@DXWorldExpo Authors: Zakia Bouachraoui, Elizabeth White, Liz McMillan, Pat Romanski, Carmen Gonzalez

News Feed Item

Confusion Over Food Safety Registration Requirements Puts Industries At Risk

Companies that produce, package or store dietary supplements, alcoholic beverages and processed agricultural products must register with the FDA.

MIAMI, Dec. 20, 2012 /PRNewswire-iReach/ -- Companies involved in the manufacture, processing, packaging, or storage of food products--including dietary supplements, alcoholic beverages and some agricultural products--must register with the Food and Drug Administration (FDA) by January 31, 2013 or face the consequences of being in violation of the Food Safety Modernization Act (FSMA). But many of the companies affected by the new law may be unaware that the requirements apply to them.

"We are finding that a lot of businesses affected by the new registration renewal requirement are unaware of their obligations," explains Ann Marie Gaitan, managing director of FDA Solutions Group, a company that specializes in helping businesses meet FSMA requirements. "The confusion arises because there are so many laws that overlap. The danger is a company will inadvertently fail to renew under the FSMA and face a denial of entry of its goods into the U.S.," she adds. "That could be catastrophic for businesses across the supply chain."

Under the FSMA Section 102, all domestic and foreign facilities that manufacture, process, pack or store food, beverages, food ingredients, pet foods or dietary supplements are required to renew their current registration with the FDA before January 31, 2013. FSMA Section102 changes the registration requirement for food facilities originally established in 2002 under the Bioterrorism Act (BTA). In addition to requiring all food facilities to re-registerbeginning in 2012, FSMA also requires renewal every two years thereafter, on even-numbered years.

"Many producers of dietary supplements could falsely believe that they are not covered by the renewal requirement since those products are excluded from many provisions of the FSMA," Gaitan says. "However, since the passage of the Bioterrorism Act in 2002, facilities engaged in the manufacturing, processing, packaging or holding of dietary supplements have been required to register with the FDA. The FSMA did not change this requirement. Dietary supplement producers must re-register."

Similarly, companies involved in the alcoholic beverage trade could be unaware that they too must register, Gaitan says, pointing out that the requirement stands regardless of the fact that other agencies generally regulate that industry. "Generally speaking, companies involved with the manufacture, processing, storage or packaging of alcoholic beverages that contain more than 7% alcohol are not covered under the FSMA," she says. "But the exception—and it's an important exception—is the FDA registration requirement. All facilities where alcoholic beverages are manufactured, processed, stored or packaged must register. In fact, this has been the case since 2003, when the FDA's food facility registration requirement first went into effect."

The greatest confusion over FSMA registration seems to be within the agricultural industry. According to Gaitan, agricultural products are primarily regulated by the United States Department of Agriculture (USDA), and farms are explicitly exempt from the FDA registration requirement. However, if an agricultural product undergoes any "processing" at the farm, including a post-harvest pesticide treatment, waxing, or other preservation treatment, the farm is subject to the registration requirement, unless otherwise exempt 

"If your company is involved in any industry that manufactures, produces, packs or stores a consumable product, you should thoroughly research the FSMA requirements. Don't just assume you are not covered because your industry is regulated by agencies other than the FDA." Gaitan says. Further information about the requirements for registration can be found on FDA Solution Group's website: www.fdasolutionsgroup.com. The company offers a simple, online process that allows companies to submit their food facility registration renewal electronically, at any time of the day and from anywhere around the world.

Along with registration services, FDA Solutions Group also acts as U.S. Agent for its clients, allowing them to both register and designate an agent through its website.

The FDA Solutions Group website can be accessed in English, Spanish, Portuguese, Italian and Japanese.

More information about FDA Solutions Group and its services can be found at www.fdasolutionsgroup.com or by calling 305.702.3161.

