FDA Proposes New Fees Under FSMA – Comment Now

FDA-user-fee2FDA’s proposed FY2014 budget needs to be analyzed carefully by food importers. FDA needs funding to fully implement FSMA, and a chunk of it will be from you!  On the image to your left, note the new FDA Food Facility Registration and Inspection Fee, and the new FDA  Import fee (among others).  This link and more information is found on the hyperlink provided – go to page 65 of 531.

The facility registration fee would cost small companies $125, midsize companies $500 and large companies $1,000, according to the FDA. The import fee would cost companies $21 per line entry, though there would be exemptions for small importers and a maximum charge for large importers.

 

 

 

 

By |2015-11-30T13:09:08-05:00July 12, 2013|Best Practices, FDA Issues, FSMA, Import|0 Comments

June 10 – FSMA Rules Will be Released!

The U.S. Food and Drug Administration (FDA) has been court ordered to set firm dates for FSMA’s implementation.  Details of the court case forcing FDA to set these dates, and the organization that sued the FDA to make this happen follow.
Background
The Center for Food Safety (CFS), a national non-profit public interest and environmental advocacy organization, filed a lawsuit against the FDA on August 29, 2012.  The complaint alleged FDA failed to promulgate 7 food safety regulations required by the Food Safety Modernization Act (FSMA).  Congress enacted the FSMA – which was signed into law on January 4, 2011 – to modernize food safety laws and regulations by mandating science-based standards and controls; by providing the FDA with greater authority to prevent and address food safety hazards by taking steps to prevent them from occurring; by strengthening the FDA’s inspection and enforcement powers; and by improving coordination among federal, state, and foreign food safety agencies. CFS documented the foodborne illness outbreaks since FSMA was signed into law, January 4, 2011.

Court Order
The court case is being heard by Judge Phyllis Hamilton, in the U.S. District Court for the Northern District of California.  Yesterday, May 21, 2013, Judge Hamilton ordered that the FDA and CFS have an extended deadline of June 10, 2013 to file a joint statement with a […]

FDA Investigates Caffeine in Foods

Recently, there have been several reports citing illness, hospitalizations, and death after consumption of food and beverages containing high doses of caffeine. These reports have prompted the FDA to investigate multiple products with high amounts of caffeine that are currently being sold on the market. Some of the most notable reports include products such as 5-Hour Energy, Monster Energy Drink, and Wrigley Alert Energy Gum.

The FDA is closely monitoring these types of products and is investigating their safety. They are primarily concerned with the effects of these products on children. The manufacturers of this merchandise claim that they are marketed and labeled exclusively for adult use. However, critics of these products remain skeptical due to the fact that caffeine is added to items like candy, which is attractive to children.

The FDA seeks to limit the intake of unhealthy dosages of caffeine, especially with respect to children. The FDA believes that the dissemination of products composed of high amounts of caffeine create concerns because, “it will be increasingly easy to consume caffeine throughout the day, sometimes unwittingly, as companies add caffeine  to candies, nuts, snacks and other foods.” Although several hospital reports mention these caffeinated products, it is still unclear whether the adverse effects were triggered by the caffeine intake. FDA officials state that they would take action if they could link the deaths to consumption of the energy drinks, including forcing the companies to take the products off the market.

Some manufacturers of caffeinated products have already taken internal measures to mitigate the problems caused by their product. For instance, Wrigley […]

By |2022-07-07T09:56:45-04:00May 3, 2013|FDA Issues|0 Comments

Deadline for FDA Rules Demanded

Proponents of food safety, such as The Center for Food Safety, are putting pressure on the FDA to implement the proposed regulations enacted under the Food Safety Modernization Act. Currently, there is an ongoing case between The Center for Food Safety and the FDA. The case has been presented to a California federal judge who is being urged to impose strict deadlines. The regulations that are being discussed are aimed at making the national food supply safer. Advocates for the Center for Food Safety argue that the FDA has missed deadlines set by Congress.

The multiple deadlines set by Congress originally expired on October 2011, January 2012, and July 2012. However, the FDA has not finalized the implementation of the provisions desired by food safety proponents of the 2011 Food Safety Modernization Act. These provisions would regulate farms, food imports, food transportation, and the analysis of human and pet foods. Implementing these provisions is an urgent issue; food borne illnesses kill approximately 3,000 Americans each year.

The FDA argues that an unrealistic timeline was placed on them to fulfill the goals of this act. The agency claims that completing this task will take longer than expected because they are understaffed. Arguably, this delay can be seen as one of the side effects of the recent sequestration. The agency has submitted a set of rules to the Office of Management and Budget (OMB) in order to enact the law. However, the OMB has not yet […]

By |2015-11-30T13:17:38-05:00April 17, 2013|FDA Issues|0 Comments

FDA Discusses TOP Reasons for Detention of Goods

At today’s Import Operations Training, sponsored by the U.S. Food and Drug Administration (FDA) and the Florida Customs Brokers and Forwarders Association (FCBF), top officials from FDA traveled to Miami to educate importers and brokers. Topics ranged from a general overview of FDA compliance, TOP rationales for FDA detentions, Food Safety and Modernization Act (FSMA) updates, an overview of the newly re-organized (now DIO) Division of Import Operations (formerly DIOP – policy has now been removed), an overview of CBP & FDA’s Joint Team 488 – which handles liquidated damages claims for underlying FDA violations and much more. Highlights of the TOP rationale for detentions follows, as I feel this is of most value to you to know and is arranged by commodity.

Food Products Top Rationales for Detention

•Manufacturer (processor, packer or person holding food product) is not registered with the FDA pursuant to the Bioterrorism Act. (You can Register with the FDA here: www.FDA-USA.com)

•Low Acid Canned Foods (LACF) are imported without establishment registration (FCE #) or scheduled process (SID #)

•The products are subject to an Import Alert

•Product labeling is not compliant (FDA does not pre-approve food labeling, it is up to importers to assure it is compliant before importing)

•Common labeling violations include:

1.Label is not in English

2.Incorrect or missing statement of identity

3.Failure to list allergens

4.Failure to declare ingredients

5.Failure to include a proper “Nutrition Facts” label (incorrect formats […]

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