GFI: Qs and As Labeling for Dietary Supplements Required by the NPDCPA

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Contains Nonbinding Recommendations
December 2007; Revised December 2008 and September 2009
Additional copies from:
Office of Nutrition, Labeling, and Dietary Supplements
Division of Dietary Supplement Programs, HFS-810
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5001 Campus Drive
College Park, MD 20740
(Tel) 240-402-2375
http://www.fda.gov/FoodGuidances
You may submit written or electronic comments regarding this guidance at any time.
Submit written comments on the guidance to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers lane, rm. 1061, Rockville,
MD 20852. Submit electronic comments to http://www.regulations.gov
(http://www.regulations.gov/). All comments should be identified with the docket
number listed in the notice of availability that publishes in the Federal Register.

This guidance represents the Food and Drug Administration's (FDA's) current
thinking on this topic. It does not create or confer any rights for or on any person
and does not operate to bind FDA or the public. You can use an alternative
approach if such approach satisfies the requirements of the applicable statute
and regulations. If you wish to discuss an alternative approach, contact the FDA

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staff responsible for implementing this guidance. If you cannot identify the
appropriate FDA staff, call the telephone number listed on the title page of this
document.

I. Introduction
This document provides guidance to the dietary supplement industry for complying
with the labeling requirements prescribed for dietary supplement manufacturers,
packers, and distributors by the Dietary Supplement and Nonprescription Drug
Consumer Protection Act (Pub. L. 109-462, 120 Stat. 3469). The guidance covers the
following topics:
(1) what "domestic address" means for purposes of the dietary supplement
labeling requirements in section 403(y) of the Federal Food, Drug, and Cosmetic
Act (FD&C Act);
(2) FDA's recommendation for the use of an introductory statement before the
domestic address or phone number that is required to appear on the product
label under section 403(y);
(3) when FDA intends to begin enforcing the labeling requirements of section
403(y).
FDA's guidance documents, including this document, do not establish legally
enforceable responsibilities. Instead, guidance documents describe the Agency's
current thinking on a topic and should be viewed only as recommendations, unless
specific regulatory or statutory requirements are cited. The use of the word should in
Agency guidance means that something is suggested or recommended, but not
required.
II. Background
On December 22, 2006, the President signed into law the Dietary Supplement and
Nonprescription Drug Consumer Protection Act. This law amends the FD&C Act with
respect to adverse event reporting and recordkeeping for dietary supplements and
non-prescription drugs marketed without an approved application. This guidance
document contains questions and answers relating to the new labeling requirements
for dietary supplements under the Dietary Supplement and Nonprescription Drug
Consumer Protection Act.
III. Questions and Answers
1. What information must be included on the label of a dietary supplement to
enable consumers to report serious adverse events associated with the
use of the dietary supplement?
Section 403(y) of the FD&C Act (21 U.S.C. 343(y)) requires the label of a dietary
supplement being marketed in the United States to include "a domestic address
or domestic phone number through which the responsible person … may receive
a report of a serious adverse event with such dietary supplement." If the label
does not include the required domestic address or phone number, the dietary

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supplement is misbranded.
When the responsible person chooses to provide a domestic address (rather
than a phone number) for adverse event reporting, FDA concludes that the
statute requires the product label to bear a full U.S. mailing address that includes
the street address or P.O. box, city, state, and zip code of the responsible person
(i.e., the manufacturer, packer, distributor, or retailer identified on the dietary
supplement label). FDA finds that Congress's use of the term "domestic address"
in section 403(y) is a clear and unambiguous directive that dietary supplement
labels include all information necessary to enable a serious adverse event report
to reach the responsible person. This reading of section 403(y) is supported by
dictionary definitions of "address," which include "the indication of destination, as
on mail or parcels" and "the location at which a person or an organization may be
reached" (Ref. 1). Indeed, an address does not serve its intended purpose
unless it includes all the information necessary to enable mail to reach its
destination.
Similarly, when the responsible person chooses to provide a domestic phone
number for adverse event reporting, FDA concludes that the statute requires the
phone number on the product label to include an area code (e.g., a toll-free area
code such as 800 or a local area code such as 301). Without the area code, the
phone number is incomplete and does not serve its intended purpose of enabling
the consumer to contact the responsible person to report a serious adverse
event.
Congress's use of the phrase "through which the responsible person … may
receive a report" to modify "domestic address or domestic phone number" further
supports FDA's conclusion that "domestic address or domestic phone number"
means a complete address or phone number (see section 403(y) of the FD&C
Act (21 U.S.C. 343(y))). This phrase shows Congress's intent that the domestic
address or phone number on the label be sufficient to ensure that the responsible
person will actually receive the serious adverse event reports that consumers
submit. If the address provided on the product label for adverse event reporting is
incomplete (e.g., no street address or P.O. box), some of the serious adverse
event reports that are submitted to the responsible person by mail likely will not
be received. In addition, when consumers notice the incomplete address, they
may decide not to submit a report to the responsible person because they
believe it will not be received. Similarly, a phone number without an area code
would be useless to consumers except for those who happen to be in the same
area code as the responsible person.
The use of the term "domestic address" in section 403(y) contrasts with
Congress's use of a different term, "place of business," in section 403(e) of the
FD&C Act (21 U.S.C. 343(e)). Section 403(e) provides that foods, including
dietary supplements, are misbranded unless the product label bears the name
and place of business of the manufacturer, packer, or distributor of the food.
FDA's regulations interpret "place of business" to require only the firm's city,
state, and zip code to appear on the product label, as long as the firm's street
address is listed in a current telephone directory or other city directory (21 C.F.R.
101.5(d)). The use of the term "domestic address" in section 403(y)
demonstrates Congress's intent to require the responsible person's full address,

