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LEGAL OPINION MEMORANDUM
Re: Labeling Rules and Nutrient Claims
Index:
Categories of Nutrient Claims
Technical Label Requirements
Updates & Links - through 12/2009
Further Information: The Right to the Truth
Further Updated Information through 08/2007:
SOPs, cGMPs, etc:
http://tinyurl.com/2eu6yj
Blog:
http://vitaminlawyerhealthfreedom.blogspot.com
FDA Labeling Guides:
http://www.cfsan.fda.gov/~dms/dslg-1.html
http://www.cfsan.fda.gov/~dms/dslg-toc.html
http://www.cfsan.fda.gov/~dms/dsaergu3.html
Re: Overview of Nutrient Labeling
Date: 03/16/01
Dear
Dr. G:
You requested that I provide you with my legal opinion regarding the
statements that are permitted on labels and literature for dietary
supplements.
Such labels and literature are governed by statutes and regulations
enforced
by the Food and Drug Administration (FDA) and the Federal Trade
Commission
(FTC). The primary statute is the Dietary Supplement Health and
Education Act
of 1994 (DSHEA). This act classifies statements about Dietary
Supplements in
to four categories:
CATEGORIES
OF NUTRIENT CLAIMS
1. General Wellness Claims -- such claims may be made so long as they
meet
the FTC standard of "truthful and not misleading." The distributor must
have
adequate "prior substantiation" for such claims.
2. Structure and Function Claims -- these are claims about the
relationship
between nutrients and normal body structure and function. The same
standard
applies to them and FDA regulations require that a Statement of Claims
be
filed with the FDA within 30 days of first making a specific claim. The
FDA
reviews these claims solely to see if the language used states a
Structure and
Function Claim, but does not evaluate the adequacy of the
substantiation.
See: Rule on Botanicals in Dietary
Supplements Labels
3. Health Claims / Qualified Health Claims -- these claims
characterize the relationship between a
nutrient and a disease or health condition. Such claims may not be made
unless the FDA has given prior approval and a formal Petition is
required.
See: FDA allows qualified health claims.
4. Medical Claims -- claims to diagnose, treat, prevent, mitigate, or
cure
disease are not permitted. Such claims result in the nutrient being
treated
as a "drug" and requiring full FDA drug approval.
The statute requires certain statements and disclaimers for a substance
to
qualify as a Dietary Supplement. The product label must state "Dietary
Supplement" and the label must state: "These statements have not been
evaluated by the Food and Drug Administration. Not intended to
diagnose,
treat, prevent, mitigate or cure disease." It is not advisable to make
any
claims whatsoever on the actual product label. If the claim you make is
improper, the product will be seized if the claim is on the bottle
label, but
if only on accompanying literature, the literature can be replaced.
The bottle label must also include a proper ingredient list that
conforms to
specific regulations (your contract manufacturer or label printer will
be able
to make sure your label conforms to these regulations).
Any product literature must also have the FDA disclaimer (as stated
above) and
is subject to the FTC "truthful and not misleading" rule.
To help marketers comply, the FTC has published, on the Internet, a
Guideline
for Nutrient Marketers and the FDA has published extensive commentaries
on the
Structure and Function Rule and the Health Claims Rule.
FDA & FTC
Requirements.
You may not put any statement on Dietary Supplement labels such as "FDA
approved" since the FDA does not approve Dietary Supplement claims and
ingredients. The FDA states, on its web site, that nutrients are
governed by
different rules than foods and drugs, and that marketers must, in the
first
instance, ensure that the products are safe. The FDA usually only steps
in
when there are safety complaints. The FTC usually only steps in when
there
are complaints about the truthfulness of the claims. The FTC also says
that
products intended for human ingestion are subject to the strict
requirement
that there be competent scientific evidence to support the claims made.
I trust that this answers your questions. Additional information is
available
on my web site, www.vitaminlawyer.com
and on the FDA (www.fda.gov) and
FTC (www.ftc.gov) web sites.
Index
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FDA ALLOWS QUALIFIED HEALTH CLAIMS
"FDA's 2003
Consumer Health Information for Better Nutrition Initiative
provides for the use of qualified health claims when there is emerging
evidence for a relationship between a food, food component, or dietary
supplement and a reduced risk of a disease or health-related condition.
In this case, the evidence is not well enough established to meet the
significant scientific agreement standard required for FDA to issue an
authorizing regulation. Qualifying language is included as part of the
claim to indicate that the evidence supporting the claim is limited.
