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FDA recently released its Guidance for Industry: Questions and Answers on FDA’s Fortification Policy (Guidance) to “clarify the existing policy” in response to questions FDA has received from the food industry, other federal agencies, and academia, and also to “remind manufacturers of this policy.”  FDA’s “fortification policy” was first published in a 1980 Federal Register

The world’s largest food distributor, Sysco Corp., has entered into a settlement with the California Department of Public Health to resolve allegations that the company had engaged in unlawful food transportation and storage practices and had misrepresented its practices on the company’s website. 

The Department alleged that the company held “perishable food and other food

On February 3, 2014, FDA issued a Direct Final Rule to adjust for inflation the maximum civil money penalty (“CMP”) amounts it can seek for certain violations of the Food, Drug, and Cosmetics Act (“FDCA”).  The direct final rule revises the current list of statutory monetary penalties set forth 21 C.F.R. Part 17, including for

On Monday, FDA announced a new proposed rule that would amend the 1994 TFM for OTC antiseptic drug products.  The change would require companies that sell antibacterial soaps and body washes that are labeled “antibacterial” or “antimicrobial” to prove through a “controlled clinical outcome study” that their products prevent the spread of illness better than

Recently, H&M USA, an importer of  periodic bulk shipments of active pharmaceutical ingredients (API) turned to the courts in an effort to gain relief when the company’s efforts to resolve an unexpected import detention through FDA’s administrative process proved unsuccessful.  The FDA issued a Notice of Refusal, alerting the company that it had failed to

The 2nd District Court of Appeals agreed with the lower court’s decision that no reasonable consumer would be misled into thinking that a product labeled as spreadable butter with canola oil was not 100% butter.  Mary Simpson sued Kelley Drye clients Kroger Corp. and Challenge Dairy Products alleging that the labeling of Challenge’s “Spreadable

Still buying imports of dubious foreign origin from unrelated U.S. importers? Consider the case of Groeb Farms, Inc., which recently accepted criminal responsibility for fraudulently entered Chinese honey that had avoided $79 million in duties – despite not being directly involved in the honey’s importation.

The takeaway: Not being the importer of record for fraudulently

Last week, the Department of Justice brought a sweeping indictment against several former Peanut Corporation of America executives alleging egregious, and intentional, violations of food safety laws that caused the salmonella peanut outbreak of 2008. The government charged four individuals who allegedly directed the scheme in an indictment that contains 76 counts of conspiracy, wire

Californians voted against Proposition 37 yesterday, the California ballot initiative that would have compelled labeling for foods developed with the use of recombinant DNA and related technologies, as well as prohibited “natural” claims for certain processed foods. With 98.5 percent of precincts reporting, Californians had voted against Proposition 37 by a margin of 53 to