On March 3, 2014, the U.S. Food and Drug Administration (FDA) released two proposed rules that impact the agency’s food labeling regulations: Food Labeling: Revision of the Nutrition and Supplement Facts Labels and Food Labeling: 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. Last week, on the heels of FDA’s release of the proposed rules, the Grocery Manufacturers Association (GMA) and the Food Marketing Institute (FMI) announced its “Facts Up Front” voluntary program that would provide nutrition information on the front of food and beverage packages.
FDA’s Proposed Changes to “Nutrition Facts” Panel
The Nutrition Facts panel has not had a comprehensive update since first released in 1993 (in 2006 trans fat was added as a Nutrition Facts label requirement). FDA has proposed two rules that, among other things, would modify the way serving sizes are calculated to reflect how people currently eat and drink, how calorie information is displayed, require added sugars be listed on the label, and declare the amount of potassium and Vitamin D in each serving. FDA’s proposed changes would affect all packaged foods except for certain meat, poultry and processed egg products which are regulated by the U.S. Department of Agriculture’s Food Safety and Inspection Service. According to FDA, the proposed rules are in partial response to the recommendations of the 2003 FDA Obesity Working Group and FDA's recognition that portion sizes have changed since the original serving size regulations were published in 1993.
Graphic: FDA has provided this example of the original food panel (left) and the new food panel as proposed by FDA (right).
The food industry is already raising questions and concerns about FDA’s proposed regulations. A few of these are:
- Health claims: With changes in the “reference amount customarily consumed” information (the data upon which serving sizes are based) there will undoubtedly be a need for significant modifications to health and content claims in products with revised serving size information. Although FDA acknowledges its proposed rules will impact health claims, the proposed rules do not take on the specifics and instead FDA intends to revisit these claims at a later date. Companies that rely on health claims to market their products (“healthy” or “low fat” in their brand name, etc.) may be particularly impacted by the proposed rules.
- Declaring added sugars: The food industry has taken the position that there is no accurate laboratory method to measure the difference between “added sugars” and “natural sugars” so as to determine a food product’s “added sugar” nutritional content. Now that FDA has proposed to label “added sugars” as a separate line on the nutrition facts panel, FDA would require manufacturers to generate and maintain records to verify the amount of added sugars in food and beverage products if there is no other analytical method to test the amount of added sugars in the product. An FDA official has confirmed the agency will have access to the sugar-related verification records during routine inspections. For manufacturers with added sugar in their food and beverage products, this requirement could require significant analytical efforts in order to comply with the proposed regulations.
- Cost-benefit analysis: FDA has estimated the proposed rules will cost the food industry approximately $2.3 billion (for relabeling, reformulating, package re-design, recordkeeping, etc.), while the public will see about $31.4 billion in benefits over the next 20 years, for a “net benefit” of $29.1 billion. However, the proposed regulations provide no details on how the agency calculated the over $30 billion in benefits to the public. Given FDA’s assertion of a significant “net benefit”, expect the food industry to demand the details of FDA’s cost-benefit analysis.
The proposed rules would allow manufacturers two years from the effective date of the final regulations to comply with any new requirements. Imported foods would also need to meet any final requirements imposed by FDA. Comments are accepted on the proposed rules (available here and here) until June 2, 2014.
The GMA’s and FMI’s “Facts Up Front” Campaign
This voluntary program puts four basic icons on the front of the packages to indicate calories, saturated fat, sodium and sugars from the grocery store aisle. Currently, there are 50 companies that have are voluntarily implementing Facts Up Front on their branded and private label products. Although the icons have already been placed on thousands of food and beverage items, this campaign will be the first national advertising effort to increase consumer education about the initiative.
Graphic: The “Facts Up Front” campaign will move to the front of food packages certain key facts from the nutrition facts label on the side or back of a food package.
The food industry’s approach is supported by industry studies that found consumers had a better understanding of nutrition facts when basic information was displayed on the front of food packages. However, many in the food industry saw the “Facts Up Front” effort as a way to preempt FDA’s proposed revisions. Now that FDA is moving forward with its proposed revisions, the “Facts Up Front” effort may make the FDA’s changes to serving size and calorie calculation changes even more noticeable.
Michael Best & Friedrich LLP’s FDA Regulatory and Agribusiness, Food and Beverage teams will be monitoring FDA’s proposed regulations and are available to answer specific questions about how they may impact your business, draft comments on FDA’s proposed regulations and/or provide review and analysis of how current labels would need to be modified under FDA’s proposed regulations.