Clarifying FDA’s Food Labeling Rules and Compliance
Updated: Nov 22, 2018
Back in mid-2016, the FDA issued final rules for new Nutrition Facts and Supplement Facts Labels and Serving Sizes. Recently the FDA extended the original compliance deadlines, providing manufactures more time to comply:
(1) Manufacturers with $10 million or more in annual food sales now have until January 1, 2020
(2) Manufactures with less than $10 million, until January 1, 2021
The nutritional requirements are based on the total daily diet of Americans and the 2016 updated serving sizes now better reflect current consumer consumption trends. Why did FDA do this? Mainly because it had been over 20 years since the last update, and in that timeframe, there was a great deal of improved science on which to base the requirements – and increased health issues among Americans such as diabetes and obesity.
As a reminder, the major areas of change with the nutrition facts panel and labeling rules included:
Mandatory declaration of “added sugars” in addition to the natural sugars of the food. This is intended to provide consumers with additional information and potentially limit overall sugar intake.
Highlighting of calories and servings by requiring these declarations be in bold type and larger lettering. The goal is to address obesity and other health issues.
Update of some daily values to reflect current scientific understanding. For example, total fats have been increased in recognition that not all fats are bad.
Required nutrient declarations. Two of note are potassium and Vitamin D which are newly required to be declared because they have been found to be lacking in the diets of the U.S. population. Vitamin A and C, however, no longer have to be declared, but can be included voluntarily.
Clarification on Trans Fat. Partially hydrogenated oils, are no longer deemed GRAS, so can no longer be used in food. The deadline for use was June 2018, although product made prior to that can still be on store shelves.
Dietary Fiber. Any fiber has to have a physiological benefit to human health to be declared as dietary fiber.
Records requirements – Records must be maintained for the justification of any declarations on sugars and dietary fibers.
Serving Size. FDA has adjusted the Reference Amounts Customarily Consumed (RACCs) for about 30 foods and added about 25 new ones. As such, label declarations must be made in accordance with these as a single serving; that is, the amount customarily consumed in one sitting. For example, serving sizes for ice cream have increased from 1/2 cup to 2/3 cup; yogurt decreased from 8 ounces to 6 ounces; and beverages increased from 8 ounces to 12 ounces (to reflect a typical can serving).
When declaring serving size, products that contain less than 200% of the RACC must be labeled as a single serving because they could, and are commonly eaten in one sitting. If the packaging contains 200%-300% of RACC, dual labeling is required – with full package information along with single serving information. Dual columns are voluntary when the package contains more than 150%, but less than 200%.
While the compliance deadline has given companies more time to comply, many manufactures acknowledge that complying will require decent number of updates to processes and systems that can’t be done overnight. It will take some time just to review new guidance documents that explain the FDA’s current thinking in regard to compliance and enforcement.
In addition, there are a couple other areas of labeling regulation worth watching as well. FDA’s menu labeling rule requiring restaurant chains with 20 or more locations to declare calories on the menu recently went into effect. Another item worth mentioning at this juncture, is that the comment period has just closed on the USDA’s draft Bio-engineered Food Disclosure rule.
The Acheson Group will continue to monitor these and other regulations and keep the industry apprised!
About The Acheson Group (TAG)
Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG's team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. Learn more at: www.AchesonGroup.com