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including the street address or P.O. box, to appear on dietary supplement labels
when the responsible person has opted to receive serious adverse event reports
by mail. If Congress had considered the less complete address already required
under the "place of business" labeling regulation to be adequate for serious
adverse event reporting, there would have been no need to impose a new, more
specific requirement in section 403(y) for the responsible person's "domestic
address" to appear on dietary supplement labels.
2. Should the label of a dietary supplement also include language indicating
that the purpose of the domestic address or phone number is to report
serious adverse events associated with use of the dietary supplement?
Although section 403(y) does not require a label to include anything other than a
domestic address or domestic phone number for the responsible person, FDA
recommends that the label also bear a clear, prominent statement informing
consumers that they may report serious adverse events to the domestic address
or domestic phone number on the label.
FDA would have no objection to a firm's combining the recommended statement
with language informing consumers that the domestic address or phone number
on the label may also be used for other purposes, as long as the information
provided is not false or misleading. The responsible person can also clarify that a
doctor should be called for medical advice. For example, a multi-purpose label
statement might be "You should call your doctor for medical advice about serious
adverse events. To report a serious adverse event or obtain product information,
contact…" or other similar language.
Responsible persons may also provide on the product label an email address or
website to which reports may be made, provided that such email address or
website is in addition to the domestic phone number or domestic address
required by Section 403(y) of the FD&C Act (21 U.S.C. 343(y)).
3. When do the labeling requirements in section 403(y) become effective?
Under section 3(d)(2) of the Dietary Supplement and Nonprescription Drug
Consumer Protection Act, the labeling requirements of section 403(y) of the
FD&C Act apply to all dietary supplements labeled on or after December 22,
2007. Therefore, these labeling requirements are already in effect. However,
FDA intends to exercise enforcement discretion for the new labeling
requirements until September 30, 2010.
Congress provided one year after the Dietary Supplement and Nonprescription
Drug Consumer Protection Act was signed into law on December 22, 2006, for
affected firms to comply with its new requirements. However, due to competing
priorities, FDA was not able to consider, develop and finalize guidance on the
labeling requirements of Section 403(y) until now. As a result, firms did not have
the benefit of FDA's guidance on how to comply with the new labeling
requirements when the requirements went into effect. Although the December
2008 revised draft guidance notified industry that the agency intended to exercise
enforcement discretion for the new labeling requirements until January 1, 2010,
this final guidance sets forth FDA's intention to exercise enforcement discretion
for the new labeling requirements for dietary supplements labeled on or after
September 30, 2010, approximately one year after this final guidance issues.

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This period of enforcement discretion should be adequate to enable all firms to
meet the new labeling requirements for dietary supplements. FDA intends to
begin enforcing the requirements of 403(y) for dietary supplements labeled on or
after September 30, 2010.
IV. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction Act of
1995 (44 U.S.C. 3501-3520).
The time required to complete this information collection is estimated to average 8
hours per response, including the time to review instructions, search existing data
sources, gather the data needed, and complete and review the information collection.
Send comments regarding this burden estimate or suggestions for reducing this
burden to:
Office of Nutrition, Labeling, and Dietary Supplements
Division of Dietary Supplement Programs, HFS-810
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5001 Campus Drive
College Park, MD 20740
An agency may not conduct or sponsor, and a person is not required to respond
to, a collection of information unless it displays a currently valid OMB control
number. The OMB control number for this information collection is 0910-0642
(expires 08/31/2012).

References:
1. Webster's II New Riverside University Dictionary (Houghton Mifflin 1984), p.77.

This document supercedes the previous version, issued December 2008.

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