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FOOD & DRUG LAW
Import & Export Requirements of FDA Regulated Products
WHAT OVERSIGHT?
05/07
On May 4th, FDA issued a letter to food manufacturers reminding them they are
responsible to make sure they have in place processes to test and insure their ingredients are safe for human consumption. There is nothing surprising in such a letter, except that it comes so long after the E-coli
and contaminated pet food outbreaks and FDA is saying we are testing at time of import or domestically. Of course, there is also an Import Alert (99-29) for all vegetable proteins from China, but since much of the
pet food contamination occurred from misdescribed ingredients, you have to ask - is this enough?
WHOLE GRAIN GUIDANCE DOCUMENT
04/06
FDA has published on its website a guidance document dealing with whole grain
labels which is considered to be a draft so comments may be filed no later than April 18, 2006. The guidance can be found at http://www.cfsan.fda.gov/~dms/flgragui.html.
FDA ISSUES FRESH-CUT FRUITS AND VEGETABLES GUIDANCE DOCUMENT
04/06
In an effort to minimize food safety hazards common to the processing of most fresh-cut fruits and vegetables sold to consumers in
ready-to-eat form, FDA has also published a draft guidance document about such processing, again on its website, entitled “Guide to Minimize Microbial Food Safety Hazards of Fresh-cut fruits and Vegetables.” It can
be found at http://www.cfsan.fda.gov/~dms/prodgui2.html .
In it, FDA recommends processors encourage the adoption of safe practices by
their partners throughout the supply chain, including produce growers, packers, distributors, transporters, importers, exporters, retailers, food service operators and consumers to include establishing policies
which encourage employees to report active cases of illness before beginning work or training, plus training supervisors to recognize typical signs/symptoms of infectious diseases, maintain proper first aid to
protect and cover any wound and not allow employees to work with any aspect of fresh or fresh-cut produce, processing equipment or tools until the wound has healed and/or the infectious disease has been treated.
FDA is urging fresh-cut processors to adopt HACCP type systems with the goal to prevent, eliminate or reduce to acceptable levels the microbial, chemical and physical hazards associated with food production.
FOOD AND GOOD MANUFACTURING PRACTICES
02/06
In its on-going efforts at regulatory review, the FDA formed a Food
Current Good Manufacturing Practice Modernization Working Group which studied existing regulations with an eye towards determining whether those regulations needed to be updated. The Group’s report and
recommendations can be found at: http://www.cfsan.fda.gov/~dms/cgmps3.html
Also available on the FDA website is a copy of the letter to
California firms that grow, pack, process or ship fresh and fresh-cut lettuce/leafy greens. http://www.cfsan.fda.gov/~dms/prodltr2.html. The letter outlines FDA’s expectations to enhance safety. Also posted is the
FDA/CDC action plan regarding Listeria monocytogenes. It can be found at http://www.foodsafety.gov/~dms/lmr2plan.html.
Finally, at the Bureau of Alcohol, Tobacco and Firearms website, there are recent
announcements clarifying the advertising rules for malt beverages, distilled sprits and wines, see http://www.ttb.gov/
Food Allergen Labeling & Consumer Protection Act of 2005
02/06
Click here to view complete article in pdf format.
This legislation amends the Food Drug and Cosmetic Act to require the labeling of food and
dietary supplement products to indicate the presence of eight listed major food allergens, if contained in the ingredients of the product. These include milk, egg, fish, crustacean shell fish, tree nuts, wheat,
peanuts, and soybeans. This requirement also applies to any other ingredients in food/dietary supplements products that contain protein derived from any of the major allergens listed above. The new legislation
applies to any food or dietary supplement products that are labeled after January 1, 2006.
EPA “FLOW THROUGH” PROVISION
06/05
Do you import food which contains pesticides? Are you having trouble with
FDA finding your pesticide levels are too high? If so, you’ll be interested in an article on our website dealing with EPA’s new rule requiring the testing be done on food in its ready-to-eat state, rather than
when raw. Click the Processed Food Imports button on our home page for more details.
PESTICIDES IN FOOD
06/05
One of the on-going frustrations with FDA has been findings that pesticide levels are too high. It arises when FDA tests food in its raw state that is imported with the intent
to further process. On June 8, 2005, EPA published a final rule which changes the testing regime. Based on this update, pesticide levels in food will now be tested once the food is in its ready-to-eat stage. If you
found your goods held under FDA’s Import Alert 99-08, there may be grounds for immediate removal.
