U.S. Food and Drug Administration (FDA) Archives - Page 35 of 42

As U.S. Imports from China Intensify so does CBP Enforcement

With the concentration of US imports from China increasing in parallel with intellectual property rights seizures, companies rely heavily on the government, specifically on US Customs and Border Protection (“CBP”) to help protect and enforce their intellectual property rights (“IPR”).

According to Global Sources, a leading business-to-business media company and a primary facilitator of trade with Greater China, “US imports from China [are] more concentrated than ever“.

Data from the U.S. Department of Commerce establishes that importation into the U.S. is a concentrated field, with the top 500 U.S. importers – 0.4 % of all importers – comprising roughly 68% of all imports by value in 2010. Imports from China, although somewhat less concentrated, are still dominated by larger enterprises, as companies with more than 500 employees – 4% of all importers from China – account for 60% of all imports from China. As concentration increases, the opportunity to trade in quantities that take advantage of China’s economies of scale decrease; thus, heightened concentration is not a good thing for Chinese manufacturers.

While the import concentration from China is growing, CBP is reporting a record number of IPR seizures. From 2010-2011 alone, IPR seizures increase by 24%, and have nearly doubled since 2009. Considering that China is the number one source company of imports, it should come as no surprise that it also accounts for the largest number of IPR seizures, with 62% of […]

By Jennifer Diaz|2022-07-07T09:24:36-04:00September 18, 2012|Best Practices, China, China Trade War, Counterfeits, Import, Import Alert, International Business, International Law, International Trade, IPR, Trademarks and Logos, Supply Chain, U.S. Customs and Border Protection (CBP)|0 Comments

Don’t Let Your Bioterrorism Act Registration Lapse

The Food Safety Modernization Act of 2011 (FSMA) 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 Biannual Registration Requirements

FSMA amended the Food, Drug & Cosmetic Act (FD&C Act) Section 415 to provide for biannual 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 […]

By Jennifer Diaz|2012-09-04T14:00:00-04:00September 4, 2012|Bioterrorism Act, Food, U.S. Food and Drug Administration (FDA)|0 Comments

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

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