Search results for: nutrition innovation

  • As previously reported on this blog, FDA’s Nutrition Innovation Strategy (NIS) is intended to improve public health via education regarding, and encouraging innovation in, the use of nutrition to promote health. The NIS was initiated under the leadership of FDA Commissioner Scott Gottlieb. Areas of emphasis are modernizing the approach to label claims, modernizing standards of identity, modernizing ingredient labels, and the use of healthy symbols. FDA held a public meeting on July 26, 2018 to discuss and solicit public input regarding the NIS. Our analysis of the comment submissions can be found here.
  • With the impending departure of Dr. Scott Gottlieb as FDA Commissioner, in recent comments at the Grocery Manufacturers Association’s Science Forum, Claudine Kavanaugh, senior advisor for nutrition policy at FDA’s Office of Food Policy and Response made clear, “We are going to keep moving forward on the innovation strategy. There are no changes.” Ned Sharpless will carry forward the initiative as the recently-named Acting FDA Commissioner.
  • As for next steps, Kavanaugh specifically highlighted modernizing claims, including the term “healthy,” where FDA is planning to publish a proposed rule this year updating the term and including a potential symbol to represent it. In addition, Kavanaugh noted the agency’s work to modernize the standard of identities (SOI), specifically mentioning the SOI for cheddar cheese as a focus moving forward. Kavanaugh also said the Agency is looking to reevaluate how ingredient information is presented on food labels and will roll out an education campaign to raise awareness for the new Nutrition Facts label.
  • The Daily Intake has blogged on several occasions, and Keller and Heckman has published a client alert, about the Nutrition Innovation Strategy (NIS).  Briefly, the NIS is intended to improve public health via education regarding, and encouraging innovation in, the use of nutrition to promote health.  Areas of emphasis are modernizing the approach to label claims, modernizing standards of identity, modernizing ingredient labels, and the use of healthy symbols.  The deadline for comments was extended until October 11, 2018 and the last round of comments submitted appear to finally have been posted.
  • There were 1,357 public comments submitted.  Some notable companies or organizations to submit comments include, but are not limited to: Campbell Soup Company, Conagra Brands, Danone North America, Nestle, the Northwest Dairy Association, Food and Beverage Issue Alliance, American Olive Oil, American Dairy Coalition, Juice Products Association, Edge Dairy Farmer Cooperative, National Coffee Association, Kraft Heinz, Coca Cola, Grocery Manufacturers Association, and Chobani
  • On initial review of some of the food producer comments, companies appear to have provided comments on –
    • The definition of “healthy”;
    • A “healthy” symbol;
    • Consumer education, including updates to the nutrition facts label and qualified health claims; and
    • Standards of IdentityThough companies focused their comments on specific areas of interest or concern to them, i.e. Coca Cola partially geared its comments to beverage related issues, Chobani focused on yogurt and dairy, and Campbell Soup’s comments included a focus on foods that might impact the consumption of soup, certain patterns emerge. Companies are interested in adding clarity for consumers and increasing their ability to innovate.  For example, Chobani is seeking additional ability to market Greek Yogurt under a Standard of Identity as a high protein food and Campbell Soup believes that “a significant liberalization of qualified health claim language would help drive innovation and be beneficial to consumers” but that “an approved claim that is so laden as to render the claim entirely unappealing to consumers” is not commercially viable and will stifle research and innovation.   At the same time, companies stress their interest in protecting the public health, sometimes through maintaining the status quo or enforcing the standards of identity.  For example, Coca Cola is seeking to amend the rules prohibiting fortification of carbonated beverages – but Coca Cola stresses in its comments that it is not seeking to fortify traditional sodas; Chobani seeks revision to the standards of identity to include Greek Yogurt, and they noted their position that the consumption of “plant-milks is at a level that is likely to cause a public health concern”, suggesting that FDA should “consider consumer perceptions of foods defined by [standards of identity]” in setting policies.
  • We will continue to monitor FDA’s progress on this initiative.

 

