FDA ANPR Seeks Comments on Recordkeeping/Notification Requirements for "Export Only" Food, Cosmetics, Devices, Etc
The Food and Drug Administration (FDA) has issued an advance notice of proposed rulemaking (ANPR) in order to invite comments on whether it should revise 21 CFR Part 1.101, which pertains to the recordkeeping and notification requirements for persons exporting human drugs, biological products, devices, animal drugs, food and cosmetics that may not be marketed or sold in the U.S. ("export only").
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(On December 19, 2001, the FDA issued a final rule in order to implement parts of the 1996 FDA Export Reform and Enhancement Act (Export Act), which amended certain export provisions of sections 801 and 802 of the Federal Food, Drug, and Cosmetic Act (FFDCA) and section 351 of the Public Health Service Act (PHSA). After a delayed implementation date and a 90-day stay, the majority of this final rule became effective on June 19, 2002. See ITT's Online Archives or 01/17/02 news, 02011720, for BP summary of this final rule. See ITT's Online Archives or 06/04/02 news, 02060415, for BP summary of FDA's stay of the final rule.)
ANPR is in Response to a 2002 Petition for Reconsideration
According to FDA, this ANPR is in response to a petition for reconsideration submitted on June 17, 2002 which claimed: (1) the agency lacks legal authority to inspect export records held by food and cosmetic companies, and (2) that regulations describing the types of records that should be kept to demonstrate that an exported product does not conflict with the foreign country's laws are overly burdensome.
As a result of the June 17, 2002 reconsideration petition, FDA states that it has been exercising enforcement discretion regarding the final rule's regulations (1) on access to records of food and cosmetic exporters under 21 CFR 1.101(b) and (2) for all exporters and the requirement for specific types of records under 21 CFR 1.101(b)(2) demonstrating that the exported product is not in conflict with the foreign country's laws. (FDA notes that affected parties must still comply with the statutory requirements pertaining to exports.)
FDA sources explain that, in these two instances, enforcement discretion means (1) food and cosmetics exporters can claim that FDA lacks authority to examine their records, and (2) while exporters must demonstrate that an export does not conflict with the laws of the importing country, the manner in which they demonstrate this is at their discretion.
(According to FDA, the reconsideration petition claimed that FDA lacks the authority to require food or cosmetic companies to disclose records, as its inspection authority does not extend to the mandatory examination of records maintained by food and cosmetic manufacturers.
In addition, the reconsideration petition contested as overly burdensome the provision in the final rule which states that records demonstrating the export does not conflict with a foreign country's laws may consist of either a letter from an appropriate foreign government agency, department, or other authorized body stating that the product has marketing approval from the foreign government or does not conflict with the country's laws, or a notarized certification by a responsible company official in the U.S. that the product does not conflict with the laws of the importing country and that includes a statement acknowledging that he or she is subject to the provisions of 18 USC 1001 (which makes certain false or fraudulent statements a criminal offense).)
-written or electronic comments on certain listed questions regarding the above two issues are due by August 16, 2004
FDA Contact - Philip Chao (301) 827-0587
FDA ANPR (D/N 1998N-0583, FR Pub 06/01/04) available at http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2004/pdf/04-12271.pdf