SupplySide West: F.S.M.A. may give plaintiff lawyers more firepower

by Jeff Gelski
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LAS VEGAS – Two sessions at SupplySide West in Las Vegas covered federal regulations of importance to the food and beverage industry:  the Food Safety Modernization Act and the Generally Recognized As Safe program.

The F.S.M.A. was signed into law in January 2011 and mandates an overhaul of U.S. food safety. When implemented, the F.S.M.A. will replace broad terms with specific standards that will require more record-keeping from food and beverage manufacturers and ingredient suppliers, said Marc C. Sanchez, Esq., an attorney and regulatory consultant for In-House Counsel and Consultants, L.L.C., Asheville, N.C. Plaintiff lawyers, when preparing for a lawsuit, may use those records to their advantage.

 “Plaintiff lawyers love records,” Mr. Sanchez said at a Nov. 13 session.

New computer technology also may allow plaintiff lawyers to search social media, including Facebook and Twitter, for potential plaintiffs when preparing for class-action lawsuits.

“You won’t have to see all those cheesy ads on TV – ‘Have you been injured?’” Mr. Sanchez said, meaning the lawyers already will know you were injured because they read about it on social media.

Plaintiff lawyers will look for “deep pockets,” meaning big companies, to sue, Mr. Sanchez said. The Food and Drug Administration also may investigate big companies. Since the F.D.A. may not have enough funds to investigate every company, the agency instead may turn to big companies for high profile examples, Mr. Sanchez said.

He urged food and beverage companies and ingredient suppliers to provide comments when the F.D.A. gives them the opportunity to do so on pending legislation. If a company, perhaps after receiving a warning letter, argues against the perceived injustice of an implemented food safety rule, the F.D.A. may ask the company if it commented during the comment period on the rule. If a company did not comment, the F.D.A. may have a negative view on that inaction.

“It’s absolutely vital to comment,” Mr. Sanchez said.

A Nov. 14 session at SupplySide West focused on Generally Recognized As Safe (GRAS). A substance that will be added to food is subject to premarket approval by the F.D.A. unless its use is generally recognized as safe (GRAS) by qualified experts.

Companies may use their own experts to self-determine or self-affirm that an ingredient is GRAS for specific intended uses.  Then, companies voluntarily may notify the F.D.A. about its GRAS findings.

Antonia Mattia, Ph.D., director of the division of biotechnology and GRAS notice review for the F.D.A., spoke about potential conflict of interests in GRAS panels hired by companies and the issue of companies not having to notify the F.D.A. of self-determined GRAS reports on ingredients. The U.S. Government Accountability Office previously has stated its issues with those two areas of GRAS.

Dr. Mattia said the F.D.A.’s Center for Food Safety and Applied Nutrition plans to publish draft guidance on conflicts of interest for people on GRAS panels hired by companies.

The F.D.A. does not have the authority to require companies to notify the agency of the company’s GRAS findings on an ingredient, she said. Congress would need to pass a law to make GRAS submissions to the F.D.A. mandatory.

The F.D.A. encourages companies to notify the agency of their GRAS findings, Dr. Mattia said. Doing so allows companies to know science backs their determinations prior to marketing, she said, adding the F.D.A. issuing a “no objections” letter on the GRAS status may have value when companies begin marketing.

The F.D.A. in the future may make GRAS re-assessments for several reasons, Dr. Mattia said. Consumer use levels of an ingredient may change. Food categories may change, and additional safety data may be generated.

The F.D.A. GRAS notification program already works reasonably well, she said. From the beginning of the current notification program in 1997 through October of this year, the F.D.A. received 488 notices, or about 30 per year, from companies informing the agency of a GRAS determination. About 80% of the notices were successful and about 20% were unsuccessful, Dr. Mattia said.

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