FDA Updates List of HTS Numbers Flagged with Imported Food Prior Notice FD3 & FD4 Indicators

This updated Industry Guidance, which is dated April 14, 2004 and is 141 pages in length, replaces the FDA's initial, November 20, 2003 Industry Guidance, which was 135 pages in length. The updated guidance also identifies the HTS numbers that are revised or newly listed as subject to FD3 or FD4 indicators.

(See ITT's Online Archives or 11/25/03 news, 03112505, for BP summary of FDA's initial guidance.)

According to the FDA, the HTS numbers that apply to foods for which FDA believes prior notice is required have an FD4 flag, while those HTS numbers that may apply to food and therefore may require prior notice have a FD3 flag.

FDA to Update List of FD3 and FD4 HTS Numbers Periodically

FDA states that the list of HTS numbers in the Industry Guidance will be periodically updated to reflect changes in the HTS numbers or the FDA indicators for those numbers, and will be posted to the FDA's Web site at www.cfsan.fda.gov/guidance.html. (According to FDA sources, additional tariff numbers in HTS Chapters 29 and 30 may receive FD3 flags in the future.)

Prior Notice Allowed for All Flags Except FD0; Disclaimers for FD3 Flags

FDA's industry guidance states that effective April 14, 2004, Automated Broker Interface (ABI) filers can file Prior Notice for all tariff numbers regardless of the FDA indicator, except those tariff records marked FD0.

Effective April 14, 2004, filers can also submit a Prior Notice disclaimer (Affirmation of Compliance Code 'PND') for entries classified under tariff numbers with an FD3 flag, while still submitting 801(a) entry data. (See ITT's Online Archives or 03/26/04 news, 04032610, for BP summary of Adm 04-0586, which announced this and other ABI modifications. See ITT's Online Archives or 04/13/04 news, (Ref: 04041310), for BP summary of Adm 04-0802, which clarified Adm 04-0586.)

(For example, FDA states that placebos are products classified under a tariff number flagged with the FD3 indicator. A placebo is a product that mimics a drug but contains no active ingredient and is normally classified by CBP as a food preparation, a classification for which prior notice would be required. However, under FDA regulations, a placebo is defined as a drug. The FD3 indicator will allow a filer to submit a Prior Notice disclaimer (Affirmation of Compliance 'PND') for shipments of products intended for use as a placebo.)

Updated Guidance Contains FDA's Explanation of Different Prior Notice "Flags"

In its updated Industry Guidance, the FDA has provided the following explanations of the different "flags" with which HTS numbers are marked in ACS. The FDA states that these flags and their indicators are as follows:

FD0 - Indicates that the FDA has determined that the article, even though subject to FDA's laws and regulations, is acceptable for CBP release without further presentation of prior notice or other entry information to FDA;

FD1 - Indicates that the article may be subject to FDA jurisdiction, including FDA review under Section 801(a) of the Federal Food Drug and Cosmetic Act (Act). For products not subject to FDA jurisdiction, a filer can "Disclaim" product from FDA 801(a) notification requirements;

FD2 - Indicates that the article is under FDA jurisdiction and review of entry information by FDA under section 801(a) of the Act will take place. However, the article is not "food" for which prior notice information is required;

FD3 - Indicates that the article may be subject to prior notice under section 801(m) of the Act and 21 CFR Part 1, Subpart I (e.g. the article has both food and non-food uses); and

FD4 - Indicates that the article is "food" for which prior notice is required under section 801(m) of the Act and 21 CFR Part 1, Subpart I.

- comments and suggestions regarding this guidance may be submitted at any time.

- FDA contact (general questions): Ted Poplawski (301) 443-6553

FDA's Updated Industry Guidance (141 pages) (dated 04/14/04) available at http://www.cfsan.fda.gov/dms/htsguid2.html