Contact information for Dietary Supplements and Non-Prescription Drugs

Guidance for Industry

Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Revision 1

Draft Guidance

This guidance document is being distributed for comment purposes only.

Submit comments to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this document, contact the Center for Food Safety and Applied Nutrition (CFSAN) at 301-436-2375.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
December 2008

Guidance for Industry

Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Revision 1

This guidance, when finalized, will represent the current thinking of the Food and Drug Administration 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 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This draft guidance document is intended to assist the dietary supplement industry in complying with the labeling requirements prescribed for dietary supplement manufacturers,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   The draft guidance covers the following topics:

1. (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 (FFD&C Act);

2. (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. (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 FFD&C Act with respect to adverse event reporting and recordkeeping for dietary supplements and non-prescription drugs marketed without an approved application.  This draft 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

Table of Contents

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?

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?

3. When do the labeling requirements in section 403(y) become effective?

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 FFD&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 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 the area code.  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 a complete address or phone number must be provided. 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 FFD&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, 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 dietary supplement label to include anything other than a domestic address or phone number for the responsible person, FDA recommends that the label also bear a clear, prominent statement informing consumers that the domestic address or phone number is for reporting serious adverse events associated with use of the product.

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. For example, a dual-purpose label statement might be "To report a serious adverse event or obtain product information, contact..." or other similar language.

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 FFD&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 January 1, 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 and develop guidance on the labeling requirements of Section 403(y) within this time period. 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.  Therefore, we find that it is reasonable to allow an additional two-year period for firms whose dietary supplement labels do not yet meet the requirements of section 403(y) to bring their labeling into full compliance.  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 January 1, 2010.

References:

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