2011-16711. Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.” The draft guidance, when finalized, will assist industry in deciding when a premarket safety notification for a dietary supplement containing a new dietary ingredient (NDI) is necessary and in preparing premarket safety notifications (also referred to as “NDI notifications”).

DATES:

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on the draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 3, 2011.

ADDRESSES:

Submit written requests for single copies of this draft guidance to the Office of Nutrition, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition (HFS-850), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance.

Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Corey Hilmas, Center for Food Safety and Applied Nutrition (HFS-850), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2375.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry entitled “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.” This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115(g)(2)).

This draft guidance is intended to assist industry in deciding when a premarket safety notification for a dietary supplement containing an NDI is necessary and in preparing NDI notifications. The draft guidance discusses in question and answer format FDA's views on what qualifies as an NDI, when an NDI notification is required, the procedures for submitting an NDI notification, the types of data and information that manufacturers and distributors should consider when they evaluate the safety of a dietary supplement containing an NDI, and what should be included in an NDI notification. In addition, the draft guidance contains questions and answers about parts of the dietary supplement definition that can affect whether a particular substance may be marketed as a dietary ingredient in a dietary supplement.

On October 25, 1994, the Dietary Supplement Health and Education Act of 1994 (DSHEA) (Pub. L. 103-417) was signed into law. DSHEA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding, among other provisions, (1) Section 201(ff) (21 U.S.C. 321(ff)), which defines the term “dietary supplement” and (2) section 413 (21 U.S.C. 350b), which defines the term “new dietary ingredient” and requires the manufacturer or distributor of an NDI, or of the dietary supplement that contains the NDI, to submit a premarket notification to FDA at least 75 days before introducing the supplement into interstate commerce or delivering it for introduction into interstate commerce, unless the NDI and any other dietary ingredients in the dietary supplement “have been present in the food supply as an article used for food in a form in which the food has not been chemically altered” (section 413(a)(1)). The notification must contain the information, including any citation to published articles, which is the basis on which the manufacturer or distributor of the NDI or dietary supplement has concluded that the dietary supplement containing the NDI will reasonably be expected to be safe. If the required premarket notification is not submitted to FDA, section 413(a) of the FD&C Act provides that the dietary supplement containing the NDI is deemed to be adulterated under section 402(f) of the FD&C Act (21 U.S.C. 342(f)). Even if the notification is submitted as required, the dietary supplement containing the NDI is adulterated under section 402(f) unless there is a history of use or other evidence of safety establishing that the NDI, when used under the conditions recommended or suggested in the labeling of the dietary supplement, will reasonably be expected to be safe.

To assist industry in complying with DSHEA, FDA issued a regulation, § 190.6 (21 CFR 190.6), to implement the FD&C Act's premarket notification requirements for dietary supplements that contain an NDI (62 FR 49886, September 23, 1997). The NDI regulation specifies the information the manufacturer or distributor must include in its premarket NDI notification (§ 190.6(b)) and establishes the administrative procedures for these notifications. FDA's goal in issuing the 1997 regulation was to ensure that NDI notifications contained the information that would enable FDA to evaluate whether a dietary supplement containing an NDI is reasonably expected to be safe.

On January 4, 2011, the President signed into law the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353). Section 113(b) of FSMA requires FDA to publish, not later than 180 days after the date of enactment, guidance that clarifies when a dietary supplement ingredient is an NDI, when the manufacturer or distributor of a dietary ingredient or dietary supplement should submit an NDI notification to FDA under section 413(a)(2) of the FD&C Act, the evidence needed to document the safety of an NDI, and appropriate methods for establishing the identity of an NDI. This draft guidance is being published to comply with section 113(b) of FSMA.

The draft guidance, when finalized, will represent the Agency's current thinking on NDIs and dietary supplements that contain NDIs. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternate approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This draft guidance contains proposed collections of information. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to publish a 60-day notice in the Federal Register soliciting public comment on each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA will publish a 60-day notice on the proposed collections of information in this draft guidance in a future issue of the Federal Register.

This draft guidance also refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR Part 111 have been approved under OMB control number 0901-0606, and the collections of information in § 190.6 have been approved under OMB control number 0910-0330.

III. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments 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.

IV. Electronic Access

Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/​RegulatoryInformation/​Guidances/​default.htm or http://www.regulations.gov. Always access an FDA guidance document by using FDA's Web site listed previously to find the most current version of the guidance.

Dated: June 29, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.