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Dear Colleagues, See the attached letter released August 1, 2018 from FDA Commissioner Scott Gottlieb regarding the new Produce Safety Rule. This rule was introduced as one of the seven foundational rules under the Food Safety Modernization Act (FSMA). The produce rule may impact some of our members in the dietary supplement industry, including raw material suppliers. It applies to those who grow, harvest, package, or hold botanically derived raw materials intended for human consumption. The definition of produce includes herbs, spices, and DS ingredients.
The Produce Safety Rule also applies to those who are purchasing botanicals, since FSMA requires companies to verify their supplier, including foreign suppliers under the FSVP rule. Verification includes risk-based activities to help ensure the supplier is meeting the applicable food safety standard (i.e., the Produce Safety Rule), the product is not adulterated, or misbranded. Misbranding under FSMA includes allergen labeling. It appears the FDA is considering industry comments and concerns regarding the "farm" definition, agricultural water testing and monitoring, and the presence of pathogens in Biological Soil Amendments of Animal Origin (BSAAOs -- aka manure). Also discussed are the draft produce guidance documents and implementation of the new rule. Best, Larisa FDA Food Safety Modernization Act (FSMA) https://www.fda.gov/fsma Commissioner Reaches Out to State Leaders on Implementation of the Produce Safety Rule August 1, 2018 FDA Commissioner Scott Gottlieb, MD, has reached out to state agricultural commissioners, secretaries and directors to update them on progress made on issues of joint interest related to implementation of the Produce Safety Rule mandated by the FDA Food Safety Modernization Act (FSMA). The commissioner’s letter covers updates in the areas of rule-making and implementation preparedness. Comments are closed.
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