  • At the National Food Policy Conference in March 2018, FDA Commissioner Scott Gottlieb, M.D., announced the creation of the Nutrition Innovation Strategy (NIS).  The NIS is intended to improve public health by educating consumers and encourage innovation to expand the use of nutrition in reducing the instances and impact of chronic disease.  FDA held a public meeting on July 26, 2018 to discuss and solicit public input regarding the NIS.  The Daily Intake has previously published posts regarding the NIS here and here.  Keller and Heckman also published a client alert regarding the meeting.
  • Topics of discussion during the meeting included modernizing the approach to label claims, modernizing standards of identity (including for milk and dairy products), modernizing ingredient labels, and healthy symbols.
  • In the announcement for the July 26 meeting, FDA provided an opportunity for public comment until August 27, 2018.  In response to multiple requests for a longer comment period, FDA has extended the comment period until October 11, 2018.
  • In a March 29 speech at the National Food Policy Conference, FDA Comissioner Dr. Scott Gottlieb announced the Nutrition Innovation Strategy (NIS).  Commissioner Gottlieb hopes to improve public health by: (1) empowering consumers to make better and more informed decisions about their diets, (2) encourage the development of healthier foods, and (3) expand the use of nutrition to reduce the instances and impact of chronic disease.  As part of NIS, Dr. Gottlieb announced a plan to limit the use of the term “milk” to “the lacteal secretion” of mammals.
  • On June 26, FDA announced a public meeting to discuss the implementation of NIS.  The meeting was held on July 26 (see agenda) and included remarks by Dr. Gottlieb, a presentation of consumer trends in the marketplace, and discussions regarding standards of identity, ingredient lists, nutrition facts, and label claims.
  • Some highlights from the meeting:
    • In the Opening Remarks, Dr. Gottlieb reiterated and elaborated on his concerns regarding plant-based products using the term “milk” (or other dairy related terms) as part of their name.
    • In the Consumer Trends in the Marketplace discussion, it was noted that there is a growing preference for minimally processed foods.
    • In the Evolving Food Landscape and Industry Innovation Panel there continued discussion on the need for a reworking of standards of identity to enable innovation of healthier food options that would still fall within the standard.
    • In the morning Claims and Statements Used on Food Labels / Icon for “Healthy” breakout session there was a discussion regarding “healthy” claims.  In this discussion there was a general consensus that a major hurdle in properly implementing healthy icons and in making health claims is consumer understanding.  There is still a wide diversion of opinions on what constitutes a “healthy” food and this undoubtedly contributes to continued consumer confusion.  Many participants seemed to agree that increased consumer education regarding existing label requirements would help.
  • Keller and Heckman will be publishing a client alert summarizing the remainder of the meeting.
  • In March, FDA Commissioner Dr. Scott Gottlieb announced a comprehensive, multi-year FDA Nutrition Innovation Strategy, which aims to modernize FDA’s approach to nutrition, help reduce the burden of chronic disease that stems from poor nutrition, and remove barriers to industry innovation.
  • On June 27, 2018, FDA published a notice of public meeting and a request for comments to give interested persons an opportunity to discuss FDA’s Nutrition Innovation Strategy. In the press release, Commissioner Gottlieb stated that much of the public meeting will cover three areas: (1) modernizing labeling claims, (2) modernizing ingredient labels, and (3) modernizing standards of identity, and expects the topics addressed at the meeting will include the following:
    • A standard icon or symbol to denote the claim “healthy” on food labels;
    • Creating a more efficient review strategy for evaluating qualified health claims on food labels;
    • Discussing new or enhanced labeling statements or claims that could facilitate innovation to promote healthful eating patterns;
    • Modernizing the standards of identity to provide more flexibility for the development of healthier products, while making sure consumers have accurate information about the products;
    • Providing opportunities to make ingredient information more consumer friendly; and
    • FDA’s educational campaign for consumers about the Updated Nutrition Facts Label.
  • FDA will be opening a docket to take public feedback on these topics. FDA stated their specific interest in hearing about the implementation of current standards of identity, and whether FDA should update the existing standards or change enforcement methods. FDA wants to know “if consumers are being misled in ways that can adversely affect their dietary decisions when certain products qualify themselves with terms such as milk or rice, but are made from ingredients that don’t reflect the traditional assumptions about how products labeled that way are derived.” As previously mentioned on this blog, this issue has most recently focused on the labeling of plant-based products as “milk.”
  • The public meeting will take place on July 26, 2018. Interested parties may submit comments on this public meeting by August 27, 2018. Those with questions regarding the upcoming meeting or who would like assistance in preparing comments are encouraged to email us at fooddrug@khlaw.com.
  • As previously  covered on this blog, FDA issued final rules in May 2016 to implement changes to the nutritional labeling and serving size regulations.  For manufacturers with $10 million or more in annual food sales, the compliance deadline was January 1, 2020.  Manufacturers with less than $10 million in annual food sales have until January 1, 2021 to comply.
  • On March 11, 2020, FDA launched an education campaign  to raise awareness concerning changes to the label and help consumers learn to use the nutrition labels as a tool for healthy dietary practices.
  • The campaign, titled “The New Nutrition Facts Label: What’s in it for You?”, includes outreach through social media, videos, downloadable educational material, and indoor/outdoor advertising.  This campaign is part of FDA’s Nutrition Innovation Strategy that seeks to reduce preventable death and disease associated with poor nutrition.
  • On March 22, 2018, Susan Mayne, Ph.D., Director of FDA’s Center for Food Safety and Applied Nutrition, addressed the audience at the Future Food-Tech Summit about FDA’s role in supporting innovation in food technology. Dr. Mayne divided her talk into four key questions:

(1) How can food-tech innovators get the support and information they need from FDA to bring a product to market that is safe and lawful?

