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| **[World Trade]{.smallcaps}**                    |                   |
|                                                  |                   |
| **[Organization]{.smallcaps}**                   |                   |
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|                                                  | **                |
|                                                  | G/SPS/N/USA/907** |
|                                                  |                   |
|                                                  | 14 May 2004       |
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|                                                  | (04-2158)         |
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|                                                  |                   |
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| **Committee on Sanitary and Phytosanitary        | Original: English |
| Measures**                                       |                   |
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**NOTIFICATION**

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| ** | **Member to Agreement notifying:** [UNITED STATES]{.underline}  |
| 1. |                                                                 |
| ** | If applicable, name of local government involved:               |
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| ** | **Agency responsible:** US Food and Drug Administration (FDA)   |
| 2. |                                                                 |
| ** |                                                                 |
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| ** | **Products covered (provide tariff item number(s) as specified  |
| 3. | in national schedules deposited with the WTO; ICS numbers       |
| ** | should be provided in addition, where applicable):** Food       |
|    | (including dietary supplements) for human consumption in the    |
|    | United States, except for meat, poultry and egg products that   |
|    | are exclusively regulated by the US Department of Agriculture   |
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| ** | **Regions or countries likely to be affected, to the extent     |
| 4. | relevant or practicable:** US trading partners                  |
| ** |                                                                 |
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| ** | **Title, language and number of pages of the notified           |
| 5. | document:** Food labelling: Nutrient content claims, general    |
| ** | principles; health claims, general requirements and other       |
|    | specific requirements for individual health claims; reopening   |
|    | of the comment period (available in English, 7 pages).          |
+----+-----------------------------------------------------------------+
| ** | **Description of content:** The Food and Drug Administration    |
| 6. | (FDA or the agency) is reopening for 60 days the comment period |
| ** | for the proposed rule entitled \"Food Labeling: Nutrient        |
|    | Content Claims, General Principles; Health Claims, General      |
|    | Requirements and Other Specific Requirements for Individual     |
|    | Health Claims\" that was published in the Federal Register of   |
|    | 21 December 1995 (60 FR 66206) (the 1995 proposal). In that     |
|    | document, FDA proposed a number of amendments to its existing   |
|    | nutrient content claims and health claims regulations to        |
|    | provide additional flexibility in the use of these claims on    |
|    | food products. Since the publication of the 1995 proposal, FDA  |
|    | established a Task Force for the Consumer Health Information    |
|    | for Better Nutrition Initiative, which recommended that FDA     |
|    | seek public comment on several topics related to qualified      |
|    | health claims and unqualified health claims (i.e., health       |
|    | claims that are supported by significant scientific agreement   |
|    | (SSA) and authorized by FDA by regulation). Some of these       |
|    | topics on unqualified health claims were specifically addressed |
|    | in the 1995 proposal and, therefore, FDA is reopening the       |
|    | comment period on the 1995 proposal to seek comment on: the     |
|    | proposed amendments to permit unqualified health claims on      |
|    | certain foods that do not contain 10 per cent or more of one of |
|    | certain required nutrients; the proposed amendments to provide  |
|    | criteria that FDA would consider in determining whether to      |
|    | grant an exemption from disqualifying nutrient levels related   |
|    | to unqualified health claims; and the proposed amendments to    |
|    | retain the word \"may\" or \"might\" in unqualified health      |
|    | claims. In addition, FDA is seeking comment on the proposed use |
|    | of unlisted synonyms and abbreviated health claims.             |
|    | Specifically, for unlisted synonyms (i.e., terms not defined by |
|    | regulation), FDA repeats its request for data or other          |
|    | information demonstrating that unlisted synonyms that are       |
|    | anchored to defined terms in nutrient content claims are        |
|    | reasonably understood by consumers to be synonyms of the        |
|    | defined terms. For abbreviated health claims, FDA seeks         |
|    | comments and requests data or other information regarding       |
|    | whether abbreviated health claims would mislead consumers.      |
