International Trade Today is a service of Warren Communications News.
Subscriber Login
FDA and EPA
to
Refine Category Search
Clear Terms

Search Primer

Multi-word term: Place inside quotes to ensure an exact match together (e.g. "forced labor").

Term list: Separate terms with spaces, not commas or semicolons to find either word (e.g. AD/CVD CBP).

Acronyms: Use all capital letters (e.g., ACE).

Required term: If a term must be included in any resulting articles, prefix it with a plus sign (e.g., tariffs +Canada).

Excluded term: If a term should be excluded from any articles being found, prefix it with a minus sign (e.g., FDA -alert).

Simplest form: Use the simplest form of a term (e.g. "metal" instead of "metals" or "entity list" instead of "entity listing" or "entity listed").

FDA Official to Speak May 19 on Prevention as Key to Food Safety Reform
May 5, 2011 by Barbara Chaves|FDA and EPA

The Food and Drug Administration has announced that Deputy Commissioner for Foods Mike Taylor will speak at the George Washington University School of Public Health and Health Services on May 19, 2011 on the core principal - prevention - of the newly enacted FDA Food Safety Modernization Act and how it has come to be embraced both by the public health community and the food industry as the key to effective food safety reform. Taylor will take questions from the audience and will be joined by food safety experts from the Grocery Manufacturers Association and Center for Science in the Public Interest.

FDA to Make Admin Detention of Food More Likely
May 5, 2011 by Karen Marzullo|FDA and EPA

The Food and Drug Administration has issued an interim final rule, effective July 3, 2011, that will amend its regulations to lower the threshold for ordering administrative detention of food for human or animal consumption, as required by the Food Safety Modernization Act1. FDA states that with the new criteria, the number of administrative detentions2 for food is likely to increase.

FDA to Require New PN Element on Other Countries Refusing Food
May 5, 2011 by Karen Marzullo|FDA and EPA

The Food and Drug Administration has issued an interim final rule, effective July 3, 2011, that will amend its regulations to require an additional element of information in a prior notice (PN) of imported food, as required by the Food Safety Modernization Act1. This change requires a person submitting PN of imported food, including food for animals, to report the name of any country to which the article has been refused entry.

Revised FDA Import Alerts on May 3
May 4, 2011 by Elizabeth Parker|FDA and EPA

On May 3, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:

FDA Quarterly Update Tracks Performance of Its Offices
May 4, 2011 by Barbara Chaves|FDA and EPA

The Food and Drug Administration has made its quarterly update to FDA-TRACK, an agency-wide performance management system that monitors over 100 FDA program offices, including the Office of International Programs (OIP), the Office of Regulatory Affairs (ORA), Center for Devices and Radiological Health (CDRH) Center for Drugs Evaluation and Research (CDER), and Office of the Commissioner (OC). Among other things, the update shows that 57 verifications of foreign firm registrations were completed for China, India, and Latin America from Jan - Feb 2011.

Revised FDA Import Alerts on May 2
May 3, 2011 by Elizabeth Parker|FDA and EPA

On May 2, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:

FDA Posts Transcripts, More Webcasts of March FSMA Import Meeting
May 3, 2011 by Marie Rapport|FDA and EPA

The Food and Drug Administration has posted the transcript and additional webcasts from its March 29, 2011 public meeting on the import safety provisions of the Food Safety Modernization Act (FSMA). The additional webcasts include the breakout sessions on Import Certification of Food and the Voluntary Qualified Importer Program which were previously unavailable. (See ITT's Online Archives or 03/31/11 news, 11033124, for BP summary of the meeting which covered these two issues, though less extensively than the other topics which were webcast.)

FDA Warns Cosmetics Co. on Possible Seizure, Etc. for FFDCA Marketing Violation
May 2, 2011 by Kelly Sly|FDA and EPA

The Food and Drug Administration has issued a warning letter to Refine USA, LLC regarding its marketing of the VeinGogh Ohmic Thermolysis System without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act. FDA states that failure to promptly correct the violations may result in regulatory action being initiated, including, but not limited to, seizure, injunction, and/or civil penalties.

FDA Warns Korean Hair Removal Device Mfr on Possible Refusal of Admission
May 2, 2011 by Kelly Sly|FDA and EPA

The Food and Drug Administration has issued a warning letter to BNB Medical Co., Ltd. of Seoul, Korea regarding its manufacturing and marketing of BND Laser Hair Removal devices, Models W-808, CW-808 also known as Epila and Venus Laser Hair Removal devices without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act, and are subject to refusal of admission under the FFDCA. FDA may take steps to refuse these products, known as "detention without physical examination," until these violations are corrected.