Stay abreast of legislative and regulatory activity.
Updated November 22, 2016
Request for Information and Draft Guidance on Fiber for the Nutrition Facts Label (November, 2016)
The US Food and Drug Administration (FDA) is requesting scientific data, information, and comments on the physiological effects of 26 isolated and synthetic non-digestible carbohydrates to determine whether any of these provide a physiological effect that is beneficial to human health and thus should be included in the fiber definition. The FDA has also released draft guidance entitled “Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-digestible Carbohydrates Submitted as a Citizen Petition” for the industry. The request for scientific data and the draft guidance together provides information on the type of scientific evidence needed and FDA’s review process to evaluate the physiological effect(s) of isolated and synthetic non-digestible carbohydrates for the purpose of declaration as dietary fiber on the Nutrition Facts label.
Comments on the draft guidance can be submitted anytime, however, for comments to be considered before FDA finalizes the guidance, comments should be submitted within 60 days of the of publication in the Federal Register of the notice announcing the availability of the draft guidance. Scientific data, information and comments on physiological effects of 26 isolated and synthetic non-digestible carbohydrates should be submitted within 45 days after the request for information is published in the Federal Register (expected to be published November 23rd).
“Healthy” Claim for Food Labeling: Guidance for Industry (September, 2016)
The U.S. Food and Drug Administration (FDA) has initiated a public process to redefine the “healthy” nutrient content claim for food labeling. While FDA is considering how to redefine the term “healthy” as a nutrient content claim, food manufacturers can continue to use the term “healthy” on foods that meet the current regulatory definition. FDA has released a guidance document entitled “Use of the Term “Healthy” in the Labeling of Human Food Products: Guidance for Industry” to advise manufacturers who wish to use the implied nutrient content claim “healthy” to label their food products as provided by FDA’s regulations.
Vending Machine Labeling - Guidance for Industry (August, 2016)
The U.S. Food and Drug Administration (FDA) has released the Small Entity Compliance Guide (SECG) and draft guidance for industry to help comply with FDA’s final rule on calorie labeling for vending machine foods. The SECG is intended to help small businesses comply with the rule and restates the requirements of the final rule in plain language. The draft guidance provides additional information and responds to frequently asked questions about the vending machine labeling requirements.
FDA Finalizes GRAS Rule (August, 2016)
The U.S. Food and Drug Administration issued final rule on “Substances Generally Recognized as Safe.” The agency amends its regulations to replace the voluntary GRAS affirmation petition process with a voluntary notification procedure, and amends and clarifies the criteria in its regulations for when the use of a substance in food for humans or animals is not subject to the premarket approval requirements of the Federal FD&C Act because the substance is GRAS under the conditions of its intended use. The rule also addresses the procedure for submitting a GRAS notice, specific information that must be provided in a GRAS notice, the agency’s commitment to respond to filing of GRAS notices, and impact of the final rule effective date on any pending GRAS affirmation petitions.
National Bioengineered Food Disclosure Standard (July, 2016)
On July 29, President Barack Obama signed bill S. 764, amending the Agricultural Marketing Act to require establishment of a national disclosure standard for bioengineered foods subject to certain labeling requirements and with some exceptions. The bill allows food and beverage companies disclosure options (e.g., text, symbol, or electronic digital link). The U.S. Department of Agriculture has two years to write up the rules.
The Global Food Security Act of 2016 (July, 2016)
On July 6, the House passed the Senate version, S. 1252 of the Act, which became law, would formally authorize the Feed the Future initiative and the Emergency Food Security Program. The Act specifies that it is in the U.S. national interest to promote global food security, resilience, and nutrition, consistent with national food security investment plans.
FDA Issues Draft Guidance for Industry on Voluntary Sodium Reduction in Commercially Packaged and Prepared Foods (June, 2016)
The U.S. Food and Drug Administration (FDA) released June 2 draft guidance entitled “Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods. The draft voluntary guidance reflects a gradual approach to sodium reduction, with short-term (2-year goal = 3,000 mg/day) and long-term (10-year goal = 2,300 mg/day) goals. FDA set target means (applying to average sodium levels of foods in a category, not individual products) and upper bound concentrations (applying to all individual products, and discouraging products with excessive sodium) for both short- and long-term goals. The goals apply to 150 categories of foods, and impact food manufacturers, restaurants, and food service operations. The goals are intended to reduce the amount of sodium added to foods during processing, manufacturing, and preparation, especially if not necessary for microbial safety, stability, and/or physical integrity, address excessive intake of sodium in the current population, and promote improvements in public health.
Nutrition Facts Label – Final Rules (May, 2016)
On May 20, the U.S. Food and Drug Administration (FDA) announced final rules on the Revision of the nutrition and supplement facts labels and serving sizes of foods that can reasonably be consumed at one eating occasion; dual-column labeling; updating, modifying, and establishing certain reference amounts customarily consumed; serving size for breath mints; and technical amendments. Both rules were published May 27.
