U.S. Food and Drug Administration (FDA)

Why Your Freight Forwarder MUST Segregate Hazardous Materials

It’s important to understand why freight forwarders take certain steps prior to shipping your goods. We previously discussed why it’s important to complete a Shipper’s Letter of Instruction. Now we are addressing why your Freight Forwarder segregates your hazardous materials, even if you request otherwise. The fines for non-compliance are severe. 49 CFR 107.329 provides for the maximum civil penalty amounts. Violators that knowingly violate hazardous material transportation laws and regulations may face no more than a $78,376.00 penalty for each violation, but if the violation results in death, serious illness, severe injury to any person, or substantial destruction of property the maximum civil penalty is $182,877.00. There is no minimum civil penalty, except for a minimum civil penalty of $471 for violations relating to training. When the violation is a continuing one, each day of the violation constitutes a separate offense. […]

Bioengineered Food Labeling

In our July 27, 2018 blog , we explained what bioengineered (BE) food is and informed you about the United States Department of Agriculture’s (USDA) Agricultural Marketing Service’s (AMS) new proposed rule for BE foods. The new rule is a result of the 2016 amendment to the Agricultural Marketing Act of 1946, which would require food manufacturers and other entities that label foods for retail sale to disclose information about BE food and BE food ingredient content. The amended Act directs the Secretary to establish the National Bioengineered Food Disclosure Standard (NBFDS) for disclosing any BE food and any food that may be bioengineered. This proposed rule is intended to provide a mandatory uniform national standard for disclosure of information to consumers about the BE status of foods. The standardized disclosure of information will facilitate food purchasing for consumers by eliminating the current uncertainty when purchasing food; effectively improving overall consumer confidence, without harming food manufacturing; and providing farms and production companies a logical, consistent standard for future labeling and packaging. […]

FDA Issues New Guidance to Help Food Facilities Meet Registration Requirements

fdaOn May 25, 2018, the U.S. Food and Drug Administration issued a Small Entity Compliance Guide (SECG) to help food facilities meet their registration requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The FD&C Act requires food facilities engaged in manufacturing/processing, packing, or holding of food for human or animal consumption in the United States to register with the FDA. The Food Safety Modernization Act (FSMA) added new registration provisions to the FD&C Act. In 2016, FDA issued a final rule to reflect these changes, which include the following:

  • Facilities are required to provide FDA with assurance that they will be permitted to inspect their facility (in accordance with the FD&C Act).
  • Facilities are required to renew their registration every other year.
  • FDA now has the authority to suspend a facility’s registration.

Under the 2016 final rule, additional information is also required that supports FDA’s ability to respond quickly to food-related emergencies and that will also help the agency more efficiently use the resources it has for inspections.

The SECG explains which types of facilities are required to register, and when and how to do that. The guide also explains the consequences for facilities that fail to register or to renew their registration as required. In addition, the guide explains when FDA can suspend a facility’s registration and the effect of a suspension order. To further assist small facilities, the SECG includes an “At-a-Glance” that summarizes all of the key information in the […]

By |2018-05-31T15:51:36-04:00May 31, 2018|FDA Issues, Food, FSMA|1 Comment

Top International Law Blogs To Follow in 2018

badgeWe’re ecstatic to announce Diaz Trade Law’s Customs and International Trade Law blog was included in TOP 30 International Law Blogs! We were chosen from thousands of International Law blogs on the web using search and social metrics because we actively work to educate, inspire, and empower our readers with frequent updates and high-quality information. […]

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