In the Caribbean: New FDA Act Impacts Exports to the U.S.

7 October 2011

The American FDA Food Safety Modernisation Act may bring about more red tape for exporters such as “mandatory preventive controls for food companies”

The FDA Food Safety Modernisation Act, which was signed by the American President Barak Obama early this year, brought with it sweeping changes to how the Food and Drug Administration (FDA) would deal with regulating food, both domestically produced and imported from elsewhere.

Recently, representa-tives of the Barbadian Food and Beverage Manufacturing sector benefited from being able to interact with Ms. Cornelia Rooks, Senior Regulatory Specialist of Registrar Corp, which is a private entity that helps companies comply with US FDA’s regulations, whether this be in labelling requirements, FCE-SID registrations or Drug, Medical Device and Cosmetic establishment registrations. Some of the key components of the law which were addressed by Rooks, surrounded preventive measures such as mandatory preventive controls for food companies, effective July 2012; inspection and compliance (each food facility must renew its US FDA registration every two years) effective October 2012; and import – this includes: importer accountability, third party certification and certification of high risks foods, as well as the authority to deny entry in to the US market.

Special focus was given to FDA inspections, reasons for detentions and what recourse was in place to address detained shipments. Attention was also paid to addressing incorrect labelling of products which, according to an analysis conducted on FDA detentions, contributed to almost 34 per cent of detentions. This was superseded only by
food adulteration (contamination) at 35 per cent and was followed by the use of unapproved new drugs at 9.81 per cent.

Ms. Cornelia Rooks advised the various representatives to stay informed of the many changes that would be coming over the next four years. She urged them to invest the time and money to be in compliance in order to avoid expensive mistakes.

Ms. Diana Brooks, CEO (ag.) of the Barbados Investment and Development Corporation (BIDC) – sponsors of the workshop along with FINPYME Export Plus – told the attendants in her opening remarks that it was imperative to know and understand specific requirements of any market into which a company might wish to do business.
She also recognised the need for all the relevant agencies and ministries to work together in a symbiotic relation to facilitate our country’s exporting efforts, adding that oftentimes “assimilating of foreign regulations [could] be cumbersome … in their legality and effect”. Brooks further noted that, “This seminar is part of the BIDC’s ongoing efforts towards ensuring that our manufacturers and relevant agencies are sufficiently knowledgeable with the US market requirements.”

She also remarked that the partnership between BIDC, FINPYME and the Registrar Corp was to facilitate local companies’ preparedness for any potential direct FDA intervention or inspection – which might take place with their products or factories – as they sought to execute their extended mandates under the Food Safety Modernisation Act.
Following the seminar, companies were able to benefit from one on one discussions with Ms. Cornelia Rooks.


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