Weren't able to squeeze the legal press into your summer reading list? No one has to know. This Advisory provides an overview of the nine key US Food and Drug Administration (FDA or the Agency) and US Department of Agriculture (USDA) regulatory developments impacting conventional food and dietary supplements that occurred between Memorial and Labor Day.
1. Publication of Additional Guidance Regarding the New Nutrition Facts and Supplement Facts Labels
Following FDA's update of its Nutrition Facts and Supplement Facts labels in May (discussed in a previous Advisory, FDA Gives Nutrition Facts and Supplement Facts Labels a Major Makeover After Two Decades), the Agency published an evolving question-and-answer document for industry, which addresses the most frequently asked questions that stakeholders have submitted to FDA regarding the updated label.
According to the FAQ document, FDA plans to release additional guidance to facilitate compliance with the labeling rules by early next year. The first two guidances are intended to help industry comply with the added sugars requirement and to address the scientific evaluation of the physiological benefits of dietary fiber. FDA is also planning to release further guidance addressing the updated Reference Amounts Customarily Consumer (RACC) tables and units of measure.
2. Publication of Draft Guidance on Voluntary Sodium Reduction Goals
On June 2, 2016, the FDA released draft guidance for industry on the Agency's effort to work with food companies and restaurants to gradually reduce sodium levels in food. Once finalized, the draft guidance document will provide short-term (two year) and long-term (ten year) voluntary mean and upper-bound targets for sodium concentrations in categories of commercially processed, packaged, and prepared foods.
The Agency has requested comments on the guidance and eight specific issues covering the proposed baseline and target sodium concentration levels, including the proposed categorization of the foods, the feasibility of achieving the targets within the timeframes, and whether any amendments to FDA's standards of identity are needed to facilitate sodium reduction efforts. After receiving requests for additional time, the Agency extended the comment period for the first four issues to October 17, 2016, and the comment period for the remaining issues to December 2, 2016.
3. Publication of Strategic Plan for Food and Veterinary Medicine
On July 14, 2016, FDA's Food and Veterinary Medicine (FVM) Program released its Strategic Plan for the next ten fiscal years. The Strategic Plan is organized around four principal goals geared at protecting and enhancing the health of people and animals: (1) food safety; (2) nutrition; (3) animal health; and (4) organizational excellence.
The Strategic Plan places a high priority on implementation of the Food Safety Modernization Act of 2011 (FSMA), with the overall aim of reducing the incidence of illnesses and death attributable to preventable contamination of FDA-regulated food and animal feed products. The Agency also intends to focus on reducing risk factors for, and the incidence of, nutrition-related chronic disease by: (1) improving the availability and accuracy of information on nutrition and supplement facts labels; and (2) finalizing the implementation of the vending machine and menu labeling rules, discussed below.
4. Delay of Vending Machine Labeling Implementation Deadline
This summer, the FDA continued its five-year implementation of the calorie declaration requirement for food sold from vending machines. Under Section 4205 of the Affordable Care Act, food sold from certain vending machines and chain restaurants are required to post calorie declarations. While FDA proposed implementing regulations in 2011, the Agency did not finalize the regulations until 2014, with compliance required by December 1, 2016.
Most recently, on August 1, 2016, FDA announced that it is extending the compliance date until July 26, 2018 for limited categories of foods covered under the vending labeling rule, including gum, mints, roll candy, and foods with visible front-of-pack (FOP) calorie disclosures. The Agency is taking this action in response to comments voicing technical challenges with the rule's type size requirements for FOP labeling, and requests from trade associations that the compliance date better align with the compliance date for the recently released Nutrition Facts label final rule.
Despite the extension, the December 1, 2016 compliance date will apply in most circumstances. As such, this summer FDA also released guidance documents for industry and small entities on how to comply with the vending labeling rule.
5. Revision to Guidance Regarding Premarket Safety Notification for New Dietary Ingredients
On August 12, 2016, FDA released revised draft guidance to help manufacturers and distributors of dietary ingredients and dietary supplements determine whether it is necessary for the company to submit a premarket safety notification to the Agency for a product that contains any new dietary ingredients (NDI).
