive accurate information about the claim.
The genesis of qualified health claims was the court of appeals
decision in Pearson v. Shalala (Pearson). In that case, the plaintiffs
challenged FDA's decision not to authorize health claims for four
specific substance-disease relationships in the labeling of dietary
supplements. Although the district court ruled for FDA (14 F. Supp. 2d
10 (D.D.C. 1998)), the U.S. Court of Appeals for the D.C. Circuit
reversed the lower court's decision (164 F.3d 650 (D.C. Cir.1999)). The
appeals court held that the First Amendment does not permit FDA to
reject health claims that the agency determines to be potentially
misleading unless the agency also reasonably determines that a
disclaimer would not eliminate the potential deception.
In the Federal Register of October 26, 1999 (64 FR 57700), the
agency authorized a health claim for soy protein and risk of coronary
heart disease (21 CFR 101.82). Since authorizing this health claim,
numerous studies have evaluated the relationship between soy protein
and coronary heart disease, and the findings of these studies are
inconsistent. The Agency for Healthcare Research and Quality (AHRQ)
released a report in July 2005 outlining the effects of soy products on
health outcomes including cardiovascular disease and concluded that soy
products appear to exert a small benefit on low-density lipoprotein
(LDL)-cholesterol (Ref. 1). However, it is not clear whether soy
protein (versus other types of soy products) was responsible for such a
benefit. The AHRQ report included studies that evaluated substances in
addition to soy protein (e.g., isoflavones). In addition, the AHRQ
report used markers of cardiac function (e.g., triglycerides,
endothelial function, oxidized LDL) that are not validated surrogate
endpoints recognized by the agency for heart disease risk. The agency
intends to evaluate the scientific evidence on soy protein and the risk
of coronary heart disease to determine if the totality of the
scientific evidence continues to meet the significant scientific
agreement standard.
In the Federal Register of January 6, 1993 (58 FR 2787), FDA
authorized a health claim on dietary lipids (fat) and cancer (21 CFR
101.73). In the years since authorizing this health claim, numerous
studies have been published evaluating this substance-disease
relationship. The Institute of Medicine (IOM) of the National Academy
of Sciences, an authoritative body, published a report that reviewed
the evidence on dietary lipid consumption and cancer risk (Ref. 2). The
IOM reported in its review of the literature that the association
between diets high in fat and increased cancer risk has been weakened
by recent epidemiological studies. The IOM report set an acceptable
macronutrient distribution range (AMDR) for total fat, however, it was
not set based on cancer as a disease outcome because of insufficient
scientific evidence linking consumption of fat with cancer risk. One
factor in determining the AMDR is the long-term intake level of a
nutrient that can minimize the potential for chronic disease. The
agency intends to reevaluate the scientific evidence on dietary lipids
and cancer risk and determine if the totality of the evidence continues
to meet the significant scientific agreement standard.
Section 10.25(b) (21 CFR 10.25(b)) states that the Commissioner of
Food and Drugs may initiate a proceeding to issue, amend, or revoke a
regulation or take or refrain from taking any other form of
administrative action. FDA intends to evaluate whether the currently
available scientific evidence concerning the substance-disease
relationship for the authorized health claims, dietary lipids and
cancer and soy protein and coronary heart disease, continues to support
its previous decisions on these authorized health claims. If the agency
decides to take action to amend or revoke one or both of these health
claims, after completing its review of the current scientific evidence,
the agency will publish its findings and solicit comments on them
before the agency takes any action with respect to revising the
particular health claim. Interested persons may submit scientific
information about these two specific health claims in response to this
notice.
In 2003, FDA issued two letters on the use of the agency's
enforcement discretion for qualified health claims on antioxidant
vitamins (vitamins E and C) and risk of certain cancers (Ref. 3) and
selenium and certain cancers and anticarcinogenic effects in the body
(Ref. 4). In May 2006, AHRQ issued a report evaluating the use of
multivitamin/mineral supplements and the risk of chronic disease (Ref.
5). The report did not identify any studies on the efficacy of vitamin
C supplements and cancer risk. In addition, the report concluded that
the overall strength of the evidence for vitamin E and selenium
supplements on cancer risk is very low (vitamin E) and low (selenium).
The agency intends to reevaluate the scientific evidence on these two
qualified health claims and determine if the scientific evidence
continues to support the qualified health claim, and if so, whether the
qualified health claim language should be modified to reflect a
stronger or weaker relationship.
If the agency decides a change may be needed with respect to one or
both of these claims, the agency intends to publish its findings and
solicit comments on them. Interested persons may submit scientific
information about these two specific qualified health claims in
response to this notice.
Reevaluating Cancer Health Claims by Cancer Site
In the final rule authorizing a health claim for dietary fat and
cancer, FDA considered whether such a claim should specifically address
the types of cancer affected by a diet that is low in total fat, or
whether the claim should not be site-specific (58 FR 2787 at 2788
through 2789). FDA ultimately decided that the identification of
specific sites of affected cancers would not be appropriate due, in
part, to weaker data on the relationship between dietary fat and breast
cancer and the possibility of a wider variety of affected sites for the
dietary fat and cancer relationship. Therefore, FDA required that the
terms "some types of cancer" or "some cancers" be used in specifying
the disease for this health claim relationship (id.). The antioxidant
and cancer and selenium and cancer qualified health claims also contain
similar language, i.e., "certain forms of cancer," to be used in
specifying the disease. However, in other qualified health claims for a
substance and cancer relationship (Refs. 6, 7, and 8), the agency
considered separate qualified health claims for each type of cancer.