(2) What is the thought process behind the regulation of composition, quality, safety and labeling of foods?

(3) How can regulatory bodies and food-tech innovators better collaborate to achieve greater success in scaling truly innovative solutions?

(4) How is the convergence of biotech and digital technologies shaping the future of food?

  • Throughout her speech, Dr. Mayne highlighted the importance of consulting FDA early in the process – “We can provide feedback that will give you a better understanding of what regulations you’ll be required to meet as you move forward to bring your product to market.” One example cited was FDA’s voluntary consultation process to engage with the developers of foods derived from genetically engineered plants. This process helps developers determine the necessary steps to ensure the resulting food products are safe and lawful.
  • Dr. Mayne endorsed FDA’s guidance documents as good sources of information about regulatory requirements, and stressed the importance of food safety, stating it must be part of a food innovator’s mission – “It’s our mission to protect public health and we are on board with supporting innovative products, but they must be safe products.”
  • Dr. Mayne concluded her talk by quickly mentioning FDA’s update to the Nutrition Facts label. “We know that consumers are demanding healthier foods, and industry, including many of your companies, is seeking new ways to deliver products that meet consumer needs. […] I encourage you to work with FDA, to bring your brainpower and imagination to the challenge of feeding the world, helping people have healthier diets, and providing innovative new options for consumers.”
  • FDA has long recognized the use in food labeling of Dietary Guidance Statements (e.g., fruits and vegetables are part of a nutritious dietary pattern) as a tool that could help consumers improve their health and decrease the risk of diet-related diseases by making sound dietary decisions.  On November 25, 2003, FDA issued an advance notice of proposed rulemaking (ANPRM) that solicited information and comments on alternatives for regulating qualified health claims and on the appropriateness and nature of dietary guidance statements.  More recently, as covered extensively on our blog, FDA announced a new Nutrition Innovation Strategy (NIS) in March 2018 and held a public meeting on July 26, 2018 to receive input on topics including (1) what types of claims or other nutrition-related labeling statements are most helpful in facilitating product innovation to promote healthful eating patterns and (2) what types of claims and other labeling statements are most helpful to consumers in selecting foods consistent with recommendations in the “Dietary Guidelines for Americans.” 
  • On March 27, 2023, FDA published notice on the availability of a draft guidance for industry titled, Questions and Answers About Dietary Guidance Statements in Food Labeling.  The draft guidance defines Dietary Guidance Statement as “written or graphic material, based on key or principal recommendations from a consensus report, in food labeling that represent or suggest that a food or a food group may contribute to or help maintain a nutritious dietary pattern.”  Dietary Guidance Statements focus on a food or food group in contributing to or maintaining nutritious dietary patterns (e.g., “Eat broccoli as part of a nutritious dietary pattern”) and do not undergo review by FDA prior to use in the marketplace.  They are distinguishable from Health Claims, which focus on the relationship between a particular food substance and reduced risk of a disease or health-related condition (e.g., “Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors”) and which generally undergo review by FDA through a petition process, and Nutrient Content Claims which expressly or implicitly characterize the level of a nutrient in a food (e.g., a claim that a food is “low” in fat content or is “healthy”).  
  • The guidance includes recommendations on how to use Dietary Guidance Statements as follows:
    • Identifying an appropriate source of the Dietary Guidance Statement;
    • Ensuring that a product bearing a Dietary Guidance Statement contains a “meaningful amount” of the food or food group or “food group equivalent” that is the subject of the statement;
    • Maximum levels that should be present per Reference Amount Customarily Consumed (RACC) for individual foods bearing a Dietary Guidance Statement, i.e., 15% of the daily value (DV) for sodium (345 milligrams), 10% of the DV for saturated fat (2 grams), and 10% of the DV for added sugars (5 grams), with an exception for saturated fat in seeds and nuts. 
    • Maximum levels that should be present for main dishes bearing a Dietary Guidance Statement, i.e., 30% the saturated fat and sodium DVs per RACC and 20% of the DV per RACC for added sugars.
    • Maximum levels that should be present in meals bearing a Dietary Guidance Statement, i.e., 40% of the saturated fat and sodium DVs per RACC and 30% of the DV per RACC for added sugars. 
  • FDA specifically invites comments on:
    • Use of Dietary Guidance Statements on refined grains that are staples of cultural cuisines that are not high in added sugars, saturated fat, and sodium (since consumption of whole grains is encouraged in the guidance); 