Press release distributed by online press release distribution service Submitpressrelease123.com

Media Contact: Nancy Cook, FDA Solutions Group, 305.702.3161, [email protected]

News distributed by PR Newswire iReach: https://ireach.prnewswire.com

SOURCE FDA Solutions Group

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

DXWorldEXPO Digital Transformation Stories
Steaz, the nation's top-selling organic and fair trade green-tea-based beverage company, announces its 2017 "Mind. Body. Soul." tour, which will bring authentic experiences inspired by the brand's signature Mind. Body. Soul. tagline to life across the country. The tour will inform, educate, inspire and entertain through events, digital activations and partner-curated experiences developed to support the three pillars of complete health and wellness.
The platform combines the strengths of Singtel's extensive, intelligent network capabilities with Microsoft's cloud expertise to create a unique solution that sets new standards for IoT applications," said Mr Diomedes Kastanis, Head of IoT at Singtel. "Our solution provides speed, transparency and flexibility, paving the way for a more pervasive use of IoT to accelerate enterprises' digitalisation efforts. AI-powered intelligent connectivity over Microsoft Azure will be the fastest connected pat...
There are many examples of disruption in consumer space – Uber disrupting the cab industry, Airbnb disrupting the hospitality industry and so on; but have you wondered who is disrupting support and operations? AISERA helps make businesses and customers successful by offering consumer-like user experience for support and operations. We have built the world’s first AI-driven IT / HR / Cloud / Customer Support and Operations solution.
Codete accelerates their clients growth through technological expertise and experience. Codite team works with organizations to meet the challenges that digitalization presents. Their clients include digital start-ups as well as established enterprises in the IT industry. To stay competitive in a highly innovative IT industry, strong R&D departments and bold spin-off initiatives is a must. Codete Data Science and Software Architects teams help corporate clients to stay up to date with the mod...
At CloudEXPO Silicon Valley, June 24-26, 2019, Digital Transformation (DX) is a major focus with expanded DevOpsSUMMIT and FinTechEXPO programs within the DXWorldEXPO agenda. Successful transformation requires a laser focus on being data-driven and on using all the tools available that enable transformation if they plan to survive over the long term. A total of 88% of Fortune 500 companies from a generation ago are now out of business. Only 12% still survive. Similar percentages are found throug...
In his general session at 21st Cloud Expo, Greg Dumas, Calligo’s Vice President and G.M. of US operations, discussed the new Global Data Protection Regulation and how Calligo can help business stay compliant in digitally globalized world. Greg Dumas is Calligo's Vice President and G.M. of US operations. Calligo is an established service provider that provides an innovative platform for trusted cloud solutions. Calligo’s customers are typically most concerned about GDPR compliance, application p...
Druva is the global leader in Cloud Data Protection and Management, delivering the industry's first data management-as-a-service solution that aggregates data from endpoints, servers and cloud applications and leverages the public cloud to offer a single pane of glass to enable data protection, governance and intelligence-dramatically increasing the availability and visibility of business critical information, while reducing the risk, cost and complexity of managing and protecting it. Druva's...
BMC has unmatched experience in IT management, supporting 92 of the Forbes Global 100, and earning recognition as an ITSM Gartner Magic Quadrant Leader for five years running. Our solutions offer speed, agility, and efficiency to tackle business challenges in the areas of service management, automation, operations, and the mainframe.
With 10 simultaneous tracks, keynotes, general sessions and targeted breakout classes, @CloudEXPO and DXWorldEXPO are two of the most important technology events of the year. Since its launch over eight years ago, @CloudEXPO and DXWorldEXPO have presented a rock star faculty as well as showcased hundreds of sponsors and exhibitors! In this blog post, we provide 7 tips on how, as part of our world-class faculty, you can deliver one of the most popular sessions at our events. But before reading...
DSR is a supplier of project management, consultancy services and IT solutions that increase effectiveness of a company's operations in the production sector. The company combines in-depth knowledge of international companies with expert knowledge utilising IT tools that support manufacturing and distribution processes. DSR ensures optimization and integration of internal processes which is necessary for companies to grow rapidly. The rapid growth is possible thanks, to specialized services an...