Both conventional foods and dietary supplements may use qualified health
claims. FDA uses its enforcement discretion for qualified health claims
after evaluating and ranking the quality and strength of the totality of
the scientific evidence. Also, FDA now has a process for the public to
view qualified health claim petitions, comment on these petitions, and
submit comments on these petitions through its web site."
·Qualified Health Claims Questions and Answers
http://www.cfsan.fda.gov/~dms/labqhcqa.html
·Summary of Qualified Health Claims Permitted
http://www.cfsan.fda.gov/~dms/qhc-sum.html
FDA Rule on Botanicals in Dietary
Supplements Labeling
On August 28,
2003, FDA published a proposed and companion direct final
rule on ingredient labeling of dietary supplements that contain
botanicals. FDA is proposing to amend its regulation on declaring
botanical ingredients in dietary supplements to incorporate by reference
the 2000 editions of Herbs of Commerce and the International Code of
Botanical Nomenclature (Saint Louis Code).
· Direct Final Rule (http://www.regulations.gov/fredpdfs/03-21980.pdf)
· Proposed Rule (http://www.regulations.gov/fredpdfs/03-21981.pdf)
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Index
Sec. 101.36 Nutrition labeling of dietary supplements.
Here
is what a Dietary Supplement label needs to contain, at a minimum, to
meet FDA standards for grandfathering under DSHEA:
1. Main panel of the label must include:
A. Name of Product: ______ (followed by the
®
or TM)
B. Total number of capsules/pills in bottle
C. The term "Dietary Supplement" OR "_____ Supplement"
"You must identify a dietary supplement by use of the term "dietary
supplement" as part of the statement of identity, except that you may
delete the word "dietary" and replace it with the name of the dietary
ingredient(s) in the product (e.g., calcium supplement) or an
appropriately descriptive term indicating the type of dietary
ingredient(s) in your dietary supplement product (e.g., herbal
supplement with vitamins).
If you use a Proprietary Blend (more info in the Regulations section
below),
"You must identify proprietary blends by use of the term "Proprietary
Blend" or an appropriately descriptive term or fanciful name. On the
same line, you must list the total weight of all "other dietary
ingredients" contained in the blend. Indented underneath the name of
the blend, you must list the "other dietary ingredients" in the blend,
either in a column or linear fashion, in descending order of
predominance by weight. These ingredients should be followed by a
symbol referring to the footnote "Daily Value Not Established." Dietary
ingredients having RDIs or DRVs must be listed separately and the
individual weights declared. 21 CFR 101.36(b)(2) and (c)"
2. Usually, the right side panel: the Supplement Facts Box (see details
below)
3. Usually, the left side panel: Directions, Warnings and Disclaimers.
Dietary Supplements must include Directions since such food products
are deemed safe if used as directed. Standard Warnings and Disclaimers
are also needed, including the Statutory Disclaimer, "These statements
have not been evaluated by the Food and Drug Administration. This
product is not intended to diagnose, treat, cure or prevent any
disease."
Generally, you should include other standard disclaimers, such as, "Do
not use if safety seal is broken. Keep out of reach of children. Store
in a cool dry area at room temperature. Not for use by pregnant or
lactating women." If it contains common allergens, it needs to include
that warning as well.
------------------------------------------
FDA REGULATION ON LABEL DETAILS
Sec. 101.36 Nutrition labeling of dietary supplements.
ITEMS 'INSIDE THE BOX' FOR THE 'SUPPLEMENT FACTS' BOX:
SERVING SIZE -- The subheading 'Serving Size' shall be placed under the
heading 'Supplement Facts' and aligned on the left side of the
nutrition label. Serving size for dietary supplements shall be
expressed using a term that is appropriate for the form of the
supplement, such as 'tablets,' 'capsules,' 'packets,' or
`'teaspoonfuls.'
SERVINGS PER CONTAINER -- The subheading 'Servings Per Container' shall
be placed under the subheading 'Serving Size' and aligned on the left
side of the nutrition label, except that this information need not be
provided when it is stated in the net quantity of contents declaration.