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| ** | **Objective and rationale: \[ X \] food safety, \[   \] animal  |
| 7. | health, \[   \] plant protection, \[  \] protect humans from    |
| ** | animal/plant pest or disease, \[   \] protect territory from    |
|    | other damage from pests**                                       |
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| ** | **International standard, guideline or recommendation:**        |
| 8. |                                                                 |
| ** | **\[**   **\] Codex Alimentarius Commission, \[   \] World      |
|    | Organization for Animal Health (OIE), \[   \] International     |
|    | Plant Protection Convention, \[   \] None**                     |
|    |                                                                 |
|    | **If an international standard, guideline or recommendation     |
|    | exists, give the appropriate reference and briefly identify     |
|    | deviations:**                                                   |
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| ** | **Relevant documents and language(s) in which these are         |
| 9. | available:** Federal Register 69 FR 24541, 4 May 2004           |
| ** | <http://www.fda.gov/OHRMS/DOCKETS/98fr/04-10126.htm>;           |
|    | (available in English).                                         |
|    |                                                                 |
|    | The proposed rule is available in the Federal Register, 60 FR   |
|    | 66206, 21 December 1995,                                        |
|    | <http://frwebgate5.access.gpo.gov/cgi-bin/                      |
|    | waisgate.cgi?WAISdocID=209433399494+23+0+0&WAISaction=retrieve> |
|    | (available in English.).                                        |
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| *  | **Proposed date of adoption:** N/A                              |
| *1 |                                                                 |
| 0. |                                                                 |
| ** |                                                                 |
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| *  | **Proposed date of entry into force:** N/A                      |
| *1 |                                                                 |
| 1. |                                                                 |
| ** |                                                                 |
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| *  | **Final date for comments:** 6 July 2004                        |
| *1 |                                                                 |
| 2. | **Agency or authority designated to handle comments:            |
| ** | \[   \] National notification authority, \[ X \] National       |
|    | enquiry point, or address, fax number and E-mail address (if    |
|    | available) of other body:**                                     |
|    |                                                                 |
|    | You may submit comments, identified by Docket Nos. 1994P-0390   |
|    | and 1995P-0241, by any of the following methods:                |
|    |                                                                 |
|    | E-mail: <fdadockets@oc.fda.gov>. Include Docket Nos. 1994P-0390 |
|    | and 1995P-0241 in the subject line of your e-mail message.      |
|    |                                                                 |
|    | Fax: 301-827-6870.                                              |
|    |                                                                 |
|    | Mail/Hand delivery/Courier (For paper, disk, or CD-ROM          |
|    | submissions): Division of Dockets Management, 5630 Fishers      |
|    | Lane, rm. 1061, Rockville, MD 20852.                            |
|    |                                                                 |
|    | Federal Rulemaking Portal:                                      |
|    | [http://www.regulations.gov/](http://www.regulations.gov/ )     |
|    |                                                                 |
|    | Agency Web site: E-mail: <fdadockets@oc.fda.gov>. Include       |
|    | Docket Nos. 1994P-0390 and 1995P-0241 in the subject line of    |
|    | your e-mail message.                                            |
|    |                                                                 |
|    | Fax: 301-827-6870.                                              |
|    |                                                                 |
|    | Mail/Hand delivery/Courier (For paper, disk, or CD-ROM          |
|    | submissions): Division of Dockets Management, 5630 Fishers      |
|    | Lane, rm. 1061, Rockville, MD 20852.                            |
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| *  | **Texts available from: \[   \] National notification           |
| *1 | authority, \[ X \] National enquiry point, or address, fax      |
| 3. | number and E-mail address (if available) of other body:** U.S.  |
| ** | Enquiry Point, U.S. Department of Agriculture, Stop 1027,       |
|    | Washington, DC 20250. Tel:  (202) 720-677, <fstsd@usda.gov>.    |
|    |                                                                 |
|    | Document can be found online at:                                |
|    |                                                                 |
|    | <http://www.fda.gov/OHRMS/DOCKETS/98fr/04-10126.htm>            |
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