    • Alternative options for calculating “meaningful amounts” or “food group equivalents” of a food or food group that is the subject of the Dietary Guidance Statement;
    • Disclosure statement requirements for situations when a food is recommended by a consensus report as part of a nutritious dietary pattern and the food has a nutrient profile that exceeds the recommended nutrient levels set forth in the guidance;
    • Use of Dietary Guidance Statements on bottles or containers of plain water and other calorie-free beverages ( e.g., flavored carbonated water, coffee, and tea).
  • Comments on the draft guidance that are submitted by June 26, 2023 will be considered before FDA begins work on the final version of the guidance.  FDA will also consider comments received from the 2003 ANPRM that are deemed relevant to the current dietary recommendations. 
  • On June 11, 2021, the FDA will issue its final rule to revoke the standards of identity (SOIs) for lowfat and nonfat yogurt, and amend the SOI for yogurt. The final rule regulates lowfat and nonfat yogurts under the general SOI for yogurt at 21 CFR § 131.200 and 21 CFR § 130.10 (“Requirements for foods named by use of a nutrient content claim and a standardized term”).  This action is in response to a citizen petition filed by the National Yogurt Association (NYA) in 2000 and is part of FDA’s Nutrition Innovation Strategy.  FDA states that the final rule modernizes the yogurt standard “by allowing for greater flexibilities and technological advances in yogurt production.”
  • The final rule permits the use of any optional safe and suitable milk-derived ingredient to increase “milk solids not fat content,” as well as safe and suitable emulsifiers, flavors, color additives, preservatives, cultures, stabilizers, and nutritive carbohydrate sweeteners.  FDA decided to retain reference to “nutritive carbohydrate sweeteners” instead of referring to “sweeteners” to exclude nonnutritive sweeteners.  FDA explained that, to comply with FDA’s regulatory framework under the Nutrition Labeling and Education Act (NLEA), nonnutritive sweeteners may only be added to yogurt under § 130.10 with a corresponding nutrient content claim (e.g., “reduced calorie yogurt”).  The final rule also optionally permits fortification with vitamins A (at a minimum of 10% of the daily value per serving) and vitamin D (at a minimum of 25% of the daily value per serving) and within the limits of current good manufacturing practices.
  • The final rule establishes minimum amounts of live and active cultures for yogurt products to bear the optional labeling statement, “contains live and active cultures.” To bear the label, yogurt must contain at least 107 CFU/g of live and active cultures at the time of manufacture and a reasonable expectation of 106 CFU/g throughout the product’s assigned shelf life.  If dairy ingredients are treated after culturing to inactivate viable microorganisms, the final rule requires a statement of “does not contain live and active cultures” on the label (§ 131.200(f)(1)(ii)). The statement must appear in letters not less than one-half of the height of the letters used in the product name.
  • The final rule is effective on July 11, 2021 and has a compliance date of January 1, 2024.
  •  Since launching in 2018, the FDA Nutrition Innovation Strategy (NIS) has included the possibility of FDA introducing a new symbol that could be used to convey the nutrient content claim “healthy” on packaged foods, as well as related plans to update the regulatory definition of “healthy” at 21 CFR 101.65(d).  Currently, the term may be used as an implied nutrient content claim on the label or in labeling of a food that meets certain nutrient conditions, including specific criteria for nutrients to limit in the diet, such as saturated fat.  In the interim, while FDA works on the updated rule, as discussed here, FDA issued a guidance document stating that FDA does not intend to enforce the regulatory requirements for foods that use the implied nutrient content claim “healthy” on their labels which: (1) Are not low in total fat, but have a fat profile makeup of predominantly mono and polyunsaturated fats; or (2) contain at least ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.
  • On May 7, 2021, FDA announced the availability of a procedural notice regarding plans to conduct three consecutive quantitative research studies—an experimental study and two surveys—to explore consumer responses to draft Front of Pack (FOP) symbols that manufacturers could voluntarily use on a food product as a graphic representation of the nutrient content claim ‘‘healthy.’’  The first study will be a controlled, randomized experiment that will use a 15-minute web-based questionnaire to collect information from 5,000 U.S. adult members of an online consumer panel maintained by a contractor.  The second and third studies (surveys) will each utilize a 10-minute questionnaire to test sets of draft FOP symbols in a sample of 1,000 U.S. adult participants from an online consumer panel.
  • There is no news on any FDA progress in updating the regulatory definition of “Healthy.”  Comments on FDA’s proposed collection of information for the study, ‘‘Quantitative Research on a Voluntary Symbol Depicting the Nutrient Content Claim ‘Healthy’ on Packaged Foods,” are due by July 6, 2021.  After public comments are received, FDA’s consumer research plans will be submitted for approval from the Office of Management and Budget (OMB).