AMOUNT PER SERVING / EACH CAPSULE CONTAINS -- (A) The names and the
quantitative amounts by weight of each (b)(2)-dietary ingredient shall
be presented under the heading 'Amount Per Serving.' When the
quantitative amounts by weight are presented in a separate column, the
heading may be centered over a column of quantitative amounts,
described by paragraph (b)(2)(ii) of this section, if space permits. A
heading consistent with the declaration of the serving size, such as
'Each Tablet Contains,' or 'Amount Per 2 Tablets' may be used in place
of the heading 'Amount Per Serving.' Other appropriate terms, such as
capsule, packet, or teaspoonful, also may be used in place of the term
'Serving.' The names of dietary ingredients that are declared under
shall be presented in a column aligned on the left side of the
nutrition label. Dietary ingredients shall be listed according to the
nomenclature specified in Sec. 101.9 or in paragraph (b)(2)(i)(B)(2) of
this section PLEASE NOTE 'PROPRIETARY BLEND' INFORMATION BELOW
The percent of the Daily Value of all dietary ingredients shall be
listed - the quantitative amount by weight and the percent of Daily
Value may be presented on a 'per unit' basis in addition to on a 'per
serving' basis, as required in paragraph (b)(2)(ii) of this section.
This information shall be presented in additional columns and clearly
identified by appropriate headings.
These amounts shall be expressed using metric measures in appropriate
units (i.e., 1,000 or more units shall be declared in the next higher
set of units, e.g., 1,100 mg shall be declared as 1.1 g).
The constituents of a dietary ingredient may be listed indented under
the dietary ingredient and followed by their quantitative amounts by
Weight. Other dietary ingredients shall bear a symbol (e.g., an
asterisk) in the column under the heading of '% Daily Value' that
refers to the same symbol placed at the bottom of the nutrition label
and followed by the statement 'Daily Value not established,' except
that when the heading '% Daily Value' is not used, the symbol shall
follow the quantitative amount by weight for each dietary ingredient
listed.
PROPRIETARY BLEND: A proprietary blend of dietary ingredients shall be
included in the list of dietary ingredients described in paragraph
(b)(3)(i) of this section and identified by the term 'Proprietary
Blend' or other appropriately descriptive term or fanciful name and may
be highlighted by bold type. Except as specified in this paragraph, all
other requirements for the listing of dietary ingredients in dietary
supplements are applicable.
Nutrition information specified in this section shall be presented as
follows:
(1) The title, 'Supplement Facts,' shall be set in a type size larger
than all other print size in the nutrition label and, unless
impractical, shall be set full width of the nutrition label. The title
and all headings shall be bolded to distinguish them from other
information.
(2) The nutrition information shall be enclosed in a box by using
hairlines.
(3) All information within the nutrition label shall utilize:
(i) A single easy-to-read type style,
(ii) All black or one color type, printed on a white or other neutral
contrasting background whenever practical,
(iii) Upper- and lowercase letters, except that all uppercase lettering
may be utilized for packages that have a total surface area available
to bear labeling of less than 12 square inches,
(iv) At least one point leading (i.e., space between lines of text), and
(v) Letters that do not touch.
(4) Except as provided for small and intermediate-sized packages under
paragraph (i)(2) of this section, information other than the title,
headings, and footnotes shall be in uniform type size no smaller than 8
point. Type size no smaller than 6 point may be used for columnheadings
(e.g., 'Amount Per Serving' and '% Daily Value') and for footnotes
(e.g., 'Percent Daily Values are based on a 2,000 calorie diet').
(5) A hairline rule that is centered between the lines of text shall
separate each dietary ingredient required in paragraph (b)(2) and
(b)(3) of this section from the dietary ingredient above and beneath
it, as shown in paragraph (e)(10) of this section.
(6) A heavy bar shall be placed:
(i) Beneath the subheading 'Servings Per Container' except that if
'Servings Per Container' is not required and, as a result, not
declared, the bar shall be placed beneath the subheading 'Serving Size,'
(ii) Beneath the last dietary ingredient to be listed under paragraph
(b)(2)(i) of this section, if any, and
(iii) Beneath the last other dietary ingredient to be listed under
paragraph (b)(3) of this section, if any.
(7) A light bar shall be placed beneath the headings 'Amount Per
Serving' and '% Daily Value.'
(8) If the product contains two or more separately packaged dietary
supplements that differ from each other (e.g., the product has a packet
of supplements to be taken in the morning and a different packet to be
taken in the afternoon), the quantitative amounts and percent of Daily
Value may be presented as specified in this paragraph in individual
nutrition labels or in one aggregate nutrition label as illustrated in
paragraph (e)(10)(iii) of this section.
(9) In the interest of uniformity of presentation, FDA urges that the
information be presented using the graphic specifications set forth in
Appendix B to part 101, as applicable.