The new Nutrition Facts label will require:
- Declaration of grams and a percent daily value (%DV) for “added sugars”
- Declaration of vitamin D and potassium including the actual gram amount, in addition to the %DV
- Updated daily values for nutrients such as sodium, dietary fiber, and vitamin D
- Removal of calories from fat
- An updated design to highlight “calories” and “servings”
- Requirements for serving sizes that more closely reflect amounts of food that people currently eat
- An abbreviated footnote to better explain the %DV
- “Dual column” labels to indicate both “per serving” and “per package” calorie and nutrition information for certain multi-serving food products that could be consumed in one sitting or multiple sittings
- Labeling of calories and other nutrients as one serving for packages that are between one and two servings
The FDA is also making minor changes to the Supplement Facts labeling of dietary supplements for consistency with the Nutrition Facts label.
The final rules become effective July 26, 2016, for compliance by July 26, 2018, for manufacturers with ≥ $10 million in annual food sales and by July 26, 2019 for manufacturers with <$10 million in annual food sales.
FDA Food Safety Modernization Act - Final Rules (May, 2016)
The Food Safety Modernization Act (FSMA), which became law when President Obama signed it January 4, 2011 is the most sweeping reform of our food safety laws in more than 70 years. On May 27, 2016, the Food and Drug Administration (FDA) released the final of the seven rules that comprise the FDA’s Food Safety Modernization Act. FSMA enhances FDA with new authorities to enforce new requirements for the food industry with both domestic and international scope using scientific and risk-based standards. It outlines the type of preventive control methods the industry (including producers, importers, distributors, manufacturers, and transporters) will be responsible for implementing and documenting to help ensure the safety of the nation’s food supply.
FDA Issues Final Industry Guidance on Acrylamide Reduction (March, 2016)
The guidance offers a range of steps that growers, manufacturers, and food service operators may take to help reduce acrylamide levels. The guidance focuses on raw materials, processing practices, and ingredients pertaining to potato-based foods, cereal-based foods, and coffee.
Dietary Guidelines for Americans 2015-2020 (January, 2016)
On January 7, the U.S. Departments of Health and Human Services and Agriculture released the 2015-2020 Dietary Guidelines for Americans. This 8th edition focuses primarily on healthy eating patterns. The 5 overarching guidelines are:
- “Follow a healthy eating pattern across the lifespan.
- Focus on variety, nutrient-dense foods, and amount.
- Limit calories from added sugars and saturated fats and reduce sodium intake.
- Shift to healthier food and beverage choices.
- Support healthy eating patterns for all.”
Key recommendations are:
- “A variety of vegetables from all of the subgroups—dark green, red and orange, legumes (beans and peas), starchy, and other
- Fruits, especially whole fruits
- Grains, at least half of which are whole grains
- Fat-free or low-fat dairy, including milk, yogurt, cheese, and/or fortified soy beverages
- A variety of protein foods, including seafood, lean meats and poultry, eggs, legumes (beans and peas), and nuts, seeds, and soy products
- Added sugars to less than 10 percent of calories per day
- Saturated fats to less than 10 percent of calories per day
- Sodium to less than 2,300 milligrams (mg) per day
- Alcohol, if consumed, to one drink per day for women and two drinks per day for men of legal drinking age.
Voluntary National Retail Food Regulatory Program Standards (January, 2015)
The U.S. Food and Drug Administration’s Retail Program Standards serves as a guide in the design and management of a retail food regulatory program and provide a means of recognition for those programs that meet these standards.
Menu and Vending Machines Labeling – Final Rules (December, 2014)
The U.S. Food and Drug Administration (FDA) finalized two rules requiring listing of calorie information on menus and menu boards in chain restaurants and similar retail food establishments and vending machines.
Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that Are Color Additives (June, 2014)
The guidance provides relevant recommendations for assessing the effect of a significant manufacturing process change on the safety and regulatory status of food substances, including those that are the subject of a food additive or color additive regulation, a food contact substance notification, or a generally recognized as safe (GRAS) determination. The guidance also recommends that the manufacturers consult the Food and Drug Administration regarding a significant manufacturing process change for a food substance already in the market, irrespective of the manufacturer’s conclusion about whether that change affects the safety or regulatory status of the food substance, particularly when the manufacturing process change involves emerging technologies, such as nanotechnology.
Food Code (2013)
The Food Code represents the Food and Drug Administration’s advice for a uniform system of provisions that address the safety and protection of food offered at retail and in food service. It is a model to safeguard public health and ensure that food is unadulterated and honestly presented when offered to the consumer.