The Food and Drug Administration (FDA) has issued a final rule extending the compliance date for the final rules revising the requirements for the nutrition and supplement facts labels and the declared serving sizes and reference amounts customarily consumed (RACCs). The final rule extends the compliance date for manufacturers with $10 million or more in annual food sales from July 26, 2018 to January 1, 2020, and for manufacturers with less than $10 million in annual food sales from July 26, 2019 to January 1, 2021.
On September 8, 2017, Ocean Spray Cranberries, Inc. (Ocean Spray) originally submitted a health claim petition to the Food and Drug Administration (FDA) for approval of a health claim tying together the consumption of cranberry products and the reduced risk of urinary tract infections (UTIs) in healthy women. More recently, on February 20, 2018, the FDA sent a letter to Ocean Spray stating that it is proceeding to review the petition as one for a qualified health claim. All of this information has now been posted in the agency docket. Comments on this qualified health claim petition will be accepted until May 7, 2018, and the FDA expects to issue a final decision on the claim by October 5, 2018.
This post summarizes Ocean Spray’s petition, the studies cited in support of Ocean Spray’s claim, the discussion concerning cranberry as an eligible “substance,” and the FDA’s response.
On March 29, 2018, Food and Drug Administration (FDA or the agency) Commissioner Scott Gottlieb, M.D., delivered a nutrition-related policy address. The Commissioner emphasized FDA’s role in helping Americans improve their nutrition as a step towards reducing chronic disease, with a particular focus on sodium reduction. The Commissioner’s address provides important insight into the shape that FDA nutrition and health policy can be expected to take in the next few years.
The Food and Drug Administration (FDA) announced today on its website that it intends to extend the compliance date for the Nutrition Facts Panel (NFP) final rules. The agency action provides much needed clarity and assurance to the industry that an extension will be granted.
The current compliance dates are July 26, 2018 for large businesses and July 26, 2019 for manufacturers with less than $10 million in annual food sales. The agency intends to extend the compliance date via a forthcoming Federal Register notice. In a March 2017 letter to Secretary of Health and Human Services (HHS) Dr. Tom Price, a number of trade associations requested that FDA extend the compliance date until May 2021, or 5 years after the date the final rules were published. It is unclear whether FDA will provide the requested 5-year compliance period.
The intended extension comes in response to the difficulties many companies were experiencing with getting compliant labels on food products given the absence of clear guidance from FDA on added sugars, dietary fiber, and other elements of the new requirements and the limited capacity of the packaging suppliers to print new labels for the entire food industry in the limited period of time granted by the original final regulation. We will provide additional details on the compliance date extension once available. Please do not hesitate to contact us with any questions.
Following the release of the Food and Drug Administration’s (FDA’s) nutrition labeling revisions in May 2016, the U.S. Department of Agriculture’s (USDA’s) Food Safety Inspection Service (FSIS) is proposing to amend the nutrition labeling requirements for meat and poultry products. The proposed revisions parallel almost exactly FDA’s final nutrition labeling revisions. Comments are due 60 days from the date the proposed rule is officially published in the Federal Register.
This rule proposes several significant changes for many meat and poultry product labels. As with the FDA final rule, the FSIS proposed rule would (1) require the declaration of “Added Sugars,” vitamin D, and potassium and remove the requirement to declare “Calories from Fat”; (2) revise the definition of dietary fiber; (3) revise the format of the Nutrition Facts Panel (NFP); (4) require dual-column labeling for certain containers; (5) update the reference amounts customarily consumed (RACCs) for several product categories; (6) consolidate some RACCs across meat and poultry products; and (7) create several new RACCs. The new and updated RACCs include those for appetizers and candies with meat or poultry. Additionally, the proposed rule would consolidate the nutrition labeling regulations (which are currently separate for meat and poultry products) into a single part at 9 CFR part 413. FSIS proposes a two-year compliance period for large companies and a three-year period for small companies.
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The Food and Drug Administration (FDA) has released for public comment a draft strategic priorities plan for 2014-2018 (“the Plan”). Every four year years, FDA reviews its strategic priorities for the coming years. Strategic plans highlight agency-wide themes and areas of focus that in turn drive development and emphasis of specific program areas. The strategic plan identifies five cross-cutting priorities that intersect with four mission goals. The priorities center around developing a more robust, nimble, and scientifically based regulatory framework to address 21st century public health challenges. Although the Plan identifies few specific programs, it demonstrates the types of initiatives the agency can be expected to prioritize in the near-to-mid future. Below we summarize FDA’s proposed priorities and goals as they pertain to the food industry.
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We are writing this memo to bring to your attention a guidance document on investigational new drug applications (INDs) that impacts the food industry. The Food and Drug Administration (FDA) published its final guidance: Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an IND (IND Guidance). The guidance was intended to assist clinical investigators, sponsors, sponsor-investigators, and institutional review boards (IRBs) in determining whether an IND will be required for human studies with drugs. Regardless of its original intent, section D.2. “Conventional Food” of the final guidance, which was not included in the draft guidance FDA published in 2010, has imposed IND requirements on certain human studies with conventional food. The agency’s new policy has taken an unduly restrictive view of what constitutes food and poses great challenge for food companies sponsoring human studies. Our detailed analysis follows.
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On December 29, 2010, the Food Safety and Inspection Service (FSIS) published a final rule that requires nutrition labeling for single-ingredient meat and poultry products. Under the new rule, major cuts of meat and poultry and ground or chopped meat and poultry products will have to be accompanied by nutrition information. The labeling requirements differ for the major cuts and for the ground and chopped products. Failure to provide this mandatory information will render the product misbranded. The new rule also permits ground or chopped meat and poultry products that do not qualify for a low-fat claim to bear a lean percentage claim. These changes will become effective January 1, 2012. This post summarizes the new rule’s labeling requirements.
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