(10) The following sample labels are presented for the purpose of
illustration: [deleted]
(11) If space is not adequate to list the required information as shown
in the sample labels in paragraph (e)(10) of this section, the list may
be split and continued to the right as long as the headings are
repeated. The list to the right shall be set off by a line that
distinguishes it and sets it apart from the dietary ingredients and
percent of Daily Value information given to the left. The following
sample label illustrates this display: [deleted]
(j)
Dietary supplements shall be subject to the misbranding provisions of
Sec. 101.9(k).
Index
UPDATES
& LINKS
2009 Update
New FDA Label Guide
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupplements/ucm179018.htm
Further Updates
(2007):
SOPs, cGMPs, etc:
http://tinyurl.com/2eu6yj
Blog:
http://vitaminlawyerhealthfreedom.blogspot.com
Vitamin Lawyer
FDA/FTC Page
Information and Links regarding
Federal Regulatory Concerns
2005 Label Guideline
http://www.cfsan.fda.gov/~dms/dslg-1.html
NEW
FDA "Science Based Initiative" -
FDA Press Release - 07/10/03
"FDA's Task Force on Consumer Health Information for Better Nutrition
unveiled a process for FDA to review... health claims. This process
will rely on expertise from the Agency... coupled with enhanced
consumer studies, to review health claims before they appear in food
labeling. In addition to the report, FDA is announcing enhanced
enforcement activity against dietary supplement manufacturers and
others who make misleading claims about health benefits that are not
based on science."
Task Force Report
FDA Issues Statement on Increased Enforcement -
FDA Statement - 06/30/03
"[FDA]
is committed to
pursuing Federal Food, Drug, and Cosmetic Act violations. Enforcement
activities include warning and untitled letters, injunctions, recalls,
arrests, and convictions. Overall, these point to dramatically
increased enforcement, particularly in areas related to the most
serious threats to public health, such as arrests and convictions on
criminal charges involving potentially dangerous activities and actions
against manufacturers making misleading claims about product risks and
benefits."
New Label Claims Page:
http://www.cfsan.fda.gov/~dms/lab-hlth.html
Brief Summary of All Claims that Can Be Made for Conventional Foods
and Dietary Supplements
http://www.cfsan.fda.gov/~dms/hclaims.html
Small business label exemption information,
http://www.cfsan.fda.gov/~dms/sbel.html
See also: Vitamin Lawyer Free
On Line Seminar and
Traditional Uses
FTC Policy on "compare to" advertising:
http://www.ftc.gov/bcp/policystmt/ad-compare.htm
Some Additional
Links:
Structure & Function Claims Notice Procedure,
claimnotice.html
Marketers MUST file this notice within 30 days of offering a new
dietary supplement product.
Traditional
Use Claims .htm
Some
Label Content Considerations
FDA - Consolidated Institutional
Review Board Guidance:
http://ohrp.osophs.dhhs.gov/humansubjects/guidance/exprev.htm
FDA - New Label Claims Page:
http://www.cfsan.fda.gov/~dms/lab-hlth.html
FDA - Brief Summary of All Claims that Can Be Made for Conventional
Foods
and Dietary Supplements
http://www.cfsan.fda.gov/~dms/hclaims.html
FDA - OTC Labeling Overview (not
Dietary Supplements)
http://www.fda.gov/cder/otc/label/label-fr-reg.htm
FTC - Complying with the Telemarketing
Sales Rule,
http://www3.ftc.gov/bcp/conline/pubs/buspubs/tsrcomp.htm
FTC - Fair Credit Billing Act (FCBA).
http://www.ftc.gov/bcp/conline/pubs/credit/fcb.htm
FTC - Lost or Stolen Cards,
http://www3.ftc.gov/bcp/conline/pubs/credit/atmcard.htm
FTC - Fair Credit Reporting Act,
http://www3.ftc.gov/os/statutes/fcra.htm
FTC - Consumer Guide to E-payments,
http://www3.ftc.gov/bcp/conline/pubs/online/payments.htm
FTC on internet pharmacies,
http://www.ftc.gov/os/2003/03/030327internetprescriptions.pdf
& the Rennert case,
http://www.ftc.gov/os/2000/07/iogordrennert.htm
FTC Weight Loss
Claims Guidance,
http://www.ftc.gov/bcp/conline/edcams/redflag/index.html
FDA Bioterrorism
Preparedness Guide,
http://www.cfsan.fda.gov/~pn/cpgpn.html
FDA on approved
Health Claims,
http://www.cfsan.fda.gov/~dms/flg-6c.html
FDA Device Advice,
http://www.fda.gov/cdrh/devadvice/ide/index.shtml
Vitamin Lawyer News - regular updates -
www.vitaminlawyernews.com
© 2001, 2003, 2004, 2005, 2007
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