How should FDA modernize food standards of identity?

From canned tuna and bottled water to plant-based milk and beef, food manufacturers and trade groups largely agree the U.S. Food and Drug Administration's standards of identity for food are out of date and stifle innovation.

Regulators from the FDA set up a public hearing Friday to get input on the agency's effort to modernize these rules that specify the characteristics of hundreds of different food and drinks. Although the close to 30 groups who spoke in the two-hour public comment session had different opinions on what should be updated, most agreed that change is necessary.

The purpose of the standards is "to promote honesty and fair dealing in the interest of consumers," according to FDA. Standards of identity for some products were established by the 1938 Federal Food, Drug and Cosmetic Act, which mandate legally enforceable food standards. At the time, poor quality packaged food was common, and the law defined the types of ingredients that could be included in particular products.

"We know that many standards were established decades ago and have not been recently amended to reflect changes in consumer expectations or opportunities for innovation, including the ability to produce healthier foods."

Susan Mayne

Director, FDA Center for Food Safety and Applied Nutrition

Susan Mayne, director of FDA's Center for Food Safety and Applied Nutrition, kicked off the hearing by telling the audience the agency is focused on giving consumers information to make healthy food choices. She said the FDA is "close" to proposing a new definition for "healthy" and working diligently on the "natural" claim. Its latest move is to modernize standards of identity.

The FDA has been moving toward getting rid of some of the more antiquated standards of identity. This spring, the agency announced its plan to begin revoking long-established requirements for frozen cherry pie and French dressing.

During public comment, people from different sectors of the food industry agreed the standards are important to ensuing consumer trust, but advocated for more lenient and flexible regulation to allow for companies to develop new products.

Allowing for innovation

Betsy Booren, vice president of regulatory affairs at the Grocery Manufacturers Association, said the agency needs to implement a horizontal approach, where changes could be made across different categories of standardized foods and updated as needed. This type of flexible regulation would allow for new uses of technology and flexibility for innovations in places the current laws constrain industry, Booren said.

She said there is a lack of clarity in current standards, which has led to an increase in states defining products. This has resulted in patchwork regulation, causing confusion among consumers. Several lawsuits have been filed in the last year as states including Arkansas and Mississippi have introduced labeling laws for plant-based meat.

"Consumer expectations do not change when they cross state lines," Booren said. "Clear, simple and consistent national regulatory framework informed by risk-based science will enhance consumer trust."

Many at the hearing agreed that innovation has been restricted by the current standards, including canned tuna and flavored water.

Mason Weeda, an attorney at OFW Law who spoke on behalf of Bumble Bee Foods, said many of the agency's standards have been around since the 1950s. Changes could help as the industry adjusts to consumer demands.

"Canned tuna standard only permits the use of one flavor, lemon oil, which does not allow tuna manufacturers to adapt to consumer changing tastes," he said. "FDA should take a horizontal approach by permitting safe and suitable flavor ingredients in various standards."

Ron Tanner, vice president of education, government and industry relations at the Specialty Food Association, said the need for modernization is obvious. From Virginia ham to California olive oil, members of the Specialty Food Association make more than 240,000 unique food products. Revisions to the language of this regulation to stress clarity and simplicity around allowable names and terms would allow for more variation across products, he said.

For example, FDA describes bottled water as not having added ingredients, but Tanner said bottled water today includes ingredients like rosemary, lemon, honey and vitamins. Those products are labeled as bottled water and therefore technically violating FDA's outdated standards of identity, he said.

"SFA members are the innovators in food and many are pushing the boundaries in product consumption, flavor, packaging and technology. For these companies, the standards of identity are often a hindrance to bringing their products to market," Tanner said.

Some representatives were there to ask for standards that don't yet exist. Betsy Ward, president and CEO of the USA Rice Federation, said her industry recommends a standard defining rice as grains harvested from rice plants. This standard would avoid confusion among consumers as new products, like riced cauliflower, come to market.

"It is not our goal to limit such product development, but to ensure that all products are labeled clearly and not deceptive," she said.

Defining plant-based products

Plant-based products were a major topic of discussion at the hearing. Predictably, plant-based groups advocated for changes to support conventional terms like "milk" on alternative products, while dairy and beef groups wanted those terms reserved for traditional products.

Nichole Manu, staff attorney at The Good Food Institute, said GFI supports modernizing the standards, but she said FDA should ensure the new approach will continue to allow plant-based dairy to use conventional dairy terms.

"It is clear that consumers are demanding these products, not out of confusion, but because they are seeking healthful, functional counterparts to cows' milk products," she said.

When the FDA asked for comments on labeling of dairy terms on plant-based foods last year, 76% who commented were in favor of allowing plant-based products to continue using the term "milk."

But not everyone at the hearing wanted this change. Some wanted stronger enforcement.

Anita MacMullan, director of the Food and Drug Protection Division at the North Carolina Department of Agriculture & Consumer Services, said mislabeling is against the law, and if "milk" is on the label, there should be milk in the product.

"When FDA chooses not to enforce the law, it erodes consumer trust in the agency and can endanger public health," MacMullan said. " 'Milk' has a clear definition and standard of identity established in regulation, and FDA has a clear duty to enforce it."

Some in the dairy industry said they wanted modernization efforts so traditional products could have more room for innovation. Cary Frye, senior vice president of regulatory affairs at the International Dairy Foods Association, said dairy products represent a third of all food standards. She said the regulations should maintain the basic nature of dairy while allowing for innovation, like high-pressure processing to prevent spoiling in milk products.

But it wasn't just plant-based dairy under scrutiny. Allison Rivera, executive director of government affairs for the National Cattlemen’s Beef Association, said FDA should implement new definitions and strict parameters around plant-based meat products. She said plant-based protein mimicking beef are not held to the same set of standards with food safety or labeling.

"NCBA is concerned with fake meat products," Rivera said. "A number of fake meat products are now positioning themselves as a more healthful form of beef. Some of these product labels use terms like 'beefy,' 'veggie beef' or 'just like beef,' while others make implied claims not backed by science in an attempt to position products as superior in the marketplace."

The agency is accepting written public comments on the issue until Nov. 12. The initiative is part of FDA's multi-year nutrition innovation strategy, which is intended to encourage new ideas for more nutritious foods — so it could be years before more changes are in place.