August 3, 2015
TO: JPA Members
FROM: Patricia Faison
JPA Regulatory Update: FDA Draft Guidance on Declaring Small Amounts of Nutrients; National Organic Program Sunset Review; FSMA Reinspection Fees
FDA’s Draft Guidance – Declaring Small Amounts of Nutrients and Dietary Ingredients
The FDA recently issued a Federal Register notice (80 FR 45465; July 30, 2015), available here, announcing publication of a draft guidance, “FDA’s Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels.” According to the Agency, the draft guidance, when finalized, will explain to manufacturers of conventional foods and dietary supplements the policy for determining the amount to declare on the nutrition label for certain nutrients and dietary ingredients that are present in a small amount.
The FDA states, “declaring small amounts of nutrients and dietary ingredients in nutrition labeling may result in a conflict between 21 Code of Federal Regulations (CFR) 101.9(c)(1) through (8) and 21 CFR 101.9(g)(4)(ii) and 21 CFR 101.9(g)(5).” The FDA recommends that manufacturers declare nutrients and dietary ingredients in accordance with § 101.9(c)(1) through 8. Refer to the draft guidance for complete details.
The deadline to submit comments on the draft guidance is September 28, 2015.
National Organic Program Sunset Review
The United States Department of Agriculture (USDA) recently issued a proposed rule in the Federal Register (80 FR 45449; July 30, 2015), available here, regarding several substances on the National List of Allowed and Prohibited Substances (the National List) that will sunset (i.e., their use will expire) in 2015. Substances on the National List must be reviewed every five years.
The National Organic Standards Board (NOSB) is recommending that fortified cooking wines - Marsala wine and sherry wine be removed from the National List. According to the Agency, there was a lack of public comments requesting the continued use of Marsala wine and sherry wine for use in organic processed products and as such, these products will removed from the National List effective December 14, 2015.
In addition, the proposed rule would remove the listings for streptomycin and tetracycline (used to control fire blight in apples and pears) that expired on October 21, 2014.
The deadline to submit comments to the USDA regarding this proposed rule is August 31, 2015. If you believe JPA should submit comments to the Agency, please provide your input to me by the close of business on August 14, 2015.
FDA Publishes FY 2016 FSMA Reinspection and Recall Fee Rates
JPA has previously provided updates regarding reinspection and recall fees mandated by the FDA Food Safety Modernization Act (FSMA). FSMA requires fees to be established for the following activities: (1) certain domestic and foreign facility reinspections, (2) failure to comply with a recall order, and (3) certain importer reinspection fees.
Today, the FDA issued a notice in the Federal Register (80 FR 46022), available here, announcing the fee rates for FY 2016. The rates are: $221 an hour if no foreign travel is required (an increase of $4 compared to FY 2015) and $315 an hour if foreign travel is required (an increase of $10 compared to FY 2015). The fees will become effective on October 1, 2015 and will remain in effect through September 30, 2016.
Please contact me with questions or comments.
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