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Product developers should anticipate regulatory changes

June 26, 2017

The White HouseThis year brought a new administration to the federal government with the potential to bring sweeping changes to food and dietary supplement regulation. The Trump administration has pledged to bring regulatory reform to each federal agency and to reduce regulatory burdens on the economy. Regulations that could be affected include the Food Safety Modernization Act (FSMA) with now final rules including Risk-based Preventive Controls for human and animal food. New FDA Commissioner Scott Gottlieb has pledged to streamline the agency and has already shown that his priority will be on drug approval systems and not on foods. In fact, it is possible that food regulation, currently managed by both the U.S. Food and Drug Administration and the U.S. Dept. of Agriculture, could see major reform not through congressional debate but simply by presidential executive order.

• Food Safety. FSMA Preventive Control rules for human and animal feed requirements went into effect for large companies (more than 500 employees) on Sept. 19, 2016. Most large companies that already had HACCP plans and quality systems with robust record keeping have experienced minor changes. FDA has worked to clarify requirements, including training. FDA enforcement goals are said to focus on the big picture and support businesses that instill a culture for food safety and support a sustainable prevention-oriented food safety system. Companies that are not confident of compliance should consider being on the lookout at the food expo for service vendors for consulting and/or software tools to support business and regulatory goals.

• Nutrition Labeling Changes. The Nutrition Facts Label Final Rule brought changes to the facts panel for foods and dietary supplements. Changes to the nutrition labeling were scheduled to go into effect on July 26, 2018, but the administration announced its decision to extend the compliance date to allow businesses to implement changes; there is no deadline set at this time. Key changes include highlighting calories, deleting calories from fat, and requiring declaration of actual values and % Daily Value (DV) for potassium and vitamin D. Mandatory labeling remains in effect for calcium and iron but no longer for vitamin A and C. Added sugar will be required to be labeled to help consumers limit added sugar intake to no more than 10% of total calories and will need to be labeled in grams and % DV based on DV of 50 grams. Some serving sizes are also being modified. Look for service providers to help with updating analytical values and labels.

• Verified. The trend for clean label and minimally processed foods has lost no traction. Consumers are seeking transparency from food manufacturers and some want proof for claims on products. Look for services that verify label claims, including non-GM ingredients, vegan, and sustainably sourced.

Catherine Adams Hutt is chief science and regulatory officer for SloanTrends and president and CEO of RdR Solutions Consulting (cadams@rdrsol.com).