Over July 10 and 11, nearly 70 people gathered at the Hilton Chicago to attend Labeling Requirements and Implications for Foods Marketed in the U.S. This pre-event short course aimed to provide attendees with a framework for understanding food labeling regulations and what claims can be made, as well as creating a discussion around what labeling controversies may lie down the road.
Speakers included Robert C. Post, senior director of nutrition and regulatory affairs at Chobani and former associate executive director of the U.S. Dept. of Agriculture’s (USDA) Center for Nutrition Policy and Promotion and Eric F. Greenberg, a lawyer who advises on regulatory compliance with requirements of the Food and Drug Administration (FDA) and state and local laws. In their introduction to the course, they spoke about the overall framework of each agency and the differences between them. One element that the agencies share, though, are the definitions of label and labeling: the first refers to the actual printed packaging on the food, while the latter deals with all other written and printed materials associated with the product, including graphics and even social media.
The FDA puts the burden of labeling on the regulated companies, while the USDA inspects all products before they can be sold. The FDA regulates roughly 85% of foods—25% of consumer dollars spent—while the USDA regulates meat, poultry, egg products (not including shelled eggs), and catfish. Interestingly, the FDA regulates bagel dogs and sandwiches, as these products have a historical association with bakeries, which fall under the FDA. Corndogs and open-faced sandwiches, however, are overseen by the USDA.
Kathleen Crossman, who leads FONA’s regulatory team, spoke about the Alcohol & Tobacco Tax and Trade Bureau, and Riëtte van Laack, an attorney with Hyman, Phelps & McNamara, P.C., a law firm that specializes in FDA regulatory matters, provided an overview of states’ jurisdiction over labeling. States cannot add extra requirements to labeling, but they can petition for exceptions. Most though have adopted a uniform food and drug law that matches the FDA’s Food Drug and Cosmetic Act. California’s Proposition 65 is not a food law, she explained, which is why the state is allowed to add warnings to product labels. She also touched on the idea of state-enacted GMO laws and how difficult and confusing regulating these products across state lines would be.
Van Laack and Post then discussed the basic and mandatory labeling requirements for the FDA and USDA. For the FDA, these include statement of identity, net contents, Nutrition Facts box, ingredient statement, allergen statement, and the name and place of the business producing the product. The statement of identity refers to the name of the product as defined by law or regulation—such as mozzarella, mayonnaise, and Greek yogurt—the common or usual name for the product, a descriptive term, or a name commonly used by the public for the food.
On the USDA side, these requirements include product name, handling statement, inspection legend (establishment and number), net weight statement, ingredients statement, company name and address, nutrition facts, and safe handling instructions. Country of origin is not required for FDA-regulated foods made from ingredients all sourced from the United States, only for imported foods, though there has been ongoing debate about country of origin labeling laws, particularly as it applies to meat.
Greenberg provided a breakdown of ingredient statements required by the FDA, which resulted in a healthy debate among attendees about how various ingredients should be addressed. He also touched on the order that ingredients must be listed—in decreasing order by weight—and discussed how water, caseinate, and juice are treated.
According to Greenberg, major allergens must be listed on labels as well; these are crustaceans, eggs, fish, milk, peanuts, soy, tree nuts, and wheat. These must be listed by common name (milk, not whey); the “may contain” statement, however, is voluntary. According to Crossman, this label was intended for chocolate manufacturers or for other facilities that have the chance of dust, and not as a way for plants to get away with not cleaning their machinery fully.
Post then spoke about ingredient statements as they relate to meat and poultry products, which are intended to help consumers make informed decisions. The FDA and USDA’s Food Safety and Inspection Service jointly approve ingredients used in the production of meat and poultry products. The USDA uses the common FDA naming conventions for ingredients such as eggs and sugar, unless the FDA regulation is contrary to the USDA regulation of policies—in general, the conventions among both agencies are very close. Post also discussed labeling of flavorings, spices, and colorings, as well as some flavoring ingredients that must be identified by source, such as hydrolyzed gelatin and autolyzed yeast. He also added that a product derived from meat or poultry must list the species or kind—dried chicken stock, not dried poultry stock, for instance.
In a hands-on workshop, Crossman asked attendees to put together the ingredient list for pasta based on a provided recipe and then determine which ingredients in another product need to appear on the label. Afterward, she discussed the requirements associated with labeling flavors before leading a second hands-on workshop. In this one, attendees determined if flavors could be labeled as natural or artificial based on their names, then decided if these could be included in a chocolate bar. Finally, the day concluded with an exercise that asked attendees which ingredients used to create flavors needed to be included on the overall product label.
During the second day of the course, Post and van Laack opened the day’s session with a discussion of the FDA’s and USDA’s nutritional labeling requirements. After touching on the proposed changes to the nutritional panel, they went over the nutrients required for listing, as well as serving sizes, the concept of the daily value (DV), and how these all must be formatted on the labels. They also listed some exemptions to these rules, such as small businesses, low-volume food products, and medical foods.
Carolyn Fisher, a senior scientist at Decernis who manages the global food additive database in gComply Plus, led a hands-on workshop on these requirements. She asked attendees to determine which nutrients from a list must be included on nutritional labels, pointing out differences between the FDA and USDA requirements.
Afterward, Greenberg and Post examined the types of health claims and nutrient content claims that are allowed by the FDA and USDA, as well as structure/function claims for the FDA; van Laack then talked about other types of claims, which included organic, natural, non-GMO, gluten-free, and cage-free. To solidify participants’ understanding of how these claims can be applied, Greenberg led a hands-on workshop in which he flashed product claims on the screen and asked the audience which were permissible to include as structure/function claims and which were unlawful drug claims.
The course concluded with a panel discussion that provided updates on recent developments relating to food label regulatory decisions, trends in litigation, and issues to keep an eye on, including pending changes to the nutritional label and the 2015 Dietary Guidelines.