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  1. Economic Impact Analyses of FDA Regulations

Nutrition Facts Label and Serving Size; Extension of Compliance Dates (Proposed Rule)

The Food and Drug Administration (FDA or we) is proposing to extend the compliance dates by approximately 1.5 years for provisions in the Nutrition Facts Label Final Rule (81 FR 33742) and the Serving Size Final Rule (81 FR 34000). FDA is proposing to extend the compliance dates in response to the receipt of information demonstrating that extending the compliance dates would help provide for adequate time to fully implement the provisions of the Nutrition Facts Label and Serving Size Final Rules. Because the compliance dates would be extended by approximately 1.5 years, the discounted value of the estimated costs and benefits of the Nutrition Facts Label and Serving Size Final Rules would be reduced. This proposed rule to extend the compliance dates would reduce the costs to food manufacturers. We estimate that, at the mean, the present value of the cost savings (i.e., benefits) to industry of this proposed rule over the next 20 years is $1.0 billion using a 3 percent discount rate and $1.0 billion using a 7 percent discount rate (2016$). The foregone benefits to consumers is the principal “cost” of this proposed rule. We acknowledged in the Regulatory Impact Analysis for the Final Rules that there were potential shortcomings related to our estimates of the Rules’ benefits, but public comments have not offered any additional data or information to improve the estimation of benefits. For purposes of this Preliminary Regulatory Impact Analysis, we will thus continue to use the benefit estimates from the Final Rules. We estimate that, at the mean, the present value of the foregone benefits to consumers of this proposed rule over the next 20 years is $0.9 billion using a 3 percent discount rate and $0.9 billion using a 7 percent discount rate (2016$). We estimate that, at the mean, the present value of the net benefits (cost savings minus foregone benefits) of this proposed rule over the next 20 years is $0.1 billion using a 3 percent discount rate and $0.1 billion using a 7 percent discount rate (2016$).

Regulatory Impact Analysis

Nutrition Facts Label and Serving Size; Extension of Compliance Dates (Proposed Rule) RIA (PDF - 198KB)

Federal Register: Vol. 82, No. 189, Monday, October 2, 2017, pp. 45,753 – 45,756

Dockets: FDA-2012-N-1210 and FDA-2004-N-0258