FDA

Time to Re-register Your Food Facilities With FDA

For those who import food products, it is time to re-register your food facilities with FDA. Starting in 2012, companies were required to re-register their food facilities with FDA on a biennial basis. The re-registration period is from October 1 through December 31 of each even-numbered year.

Re-registration can be down via the FDA Food Facility Registration website. Please note that “renewing” your registration is different from “updating” your registration. If you recently “updated” your registration, you still need to go into the FDA Food Facility Registration website to “renew” your registration.

Remember that the FDA Food Facility re-registration requirement applies to both food importers as well as their overseas manufacturers. Please remind your food manufacturers to renew their FDA Food Facility registration before the end of the year. As your food manufacturers go through the renewal process, please also be aware of the U.S. Agent appointment process. Domestic food facilities are not required to appoint a U.S. Agent. However foreign food facilities are required to appoint a U.S. agent. It is extremely important for U.S. Agents to remember that under the FDA Food Safety Modernization Act (FSMA), the U.S. agent is responsible for paying for any FDA re-inspections of foreign food facilities. FDA’s fees are not cheap. FDA will be billing for foreign travel at a rate of $305 per hour. Therefore I would HIGHLY recommend that U.S. food facilities think twice before accepting responsibility to be the U.S. Agent for foreign food manufacturers.

Food facilities have until the end of this year to get re-registered. Please do not waste time and get your re-registration completed early to avoid being denied import privileges by FDA.

Let me know if you have any questions.

-Jimmy Ting

GWL Corp

Great World Customs Service

jimmyting@gwlcorp.com

tel# 650-873-9050 x1019

MUST READ for Food Importers: FDA Publishes Proposed Rule for Foreign Supplier Verification Programs for Importers of Food

This is posting is a MUST READ for importers of food products (whether for humans or animals).

1.) The FDA published on July 26, 2013 a set of proposed regulations meant to help ensure that imported food meets the same level of public health protection as that required of domestic food producers. In doing so, they have created a proposed program (Food Safety Verification Program) that I believe will put a great burden on the food importing community.

The FSVP required importers to conduct audits and keep records of their suppliers. There are various exceptions.  However most medium and large importers of food products will be required to greatly increase the record keeping of their food imports. The FDA has published a number of diagrams/flow charts that help explain to importers the possible required tasks they will have to follow. I highly recommend that importers familiarize themselves with the rules. 

The potential impact of the rules is quite vast. I expect larger importers with strong relationships with large food manufacturers probably will be able to implement the FSVP the most smoothly. While they will have the most work to do, they will also have the manpower, expertise, and relationships necessary to make sure the FSVP is implemented. I am most worried for mid-sized and especially smaller food importers.

 

2.) FDA also published a proposed rule for Accreditation of Third-Party Auditors. What importers should understand is how FDA proposes to use 3rd party auditors. Thus far, they have mentioned three possible uses:

  • FDA is expected to create a Voluntary Qualified Importer Program (VQIP) which is expected to allow for expedited review and entry of food into the United States. Such a program may be welcome news to importers who are tired of the length of time it is taking FDA to currently process entries. Under FDA’s proposed regulation, importers would have to import from certified facilities (reviewed by the accredited third-party auditors).
  • FDA will have the power to required manufactures be certified by accredited third-party auditors as a condition of entry if FDA deems the product is a safety risk.
  • FDA also expects that importers may voluntarily begin to rely on third-party auditors as a progress of complying the the FSVP even in instances where it is not a requirement to use a third-party auditor.

Keep in mind that the rules mentioned above are only “proposed” regulations. Now is the time for importers to put in their comments.

– Jimmy Ting

jimmyting@great-world.com

t: 650-873-9050 x1019

 

 

FDA and Food Products Refused Entry into Other Countries

The Food and Drug Administration (FDA) has issued a final rule on May 29, 2103 on the Prior Notice (PN) requirement of submitting the name of any country that has refused entry to a food product prior to importation to the United States. The final rule is identical to the interim rule isseud on May 5, 2011. The law that mandates this data element, the Food Safety Modernization Act (FSMA), was signed into law on January 4, 2011. Although the FDA has largely been lenient of this requirement the past two years, it is expected that the agency would ramp up enforcement with the publication of its final rule. 

This additional information helps the FDA make better informed decisions in managing potential risks of imported food into the country. This information along with other Prior Notice elements provided to the FDA in advance of the arrival of goods is used to review, evaluate and asses the information, and determine whether to inspect the imported food. Failure to comply may result in refusal of admission to your food import into the country.
In order to comply with this requirement, Great World suggests that our customers indicate on their shipping documents whether or not an article has been refused entry by any country. The following statements or something similar could be used:
  • Shipment has not been refused by any other country prior to importation into the United States.
  • Shipment was refused by (Name of Country) prior to importation into the United States.
Although the FDA does not require the importer to provide the reason the entry product was refused by another country, the FDA may pursue the reason for refusal. An option to consider would be to provide an explanation on your commercial invoice or on an accompanying document to every shipment.
Great World thanks you for your time. If you have any questions, please do not hesitate to contact us.
 
