Native American corn was on the menu at the first Thanksgiving feast held in Plymouth, Massachusetts, in 1621. Today, 90% of the corn planted in the United States is bioengineered. Should you be worried? FDA doesn’t think so. And it wants you to know that you can enjoy a plethora of “reduced sugar” cranberry preserves, too.
Last week, FDA continued its efforts to modernize its regulation of food product in the United States by touching both the sweet and the savory.
First, on November 19, FDA released two draft guidance documents regarding voluntary labeling of foods derived from genetically-engineered sources: “Draft Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants”; and a similarly-titled guidance on the labeling of genetically-engineered Atlantic salmon, “Draft Guidance for Industry: Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon.” FDA contemporaneously approved a long-standing new animal drug application (NADA) for the genetically-modified AquAdvantage Salmon, with extensive containment controls.
With respect to labeling, the agency’s general position is unchanged from the stance it took in its 1992 policy statement (57 Fed. Reg. 22984): specifically, that (1) there is no evidence that bioengineered-foods are materially different from, or pose higher safety risks than, other foods; and (2) food manufacturers may voluntarily label their foods with information about bioengineering, as long as that information is truthful and not misleading.
What’s different is that FDA’s new guidance defines some “do’s and don’ts” for industry with regard to labeling of genetically-engineered foods to ensure the labeling is truthful and non-misleading. For example, the guidance warns companies that manufacturers should use terms such as “not bioengineered” or “not genetically modified through the use of modern biotechnology” in lieu of claims that a product is “free” of “genetically modified organisms” (GMOs). In fact, it frowns upon use of the acronym “GMO” (despite sharing that it does not intend to use its enforcement discretion to challenge such use). FDA’s guidance also clarifies that the NADA for the AquaAdvantage Salmon is specific to Atlantic salmon, and that no other salmon is genetically engineered. Because no other salmon is genetically engineered, FDA has stated that it expects labels for other salmon that are promoted with claims that the salmon are not genetically engineered to make this fact apparent to consumers (e.g., labeling a Sockeye salmon patty as: “Not genetically engineered. No Sockeye salmon are genetically engineered”).
Notably, FDA’s position regarding “not genetically engineered” and other “free of” claims is quite similar to the FTC’s guidance on “free claims” in the Green Guides and may also reflect continued collaboration between the agencies. The Green Guides warn advertisers that a “truthful claim that a product, package, or service is free of, or does not contain or use, a substance may nevertheless be deceptive if: (1) the product, package, or service contains or uses substances that pose the same or similar environmental risks as the substance that is not present; or (2) the substance has not been associated with the product category.”
On November 20, FDA moved the focus from GMOs in issuing a final rule revoking the standard of identity for artificially sweetened jelly, preserves, and jams. Responding to a citizen petition by the International Jelly and Preserve Association, FDA revoked the standard of identity because it believes that the rule was obsolete due to other regulations governing foods named by use of a nutrient content claim and a standardized term. Under the prior requirements, a jelly that was sweetened with saccharin had to be called “artificially sweetened jelly”, whereas a similar jelly sweetened with sucralose could be named as “reduced sugar jelly.” Now jelly sweetened with saccharin may be called “reduced sugar jelly.” FDA expects that revoking the standard will provide consistency and uniformity among such products by subjecting all fruit spreads sweetened with non-nutritive sweeteners to the same labeling requirements. We expect that, after reading this post, you may never view cranberry sauce labels the same.