FDA OFFERS TRAINING
04/05
FDA has posted to its website information about training it is offering to help protect against the intentional adulteration of the
food supply. The program was developed by USDA’s Food Safety and Inspection Service, Food and Nutrition Service, and Agricultural Marketing Service and the FDA. Although designed for food-industry regulators, law
enforcement, school food authorities and nutrition assistance program operators and administrators, the training is available on-line and open to attendees worldwide.
Presented as introductory in nature, the
program would nonetheless be a good refresher for those in the industry.
FOOD RECORD KEEPING
04/05
One of the issue which concerns all companies these days is record keeping. When it
comes to food and food products, there are several sets of regulations to consider. For example, there are the FDA requirements under the Bioterrorism Act. For non-transporters, i.e., those who own, hold,
manufacture, process, pack, import, receive or distribute food, non-transporters must establish and maintain specific detailed information about the food they receive, about the previous source of that food, and
about the transporters who deliver that food to them. Non-transporters of food are also required to establish and maintain specific detailed information about the food they release, about the non-transporters to
whom they release that food, and about the transporters which move the released food. Additionally, the records of these non-transporters must include information available to them that identifies the specific
source of each ingredient used to make every lot of finished product they release.
Then there are the COOL rules administered by USDA. These took effect for fish and shellfish on April 4, 2005 and require
retailers to label these commodities for country of origin and method of production from information obtained in their supply chain. USDA has made clear these regulations apply only to retailers under the Perishable
Agricultural Commodities Act of 1930, including butcher shops, fish markets and exporters. So, the first step is to establish whether or not your product is exempt, e.g. processed. If not, the retailer must maintain
records that identify the supplier, the product itself must be identified by a unique identifier, and for products not pre-labeled (delivered with the details on it), the origin and method of production information,
all of which must be maintained for a year from purchase by the consumer. Intermediary suppliers must meet the same requirements. USDA has gone so far as to publish a list of examples on its website: official
inspection certificates, confirmation and memoranda of sales, harvest records, delivery tickets, weight tickets, pesticide application records, bills/statements of sales to customers, purchase records, loss/damage
claim documents, production and sales contracts, production records, sales tickets, carrier manifests, bills of lading, pick tickets and sales ledgers.
Additionally, FDA has declared January 1, 2008 as the
uniform compliance date for food labeling regulations issued between March 14, 2005 and December 31, 2006.
These requirements are, of course, in addition to those imposed by U.S. Customs as part of the
obligations on an importer, the so called a1A list, and are also in addition to those documents required to be maintained by the various agencies with jurisdiction over exports, e.g., Commerce, State, OFAC,
Treasury, etc.
Customs Update: FDA and Export Records
(Published in the Journal of Commerce Online on August 12, 2004)
 to view document in printable format
In the June 1, 2004 Federal Register, the Food and Drug Administration issued its latest thoughts about the records it expects companies to possess when exporting food and
cosmetics. Written comments are due to the agency no later than Aug. 16.
The FDA Export Reform and Enhancement Act establishes record-keeping and notification
provisions for companies which export certain FDA regulated products. If exporting a drug or device, notification must be given to the agency identifying that drug or device when exports
first start. Originally these rules were to become effective in March 2002, but have been delayed due to objections filed by industry.
The focus of these objections are two-fold. First, there is the question of giving FDA access to these records. Does FDA have authority to seek export records when it is food or
cosmetics which are exported? Second, what type of records must be maintained by a company to confirm its exports do not conflict with the foreign country's laws?
The food and cosmetic industries assert that FDA has the burden to show an exporter violated the foreign law, not the other way around. Further, it was argued the form of the
records need not be affidavits from high-ranking company officials. Instead, certification should be required only if FDA has established a label warning for a product or if there is a
specific limit on the presence of an ingredient or substance because of safety concerns. Otherwise, a company should be free to maintain any records which satisfy its internal corporate compliance requirements.
In this Federal Register notice, FDA has asked the public to comment regarding its ability to inspect export records held by food and cosmetic exporters. Additionally, FDA wants to
know what records should an exporter be required to maintain. The notice asks specific questions under each topic, such as:
1) Is it enough if the company has records but FDA has no access to them?
2) What about FDA's ability to confirm that import for export product is actually being exported?
3) Should there be specific records required?
4) Who needs to sign any certifications which might be required?
5) Should certification be limited to only those circumstances where FDA has a policy position in place?
6) What regulatory standard should apply?
7) What records are sufficient to provide an exporter with a reasonable belief there is compliance?
8) What records will allow enforcement in the U.S., and can they be fashioned to be simple and easy to identify?
How will these policy questions affect your company? What will be required to show due
diligence? What, if any, implication does this have on a company's Sarbanes-Oxley compliance/internal controls if it is publicly traded? What are the implications if the company is privately held?
Let us know.
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