Cancer is a constellation of more than 100 different diseases, each
characterized by the uncontrolled growth and spread of abnormal cells
(Ref. 9). Cancer is categorized into different types of diseases based
on the organ and tissue sites (Ref. 10). Cancers at different organ
sites have different risk factors, treatment modalities, and mortality
risk (Ref. 9). Both genetic and environmental (including diet) risk
factors may affect the risk of different types of cancers. Risk factors
may include a family history of a specific type of cancer, cigarette
smoking, alcohol consumption, overweight and obesity, exposure to
ultraviolet or ionizing radiation, exposure to cancer-causing
chemicals, and dietary factors. The etiology, risk factors, diagnosis,
and treatment for each type of cancer are unique (Refs. 11 and 12).
Because each form of cancer is a unique disease based on organ site,
risk factors, treatment options, and mortality risk, FDA's current
approach is to evaluate each form of cancer individually in a health
claim or qualified health claim petition to determine whether the
scientific evidence supports the potential substance-disease
relationship for any type of cancer, each of which constitutes a
disease under SEC 101.14(a)(5).
The agency intends to consider, as part of its reevaluation of the
scientific evidence for dietary fat, antioxidant, and selenium and
their association with a reduced risk of cancer, claim language to
reflect specific types of cancer rather than "certain forms of cancer"
(or similar language).
II. How to Submit Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individual may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Please note that in January 2008, the FDA Web site is expected to
transition to the Federal Dockets Management System (FDMS). FDMS is a
Government-wide, electronic docket management system. After the
transition date, electronic submissions will be accepted by FDA through
the FDMS only. When the exact date of the transition to FDMS is known,
FDA will publish a Federal Register notice announcing that date.
III. References
The following references have been placed on display in the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site addresses, but we are not responsible
for subsequent changes to the Web sites after this document publishes
in the Federal Register.)
1. Balk E, Chung M, Chew P, Ip S, Raman G, Kupelnick B, Tatsioni A,
Sun Y, Wolk B, DeVine D, Lau J. Effects of Soy on Health Outcomes.
Summary, Evidence Report/Technology Assessment No. 126. (Prepared by
the Tufts-New England Medical Center Evidence-based Practice Center
under Contract No. 290-02-0022.) AHRQ Publication No. 05-E024-1.
Rockville, MD: Agency for Healthcare Research and Quality. July
2005.
2. Institute of Medicine, National Academy of Sciences. Dietary
Referece Intakes for energy, carbohydrate, fiber, fat, fatty acids,
cholesterol, protein and amino acids, Chapter 11 page 808. National
Academy Press. Washington, D.C. 2005.
3. Antioxidant vitamins and risk of certain cancers, April 1, 2003,
http://www.cfsan.fda.gov/[tilde]dms/ds-ltr34.html.
4. Selenium and certain cancers, February 21, 2003, Docket No.
2002P-0457 (formerly Docket No. 02P-0457),
http://www.cfsan.fda.gov/[tilde]dms/ds-ltr35.html.
5. Huang HY, Caballero B, Chang S, Alberg A, Semba R, Schneyer C,
Wilson RF, Cheng TY, Prokopowicz G, Barnes II GJ, Vassy J, Bass EB.
Multivitamin/Mineral Supplements and Prevention of Chronic Disease.
Evidence Report/Technology Assessment No. 139. (Prepared by The Johns
Hopkins University Evidence-based Practice Center under Contract No.
290-02-0018). AHRQ Publication No. 06-E012. Rockville, MD: Agency for
Healthcare Research and Quality. May 2006.
6. Tomatoes and prostate, ovarian, gastric and pancreatic cancers,
November 8, 2005, Docket No. 2004Q-0201,
http://www.cfsan.fda.gov/[tilde]dms/qhclyco.html.
7. Green tea and prostate and breast cancer risk, June 30, 2005,
Docket No. 2004Q-0083,
http://www.cfsan.fda.gov/[tilde]dms/qhc-gtea.html.
8. Calcium and colon/rectal, breast and prostate cancers and
recurrent polyps, October 12, 2005, Docket No. 2004Q-0097,
http://www.cfsan.fda.gov/[tilde]dms/qhcca2.html.
9. American Cancer Society, Cancer Facts and Figures, 2004.
10. National Cancer Institute, Dictionary of Cancer Terms,
http://www.cancer.gov/Templates/db_alpha.aspx?CdrID=45333.
11. Hord NG, Fenton JI. Context is everything: mining the normal and
preneoplastic microenvironment for insights into the diet and cancer
risk conundrum. Molecular Nutrition and Food Research, 2007,
51:100-106.
12. Milner JA. Diet and Cancer: Facts and Controversies. Nutrition
and Cancer, 2006, 56:216-224.
Dated: December 6, 2007.
Barbara Schneeman,
Director, Office of Nutritional Products, Labeling, and Dietary
Supplements, Center for Food Safety and Applied Nutrition.
[FR Doc. E7-24813 Filed 12-20-07; 8:45 am]
BILLING CODE 4160-01-S
Copyright © 2007 Federal Information & News Dispatch, Inc.
|
HOME