Sources:

  
 
-John Christopher Jimenez

 Customs Entry Writer

Great World dba GWL

218 Littlefield Ave., South San Francisco, CA 94080

Dir +1 650-762-9668 | Tel 650-873-9050 x1024 | Fax 650-873-7029 | johnj@gwlcorp.com (gchat)

Stricter Enforcement of FDA Food Facility Registration Requirements under the FSMA

We’ve noticed that one byproduct of the new biennial Food Facility Registration requirement is stricter enforcement of registration rules when filing Prior Notice (PN). We have seen FDA cracking down on PN filings. In particular, FDA seems to be taking a close look at actual foreign Food Facility Registration number to make sure that the party

a.) is the actual manufacturer of the product or the facility that actually repacked the product.

b.) has authority to register the Food Facility with FDA.

We have seen two cases already where FDA questioned the authenticity and validity of the Food Facility Registration number of the foreign food facility. In both cases, FDA eventually refused the goods. The products had to be either exported or destroyed.

Keep in mind that the refusal of the product occurs at the time of filing of the PN. This is different from a typical FDA hold that occurs at the time of Customs entry submission. With a hold during the filing of PN, Customs cannot release the goods either. The goods end up sitting at the port accumulating storage charges while the issue is resolved. Most importers are used to being able to receive and hold their shipments while waiting for FDA to release goods. This is not the case with an FDA hold at the PN level.

My recommendation to the importing community is if the shipper is NOT the actual manufacturer OR the repacker of the food product, you MUST get the Food Facility Registration number and information of the actual manufacturer or repacker. FDA has on occasion accepted the name and address of the manufacturer / repacker without the Food Facility Registration number ONLY if the that manufacturer / repacker has already registered with FDA using that same name and address. Unfortunately, there is no system of verifying this with FDA without actually submitting the entry to FDA. This ends up being a great risk. You don’t know if the name address is listed with FDA until you submit the entry. I don’t believe this is a risk that most importers will find worth taking. Therefore it behooves the importer to get the actual FDA Food Facility Registration number of the foreign manufacturer / repacker.

Let me know if you have any questions or comments.

-Jimmy Ting

jimmyting@great-world.com

FDA Biennial Food Facility Registration now AVAILABLE!

All food facilities (foreign and domestic) who have previously registered their facilities with FDA must now re-register. Under the Food Safety & Modernization Act of 2011, food facilities are now required to re-register every two years (from October 1 through December 31 of each even-numbered year). Previously registered facilities can now begin re-registering via FDA’s Food Facility Registration website. Please make sure to click the link for “Biennial Registration.”

Failure to register may result in the suspension of FDA Food Facility Registration which may ultimately lead to the FDA holds on imported goods. Domestic importers should inform their overseas suppliers to re-register ASAP.

One word of caution to importers who are asked by their overseas suppliers to act as a U.S. Agent. Don’t do it, unless you are ready to face the consequences. I know in the past that many importers have been willing to help foreign facilities by acting as their U.S. agent. Under the FSMA, the U.S. Agent is liable for FDA foreign re-inspection fees. The posted/suggested rate of of inspection for foreign facilities is currently set at $289/hour. I doubt most importers would be willing to accept this type of liability.

Let me know if you have any questions.

Jimmy Ting

jimmyting@great-world.com

 

 

Medical Device Excise Tax

A part of Obama’s Affordable Care Act included a 2.3% excise tax on medical devices. I had one importer inquire about the excise tax today and the method for paying it. Unlike the Federal excise tax on alcohol, this tax is not collected via U.S. Customs at the time of import. It will be reported on Form 720, the Federal Quarterly Excise Tax Return form.  The IRS has posted an FAQ website to answer some questions that medical device manufacturers and importers may have about the tax.

Here are some other key details about the Medical Device Excise Tax:

  • It is a 2.3% tax on revenue, not profit.
  • Medical devices purchased at retail for individual use are to be exempted. Examples include eyeglasses and hearing aids.
  • The start date is the beginning of the new year, January 1, 2013.

Politicians are working on repealing this excise tax. With only three months left until the new year, manufacturers and importers should be consulting with their CPA and various accounting advisers to discuss which items will be affected by the tax.

-Jimmy Ting

jimmyting@great-world.com

Changes to Food Facility Registration under FSMA

Food manufacturers, exporters, and importers should all be familiar with the FDA Food Facility Registration requirement. What they may not be aware of are changes to the requirement as a result of the Food Safety Modernization Act that was signed by President Obama on January 4, 2011. I have listed out the major changes below:

1.)    Frequency – every two years. In the past, food facilities only need register once. Under the FSMA, food facilities must re-register every two years.

2.)    Start date: The official start date was October 1, 2012. However FDA has delayed the start of re-registration until further notice (http://www.fda.gov/Food/FoodSafety/FSMA/ucm314178.htm?source=govdelivery). Importers should continue to watch out for when the start date opens up.

3.)    Requirement of food facilities to indicate secondary products produced (in addition to the primary product produced).

