FDA Issues Archives - Page 27 of 32 - Customs & International Trade Law Firm

Don’t Let Your Bioterrorism Act Registration Lapse

has for the first time, specifically put the onus on importers to have a program to verify that the food products they are bringing into this country are safe. The idea behind FSMA is to change FDA regulatory enforcement and focus to more of a preventative approach, instead of reactionary. These new requirements include risk-based controls, foreign supplier verification program, certification, and audits. A brief overview of the requirements may be found here.

I’ve summarized the requirements relevant to your Bioterrorism Act Registration below, so you can be sure your registration doesn’t lapse.

New Biennial Registration Requirements
FSMA amended the Food, Drug & Cosmetic Act (FD&C Act) Section 415 to provide for biennial registration updates. Facilities which are required to register will have to re-register every 2 years, during the period beginning on October 1 and ending on December 31 in even numbered years. This will first occur in October-December 2012.

Note that even facilities which are already registered with the FDA are still required to renew their registrations during the October 1 – December 2012 registration renewal period.

U.S. Agent
FDA requires that foreign facilities have a U.S. agent. The U.S. agent must:

live or maintain a place of business in the U.S. and
be physically present in the U.S.

The U.S. Agent is also responsible for the payment of “reinspection fees” of foreign facilities and failure to comply with recall orders. Reinspections are follow-up inspections conducted by the FDA after a previous inspection by the FDA where the FDA identified non-compliance issues materially related to food […]

By Jennifer Diaz|2022-07-06T13:47:59-04:00August 29, 2012|Food, FSMA, Import|0 Comments

Jennifer Diaz Opens Medical Device Seminars at FIME

Attorney Jen Diaz will be presenting the first seminar “How to Effectively Resolve Typical U.S. Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) Issues for Medical Devices” at the FIME Show at 10:00 AM on Wednesday, August 8, 2012 at the Miami Beach Convention Center. This will be Jen’s third consecutive year teaching at FIME.

After attending this seminar, you will know how to effectively operate your business with a new understanding of how to effectively resolve the “worst case scenarios.” We will discuss how we handle everyday examples of difficult issues with both the U.S. Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP). FDA issues include what to do if you receive a “Notice of FDA Action” stating that a medical device is adulterated or misbranded and will be refused admission into the United States, or a “Warning Letter” that could potential state you must stop producing certain medical devices because they are adulterated or misbranded. Effectively resolving CBP issues includes the appropriate response when CBP says your goods are under “detention,” will be “seized” and “forfeited” or are included in the “detention without physical examination” list and how your company can get off the list. You will also learn the appropriate response after you receive a “liquidated damages claim” up to $50,000 from CBP.

FIME brings together the worldwide medical community for the largest and most comprehensive trade show in the United States, and features medical manufacturers from all over the globe. If you can find it in a hospital, surgery […]

By Jennifer Diaz|2022-07-06T13:50:37-04:00August 2, 2012|Medical Devices, Speaking|0 Comments

TTB Issues Interim Policy for Labeling Gluten-Free Spirits

On May 24, 2012, U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB) issued an Interim Policy on Gluten Content Statements in the Labeling and Advertising of Wines, Distilled Spirits, and Malt Beverages (TTB Ruling 2012-2).

Currently, there is no Food and Drug Administration (FDA) regulation that defines the term “gluten-free”.

FDA proposed to define gluten free as:

an ingredient that is a species of wheat, rye, barley, or a crossbred hybrid of these grains;
an ingredient derived from these grains and that has not been processed to remove gluten;
an ingredient derived from these grains and that has been processed to remove gluten, if the use of that ingredient results in the presence of 20 or more parts per million (ppm) gluten in the food; or
20 ppm or more gluten.

Pending the issuance of a final rule by FDA, TTB is providing interim guidance on the use of the term “gluten free” on alcohol beverage labels and advertisements subject to TTB’s authority.

Alcohol Products Made from Gluten-Free Materials

TTB’s position is that the term “gluten-free” will be interpreted by consumers of alcohol beverages to mean that the product contains no gluten. TTB provided the example of wine fermented from grapes, or vodka distilled from potatoes. If there are good manufacturing practices – meaning no cross-contamination, no additives, no yeast, and no storage materials with gluten – a ‘gluten-free’ claim in the labeling of the alcohol beverage will be permissible in the interim period awaiting FDA’s final rule.

Alcohol Products Made from Gluten-Containing Materials

FDA and TTB […]

By Jennifer Diaz|2022-07-06T13:52:25-04:00July 20, 2012|Food|0 Comments

2012 International Boston Seafood Show

The annual International Boston Seafood Show is today and tomorrow at the Boston Convention Center. The Show attracts 19,000 visitors, and is the largest seafood show in North America. See www.bostonseafood.com. I am again lecturing on the Food Safety and Compliance Track with emphasis on the implementation of the Food Safety Modernization Act of 2011: What every food importer and customs broker needs to know – now.

My topic is “Food Safety Compliance under the New Food Safety Modernization Act of 2011.” My fellow panelists discussing the FSMA, and import safety generally, include Ted Poplawski from the FDA, Judith Webster from U.S. Customs and Border Protection (CBP), Howard Tennen from Quirch Foods, Dean Leaman of ABC Research Laboratories, and Dan Fone of NSF International. Since 80% of the seafood consumed in the United States is imported, compliance with the food safety laws and regulations that have now been implemented by the FDA, in cooperation with CBP, is critical.

There were a record number of FDA Import Alerts for seafood in 2011, and a higher number of imported shipments of seafood are now the subject of Detention Without Physical Examination (DWPE). What is surprising to many people is that the seafood is not just being stopped and inspected from China, but also Vietnam, Chile, and Canada, to name a few. Moreover, seafood fraud in many forms such as species substitution or false country of origin to avoid the payment of anti-dumping duties is now being discovered by the FDA, CBP, and NOAA. Criminal prosecutions and civil penalties by […]

By Jennifer Diaz|2015-12-01T06:52:54-05:00March 12, 2012|Food, FSMA|0 Comments

HOW TO GET OFF THE FDA BLACK LIST (Import Alert List)

What is the Black List?

The United States Food and Drug Administration (FDA) has authority from Congress to place an importer, manufacturer, shipper, grower, geographic area, or country on a “detention without physical examination” (DWPE) list (aka the FDA’s black list). To check if a company you are doing business with is on such a list, check FDA’s Import Alert page, you can search by country, company, etc. If your company is on this list, any merchandise you import may be detained as soon as it is offered for entry into the United States. You will have to prove to the FDA that the merchandise should be allowed to enter the U.S., otherwise, it will be refused entry and must be exported or destroyed within 90 days. The company/country, etc. will remain on this black list, until information is presented to the FDA that proves the merchandise is no longer violative.

How to Get Off the Black List
FDA’s Regulatory Procedures Manual provides guidance to those who wish to get off the black list. The specific method to use to get off the black list is directly related to why you were placed on the black list in the first place. For example, if a food product was placed on the automatic detention list because it was deemed “adulterated” or “misbranded” by the FDA, a minimum of five consecutive non-violative commercial shipments must enter the U.S., and at least one […]

By Jennifer Diaz|2022-08-09T10:33:12-04:00February 14, 2012|Import Alert, U.S. Food and Drug Administration (FDA)|0 Comments

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