FDA Issues 2nd Update to List of HTS Numbers Flagged with Imported Food Prior Notice FD3 or FD4 Indicators

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

However, the August 26, 2004 version divides the prior one-part Industry Guidance into two parts (Industry Guidance - Introduction and Background, and List of HTS Numbers Flagged with FD3 or FD4 Indicators) and adds a third part (Revision History) which lists the HTS numbers and their associated FD3 or FD4 indicator flag, which are new or revised as of August 26, 2004.

FDA to Update List of HTS Numbers and Their FD3 and FD4 Flags Periodically

FDA states that the list of HTS numbers that are flagged with FD3 or FD4 indicators 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.

Guidance Contains FDA's Explanation of Different FDA/Prior Notice Flags

FDA's Industry Guidance - Introduction and Background, among other things, provides the following explanations of the different FDA indicator flags with which HTS numbers are marked in ACS:

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.

(See ITT's Online Archives or 03/26/04 news, 04032610, for BP summary of Adm 04-0586, which announced ABI modifications to allow 1) Prior Notice (PN) for all indicator flags except FD0, 2) a Prior Notice disclaimer (Affirmation of Compliance Code 'PND') for entries classified under tariff numbers with an FD3 flag that require 801(a) entry data but not PN data. See ITT's Online Archives or 04/13/04 news, 04041310, for BP summary of Adm 04-0802, which clarified Adm 04-0586.

See ITT's Online Archives or 11/25/03 news, 03112505, for BP summary of FDA's initial guidance. See ITT's Online Archives or 04/26/04 news, 04042605 for BP summary of 1^st update.)

- comments and suggestions may be submitted at any time

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

FDA's Updated Industry Guidance - Introduction and Background, revised August 26, 2004 (5 pages) (dated 08/26/04) available at http://www.cfsan.fda.gov/dms/htsguid3.html

FDA's List of HTS Numbers Flagged with FD3 or FD4 Indicators, updated as of 08/26/04 (144 pages, printed in landscape) available at http://www.cfsan.fda.gov/pn/htsrev.html

FDA's Revision History, as of April 26, 2004 (9 pages), available at http://www.cfsan.fda.gov/pn/htsrev.html