Under the Dietary Supplement Health and Education Act of 1994, the manufacturer or distributor of a new dietary ingredient or supplement must provide notice to the Secretary to support that such dietary ingredient will be "reasonably expected to be safe" at least 75 days before being introduced or delivered into interstate commerce. FDA noted in its release that while over 5,560 new dietary supplement products come on the market each year, the Agency has received fewer than 1,000 NDI notifications since the law was passed more than 20 years ago.
The FDA initially released draft guidance on this topic in 2011, and received 1,455 comments from the industry and other stakeholders pushing back on the draft guidance as burdensome and inconsistent with the underlying law. After extending the comment period for two months, the Agency received 2,478 additional comments.
The revised draft guidance supersedes the 2011 draft, and aims to clarify and fully elaborate on points that were misunderstood or not fully explained. In the form of questions-and-answers, the extensive draft outlines the public health goals, advises when an NDI notification is needed, and clarifies the procedures, timeline, and contents of an NDI notification. FDA is accepting comments until October 11, 2016, after which the Agency expects to finalize the guidance.
6. Amendment of Requirements for Generally Recognized as Safe Classification
On August 17, 2016, the FDA published a final rule, which amends and clarifies the regulatory requirements for substances in food that are generally recognized as safe (GRAS). In addition to amending the eligibility criteria for classification as GRAS, the rule replaces the existing GRAS Affirmation Petition Process with a voluntary notification procedure under which persons may notify the Agency of their conclusion that a substance is GRAS under its intended use. The rule, which becomes effective September 16, 2016, finalizes proposals first floated by the Agency in 1997.
7. Release of USDA Guidance Permitting Negative GMO Labeling for Livestock and Poultry Products
On August 24, 2016, the USDA Food Safety and Inspection Service (FSIS) released guidance for industry on negative GMO claims on products containing livestock and poultry products (i.e., claims that the livestock or poultry were not fed genetically modified feed).
In the past, FSIS has not allowed the use of "GMO" in negative claims. However, given the passage of the federal GMO preemption bill (discussed in the blog post Vermont GMO Labeling Law Preempted, Only Two Weeks After Going Into Effect) earlier this summer, which directs USDA to develop and implement a federal GMO disclosure standard, FSIS announced that it reconsidered its position and will allow the use of "genetically modified organism" or "GMO" in negative claims that are otherwise truthful and not misleading.
8. Extension of Compliance Deadlines for FSMA Implementation
As stakeholders work to comply with the extensive new requirements under FSMA (with the first significant compliance dates for large food facilities beginning this month), the FDA announced that it will extend the compliance dates for four of the seven foundational implementing rules. The extension will apply to certain provisions in the previously released final rules that cover Current Good Manufacturing Practice (CGMP), Hazard Analysis and Risk Based Preventive Controls, the Foreign Supplier Verification Program, and Standards for Growing, Harvesting, Packing, and Holding Produce for Human Consumption.
After hearing concerns about the practicality of complying with certain requirements under FSMA and the need for additional clarification, the Agency released the first five chapters of what will be a fourteen-chapter guidance designed to help businesses comply with the CGMP and Preventive Controls rules. FDA expects to release additional chapters as they are completed, with the goal of completing the draft guidance by early 2018.
9. Announcement of USDA/FTC Workshop on "Organic" Claims
Finally, the agencies continue to explore consumer understanding of claims regarding the source or processing methods used for product ingredients. While FDA solicited stakeholder comments on the use of "natural" in human food labeling earlier this year, the Federal Trade Commission (FTC) and the USDA are exploring “organics” claims in non-agricultural products (e.g., personal care products) through a roundtable (scheduled for October). Companies will want to pay close attention to the discussion, which will bring together consumer advocates, industry representatives, and academics to discuss consumers' interpretations of organic claims and a recent FTC-USDA study on organic claims. While the roundtable is focused on non-agricultural products, the discussion of consumer understanding of organic claims could have a ripple effect that impacts all manufacturers' contemplating use of "organic" claims.