4.)    “Voluntary” additional information – FDA will be sending out a separate form after the registration is complete. This separate form will ask for “voluntary” information that will be used to determine if the facility is “high risk.” It would seem obvious that it would be in the facility’s best interests to complete the form. However importers should be very careful when completing this form. It will ask for specific information about potential hazards the preventive control measures that the facility is taking.

5.) Re-Inspection Fee: FDA will have the right to inspect food facilities. The part that importers should be aware of is that FDA will be authorized to charge a “re-inspection” fee if a re-inspection is required. For domestic food facilities, the cost of the re-inspection will be born by the domestic facility. However for foreign facilities, the U.S. agent listed on the Food Facility Registration will be responsible for the costs related to the re-inspection.

More information about Registration can be found at the following FDA website: http://www.fda.gov/Food/FoodSafety/FSMA/ucm314178.htm

Registration should be be made via the following FDA website: http://www.access.fda.gov/

There is no fee for FDA Food Facility Registration.

Feel free to contact me with questions.

-Jimmy Ting

jimmyting@great-world.com

FDA- Multiple Locations and Medical Establishment Registration

Now that FDA has indicated that they will be charging importers for Establishment Registration, some importers have asked me to clarify whether they need to register each and every facility that receives goods. For example, the importer may have a head office in Chicago and satellite distribution offices in Seattle, Oakland, Los Angeles, Dallas, Chicago, New York and Miami. If each satellite office had to register as a distinct Establishment, the importer would potentially have to pay the registration fee ($2575 starting October 1, 2012) SEVEN times. If the importer has even more offices throughout the United States, the registration costs could end up being quite onerous.

I contacted FDA’s Establishment Registration email address (they responded surprisingly quickly) and was initially told that yes, each facility would need to register for a separate Establishment number. I then asked how an importer should declare their Establishment for a shipment that was sent on a “direct-ship-to-customer model” where a shipment bypasses the importer’s distribution warehouses entirely. As the importing community is well aware, one of the best ways to reduce cost is to be able to directly ship goods from the manufacturer to the end customer, thereby reducing warehousing costs along the way. This question stumped the FDA Registration clerks. The question was elevated, and I received a very quick response from someone higher up in FDA. They clarified the following:

  • If the importer has one head office and multiple branch offices that receive goods, they only need to register the Establishment of the head office.
  • The shipping documents at the time of import should clearly indicate the head office’s name with Establishment registration information clearly listed on the paperwork.
  • The shipping documents can then indicate a delivery address that is different from the head office that has the Establishment registration.

This information was of great relief to my importers of medical devices. I would like to applaud FDA and their quick response to my questions.

Feel free to contact me if you have any questions.

-Jimmy Ting

jimmyting@great-world.com

New Requirements for FDA Medical Device Establishment Registration and Listing

As I mentioned in a previous blog, FDA is updating their requirements for Medical Device Establishment Registration and Listings. The changes begin in four days, starting October 1, 2012. The two biggest changes that I initially noted were as follows:

  1. ALL establishments (including initial distributors / initial importers) will need to start paying the registration fee. In the past, initial distributors/importers were exempt from paying the registration fee.
  2. The registration fee will be increasing from $2029 to $2575.

One thing I forgot to make note of was another new requirement for initial distributors/importers. They must now “Identify manufacturers of products being imported. This may be done by listing number or searching and identifying the manufacturer in FURLS.”

The official response from FDA’s FAQ page on the new requirements has this blurb about identifying the manufacturer:

16. As an initial distributor/importer who is now required to provide the manufacturer information for devices I will be importing, must I update this information in FURLS as new firms are added or I decide not to distribute for a particular manufacturer?

FDA recommends that importers keep their manufacturer information current at all times. Failure to keep your information current may lead to your device undergoing manual review when imported, which may slow importation of your device.

We all know how bogged down and slow FDA’s response has become over the last few years. Most FDA offices are way underfunded and overworked. One thing that FDA continues to repeat to the importing community is that the best way to help them speed up the process is by making sure all the information provided to them is up-to-date. Keeping manufacturer information up to date on FURLS is just one such action that every importer should be taking.

-Jimmy Ting

jimmyting@great-world.com

Important Update – Changes to Medical Device Establishment Registration Requirements!

This is an important update for all importers who have registered Medical Device Establishments with the FDA. Owners or operators of businesses that are involved in the production and distribution of medical devices intended for use in the United States are required to register their establishment with FDA on an annual basis. FDA has made two changes for their fiscal year 2013 (actually begins October 1, 2012).

1.) The biggest change has to do with whom is required to pay the fee. In the past, initial distributors / importers in the United States were required to register, but were not required to pay the registration fee. As of October 1, 2012, this will no longer be the case. ALL establishments, both domestic and foreign, will be required to pay the annual registration user fee.

2.) The registration user fee is increasing from $2029 (FY 2012) to $2575 (FY2013).

Additional information can be found on the following FDA website: http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm314844.htm

Please be aware of these important changes as the Establishment Registration must be kept up to date in order to help ensure a smooth FDA review process.

-Jimmy Ting